ISSN 1977-091X |
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Official Journal of the European Union |
C 389 |
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English edition |
Information and Notices |
Volume 60 |
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(1) Text with EEA relevance. |
EN |
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IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
European Commission
17.11.2017 |
EN |
Official Journal of the European Union |
C 389/1 |
Commission communication in the framework of the implementation of Directive 2014/68/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment
(Publication of titles and references of harmonised standards under Union harmonisation legislation)
(Text with EEA relevance)
(2017/C 389/01)
The following list contains references to harmonised standards for pressure equipment and harmonised supporting standards for materials used in manufacturing pressure equipment. In the case of a harmonised supporting standard for materials, presumption of conformity to the essential safety requirements is limited to technical data of materials in the standard and does not presume adequacy of the material to a specific item of equipment. Consequently the technical data stated in the material standard shall be assessed against the design requirements of this specific item of equipment to verify that the essential safety requirements of the Pressure Equipment Directive are satisfied.
ESO (1) |
Reference and title of the standard (and reference document) |
First publication OJ |
Reference of superseded standard |
Date of cessation of presumption of conformity of superseded standard Note 1 |
(1) |
(2) |
(3) |
(4) |
(5) |
CEN |
EN 3-8:2006 Portable fire extinguishers — Part 8: Additional requirements to EN 3-7 for the construction, resistance to pressure and mechanical tests for extinguishers with a maximum allowable pressure equal to or lower than 30 bar |
12.8.2016 |
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EN 3-8:2006/AC:2007 |
12.8.2016 |
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CEN |
EN 19:2016 Industrial valves — Marking of metallic valves |
12.8.2016 |
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CEN |
EN 267:2009+A1:2011 Automatic forced draught burners for liquid fuels |
12.8.2016 |
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CEN |
EN 334:2005+A1:2009 Gas pressure regulators for inlet pressures up to 100 bar |
12.8.2016 |
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CEN |
EN 378-2:2016 Refrigerating systems and heat pumps — Safety and environmental requirements — Part 2: Design, construction, testing, marking and documentation |
This is the first publication |
EN 378-2:2008+A2:2012 Note 2.1 |
The date of this publication |
CEN |
EN 593:2009+A1:2011 Industrial valves — Metallic butterfly valves |
12.8.2016 |
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CEN |
EN 676:2003+A2:2008 Automatic forced draught burners for gaseous fuels |
12.8.2016 |
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EN 676:2003+A2:2008/AC:2008 |
12.8.2016 |
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CEN |
EN 764-4:2014 Pressure equipment — Part 4: Establishment of technical delivery conditions for metallic materials |
12.8.2016 |
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CEN |
EN 764-5:2014 Pressure equipment — Part 5: Inspection documentation of metallic materials and compliance with the material specification |
12.8.2016 |
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CEN |
EN 764-7:2002 Pressure equipment — Part 7: Safety systems for unfired pressure equipment |
12.8.2016 |
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EN 764-7:2002/AC:2006 |
12.8.2016 |
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CEN |
EN 1057:2006+A1:2010 Copper and copper alloys — Seamless, round copper tubes for water and gas in sanitary and heating applications |
12.8.2016 |
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CEN |
EN 1092-1:2007+A1:2013 Flanges and their joints — Circular flanges for pipes, valves, fittings and accessories, PN designated — Part 1: Steel flanges |
12.8.2016 |
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CEN |
EN 1092-3:2003 Flanges and their joints — Circular flanges for pipes, valves, fittings and accessories, PN designated — Part 3: Copper alloy flanges |
12.8.2016 |
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EN 1092-3:2003/AC:2007 |
12.8.2016 |
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CEN |
EN 1092-4:2002 Flanges and their joints — Circular flanges for pipes, valves, fittings and accessories, PN designated — Part 4: Aluminium alloy flanges |
12.8.2016 |
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CEN |
EN 1171:2015 Industrial valves — Cast iron gate valves |
12.8.2016 |
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CEN |
EN 1252-2:2001 Cryogenic vessels — Materials — Part 2: Toughness requirements for temperatures between - 80 oC and - 20 oC |
12.8.2016 |
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CEN |
EN 1349:2009 Industrial process control valves |
12.8.2016 |
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CEN |
EN 1515-4:2009 Flanges and their joints — Bolting — Part 4: Selection of bolting for equipment subject to the Pressure Equipment Directive 97/23/EC |
12.8.2016 |
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CEN |
EN 1562:2012 Founding — Malleable cast irons |
12.8.2016 |
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CEN |
EN 1563:2011 Founding — Spheroidal graphite cast irons |
12.8.2016 |
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CEN |
EN 1564:2011 Founding — Ausferritic spheroidal graphite cast irons |
12.8.2016 |
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CEN |
EN 1591-1:2013 Flanges and their joints — Design rules for gasketed circular flange connections — Part 1: Calculation |
12.8.2016 |
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CEN |
EN 1626:2008 Cryogenic vessels — Valves for cryogenic service |
12.8.2016 |
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CEN |
EN 1653:1997 Copper and copper alloys — Plate, sheet and circles for boilers, pressure vessels and hot water storage units |
12.8.2016 |
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EN 1653:1997/A1:2000 |
12.8.2016 |
Note 3 |
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CEN |
EN 1759-3:2003 Flanges and their joints — Circular flanges for pipes, valves, fittings and accessories, Class designated — Part 3: Copper alloy flanges |
12.8.2016 |
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EN 1759-3:2003/AC:2004 |
12.8.2016 |
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CEN |
EN 1759-4:2003 Flanges and their joint — Circular flanges for pipes, valves, fittings and accessories, class designated — Part 4: Aluminium alloy flanges |
12.8.2016 |
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CEN |
EN 1797:2001 Cryogenic vessels — Gas/material compatibility |
12.8.2016 |
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CEN |
EN 1866-2:2014 Mobile fire extinguishers — Part 2: Requirements for the construction, pressure resistance and mechanical tests for extinguishers, with a maximum allowable pressure equal to or lower than 30 bar, which comply with the requirements of EN 1866-1 |
12.8.2016 |
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CEN |
EN 1866-3:2013 Mobile fire extinguishers — Part 3: Requirements for the assembly, construction and pressure resistance of CO2 extinguishers which comply with the requirements of EN 1866-1 |
12.8.2016 |
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CEN |
EN 1983:2013 Industrial valves — Steel ball valves |
12.8.2016 |
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CEN |
EN 1984:2010 Industrial valves — Steel gate valves |
12.8.2016 |
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CEN |
EN ISO 4126-1:2013 Safety devices for protection against excessive pressure — Part 1: Safety valves (ISO 4126-1:2013) |
12.8.2016 |
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CEN |
EN ISO 4126-3:2006 Safety devices for protection against excessive pressure — Part 3: Safety valves and bursting disc safety devices in combination (ISO 4126-3:2006) |
12.8.2016 |
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CEN |
EN ISO 4126-4:2013 Safety devices for protection against excessive pressure — Part 4: Pilot-operated safety valves (ISO 4126-4:2013) |
12.8.2016 |
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CEN |
EN ISO 4126-5:2013 Safety devices for protection against excessive pressure — Part 5: Controlled safety pressure relief systems (CSPRS) (ISO 4126-5:2013) |
12.8.2016 |
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CEN |
EN ISO 4126-7:2013 Safety devices for protection against excessive pressure — Part 7: Common data (ISO 4126-7:2013) |
12.8.2016 |
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CEN |
EN ISO 9606-2:2004 Qualification test of welders — Fusion welding — Part 2: Aluminium and aluminium alloys (ISO 9606-2:2004) |
12.8.2016 |
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CEN |
EN ISO 9606-3:1999 Approval testing of welders — Fusion welding — Part 3: Copper and copper alloys (ISO 9606-3:1999) |
12.8.2016 |
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CEN |
EN ISO 9606-4:1999 Approval testing of welders — Fusion welding — Part 4: Nickel and nickel alloys (ISO 9606-4:1999) |
12.8.2016 |
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CEN |
EN ISO 9606-5:2000 Approval testing of welders — Fusion welding — Part 5: Titanium and titanium alloys, zirconium and zirconium alloys (ISO 9606-5:2000) |
12.8.2016 |
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CEN |
EN ISO 9712:2012 Non-destructive testing — Qualification and certification of NDT personnel (ISO 9712:2012) |
12.8.2016 |
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CEN |
EN 10028-1:2007+A1:2009 Flat products made of steels for pressure purposes — Part 1: General requirements |
12.8.2016 |
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EN 10028-1:2007+A1:2009/AC:2009 |
12.8.2016 |
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CEN |
EN 10028-2:2009 Flat products made of steels for pressure purposes — Part 2: Non-alloy and alloy steels with specified elevated temperature properties |
12.8.2016 |
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CEN |
EN 10028-3:2009 Flat products made of steels for pressure purposes — Part 3: Weldable fine grain steels, normalized |
12.8.2016 |
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CEN |
EN 10028-4:2009 Flat products made of steels for pressure purposes — Part 4: Nickel alloy steels with specified low temperature properties |
12.8.2016 |
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CEN |
EN 10028-5:2009 Flat products made of steels for pressure purposes — Part 5: Weldable fine grain steels, thermomechanically rolled |
12.8.2016 |
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CEN |
EN 10028-6:2009 Flat products made of steels for pressure purposes — Part 6: Weldable fine grain steels, quenched and tempered |
12.8.2016 |
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CEN |
EN 10028-7:2016 Flat products made of steels for pressure purposes — Part 7: Stainless steels |
This is the first publication |
EN 10028-7:2007 Note 2.1 |
The date of this publication |
CEN |
EN 10204:2004 Metallic products — Types of inspection documents |
12.8.2016 |
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CEN |
EN 10213:2007+A1:2016 Steel castings for pressure purposes |
12.8.2016 |
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CEN |
EN 10216-1:2013 Seamless steel tubes for pressure purposes — Technical delivery conditions — Part 1: Non-alloy steel tubes with specified room temperature properties |
12.8.2016 |
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CEN |
EN 10216-2:2013 Seamless steel tubes for pressure purposes — Technical delivery conditions — Part 2: Non-alloy and alloy steel tubes with specified elevated temperature properties |
12.8.2016 |
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CEN |
EN 10216-3:2013 Seamless steel tubes for pressure purposes — Technical delivery conditions — Part 3: Alloy fine grain steel tubes |
12.8.2016 |
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CEN |
EN 10216-4:2013 Seamless steel tubes for pressure purposes — Technical delivery conditions — Part 4: Non-alloy and alloy steel tubes with specified low temperature properties |
12.8.2016 |
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CEN |
EN 10216-5:2013 Seamless steel tubes for pressure purposes — Technical delivery conditions — Part 5: Stainless steel tubes |
12.8.2016 |
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CEN |
EN 10217-1:2002 Welded steel tubes for pressure purposes — Technical delivery conditions — Part 1: Non-alloy steel tubes with specified room temperature properties |
12.8.2016 |
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EN 10217-1:2002/A1:2005 |
12.8.2016 |
Note 3 |
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CEN |
EN 10217-2:2002 Welded steel tubes for pressure purposes — Technical delivery conditions — Part 2: Electric welded non-alloy and alloy steel tubes with specified elevated temperature properties |
12.8.2016 |
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EN 10217-2:2002/A1:2005 |
12.8.2016 |
Note 3 |
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CEN |
EN 10217-3:2002 Welded steel tubes for pressure purposes — Technical delivery conditions — Part 3: Alloy fine grain steel tubes |
12.8.2016 |
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EN 10217-3:2002/A1:2005 |
12.8.2016 |
Note 3 |
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CEN |
EN 10217-4:2002 Welded steel tubes for pressure purposes — Technical delivery conditions — Part 4: Electric welded non-alloy steel tubes with specified low temperature properties |
12.8.2016 |
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EN 10217-4:2002/A1:2005 |
12.8.2016 |
Note 3 |
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CEN |
EN 10217-5:2002 Welded steel tubes for pressure purposes — Technical delivery conditions — Part 5: Submerged arc welded non-alloy and alloy steel tubes with specified elevated temperature properties |
12.8.2016 |
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EN 10217-5:2002/A1:2005 |
12.8.2016 |
Note 3 |
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CEN |
EN 10217-6:2002 Welded steel tubes for pressure purposes — Technical delivery conditions — Part 6: Submerged arc welded non-alloy steel tubes with specified low temperature properties |
12.8.2016 |
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EN 10217-6:2002/A1:2005 |
12.8.2016 |
Note 3 |
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CEN |
EN 10217-7:2014 Welded steel tubes for pressure purposes — Technical delivery conditions — Part 7: Stainless steel tubes |
12.8.2016 |
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CEN |
EN 10222-1:2017 Steel forgings for pressure purposes — Part 1: General requirements for open die forgings |
This is the first publication |
EN 10222-1:1998 Note 2.1 |
31.10.2017 |
CEN |
EN 10222-2:2017 Steel forgings for pressure purposes — Part 2: Ferritic and martensitic steels with specified elevated temperatures properties |
This is the first publication |
EN 10222-2:1999 Note 2.1 |
31.10.2017 |
CEN |
EN 10222-3:2017 Steel forgings for pressure purposes — Part 3: Nickel steels with specified low temperature properties |
This is the first publication |
EN 10222-3:1998 Note 2.1 |
31.10.2017 |
CEN |
EN 10222-4:2017 Steel forgings for pressure purposes — Part 4: Weldable fine grain steels with high proof strength |
This is the first publication |
EN 10222-4:1998 Note 2.1 |
31.10.2017 |
CEN |
EN 10222-5:2017 Steel forgings for pressure purposes — Part 5: Martensitic, austenitic and austenitic-ferritic stainless steels |
This is the first publication |
EN 10222-5:1999 Note 2.1 |
31.10.2017 |
CEN |
EN 10253-2:2007 Butt-welding pipe fittings — Part 2: Non alloy and ferritic alloy steels with specific inspection requirements |
12.8.2016 |
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CEN |
EN 10253-4:2008 Butt-welding pipe fittings — Part 4: Wrought austenitic and austenitic-ferritic (duplex) stainless steels with specific inspection requirements |
12.8.2016 |
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EN 10253-4:2008/AC:2009 |
12.8.2016 |
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CEN |
EN 10269:2013 Steels and nickel alloys for fasteners with specified elevated and/or low temperature properties |
12.8.2016 |
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CEN |
EN 10272:2016 Stainless steel bars for pressure purposes |
This is the first publication |
EN 10272:2007 Note 2.1 |
The date of this publication |
CEN |
EN 10273:2016 Hot rolled weldable steel bars for pressure purposes with specified elevated temperature properties |
This is the first publication |
EN 10273:2007 Note 2.1 |
The date of this publication |
CEN |
EN 10305-4:2016 Steel tubes for precision applications — Technical delivery conditions — Part 4: Seamless cold drawn tubes for hydraulic and pneumatic power systems |
12.8.2016 |
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CEN |
EN 10305-6:2016 Steel tubes for precision applications — Technical delivery conditions — Part 6: Welded cold drawn tubes for hydraulic and pneumatic power systems |
12.8.2016 |
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CEN |
EN ISO 10931:2005 Plastics piping systems for industrial applications — Poly(vinylidene fluoride) (PVDF) — Specifications for components and the system (ISO 10931:2005) |
12.8.2016 |
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EN ISO 10931:2005/A1:2015 |
12.8.2016 |
Note 3 |
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CEN |
EN 12178:2016 Refrigerating systems and heat pumps — Liquid level indicating devices — Requirements, testing and marking |
This is the first publication |
EN 12178:2003 Note 2.1 |
The date of this publication |
CEN |
EN 12263:1998 Refrigerating systems and heat pumps — Safety switching devices for limiting the pressure — Requirements and tests |
12.8.2016 |
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CEN |
EN 12266-1:2012 Industrial valves — Testing of metallic valves — Part 1: Pressure tests, test procedures and acceptance criteria — Mandatory requirements |
12.8.2016 |
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CEN |
EN 12284:2003 Refrigerating systems and heat pumps — Valves — Requirements, testing and marking |
12.8.2016 |
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CEN |
EN 12288:2010 Industrial valves — Copper alloy gate valves |
12.8.2016 |
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CEN |
EN 12392:2016 Aluminium and aluminium alloys — Wrought products and cast products — Special requirements for products intended for the production of pressure equipment |
12.8.2016 |
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CEN |
EN 12420:2014 Copper and copper alloys — Forgings |
12.8.2016 |
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CEN |
EN 12434:2000 Cryogenic vessels — Cryogenic flexible hoses |
12.8.2016 |
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EN 12434:2000/AC:2001 |
12.8.2016 |
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CEN |
EN 12451:2012 Copper and copper alloys — Seamless, round tubes for heat exchangers |
12.8.2016 |
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CEN |
EN 12452:2012 Copper and copper alloys — Rolled, finned, seamless tubes for heat exchangers |
12.8.2016 |
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CEN |
EN 12516-1:2014 Industrial valves — Shell design strength — Part 1: Tabulation method for steel valve shells |
12.8.2016 |
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CEN |
EN 12516-2:2014 Industrial valves — Shell design strength — Part 2: Calculation method for steel valve shells |
12.8.2016 |
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CEN |
EN 12516-3:2002 Valves — Shell design strength — Part 3: Experimental method |
12.8.2016 |
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EN 12516-3:2002/AC:2003 |
12.8.2016 |
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CEN |
EN 12516-4:2014 Industrial valves — Shell design strength — Part 4: Calculation method for valve shells manufactured in metallic materials other than steel |
12.8.2016 |
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CEN |
EN 12542:2010 LPG equipment and accessories — Static welded steel cylindrical tanks, serially produced for the storage of Liquefied Petroleum Gas (LPG) having a volume not greater than 13 m3 — Design and manufacture |
12.8.2016 |
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CEN |
EN 12735-1:2016 Copper and copper alloys — Seamless, round tubes for air conditioning and refrigeration — Part 1: Tubes for piping systems |
12.8.2016 |
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CEN |
EN 12735-2:2016 Copper and copper alloys — Seamless, round tubes for air conditioning and refrigeration — Part 2: Tubes for equipment |
12.8.2016 |
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CEN |
EN 12778:2002 Cookware — Pressure cookers for domestic use |
12.8.2016 |
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EN 12778:2002/AC:2003 |
12.8.2016 |
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EN 12778:2002/A1:2005 |
12.8.2016 |
Note 3 |
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CEN |
EN 12952-1:2015 Water-tube boilers and auxiliary installations — Part 1: General |
12.8.2016 |
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CEN |
EN 12952-2:2011 Water-tube boilers and auxiliary installations — Part 2: Materials for pressure parts of boilers and accessories |
12.8.2016 |
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CEN |
EN 12952-3:2011 Water-tube boilers and auxiliary installations — Part 3: Design and calculation for pressure parts of the boiler |
12.8.2016 |
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CEN |
EN 12952-5:2011 Water-tube boilers and auxiliary installations — Part 5: Workmanship and construction of pressure parts of the boiler |
12.8.2016 |
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CEN |
EN 12952-6:2011 Water-tube boilers and auxiliary installations — Part 6: Inspection during construction; documentation and marking of pressure parts of the boiler |
12.8.2016 |
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CEN |
EN 12952-7:2012 Water-tube boilers and auxiliary installations — Part 7: Requirements for equipment for the boiler |
12.8.2016 |
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CEN |
EN 12952-8:2002 Water-tube boilers and auxiliary installations — Part 8: Requirements for firing systems for liquid and gaseous fuels for the boiler |
12.8.2016 |
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CEN |
EN 12952-9:2002 Water-tube boilers and auxiliary installations — Part 9: Requirements for firing systems for pulverized solid fuels for the boiler |
12.8.2016 |
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CEN |
EN 12952-10:2002 Water-tube boilers and auxiliary installations — Part 10: Requirements for safeguards against excessive pressure |
12.8.2016 |
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CEN |
EN 12952-11:2007 Water-tube boilers and auxiliary installations — Part 11: Requirements for limiting devices of the boiler and accessories |
12.8.2016 |
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CEN |
EN 12952-14:2004 Water-tube boilers and auxiliary installations — Part 14: Requirements for flue gas DENOX-systems using liquefied pressurized ammonia and ammonia water solution |
12.8.2016 |
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CEN |
EN 12952-16:2002 Water-tube boilers and auxiliary installations — Part 16: Requirements for grate and fluidized-bed firing systems for solid fuels for the boiler |
12.8.2016 |
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CEN |
EN 12952-18:2012 Water-tube boilers and auxiliary installations — Part 18: Operating instructions |
12.8.2016 |
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CEN |
EN 12953-1:2012 Shell boilers — Part 1: General |
12.8.2016 |
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CEN |
EN 12953-2:2012 Shell boilers — Part 2: Materials for pressure parts of boilers and accessories |
12.8.2016 |
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CEN |
EN 12953-3:2016 Shell boilers — Part 3: Design and calculation for pressure parts |
12.8.2016 |
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CEN |
EN 12953-4:2002 Shell boilers — Part 4: Workmanship and construction of pressure parts of the boiler |
12.8.2016 |
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CEN |
EN 12953-5:2002 Shell boilers — Part 5: Inspection during construction, documentation and marking of pressure parts of the boiler |
12.8.2016 |
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CEN |
EN 12953-6:2011 Shell Boilers — Part 6: Requirements for equipment for the boiler |
12.8.2016 |
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CEN |
EN 12953-7:2002 Shell boilers — Part 7: Requirements for firing systems for liquid and gaseous fuels for the boilers |
12.8.2016 |
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CEN |
EN 12953-8:2001 Shell boilers — Part 8: Requirements for safeguards against excessive pressure |
12.8.2016 |
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EN 12953-8:2001/AC:2002 |
12.8.2016 |
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CEN |
EN 12953-9:2007 Shell boilers — Part 9: Requirements for limiting devices of the boiler and accessories |
12.8.2016 |
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CEN |
EN 12953-12:2003 Shell boilers — Part 12: Requirements for grate firing systems for solid fuels for the boiler |
12.8.2016 |
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CEN |
EN 12953-13:2012 Shell boilers — Part 13: Operating instructions |
12.8.2016 |
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CEN |
EN 13121-1:2003 GRP tanks and vessels for use above ground — Part 1: Raw materials — Specification conditions and acceptance conditions |
12.8.2016 |
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CEN |
EN 13121-2:2003 GRP tanks and vessels for use above ground — Part 2: Composite materials — Chemical resistance |
12.8.2016 |
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CEN |
EN 13121-3:2016 GRP tanks and vessels for use above ground — Part 3: Design and workmanship |
12.8.2016 |
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CEN |
EN 13134:2000 Brazing — Procedure approval |
12.8.2016 |
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CEN |
EN 13136:2013 Refrigerating systems and heat pumps — Pressure relief devices and their associated piping — Methods for calculation |
12.8.2016 |
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CEN |
EN 13175:2014 LPG Equipment and accessories — Specification and testing for Liquefied Petroleum Gas (LPG) pressure vessel valves and fittings |
12.8.2016 |
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CEN |
EN 13348:2016 Copper and copper alloys — Seamless, round copper tubes for medical gases or vacuum |
12.8.2016 |
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CEN |
EN 13371:2001 Cryogenic vessels — Couplings for cryogenic service |
12.8.2016 |
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CEN |
EN 13397:2001 Industrial valves — Diaphragm valves made of metallic materials |
12.8.2016 |
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CEN |
EN 13445-1:2014 Unfired pressure vessels — Part 1: General |
12.8.2016 |
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EN 13445-1:2014/A1:2014 |
12.8.2016 |
Note 3 |
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CEN |
EN 13445-2:2014 Unfired pressure vessels — Part 2: Materials |
12.8.2016 |
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EN 13445-2:2014/A1:2016 |
This is the first publication |
Note 3 |
The date of this publication |
CEN |
EN 13445-3:2014 Unfired pressure vessels — Part 3: Design |
12.8.2016 |
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EN 13445-3:2014/A1:2015 |
12.8.2016 |
Note 3 |
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EN 13445-3:2014/A2:2016 |
This is the first publication |
Note 3 |
The date of this publication |
CEN |
EN 13445-4:2014 Unfired pressure vessels — Part 4: Fabrication |
12.8.2016 |
|
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CEN |
EN 13445-5:2014 Unfired pressure vessels — Part 5: Inspection and testing |
12.8.2016 |
|
The date of this publication |
CEN |
EN 13445-6:2014 Unfired pressure vessels — Part 6: Requirements for the design and fabrication of pressure vessels and pressure parts constructed from spheroidal graphite cast iron |
12.8.2016 |
|
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CEN |
EN 13445-8:2014 Unfired pressure vessels — Part 8: Additional requirements for pressure vessels of aluminium and aluminium alloys |
12.8.2016 |
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EN 13445-8:2014/A1:2014 |
12.8.2016 |
Note 3 |
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CEN |
EN 13458-1:2002 Cryogenic vessels — Static vacuum insulated vessels — Part 1: Fundamental requirements |
12.8.2016 |
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CEN |
EN 13458-2:2002 Cryogenic vessels — Static vacuum insulated vessels — Part 2: Design, fabrication, inspection and testing |
12.8.2016 |
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EN 13458-2:2002/AC:2006 |
12.8.2016 |
|
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CEN |
EN 13480-1:2017 Metallic industrial piping — Part 1: General |
This is the first publication |
EN 13480-1:2012 Note 2.1 |
15.12.2017 |
CEN |
EN 13480-2:2017 Metallic industrial piping — Part 2: Materials |
This is the first publication |
EN 13480-2:2012 Note 2.1 |
15.12.2017 |
CEN |
EN 13480-3:2017 Metallic industrial piping — Part 3: Design and calculation |
This is the first publication |
EN 13480-3:2012 Note 2.1 |
15.12.2017 |
CEN |
EN 13480-4:2012 Metallic industrial piping — Part 4: Fabrication and installation |
12.8.2016 |
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EN 13480-4:2012/A1:2013 |
12.8.2016 |
Note 3 |
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EN 13480-4:2012/A2:2015 |
12.8.2016 |
Note 3 |
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CEN |
EN 13480-5:2017 Metallic industrial piping — Part 5: Inspection and testing |
This is the first publication |
EN 13480-5:2012 Note 2.1 |
15.12.2017 |
CEN |
EN 13480-6:2017 Metallic industrial piping — Part 6: Additional requirements for buried piping |
This is the first publication |
EN 13480-6:2012 Note 2.1 |
15.12.2017 |
CEN |
EN 13480-8:2017 Metallic industrial piping — Part 8: Additional requirements for aluminium and aluminium alloy piping |
This is the first publication |
EN 13480-8:2012 Note 2.1 |
15.12.2017 |
CEN |
EN 13547:2013 Industrial valves — Copper alloy ball valves |
12.8.2016 |
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CEN |
EN ISO 13585:2012 Brazing — Qualification test of brazers and brazing operators (ISO 13585:2012) |
12.8.2016 |
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CEN |
EN 13648-1:2008 Cryogenic vessels — Safety devices for protection against excessive pressure — Part 1: Safety valves for cryogenic service |
12.8.2016 |
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CEN |
EN 13648-2:2002 Cryogenic vessels — Safety devices for protection against excessive pressure — Part 2: Bursting disc safety devices for cryogenic service |
12.8.2016 |
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CEN |
EN 13709:2010 Industrial valves — Steel globe and globe stop and check valves |
12.8.2016 |
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CEN |
EN 13789:2010 Industrial valves — Cast iron globe valves |
12.8.2016 |
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CEN |
EN 13831:2007 Closed expansion vessels with built in diaphragm for installation in water |
12.8.2016 |
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CEN |
EN 13835:2012 Founding — Austenitic cast irons |
12.8.2016 |
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CEN |
EN 13923:2005 Filament-wound FRP pressure vessels — Materials, design, manufacturing and testing |
12.8.2016 |
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CEN |
EN 14129:2014 LPG Equipment and accessories — Pressure relief valves for LPG pressure vessels |
12.8.2016 |
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CEN |
EN 14197-1:2003 Cryogenic vessels — Static non-vacuum insulated vessels — Part 1: Fundamental requirements |
12.8.2016 |
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CEN |
EN 14197-2:2003 Cryogenic vessels — Static non-vacuum insulated vessels — Part 2: Design, fabrication, inspection and testing |
12.8.2016 |
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EN 14197-2:2003/A1:2006 |
12.8.2016 |
Note 3 |
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EN 14197-2:2003/AC:2006 |
12.8.2016 |
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CEN |
EN 14197-3:2004 Cryogenic vessels — Static non-vacuum insulated vessels — Part 3: Operational requirements |
12.8.2016 |
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EN 14197-3:2004/A1:2005 |
12.8.2016 |
Note 3 |
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EN 14197-3:2004/AC:2004 |
12.8.2016 |
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CEN |
EN 14222:2003 Stainless steel shell boilers |
12.8.2016 |
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CEN |
EN 14276-1:2006+A1:2011 Pressure equipment for refrigerating systems and heat pumps — Part 1: Vessels — General requirements |
12.8.2016 |
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CEN |
EN 14276-2:2007+A1:2011 Pressure equipment for refrigerating systems and heat pumps — Part 2: Piping — General requirements |
12.8.2016 |
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CEN |
EN 14359:2006+A1:2010 Gas-loaded accumulators for fluid power applications |
12.8.2016 |
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CEN |
EN 14382:2005+A1:2009 Safety devices for gas pressure regulating stations and installations — Gas safety shut-off devices for inlet pressures up to 100 bar |
12.8.2016 |
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EN 14382:2005+A1:2009/AC:2009 |
12.8.2016 |
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CEN |
EN 14394:2005+A1:2008 Heating boilers — Heating boilers with forced draught burners — Nominal heat output not exceeding 10 MW and maximum operating temperature of 110 oC |
12.8.2016 |
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CEN |
EN 14570:2014 LPG equipment and accessories — Equipping of overground and underground LPG vessels |
12.8.2016 |
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CEN |
EN 14585-1:2006 Corrugated metal hose assemblies for pressure applications — Part 1: Requirements |
12.8.2016 |
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CEN |
EN 14917:2009+A1:2012 Metal bellows expansion joints for pressure applications |
12.8.2016 |
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CEN |
EN 15001-1:2009 Gas Infrastructure — Gas installation pipework with an operating pressure greater than 0,5 bar for industrial installations and greater than 5 bar for industrial and non-industrial installations — Part 1: Detailed functional requirements for design, materials, construction, inspection and testing |
12.8.2016 |
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CEN |
EN ISO 15493:2003 Plastics piping systems for industrial applications — Acrylonitrile-butadiene-styrene (ABS), unplasticized poly(vinyl chloride) (PVC-U) and chlorinated poly(vinyl chloride) (PVC-C) — Specifications for components and the system — Metric series (ISO 15493:2003) |
12.8.2016 |
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EN ISO 15493:2003/A1:2017 |
This is the first publication |
Note 3 |
The date of this publication |
CEN |
EN ISO 15613:2004 Specification and qualification of welding procedures for metallic materials — Qualification based on pre-production welding test (ISO 15613:2004) |
12.8.2016 |
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CEN |
EN ISO 15614-1:2004 Specification and qualification of welding procedures for metallic materials — Welding procedure test — Part 1: Arc and gas welding of steels and arc welding of nickel and nickel alloys (ISO 15614-1:2004) |
12.8.2016 |
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EN ISO 15614-1:2004/A1:2008 |
12.8.2016 |
Note 3 |
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EN ISO 15614-1:2004/A2:2012 |
12.8.2016 |
Note 3 |
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CEN |
EN ISO 15614-2:2005 Specification and qualification of welding procedures for metallic materials — Welding procedure test — Part 2: Arc welding of aluminium and its alloys (ISO 15614-2:2005) |
12.8.2016 |
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EN ISO 15614-2:2005/AC:2009 |
12.8.2016 |
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CEN |
EN ISO 15614-4:2005 Specification and qualification of welding procedures for metallic materials — Welding procedure test — Part 4: Finishing welding of aluminium castings (ISO 15614-4:2005) |
12.8.2016 |
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EN ISO 15614-4:2005/AC:2007 |
12.8.2016 |
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CEN |
EN ISO 15614-5:2004 Specification and qualification of welding procedures for metallic materials — Welding procedure test — Part 5: Arc welding of titanium, zirconium and their alloys (ISO 15614-5:2004) |
12.8.2016 |
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CEN |
EN ISO 15614-6:2006 Specification and qualification of welding procedures for metallic materials — Welding procedure test — Part 6: Arc and gas welding of copper and its alloys (ISO 15614-6:2006) |
12.8.2016 |
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CEN |
EN ISO 15614-7:2007 Specification and qualification of welding procedures for metallic materials — Welding procedure test — Part 7: Overlay welding (ISO 15614-7:2007) |
12.8.2016 |
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CEN |
EN ISO 15614-8:2016 Specification and qualification of welding procedures for metallic materials — Welding procedure test — Part 8: Welding of tubes to tube-plate joints (ISO 15614-8:2016) |
12.8.2016 |
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CEN |
EN ISO 15614-11:2002 Specification and qualification of welding procedures for metallic materials — Welding procedure test — Part 11: Electron and laser beam welding (ISO 15614-11:2002) |
12.8.2016 |
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CEN |
EN ISO 15620:2000 Welding — Friction welding of metallic materials (ISO 15620:2000) |
12.8.2016 |
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CEN |
EN 15776:2011+A1:2015 Unfired pressure vessels — Requirements for the design and fabrication of pressure vessels and pressure parts constructed from cast iron with an elongation after fracture equal or less than 15 % |
12.8.2016 |
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CEN |
EN ISO 16135:2006 Industrial valves — Ball valves of thermoplastics materials (ISO 16135:2006) |
12.8.2016 |
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CEN |
EN ISO 16136:2006 Industrial valves — Butterfly valves of thermoplastics materials (ISO 16136:2006) |
12.8.2016 |
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CEN |
EN ISO 16137:2006 Industrial valves — Check valves of thermoplastics materials (ISO 16137:2006) |
12.8.2016 |
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CEN |
EN ISO 16138:2006 Industrial valves — Diaphragm valves of thermoplastics materials (ISO 16138:2006) |
12.8.2016 |
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CEN |
EN ISO 16139:2006 Industrial valves — Gate valves of thermoplastics materials (ISO 16139:2006) |
12.8.2016 |
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CEN |
EN 16767:2016 Industrial valves — Steel and cast iron check valves |
12.8.2016 |
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CEN |
EN ISO 21009-2:2015 Cryogenic vessels — Static vacuum insulated vessels — Part 2: Operational requirements (ISO 21009-2:2015) |
12.8.2016 |
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CEN |
EN ISO 21013-3:2016 Cryogenic vessels — Pressure-relief accessories for cryogenic service — Part 3: Sizing and capacity determination (ISO 21013-3:2016) |
12.8.2016 |
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CEN |
EN ISO 21028-1:2016 Cryogenic vessels — Toughness requirements for materials at cryogenic temperature — Part 1: Temperatures below - 80 oC (ISO 21028-1:2016) |
This is the first publication |
EN 1252-1:1998 Note 2.1 |
The date of this publication |
CEN |
EN ISO 21787:2006 Industrial valves — Globe valves of thermoplastics materials (ISO 21787:2006) |
12.8.2016 |
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Note 1: |
Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. |
Note 2.1: |
The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
Note 2.2: |
The new standard has a broader scope than the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
Note 2.3: |
The new standard has a narrower scope than the superseded standard. On the date stated, the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected. |
Note 3: |
In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
NOTE:
— |
Any information concerning the availability of the standards can be obtained either from the European standardisation organisations or from the national standardisation bodies the list of which is published in the Official Journal of the European Union according to Article 27 of the Regulation (EU) No 1025/2012 (2). |
— |
Standards are adopted by the European standardisation organisations in English (CEN and Cenelec also publish in French and German). Subsequently, the titles of the standards are translated into all other required official languages of the European Union by the national standardisation bodies. The European Commission is not responsible for the correctness of the titles which have been presented for publication in the Official Journal. |
— |
References to Corrigenda ‘…/AC:YYYY’ are published for information only. A Corrigendum removes printing, linguistic or similar errors from the text of a standard and may relate to one or more language versions (English, French and/or German) of a standard as adopted by a European standardisation organisation. |
— |
Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the official languages of the European Union. |
— |
This list replaces all the previous lists published in the Official Journal of the European Union. The European Commission ensures the updating of this list. |
— |
More information about harmonised standards and other European standards on the Internet at: http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/index_en.htm |
(1) ESO: European standardisation organisation:
— |
CEN: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5500811; fax + 32 2 5500819 (http://www.cen.eu) |
— |
CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5196871; fax + 32 2 5196919 (http://www.cenelec.eu) |
— |
ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. +33 492 944200; fax +33 493 654716, (http://www.etsi.eu) |
(2) OJ C 338, 27.9.2014, p. 31.
17.11.2017 |
EN |
Official Journal of the European Union |
C 389/22 |
Commission communication in the framework of the implementation of Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices
(Publication of titles and references of harmonised standards under Union harmonisation legislation)
(Text with EEA relevance)
(2017/C 389/02)
ESO (1) |
Reference and title of the standard (and reference document) |
First publication OJ |
Reference of superseded standard |
Date of cessation of presumption of conformity of superseded standard Note 1 |
(1) |
(2) |
(3) |
(4) |
(5) |
CEN |
EN 556-1:2001 Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilized medical devices |
31.7.2002 |
EN 556:1994 + A1:1998 Note 2.1 |
30.4.2002 |
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EN 556-1:2001/AC:2006 |
15.11.2006 |
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CEN |
EN 556-2:2015 Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices |
13.5.2016 |
EN 556-2:2003 Note 2.1 |
30.6.2016 |
CEN |
EN 1041:2008 Information supplied by the manufacturer of medical devices |
19.2.2009 |
EN 1041:1998 Note 2.1 |
31.8.2011 |
CEN |
EN ISO 10993-1:2009 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) |
2.12.2009 |
EN ISO 10993-1:2009 Note 2.1 |
21.3.2010 |
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EN ISO 10993-1:2009/AC:2010 |
18.1.2011 |
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CEN |
EN ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) |
10.7.2015 |
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CEN |
EN ISO 10993-4:2009 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006) |
2.12.2009 |
EN ISO 10993-4:2002 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) |
2.12.2009 |
EN ISO 10993-5:1999 Note 2.1 |
31.12.2009 |
CEN |
EN ISO 10993-6:2009 Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:2007) |
2.12.2009 |
EN ISO 10993-6:2007 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 10993-7:2008 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) |
7.7.2010 |
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EN ISO 10993-7:2008/AC:2009 |
7.7.2010 |
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CEN |
EN ISO 10993-9:2009 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009) |
2.12.2009 |
EN ISO 10993-9:2009 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 10993-11:2009 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006) |
2.12.2009 |
EN ISO 10993-11:2006 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 10993-12:2012 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
24.1.2013 |
EN ISO 10993-12:2009 Note 2.1 |
31.1.2013 |
CEN |
EN ISO 10993-13:2010 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) |
18.1.2011 |
EN ISO 10993-13:2009 Note 2.1 |
31.12.2010 |
CEN |
EN ISO 10993-16:2010 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010) |
7.7.2010 |
EN ISO 10993-16:2009 Note 2.1 |
31.8.2010 |
CEN |
EN ISO 10993-17:2009 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) |
2.12.2009 |
EN ISO 10993-17:2002 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 10993-18:2009 Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005) |
2.12.2009 |
EN ISO 10993-18:2005 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 11135-1:2007 Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) |
9.8.2007 |
EN 550:1994 Note 2.1 |
31.5.2010 |
CEN |
EN ISO 11137-1:2015 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) |
13.5.2016 |
EN ISO 11137-1:2006 Note 2.1 |
30.6.2016 |
CEN |
EN ISO 11137-2:2015 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
13.5.2016 |
EN ISO 11137-2:2013 Note 2.1 |
30.6.2016 |
CEN |
EN ISO 11138-2:2009 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006) |
2.12.2009 |
EN ISO 11138-2:2006 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 11138-3:2009 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006) |
2.12.2009 |
EN ISO 11138-3:2006 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 11140-1:2009 Sterilization of health care products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005) |
2.12.2009 |
EN ISO 11140-1:2005 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) |
2.12.2009 |
EN ISO 11607-1:2006 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 11737-1:2006 Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) |
7.9.2006 |
EN 1174-1:1996 EN 1174-2:1996 EN 1174-3:1996 Note 2.1 |
31.10.2006 |
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EN ISO 11737-1:2006/AC:2009 |
2.12.2009 |
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CEN |
EN ISO 11737-2:2009 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) |
7.7.2010 |
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CEN |
EN ISO 13408-1:2015 Aseptic processing of health care products — Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
13.5.2016 |
EN ISO 13408-1:2011 Note 2.1 |
30.6.2016 |
CEN |
EN ISO 13408-2:2011 Aseptic processing of health care products — Part 2: Filtration (ISO 13408-2:2003) |
19.8.2011 |
EN 13824:2004 Note 2.1 |
31.12.2011 |
CEN |
EN ISO 13408-3:2011 Aseptic processing of health care products — Part 3: Lyophilization (ISO 13408-3:2006) |
19.8.2011 |
EN 13824:2004 Note 2.1 |
31.12.2011 |
CEN |
EN ISO 13408-4:2011 Aseptic processing of health care products — Part 4: Clean-in-place technologies (ISO 13408-4:2005) |
19.8.2011 |
EN 13824:2004 Note 2.1 |
31.12.2011 |
CEN |
EN ISO 13408-5:2011 Aseptic processing of health care products — Part 5: Sterilization in place (ISO 13408-5:2006) |
19.8.2011 |
EN 13824:2004 Note 2.1 |
31.12.2011 |
CEN |
EN ISO 13408-6:2011 Aseptic processing of health care products — Part 6: Isolator systems (ISO 13408-6:2005) |
19.8.2011 |
EN 13824:2004 Note 2.1 |
31.12.2011 |
CEN |
EN ISO 13408-7:2015 Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012) |
13.5.2016 |
|
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CEN |
EN ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2016) |
This is the first publication |
EN ISO 13485:2012 Note 2.1 |
31.3.2019 |
|
EN ISO 13485:2016/AC:2016 |
This is the first publication |
|
|
CEN |
EN ISO 14155:2011 Clinical investigation of medical devices for human subjects — Good clinical practice (ISO 14155:2011) |
27.4.2012 |
EN ISO 14155:2011 Note 2.1 |
30.4.2012 |
|
EN ISO 14155:2011/AC:2011 |
This is the first publication |
|
|
CEN |
EN ISO 14937:2009 Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) |
7.7.2010 |
EN ISO 14937:2000 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 14971:2012 Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
30.8.2012 |
EN ISO 14971:2009 Note 2.1 |
30.8.2012 |
CEN |
EN ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements (ISO 15223-1:2016, Corrected version 2016-12-15) |
This is the first publication |
EN 980:2008 Note 2.1 |
31.12.2017 |
CEN |
EN ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
15.11.2006 |
EN 554:1994 Note 2.1 |
31.8.2009 |
CEN |
EN 45502-1:1997 Active implantable medical devices — Part 1: General requirements for safety, marking and information to be provided by the manufacturer |
27.8.1998 |
|
|
Cenelec |
EN 45502-2-1:2003 Active implantable medical devices — Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) |
8.7.2004 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 45502-2-2:2008 Active implantable medical devices — Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) |
27.11.2008 |
|
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EN 45502-2-2:2008/AC:2009 |
18.1.2011 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 45502-2-3:2010 Active implantable medical devices — Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems |
18.1.2011 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-1:2006 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005 |
27.11.2008 |
EN 60601-1:1990 + A13:1996 + A1:1993 + A2:1995 Note 2.1 |
1.6.2012 |
|
EN 60601-1:2006/AC:2010 |
18.1.2011 |
|
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EN 60601-1:2006/A1:2013 IEC 60601-1:2005/A1:2012 |
10.7.2015 |
Note 3 |
31.12.2017 |
Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN 60601-1:2006. The date of cessation of presumption of conformity when applying EN 60601-1:2006 is 31.12.2017. However the Annex ZZ to EN 60601-1:2006 ceases to specify the presumption of conformity with the Essential Requirements of Directive 90/385/EEC on 31.12.2015. As from 1.1.2016, only the clauses and sub-clauses of EN 60601-1:2006 corresponding to the clauses and sub-clauses referred to in Annex ZZ to EN 60601-1:2006/A1:2013 provide presumption of conformity with the Essential Requirements of Directive 90/385/EEC, to the extent indicated in the Annex ZZ to EN 60601-1:2006/A1:2013. |
||||
Cenelec |
EN 60601-1-6:2010 Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral standard: Usability IEC 60601-1-6:2010 |
18.1.2011 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
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Cenelec |
EN 62304:2006 Medical device software — Software life-cycle processes IEC 62304:2006 |
27.11.2008 |
|
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EN 62304:2006/AC:2008 |
18.1.2011 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
Note 1: |
Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. |
Note 2.1: |
The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
Note 2.2: |
The new standard has a broader scope than the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
Note 2.3: |
The new standard has a narrower scope than the superseded standard. On the date stated, the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected. |
Note 3: |
In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
NOTE:
— |
Any information concerning the availability of the standards can be obtained either from the European standardisation organisations or from the national standardisation bodies the list of which is published in the Official Journal of the European Union according to Article 27 of the Regulation (EU) No 1025/2012 (2). |
— |
Standards are adopted by the European standardisation organisations in English (CEN and Cenelec also publish in French and German). Subsequently, the titles of the standards are translated into all other required official languages of the European Union by the national standardisation bodies. The European Commission is not responsible for the correctness of the titles which have been presented for publication in the Official Journal. |
— |
References to Corrigenda ‘…/AC:YYYY’ are published for information only. A Corrigendum removes printing, linguistic or similar errors from the text of a standard and may relate to one or more language versions (English, French and/or German) of a standard as adopted by a European standardisation organisation. |
— |
Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the official languages of the European Union. |
— |
This list replaces all the previous lists published in the Official Journal of the European Union. The European Commission ensures the updating of this list. |
— |
More information about harmonised standards and other European standards on the Internet at: http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/index_en.htm |
(1) ESO: European standardisation organisation:
— |
CEN: Avenue Marnix/Marnixlaan 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË; tel. +32 25500811; fax +32 25500819 (http://www.cen.eu) |
— |
Cenelec: Avenue Marnix/Marnixlaan 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË; tel. +32 25196871; fax +32 25196919 (http://www.cenelec.eu) |
— |
ETSI: 650 route des Lucioles, 06921 Sophia Antipolis, FRANCE; tel. +33 492944200; fax +33 493654716 (http://www.etsi.eu) |
(2) OJ C 338, 27.9.2014, p. 31.
17.11.2017 |
EN |
Official Journal of the European Union |
C 389/29 |
Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices
(Publication of titles and references of harmonised standards under Union harmonisation legislation)
(Text with EEA relevance)
(2017/C 389/03)
ESO (1) |
Reference and title of the standard (and reference document) |
First publication OJ |
Reference of superseded standard |
Date of cessation of presumption of conformity of superseded standard Note 1 |
(1) |
(2) |
(3) |
(4) |
(5) |
CEN |
EN 285:2006+A2:2009 Sterilization — Steam sterilizers — Large sterilizers |
2.12.2009 |
EN 285:2006+A1:2008 Note 2.1 |
21.3.2010 |
CEN |
EN 455-1:2000 Medical gloves for single use — Part 1: Requirements and testing for freedom from holes |
30.9.2005 |
EN 455-1:1993 Note 2.1 |
30.4.2001 |
CEN |
EN 455-2:2009+A2:2013 Medical gloves for single use — Part 2: Requirements and testing for physical properties |
16.5.2014 |
EN 455-2:2009+A1:2011 Note 2.1 |
31.10.2014 |
CEN |
EN 455-3:2006 Medical gloves for single use — Part 3: Requirements and testing for biological evaluation |
9.8.2007 |
EN 455-3:1999 Note 2.1 |
30.6.2007 |
CEN |
EN 455-4:2009 Medical gloves for single use — Part 4: Requirements and testing for shelf life determination |
7.7.2010 |
|
|
CEN |
EN 556-1:2001 Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilized medical devices |
31.7.2002 |
EN 556:1994 + A1:1998 Note 2.1 |
30.4.2002 |
|
EN 556-1:2001/AC:2006 |
15.11.2006 |
|
|
CEN |
EN 556-2:2015 Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices |
13.5.2016 |
EN 556-2:2003 Note 2.1 |
30.6.2016 |
CEN |
EN 794-3:1998+A2:2009 Lung ventilators — Part 3: Particular requirements for emergency and transport ventilators |
7.7.2010 |
EN 794-3:1998 Note 2.1 |
21.3.2010 |
CEN |
EN 1041:2008 Information supplied by the manufacturer of medical devices |
19.2.2009 |
EN 1041:1998 Note 2.1 |
31.8.2011 |
CEN |
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers — Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems |
7.7.2010 |
EN 1060-3:1997 Note 2.1 |
31.5.2010 |
CEN |
EN 1060-4:2004 Non-invasive sphygmomanometers — Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers |
30.9.2005 |
|
|
CEN |
EN ISO 1135-4:2011 Transfusion equipment for medical use — Part 4: Transfusion sets for single use (ISO 1135-4:2010) |
27.4.2012 |
EN ISO 1135-4:2010 Note 2.1 |
30.4.2012 |
CEN |
EN 1282-2:2005+A1:2009 Tracheostomy tubes — Part 2: Paediatric tubes (ISO 5366-3:2001, modified) |
7.7.2010 |
EN 1282-2:2005 Note 2.1 |
21.3.2010 |
CEN |
EN 1422:1997+A1:2009 Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods |
2.12.2009 |
EN 1422:1997 Note 2.1 |
21.3.2010 |
CEN |
EN 1618:1997 Catheters other than intravascular catheters — Test methods for common properties |
9.5.1998 |
|
|
CEN |
EN 1639:2009 Dentistry — Medical devices for dentistry — Instruments |
7.7.2010 |
EN 1639:2004 Note 2.1 |
30.4.2010 |
CEN |
EN 1640:2009 Dentistry — Medical devices for dentistry — Equipment |
7.7.2010 |
EN 1640:2004 Note 2.1 |
30.4.2010 |
CEN |
EN 1641:2009 Dentistry — Medical devices for dentistry — Materials |
7.7.2010 |
EN 1641:2004 Note 2.1 |
30.4.2010 |
CEN |
EN 1642:2011 Dentistry — Medical devices for dentistry — Dental implants |
27.4.2012 |
EN 1642:2009 Note 2.1 |
30.4.2012 |
CEN |
EN 1707:1996 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Lock fittings |
17.5.1997 |
|
|
CEN |
EN 1782:1998+A1:2009 Tracheal tubes and connectors |
7.7.2010 |
EN 1782:1998 Note 2.1 |
21.3.2010 |
CEN |
EN 1789:2007+A1:2010 Medical vehicles and their equipment — Road ambulances |
18.1.2011 |
|
|
CEN |
EN 1820:2005+A1:2009 Anaesthetic reservoir bags (ISO 5362:2000, modified) |
7.7.2010 |
EN 1820:2005 Note 2.1 |
21.3.2010 |
CEN |
EN 1865-1:2010+A1:2015 Patient handling equipment used in road ambulances — Part 1: General stretcher systems and patient handling equipment |
13.5.2016 |
|
|
CEN |
EN 1865-2:2010+A1:2015 Patient handling equipment used in road ambulances — Part 2: Power assisted stretcher |
13.5.2016 |
|
|
CEN |
EN 1865-3:2012 Patient handling equipment used in road ambulances — Part 3: Heavy duty stretcher |
30.8.2012 |
EN 1865:1999 Note 2.1 |
31.12.2012 |
CEN |
EN 1865-4:2012 Patient handling equipment used in road ambulances — Part 4: Foldable patient transfer chair |
30.8.2012 |
EN 1865:1999 Note 2.1 |
31.10.2012 |
CEN |
EN 1865-5:2012 Patient handling equipment used in road ambulances — Part 5: Stretcher support |
30.8.2012 |
EN 1865:1999 Note 2.1 |
31.12.2012 |
CEN |
EN 1985:1998 Walking aids — General requirements and test methods |
10.8.1999 |
|
|
This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. |
||||
CEN |
EN ISO 3826-2:2008 Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008) |
19.2.2009 |
|
|
CEN |
EN ISO 3826-3:2007 Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features (ISO 3826-3:2006) |
27.2.2008 |
|
|
CEN |
EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015) |
13.5.2016 |
|
|
CEN |
EN ISO 4074:2002 Natural latex rubber condoms — Requirements and test methods (ISO 4074:2002) |
31.7.2002 |
EN 600:1996 Note 2.1 |
31.8.2005 |
CEN |
EN ISO 4135:2001 Anaesthetic and respiratory equipment — Vocabulary (ISO 4135:2001) |
31.7.2002 |
EN ISO 4135:1996 Note 2.1 |
28.2.2002 |
CEN |
EN ISO 5359:2008 Low-pressure hose assemblies for use with medical gases (ISO 5359:2008) |
23.7.2008 |
EN 739:1998 Note 2.1 |
30.6.2010 |
|
EN ISO 5359:2008/A1:2011 |
30.8.2012 |
Note 3 |
30.6.2012 |
CEN |
EN ISO 5360:2009 Anaesthetic vaporizers — Agent-specific filling systems (ISO 5360:2006) |
2.12.2009 |
EN ISO 5360:2007 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 5366-1:2009 Anaesthetic and respiratory equipment — Tracheostomy tubes — Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000) |
2.12.2009 |
EN ISO 5366-1:2004 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 5840:2009 Cardiovascular implants — Cardiac valve prostheses (ISO 5840:2005) |
2.12.2009 |
EN ISO 5840:2005 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 7197:2009 Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007) |
2.12.2009 |
EN ISO 7197:2006 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 7376:2009 Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation (ISO 7376:2009) |
2.12.2009 |
EN ISO 7376:2009 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 7396-1:2007 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007) |
9.8.2007 |
EN 737-3:1998 Note 2.1 |
30.4.2009 |
|
EN ISO 7396-1:2007/A1:2010 |
7.7.2010 |
Note 3 |
31.7.2010 |
|
EN ISO 7396-1:2007/A2:2010 |
7.7.2010 |
Note 3 |
31.8.2010 |
CEN |
EN ISO 7396-2:2007 Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007) |
9.8.2007 |
EN 737-2:1998 Note 2.1 |
30.4.2009 |
CEN |
EN ISO 7886-3:2009 Sterile hypodermic syringes for single use — Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005) |
7.7.2010 |
EN ISO 7886-3:2005 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 7886-4:2009 Sterile hypodermic syringes for single use — Part 4: Syringes with reuse prevention feature (ISO 7886-4:2006) |
7.7.2010 |
EN ISO 7886-4:2006 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 8185:2009 Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification systems (ISO 8185:2007) |
2.12.2009 |
EN ISO 8185:2007 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 8359:2009 Oxygen concentrators for medical use — Safety requirements (ISO 8359:1996) |
2.12.2009 |
EN ISO 8359:1996 Note 2.1 |
21.3.2010 |
|
EN ISO 8359:2009/A1:2012 |
16.1.2015 |
Note 3 |
31.1.2013 |
CEN |
EN ISO 8835-2:2009 Inhalational anaesthesia systems — Part 2: Anaesthetic breathing systems (ISO 8835-2:2007) |
2.12.2009 |
EN ISO 8835-2:2007 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 8835-3:2009 Inhalational anaesthesia systems — Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007) |
2.12.2009 |
EN ISO 8835-3:2007 Note 2.1 |
21.3.2010 |
|
EN ISO 8835-3:2009/A1:2010 |
13.5.2011 |
Note 3 |
30.4.2011 |
CEN |
EN ISO 8835-4:2009 Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004) |
2.12.2009 |
EN ISO 8835-4:2004 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 8835-5:2009 Inhalational anaesthesia systems — Part 5: Anaesthetic ventilators (ISO 8835-5:2004) |
2.12.2009 |
EN ISO 8835-5:2004 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 9170-1:2008 Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008) |
19.2.2009 |
EN 737-1:1998 Note 2.1 |
31.7.2010 |
CEN |
EN ISO 9170-2:2008 Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008) |
19.2.2009 |
EN 737-4:1998 Note 2.1 |
31.7.2010 |
CEN |
EN ISO 9360-1:2009 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000) |
2.12.2009 |
EN ISO 9360-1:2000 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 9360-2:2009 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001) |
2.12.2009 |
EN ISO 9360-2:2002 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 9713:2009 Neurosurgical implants — Self-closing intracranial aneurysm clips (ISO 9713:2002) |
2.12.2009 |
EN ISO 9713:2004 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 10079-1:2009 Medical suction equipment — Part 1: Electrically powered suction equipment — Safety requirements (ISO 10079-1:1999) |
2.12.2009 |
EN ISO 10079-1:1999 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 10079-2:2009 Medical suction equipment — Part 2: Manually powered suction equipment (ISO 10079-2:1999) |
2.12.2009 |
EN ISO 10079-2:1999 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 10079-3:2009 Medical suction equipment — Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999) |
2.12.2009 |
EN ISO 10079-3:1999 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 10328:2016 Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods (ISO 10328:2016) |
This is the first publication |
EN ISO 10328:2006 Note 2.1 |
30.6.2018 |
CEN |
EN ISO 10524-1:2006 Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006) |
2.6.2006 |
EN 738-1:1997 Note 2.1 |
31.10.2008 |
CEN |
EN ISO 10524-2:2006 Pressure regulators for use with medical gases — Part 2: Manifold and line pressure regulators (ISO 10524-2:2005) |
7.6.2009 |
EN 738-2:1998 Note 2.1 |
31.10.2008 |
CEN |
EN ISO 10524-3:2006 Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005) |
7.9.2006 |
EN 738-3:1998 Note 2.1 |
31.10.2008 |
CEN |
EN ISO 10524-4:2008 Pressure regulators for use with medical gases — Part 4: Low-pressure regulators (ISO 10524-4:2008) |
23.7.2008 |
EN 738-4:1998 Note 2.1 |
30.6.2010 |
CEN |
EN ISO 10535:2006 Hoists for the transfer of disabled persons — Requirements and test methods (ISO 10535:2006) |
9.8.2007 |
EN ISO 10535:1998 Note 2.1 |
30.6.2007 |
This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. |
||||
CEN |
EN ISO 10555-1:2009 Sterile, single-use intravascular catheters — Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004) |
2.12.2009 |
EN ISO 10555-1:1996 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 10651-2:2009 Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004) |
2.12.2009 |
EN ISO 10651-2:2004 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 10651-4:2009 Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002) |
2.12.2009 |
EN ISO 10651-4:2002 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 10651-6:2009 Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 6: Home-care ventilatory support devices (ISO 10651-6:2004) |
2.12.2009 |
EN ISO 10651-6:2004 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 10993-1:2009 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) |
2.12.2009 |
EN ISO 10993-1:2009 Note 2.1 |
21.3.2010 |
|
EN ISO 10993-1:2009/AC:2010 |
18.1.2011 |
|
|
CEN |
EN ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) |
10.7.2015 |
EN ISO 10993-3:2009 Note 2.1 |
The date of this publication |
CEN |
EN ISO 10993-4:2009 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006) |
2.12.2009 |
EN ISO 10993-4:2002 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) |
2.12.2009 |
EN ISO 10993-5:1999 Note 2.1 |
31.12.2009 |
CEN |
EN ISO 10993-6:2009 Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:2007) |
2.12.2009 |
EN ISO 10993-6:2007 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 10993-7:2008 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) |
19.2.2009 |
|
|
|
EN ISO 10993-7:2008/AC:2009 |
7.7.2010 |
|
|
CEN |
EN ISO 10993-9:2009 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009) |
2.12.2009 |
EN ISO 10993-9:2009 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 10993-11:2009 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006) |
2.12.2009 |
EN ISO 10993-11:2006 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 10993-12:2012 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
24.1.2013 |
EN ISO 10993-12:2009 Note 2.1 |
31.1.2013 |
CEN |
EN ISO 10993-13:2010 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) |
18.1.2011 |
EN ISO 10993-13:2009 Note 2.1 |
31.12.2010 |
CEN |
EN ISO 10993-14:2009 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) |
2.12.2009 |
EN ISO 10993-14:2001 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 10993-15:2009 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000) |
2.12.2009 |
EN ISO 10993-15:2000 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 10993-16:2010 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010) |
7.7.2010 |
EN ISO 10993-16:2009 Note 2.1 |
31.8.2010 |
CEN |
EN ISO 10993-17:2009 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) |
2.12.2009 |
EN ISO 10993-17:2002 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 10993-18:2009 Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005) |
2.12.2009 |
EN ISO 10993-18:2005 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 11135-1:2007 Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) |
9.8.2007 |
EN 550:1994 Note 2.1 |
31.5.2010 |
CEN |
EN ISO 11137-1:2015 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) |
13.5.2016 |
EN ISO 11137-1:2006 Note 2.1 |
30.6.2016 |
CEN |
EN ISO 11137-2:2015 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
13.5.2016 |
EN ISO 11137-2:2013 Note 2.1 |
30.6.2016 |
CEN |
EN ISO 11138-2:2009 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006) |
2.12.2009 |
EN ISO 11138-2:2006 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 11138-3:2009 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006) |
2.12.2009 |
EN ISO 11138-3:2006 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 11140-1:2009 Sterilization of health care products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005) |
2.12.2009 |
EN ISO 11140-1:2005 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 11140-3:2009 Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007) |
2.12.2009 |
EN ISO 11140-3:2007 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 11197:2009 Medical supply units (ISO 11197:2004) |
2.12.2009 |
EN ISO 11197:2004 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) |
2.12.2009 |
EN ISO 11607-1:2006 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) |
7.9.2006 |
|
|
CEN |
EN ISO 11737-1:2006 Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) |
7.9.2006 |
EN 1174-1:1996 EN 1174-2:1996 EN 1174-3:1996 Note 2.1 |
31.10.2006 |
|
EN ISO 11737-1:2006/AC:2009 |
2.12.2009 |
|
|
CEN |
EN ISO 11737-2:2009 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) |
7.7.2010 |
|
|
CEN |
EN ISO 11810-1:2009 Lasers and laser-related equipment — Test method and classification for the laser resistance of surgical drapes and/or patient protective covers — Part 1: Primary ignition and penetration (ISO 11810-1:2005) |
2.12.2009 |
|
|
CEN |
EN ISO 11810-2:2009 Lasers and laser-related equipment — Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers — Part 2: Secondary ignition (ISO 11810-2:2007) |
2.12.2009 |
EN ISO 11810-2:2007 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 11979-8:2009 Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements (ISO 11979-8:2006) |
2.12.2009 |
EN ISO 11979-8:2006 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 11990-1:2014 Lasers and laser-related equipment — Determination of laser resistance of tracheal tubes — Part 1: Tracheal tube shaft (ISO 11990-1:2011) |
10.7.2015 |
|
|
CEN |
EN ISO 11990-2:2014 Lasers and laser-related equipment — Determination of laser resistance of tracheal tubes — Part 2: Tracheal tube cuffs (ISO 11990-2:2010) |
10.7.2015 |
|
|
CEN |
EN 12006-2:1998+A1:2009 Non active surgical implants — Particular requirements for cardiac and vascular implants — Part 2: Vascular prostheses including cardiac valve conduits |
2.12.2009 |
EN 12006-2:1998 Note 2.1 |
21.3.2010 |
CEN |
EN 12006-3:1998+A1:2009 Non active surgical implants — Particular requirements for cardiac and vascular implants — Part 3: Endovascular devices |
2.12.2009 |
EN 12006-3:1998 Note 2.1 |
21.3.2010 |
CEN |
EN 12183:2009 Manual wheelchairs — Requirements and test methods |
7.7.2010 |
|
|
CEN |
EN 12184:2009 Electrically powered wheelchairs, scooters and their chargers — Requirements and test methods |
7.7.2010 |
|
|
CEN |
EN 12342:1998+A1:2009 Breathing tubes intended for use with anaesthetic apparatus and ventilators |
7.7.2010 |
EN 12342:1998 Note 2.1 |
21.3.2010 |
CEN |
EN 12470-1:2000+A1:2009 Clinical thermometers — Part 1: Metallic liquid-in-glass thermometers with maximum device |
2.12.2009 |
EN 12470-1:2000 Note 2.1 |
21.3.2010 |
CEN |
EN 12470-2:2000+A1:2009 Clinical thermometers — Part 2: Phase change type (dot matrix) thermometers |
2.12.2009 |
EN 12470-2:2000 Note 2.1 |
21.3.2010 |
CEN |
EN 12470-3:2000+A1:2009 Clinical thermometers — Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device |
2.12.2009 |
EN 12470-3:2000 Note 2.1 |
21.3.2010 |
CEN |
EN 12470-4:2000+A1:2009 Clinical thermometers — Part 4: Performance of electrical thermometers for continuous measurement |
2.12.2009 |
EN 12470-4:2000 Note 2.1 |
21.3.2010 |
CEN |
EN 12470-5:2003 Clinical thermometers — Part 5: Performance of infra-red ear thermometers (with maximum device) |
7.11.2003 |
|
|
This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. |
||||
CEN |
EN ISO 12870:2009 Ophthalmic optics — Spectacle frames — Requirements and test methods (ISO 12870:2004) |
2.12.2009 |
EN ISO 12870:2004 Note 2.1 |
21.3.2010 |
CEN |
EN 13060:2014 Small steam sterilizers |
10.7.2015 |
EN 13060:2004+A2:2010 Note 2.1 |
The date of this publication |
CEN |
EN ISO 13408-1:2015 Aseptic processing of health care products — Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
13.5.2016 |
EN ISO 13408-1:2011 Note 2.1 |
30.6.2016 |
CEN |
EN ISO 13408-2:2011 Aseptic processing of health care products — Part 2: Filtration (ISO 13408-2:2003) |
19.8.2011 |
EN 13824:2004 Note 2.1 |
31.12.2011 |
CEN |
EN ISO 13408-3:2011 Aseptic processing of health care products — Part 3: Lyophilization (ISO 13408-3:2006) |
19.8.2011 |
EN 13824:2004 Note 2.1 |
31.12.2011 |
CEN |
EN ISO 13408-4:2011 Aseptic processing of health care products — Part 4: Clean-in-place technologies (ISO 13408-4:2005) |
19.8.2011 |
EN 13824:2004 Note 2.1 |
31.12.2011 |
CEN |
EN ISO 13408-5:2011 Aseptic processing of health care products — Part 5: Sterilization in place (ISO 13408-5:2006) |
19.8.2011 |
EN 13824:2004 Note 2.1 |
31.12.2011 |
CEN |
EN ISO 13408-6:2011 Aseptic processing of health care products — Part 6: Isolator systems (ISO 13408-6:2005) |
19.8.2011 |
EN 13824:2004 Note 2.1 |
31.12.2011 |
CEN |
EN ISO 13408-7:2015 Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012) |
13.5.2016 |
|
|
CEN |
EN ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2016) |
This is the first publication |
EN ISO 13485:2012 Note 2.1 |
31.3.2019 |
|
EN ISO 13485:2016/AC:2016 |
This is the first publication |
|
|
CEN |
EN 13544-1:2007+A1:2009 Respiratory therapy equipment — Part 1: Nebulizing systems and their components |
7.7.2010 |
EN 13544-1:2007 Note 2.1 |
21.3.2010 |
CEN |
EN 13544-2:2002+A1:2009 Respiratory therapy equipment — Part 2: Tubing and connectors |
7.7.2010 |
EN 13544-2:2002 Note 2.1 |
21.3.2010 |
CEN |
EN 13544-3:2001+A1:2009 Respiratory therapy equipment — Part 3: Air entrainment devices |
7.7.2010 |
EN 13544-3:2001 Note 2.1 |
21.3.2010 |
CEN |
EN 13624:2003 Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area — Test method and requirements (phase 2, step 1) |
30.9.2005 |
|
|
CEN |
EN 13718-1:2008 Medical vehicles and their equipment — Air ambulances — Part 1: Requirements for medical devices used in air ambulances |
19.2.2009 |
EN 13718-1:2002 Note 2.1 |
28.2.2009 |
CEN |
EN 13718-2:2015 Medical vehicles and their equipment — Air ambulances — Part 2: Operational and technical requirements for air ambulances |
10.7.2015 |
|
|
CEN |
EN 13726-1:2002 Test methods for primary wound dressings — Part 1: Aspects of absorbency |
27.3.2003 |
|
|
|
EN 13726-1:2002/AC:2003 |
2.12.2009 |
|
|
CEN |
EN 13726-2:2002 Test methods for primary wound dressings — Part 2: Moisture vapour transmission rate of permeable film dressings |
27.3.2003 |
|
|
CEN |
EN 13727:2012 Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of bactericidal activity in the medical area — Test method and requirements (phase 2, step 1) |
30.8.2012 |
EN 13727:2003 Note 2.1 |
30.11.2012 |
CEN |
EN 13867:2002+A1:2009 Concentrates for haemodialysis and related therapies |
2.12.2009 |
EN 13867:2002 Note 2.1 |
21.3.2010 |
CEN |
EN 13976-1:2011 Rescue systems — Transportation of incubators — Part 1: Interface conditions |
19.8.2011 |
EN 13976-1:2003 Note 2.1 |
30.11.2011 |
CEN |
EN 13976-2:2011 Rescue systems — Transportation of incubators — Part 2: System requirements |
19.8.2011 |
EN 13976-2:2003 Note 2.1 |
30.11.2011 |
CEN |
EN 14079:2003 Non-active medical devices — Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze |
30.9.2005 |
|
|
CEN |
EN 14139:2010 Ophthalmic optics — Specifications for ready-to-wear spectacles |
18.1.2011 |
|
|
CEN |
EN ISO 14155:2011 Clinical investigation of medical devices for human subjects — Good clinical practice (ISO 14155:2011) |
27.4.2012 |
EN ISO 14155:2011 Note 2.1 |
30.4.2012 |
|
EN ISO 14155:2011/AC:2011 |
This is the first publication |
|
|
CEN |
EN 14180:2003+A2:2009 Sterilizers for medical purposes — Low temperature steam and formaldehyde sterilizers — Requirements and testing |
7.7.2010 |
EN 14180:2003+A1:2009 Note 2.1 |
21.3.2010 |
CEN |
EN 14348:2005 Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants — Test methods and requirements (phase 2, step 1) |
30.9.2005 |
|
|
CEN |
EN ISO 14408:2009 Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information (ISO 14408:2005) |
2.12.2009 |
EN ISO 14408:2005 Note 2.1 |
21.3.2010 |
CEN |
EN 14561:2006 Chemical disinfectants and antiseptics — Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area — Test method and requirements (phase 2, step 2) |
15.11.2006 |
|
|
CEN |
EN 14562:2006 Chemical disinfectants and antiseptics — Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area — Test method and requirements (phase 2, step 2) |
15.11.2006 |
|
|
CEN |
EN 14563:2008 Chemical disinfectants and antiseptics — Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area — Test method and requirements (phase 2, step 2) |
19.2.2009 |
|
|
CEN |
EN ISO 14602:2011 Non-active surgical implants — Implants for osteosynthesis — Particular requirements (ISO 14602:2010) |
27.4.2012 |
EN ISO 14602:2010 Note 2.1 |
30.4.2012 |
CEN |
EN ISO 14607:2009 Non-active surgical implants — Mammary implants — Particular requirements (ISO 14607:2007) |
2.12.2009 |
EN ISO 14607:2007 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 14630:2009 Non-active surgical implants — General requirements (ISO 14630:2008) |
2.12.2009 |
EN ISO 14630:2008 Note 2.1 |
21.3.2010 |
CEN |
EN 14683:2005 Surgical masks — Requirements and test methods |
2.6.2006 |
|
|
CEN |
EN ISO 14889:2009 Ophthalmic optics — Spectacle lenses — Fundamental requirements for uncut finished lenses (ISO 14889:2003) |
2.12.2009 |
EN ISO 14889:2003 Note 2.1 |
21.3.2010 |
CEN |
EN 14931:2006 Pressure vessels for human occupancy (PVHO) — Multi-place pressure chamber systems for hyperbaric therapy — Performance, safety requirements and testing |
15.11.2006 |
|
|
CEN |
EN ISO 14937:2009 Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) |
7.7.2010 |
EN ISO 14937:2000 Note 2.1 |
30.4.2010 |
CEN |
EN ISO 14971:2012 Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
30.8.2012 |
EN ISO 14971:2009 Note 2.1 |
30.8.2012 |
CEN |
EN ISO 15001:2011 Anaesthetic and respiratory equipment — Compatibility with oxygen (ISO 15001:2010) |
27.4.2012 |
EN ISO 15001:2010 Note 2.1 |
30.4.2012 |
CEN |
EN ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008) |
19.2.2009 |
EN 13220:1998 Note 2.1 |
31.7.2010 |
CEN |
EN ISO 15004-1:2009 Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006) |
2.12.2009 |
EN ISO 15004-1:2006 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03) |
This is the first publication |
EN 980:2008 Note 2.1 |
31.12.2017 |
CEN |
EN ISO 15747:2011 Plastic containers for intravenous injections (ISO 15747:2010) |
27.4.2012 |
EN ISO 15747:2010 Note 2.1 |
30.4.2012 |
CEN |
EN ISO 15798:2010 Ophthalmic implants — Ophthalmic viscosurgical devices (ISO 15798:2010) |
7.7.2010 |
|
|
CEN |
EN ISO 15883-1:2009 Washer-disinfectors — Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006) |
2.12.2009 |
EN ISO 15883-1:2006 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 15883-2:2009 Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006) |
2.12.2009 |
EN ISO 15883-2:2006 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 15883-3:2009 Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006) |
2.12.2009 |
EN ISO 15883-3:2006 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 15883-4:2009 Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008) |
2.12.2009 |
EN ISO 15883-4:2008 Note 2.1 |
21.3.2010 |
CEN |
EN 15986:2011 Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates |
13.5.2011 |
|
|
CEN |
EN ISO 16061:2009 Instrumentation for use in association with non-active surgical implants — General requirements (ISO 16061:2008, Corrected version 2009-03-15) |
7.7.2010 |
EN ISO 16061:2008 Note 2.1 |
28.2.2010 |
CEN |
EN ISO 16201:2006 Technical aids for disabled persons — Environmental control systems for daily living (ISO 16201:2006) |
19.2.2009 |
|
|
CEN |
EN ISO 17510-1:2009 Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
2.12.2009 |
EN ISO 17510-1:2007 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 17510-2:2009 Sleep apnoea breathing therapy — Part 2: Masks and application accessories (ISO 17510-2:2007) |
2.12.2009 |
EN ISO 17510-2:2007 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 17664:2004 Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004) |
30.9.2005 |
|
|
CEN |
EN ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
15.11.2006 |
EN 554:1994 Note 2.1 |
31.8.2009 |
CEN |
EN ISO 18777:2009 Transportable liquid oxygen systems for medical use — Particular requirements (ISO 18777:2005) |
2.12.2009 |
EN ISO 18777:2005 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 18778:2009 Respiratory equipment — Infant monitors — Particular requirements (ISO 18778:2005) |
2.12.2009 |
EN ISO 18778:2005 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures — Particular requirements (ISO 18779:2005) |
30.9.2005 |
|
|
CEN |
EN ISO 19054:2006 Rail systems for supporting medical equipment (ISO 19054:2005) |
7.9.2006 |
EN 12218:1998 Note 2.1 |
30.6.2008 |
CEN |
EN 20594-1:1993 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements (ISO 594-1:1986) |
18.11.1995 |
|
|
|
EN 20594-1:1993/A1:1997 |
10.8.1999 |
Note 3 |
31.5.1998 |
|
EN 20594-1:1993/AC:1996 |
2.12.2009 |
|
|
CEN |
EN ISO 21534:2009 Non-active surgical implants — Joint replacement implants — Particular requirements (ISO 21534:2007) |
2.12.2009 |
EN ISO 21534:2007 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 21535:2009 Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants (ISO 21535:2007) |
2.12.2009 |
EN ISO 21535:2007 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 21536:2009 Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants (ISO 21536:2007) |
2.12.2009 |
EN ISO 21536:2007 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 21649:2009 Needle-free injectors for medical use — Requirements and test methods (ISO 21649:2006) |
7.7.2010 |
EN ISO 21649:2006 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 21969:2009 High-pressure flexible connections for use with medical gas systems (ISO 21969:2009) |
7.7.2010 |
EN ISO 21969:2006 Note 2.1 |
31.5.2010 |
CEN |
EN ISO 21987:2009 Ophthalmic optics — Mounted spectacle lenses (ISO 21987:2009) |
7.7.2010 |
|
|
CEN |
EN ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management (ISO 22442-1:2007) |
27.2.2008 |
EN 12442-1:2000 Note 2.1 |
30.6.2008 |
CEN |
EN ISO 22442-2:2007 Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007) |
27.2.2008 |
EN 12442-2:2000 Note 2.1 |
30.6.2008 |
CEN |
EN ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007) |
27.2.2008 |
EN 12442-3:2000 Note 2.1 |
30.6.2008 |
CEN |
EN ISO 22523:2006 External limb prostheses and external orthoses — Requirements and test methods (ISO 22523:2006) |
9.8.2007 |
EN 12523:1999 Note 2.1 |
30.4.2007 |
This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. |
||||
CEN |
EN ISO 22675:2016 Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods (ISO 22675:2016) |
This is the first publication |
EN ISO 22675:2006 Note 2.1 |
30.6.2018 |
CEN |
EN ISO 23328-1:2008 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003) |
19.2.2009 |
EN 13328-1:2001 Note 2.1 |
30.9.2008 |
CEN |
EN ISO 23328-2:2009 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects (ISO 23328-2:2002) |
2.12.2009 |
EN ISO 23328-2:2008 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 23747:2009 Anaesthetic and respiratory equipment — Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007) |
2.12.2009 |
EN ISO 23747:2007 Note 2.1 |
21.3.2010 |
CEN |
EN ISO 25539-1:2009 Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005) |
2.12.2009 |
EN 12006-3:1998+A1:2009 EN ISO 25539-1:2008 Note 2.1 |
21.3.2010 |
|
EN ISO 25539-1:2009/AC:2011 |
30.8.2012 |
|
|
CEN |
EN ISO 25539-2:2009 Cardiovascular implants — Endovascular devices — Part 2: Vascular stents (ISO 25539-2:2008) |
2.12.2009 |
EN 12006-3:1998+A1:2009 EN ISO 25539-2:2008 Note 2.1 |
21.3.2010 |
|
EN ISO 25539-2:2009/AC:2011 |
30.8.2012 |
|
|
CEN |
EN ISO 26782:2009 Anaesthetic and respiratory equipment — Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009) |
7.7.2010 |
|
|
|
EN ISO 26782:2009/AC:2009 |
7.7.2010 |
|
|
CEN |
EN 27740:1992 Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985) |
18.11.1995 |
|
|
|
EN 27740:1992/A1:1997 |
10.8.1999 |
Note 3 |
31.5.1998 |
|
EN 27740:1992/AC:1996 |
2.12.2009 |
|
|
CEN |
EN ISO 81060-1:2012 Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007) |
30.8.2012 |
EN 1060-1:1995+A2:2009 EN 1060-2:1995+A1:2009 Note 2.1 |
31.5.2015 |
Cenelec |
EN 60118-13:2005 Electroacoustics — Hearing aids — Part 13: Electromagnetic compatibility (EMC) IEC 60118-13:2004 |
19.1.2006 |
EN 60118-13:1997 Note 2.1 |
1.2.2008 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60522:1999 Determination of the permanent filtration of X-ray tube assemblies IEC 60522:1999 |
14.11.2001 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60580:2000 Medical electrical equipment — Dose area product meters IEC 60580:2000 |
13.12.2002 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-1:2006 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005 |
27.11.2008 |
EN 60601-1:1990 + A13:1996 + A1:1993 + A2:1995 EN 60601-1-1:2001 EN 60601-1-4:1996 + A1:1999 Note 2.1 |
1.6.2012 |
|
EN 60601-1:2006/AC:2010 |
18.1.2011 |
|
|
|
EN 60601-1:2006/A1:2013 IEC 60601-1:2005/A1:2012 |
16.5.2014 |
Note 3 |
31.12.2017 |
Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN 60601-1:2006. The date of cessation of presumption of conformity when applying EN 60601-1:2006 is 31.12.2017. However the Annex ZZ to EN 60601-1:2006 ceases to specify the presumption of conformity with the Essential Requirements of Directive 93/42/EEC on 31.12.2015. As from 1.1.2016, only the clauses and sub-clauses of EN 60601-1:2006 corresponding to the clauses and sub-clauses referred to in Annex ZZ to EN 60601-1:2006/A1:2013 provide presumption of conformity with the Essential Requirements of Directive 93/42/EEC, to the extent indicated in the Annex ZZ to EN 60601-1:2006/A1:2013. |
||||
Cenelec |
EN 60601-1-1:2001 Medical electrical equipment — Part 1-1: General requirements for safety — Collateral standard: Safety requirements for medical electrical systems IEC 60601-1-1:2000 |
14.11.2001 |
EN 60601-1-1:1993 + A1:1996 Note 2.1 |
1.11.2003 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-1-2:2015 Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests IEC 60601-1-2:2014 |
13.5.2016 |
EN 60601-1-2:2007 Note 2.1 |
31.12.2018 |
Cenelec |
EN 60601-1-3:2008 Medical electrical equipment — Part 1-3: General requirements for basic safety and essential performance — Collateral Standard: Radiation protection in diagnostic X-ray equipment IEC 60601-1-3:2008 |
27.11.2008 |
EN 60601-1-3:1994 Note 2.1 |
1.6.2012 |
|
EN 60601-1-3:2008/AC:2010 |
18.1.2011 |
|
|
|
EN 60601-1-3:2008/A11:2016 |
This is the first publication |
Note 3 |
1.11.2019 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-1-4:1996 Medical electrical equipment — Part 1-4: General requirements for safety — Collateral standard: Programmable electrical medical systems IEC 60601-1-4:1996 |
8.11.1997 |
|
|
|
EN 60601-1-4:1996/A1:1999 IEC 60601-1-4:1996/A1:1999 |
8.11.1997 |
Note 3 |
1.12.2002 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-1-6:2010 Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral standard: Usability IEC 60601-1-6:2010 |
18.1.2011 |
EN 60601-1-6:2007 Note 2.1 |
1.4.2013 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-1-8:2007 Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 60601-1-8:2006 |
27.11.2008 |
EN 60601-1-8:2004 + A1:2006 Note 2.1 |
1.6.2012 |
|
EN 60601-1-8:2007/AC:2010 |
18.1.2011 |
|
|
|
EN 60601-1-8:2007/A11:2017 |
This is the first publication |
Note 3 |
7.1.2020 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-1-10:2008 Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral Standard: Requirements for the development of physiologic closed-loop controllers IEC 60601-1-10:2007 |
27.11.2008 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-1-11:2010 Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment IEC 60601-1-11:2010 |
18.1.2011 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-1:1998 Medical electrical equipment — Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV IEC 60601-2-1:1998 |
14.11.2001 |
|
|
|
EN 60601-2-1:1998/A1:2002 IEC 60601-2-1:1998/A1:2002 |
13.12.2002 |
Note 3 |
1.6.2005 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-2:2009 Medical electrical equipment — Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories IEC 60601-2-2:2009 |
7.7.2010 |
EN 60601-2-2:2007 Note 2.1 |
1.4.2012 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-3:1993 Medical electrical equipment — Part 2: Particular requirements for the safety of short-wave therapy equipment IEC 60601-2-3:1991 |
18.11.1995 |
|
|
|
EN 60601-2-3:1993/A1:1998 IEC 60601-2-3:1991/A1:1998 |
18.11.1995 |
Note 3 |
1.7.2001 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-4:2003 Medical electrical equipment — Part 2-4: Particular requirements for the safety of cardiac defibrillators IEC 60601-2-4:2002 |
15.10.2003 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-5:2000 Medical electrical equipment — Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment IEC 60601-2-5:2000 |
13.12.2002 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-8:1997 Medical electrical equipment — Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV IEC 60601-2-8:1987 |
14.11.2001 |
|
|
|
EN 60601-2-8:1997/A1:1997 IEC 60601-2-8:1987/A1:1997 |
14.11.2001 |
Note 3 |
1.7.1998 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-10:2000 Medical electrical equipment — Part 2-10: Particular requirements for the safety of nerve and muscle stimulators IEC 60601-2-10:1987 |
13.12.2002 |
|
|
|
EN 60601-2-10:2000/A1:2001 IEC 60601-2-10:1987/A1:2001 |
13.12.2002 |
Note 3 |
1.11.2004 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-11:1997 Medical electrical equipment — Part 2-11: Particular requirements for the safety of gamma beam therapy equipment IEC 60601-2-11:1997 |
9.10.1999 |
|
|
|
EN 60601-2-11:1997/A1:2004 IEC 60601-2-11:1997/A1:2004 |
9.10.1999 |
Note 3 |
1.9.2007 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-12:2006 Medical electrical equipment — Part 2-12: Particular requirements for the safety of lung ventilators — Critical care ventilators IEC 60601-2-12:2001 |
22.12.2007 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-13:2006 Medical electrical equipment — Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems IEC 60601-2-13:2003 |
22.12.2007 |
|
|
|
EN 60601-2-13:2006/A1:2007 IEC 60601-2-13:2003/A1:2006 |
22.12.2007 |
Note 3 |
1.3.2010 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-16:1998 Medical electrical equipment — Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment IEC 60601-2-16:1998 |
9.10.1999 |
|
|
|
EN 60601-2-16:1998/AC:1999 |
18.1.2011 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-17:2004 Medical electrical equipment — Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment IEC 60601-2-17:2004 |
8.11.2005 |
EN 60601-2-17:1996 + A1:1996 Note 2.1 |
1.3.2007 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-18:1996 Medical electrical equipment — Part 2: Particular requirements for the safety of endoscopic equipment IEC 60601-2-18:1996 |
9.10.1999 |
|
|
|
EN 60601-2-18:1996/A1:2000 IEC 60601-2-18:1996/A1:2000 |
9.10.1999 |
Note 3 |
1.8.2003 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-19:2009 Medical electrical equipment — Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators IEC 60601 IEC 60601-2-19:2009 |
7.7.2010 |
EN 60601-2-19:1996 + A1:1996 Note 2.1 |
1.4.2012 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-20:2009 Medical electrical equipment — Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators IEC 60601 IEC 60601-2-20:2009 |
18.1.2011 |
EN 60601-2-20:1996 Note 2.1 |
1.9.2012 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-21:2009 Medical electrical equipment — Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers IEC 60601-2-21:2009 |
7.7.2010 |
EN 60601-2-21:1994 + A1:1996 Note 2.1 |
1.4.2012 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-22:1996 Medical electrical equipment — Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment IEC 60601-2-22:1995 |
17.5.1997 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-23:2000 Medical electrical equipment — Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment IEC 60601-2-23:1999 |
14.11.2001 |
EN 60601-2-23:1997 Note 2.1 |
1.1.2003 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-24:1998 Medical electrical equipment — Part 2-24: Particular requirements for the safety of infusion pumps and controllers IEC 60601-2-24:1998 |
9.10.1999 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-25:1995 Medical electrical equipment — Part 2-25: Particular requirements for the safety of electrocardiographs IEC 60601-2-25:1993 |
17.5.1997 |
|
|
|
EN 60601-2-25:1995/A1:1999 IEC 60601-2-25:1993/A1:1999 |
13.12.2002 |
Note 3 |
1.5.2002 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-26:2003 Medical electrical equipment — Part 2-26: Particular requirements for the safety of electroencephalographs IEC 60601-2-26:2002 |
8.11.2005 |
EN 60601-2-26:1994 Note 2.1 |
1.3.2006 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-27:2006 Medical electrical equipment — Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment IEC 60601-2-27:2005 |
26.7.2006 |
EN 60601-2-27:1994 Note 2.1 |
1.11.2008 |
|
EN 60601-2-27:2006/AC:2006 |
18.1.2011 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-28:2010 Medical electrical equipment — Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis IEC 60601-2-28:2010 |
18.1.2011 |
EN 60601-2-28:1993 Note 2.1 |
1.4.2013 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-29:2008 Medical electrical equipment — Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators IEC 60601-2-29:2008 |
15.7.2009 |
EN 60601-2-29:1999 Note 2.1 |
1.11.2011 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-30:2000 Medical electrical equipment — Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment IEC 60601-2-30:1999 |
14.11.2001 |
EN 60601-2-30:1995 Note 2.1 |
1.2.2003 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-33:2010 Medical electrical equipment — Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis IEC 60601 IEC 60601-2-33:2010 |
This is the first publication |
EN 60601-2-33:2002 + A1:2005 + A2:2008 Note 2.1 |
31.12.2017 |
|
EN 60601-2-33:2010/A1:2015 IEC 60601-2-33:2010/A1:2013 |
This is the first publication |
Note 3 |
14.4.2018 |
|
EN 60601-2-33:2010/A2:2015 IEC 60601-2-33:2010/A2:2015 |
This is the first publication |
Note 3 |
23.7.2018 |
|
EN 60601-2-33:2010/AC:2016-03 |
This is the first publication |
|
|
|
EN 60601-2-33:2010/A12:2016 |
This is the first publication |
Note 3 |
1.11.2019 |
Cenelec |
EN 60601-2-34:2000 Medical electrical equipment — Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment IEC 60601-2-34:2000 |
15.10.2003 |
EN 60601-2-34:1995 Note 2.1 |
1.11.2003 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-36:1997 Medical electrical equipment — Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy IEC 60601-2-36:1997 |
9.10.1999 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-37:2008 Medical electrical equipment — Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment IEC 60601-2-37:2007 |
27.11.2008 |
EN 60601-2-37:2001 + A1:2005 + A2:2005 Note 2.1 |
1.10.2010 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-39:2008 Medical electrical equipment — Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment IEC 60601-2-39:2007 |
27.11.2008 |
EN 60601-2-39:1999 Note 2.1 |
1.3.2011 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-40:1998 Medical electrical equipment — Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment IEC 60601-2-40:1998 |
9.10.1999 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-41:2009 Medical electrical equipment — Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis IEC 60601-2-41:2009 |
18.1.2011 |
EN 60601-2-41:2000 Note 2.1 |
1.11.2012 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-43:2010 Medical electrical equipment — Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures IEC 60601-2-43:2010 |
18.1.2011 |
EN 60601-2-43:2000 Note 2.1 |
1.6.2013 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-44:2009 Medical electrical equipment — Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography IEC 60601-2-44:2009 |
7.7.2010 |
EN 60601-2-44:2001 + A1:2003 Note 2.1 |
1.5.2012 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-45:2001 Medical electrical equipment — Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices IEC 60601-2-45:2001 |
14.11.2001 |
EN 60601-2-45:1998 Note 2.1 |
1.7.2004 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-46:1998 Medical electrical equipment — Part 2-46: Particular requirements for the safety of operating tables IEC 60601-2-46:1998 |
14.11.2001 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-47:2001 Medical electrical equipment — Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems IEC 60601-2-47:2001 |
13.12.2002 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-49:2001 Medical electrical equipment — Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment IEC 60601-2-49:2001 |
13.12.2002 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-50:2009 Medical electrical equipment — Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment IEC 60601-2-50:2009 |
7.7.2010 |
EN 60601-2-50:2002 Note 2.1 |
1.5.2012 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-51:2003 Medical electrical equipment — Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs IEC 60601-2-51:2003 |
24.6.2004 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-52:2010 Medical electrical equipment — Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009) |
13.5.2011 |
EN 1970:2000 + A1:2005 EN 60601-2-38:1996 + A1:2000 Note 2.1 |
1.6.2012 |
|
EN 60601-2-52:2010/AC:2011 |
30.8.2012 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60601-2-54:2009 Medical electrical equipment — Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy IEC 60601-2-54:2009 |
18.1.2011 |
EN 60601-2-7:1998 EN 60601-2-28:1993 EN 60601-2-32:1994 Note 2.1 |
1.8.2012 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60627:2001 Diagnostic X-ray imaging equipment — Characteristics of general purpose and mammographic anti-scatter grids IEC 60627:2001 |
13.12.2002 |
|
|
|
EN 60627:2001/AC:2002 |
18.1.2011 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60645-1:2001 Electroacoustics — Audiological equipment — Part 1: Pure-tone audiometers IEC 60645-1:2001 |
13.12.2002 |
EN 60645-1:1994 Note 2.1 |
1.10.2004 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60645-2:1997 Audiometers — Part 2: Equipment for speech audiometry IEC 60645-2:1993 |
17.5.1997 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60645-3:2007 Electroacoustics — Audiometric equipment — Part 3: Test signals of short duration IEC 60645-3:2007 |
27.11.2008 |
EN 60645-3:1995 Note 2.1 |
1.6.2010 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 60645-4:1995 Audiometers — Part 4: Equipment for extended high-frequency audiometry IEC 60645-4:1994 |
23.8.1996 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 61217:2012 Radiotherapy equipment — Coordinates, movements and scales IEC 61217:2011 |
30.8.2012 |
EN 61217:1996 + A1:2001 + A2:2008 Note 2.1 |
11.1.2015 |
Cenelec |
EN 61676:2002 Medical electrical equipment — Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology IEC 61676:2002 |
15.10.2003 |
|
|
|
EN 61676:2002/A1:2009 IEC 61676:2002/A1:2008 |
7.7.2010 |
Note 3 |
1.3.2012 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 62083:2009 Medical electrical equipment — Requirements for the safety of radiotherapy treatment planning systems IEC 62083:2009 |
18.1.2011 |
EN 62083:2001 Note 2.1 |
1.11.2012 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 62220-1:2004 Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1: Determination of the detective quantum efficiency IEC 62220-1:2003 |
24.6.2004 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 62220-1-2:2007 Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1-2: Determination of the detective quantum efficiency — Detectors used in mammography IEC 62220-1-2:2007 |
27.11.2008 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 62220-1-3:2008 Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1-3: Determination of the detective quantum efficiency — Detectors used in dynamic imaging IEC 62220-1-3:2008 |
15.7.2009 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 62304:2006 Medical device software — Software life-cycle processes IEC 62304:2006 |
27.11.2008 |
|
|
|
EN 62304:2006/AC:2008 |
18.1.2011 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 62366:2008 Medical devices — Application of usability engineering to medical devices IEC 62366:2007 |
27.11.2008 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 80601-2-35:2009 Medical electrical equipment — Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use IEC 80601-2-35:2009 |
18.1.2011 |
EN 60601-2-35:1996 Note 2.1 |
1.11.2012 |
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 80601-2-58:2009 Medical electrical equipment — Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery IEC 80601-2-58:2008 |
7.7.2010 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
||||
Cenelec |
EN 80601-2-59:2009 Medical electrical equipment — Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening IEC 80601 IEC 80601-2-59:2008 |
18.1.2011 |
|
|
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
Note 1: |
Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. |
Note 2.1: |
The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
Note 2.2: |
The new standard has a broader scope than the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
Note 2.3: |
The new standard has a narrower scope than the superseded standard. On the date stated, the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected. |
Note 3: |
In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
NOTE:
— |
Any information concerning the availability of the standards can be obtained either from the European standardisation organisations or from the national standardisation bodies the list of which is published in the Official Journal of the European Union according to Article 27 of the Regulation (EU) No 1025/2012 (2). |
— |
Standards are adopted by the European standardisation organisations in English (CEN and Cenelec also publish in French and German). Subsequently, the titles of the standards are translated into all other required official languages of the European Union by the national standardisation bodies. The European Commission is not responsible for the correctness of the titles which have been presented for publication in the Official Journal. |
— |
References to Corrigenda ‘…/AC:YYYY’ are published for information only. A Corrigendum removes printing, linguistic or similar errors from the text of a standard and may relate to one or more language versions (English, French and/or German) of a standard as adopted by a European standardisation organisation. |
— |
Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the official languages of the European Union. |
— |
This list replaces all the previous lists published in the Official Journal of the European Union. The European Commission ensures the updating of this list. |
— |
More information about harmonised standards and other European standards on the Internet at http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/index_en.htm |
(1) ESO: European standardisation organisation:
— |
CEN: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5500811; fax + 32 2 5500819 (http://www.cen.eu) |
— |
CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5196871; fax + 32 2 5196919 (http://www.cenelec.eu) |
— |
ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. +33 492 944200; fax +33 493 654716, (http://www.etsi.eu) |
(2) OJ C 338, 27.9.2014, p. 31.
17.11.2017 |
EN |
Official Journal of the European Union |
C 389/62 |
Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices
(Publication of titles and references of harmonised standards under Union harmonisation legislation)
(Text with EEA relevance)
(2017/C 389/04)
ESO (1) |
Reference and title of the standard (and reference document) |
First publication OJ |
Reference of superseded standard |
Date of cessation of presumption of conformity of superseded standard Note 1 |
(1) |
(2) |
(3) |
(4) |
(5) |
CEN |
EN 556-1:2001 Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilized medical devices |
31.7.2002 |
EN 556:1994 + A1:1998 Note 2.1 |
30.4.2002 |
|
EN 556-1:2001/AC:2006 |
15.11.2006 |
|
|
CEN |
EN 556-2:2015 Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices |
13.5.2016 |
EN 556-2:2003 Note 2.1 |
30.6.2016 |
CEN |
EN ISO 11137-1:2015 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) |
This is the first publication |
|
|
CEN |
EN ISO 11137-2:2015 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
13.5.2016 |
EN ISO 11137-2:2013 Note 2.1 |
30.6.2016 |
CEN |
EN ISO 11737-2:2009 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) |
7.7.2010 |
|
|
CEN |
EN 12322:1999 In vitro diagnostic medical devices — Culture media for microbiology — Performance criteria for culture media |
9.10.1999 |
|
|
|
EN 12322:1999/A1:2001 |
31.7.2002 |
Note 3 |
30.4.2002 |
CEN |
EN ISO 13408-1:2015 Aseptic processing of health care products — Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
13.5.2016 |
EN ISO 13408-1:2011 Note 2.1 |
30.6.2016 |
CEN |
EN ISO 13408-2:2011 Aseptic processing of health care products — Part 2: Filtration (ISO 13408-2:2003) |
19.8.2011 |
|
|
CEN |
EN ISO 13408-3:2011 Aseptic processing of health care products — Part 3: Lyophilization (ISO 13408-3:2006) |
19.8.2011 |
|
|
CEN |
EN ISO 13408-4:2011 Aseptic processing of health care products — Part 4: Clean-in-place technologies (ISO 13408-4:2005) |
19.8.2011 |
|
|
CEN |
EN ISO 13408-5:2011 Aseptic processing of health care products — Part 5: Sterilization in place (ISO 13408-5:2006) |
19.8.2011 |
|
|
CEN |
EN ISO 13408-6:2011 Aseptic processing of health care products — Part 6: Isolator systems (ISO 13408-6:2005) |
19.8.2011 |
|
|
CEN |
EN ISO 13408-7:2015 Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012) |
13.5.2016 |
|
|
CEN |
EN ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2016) |
This is the first publication |
EN ISO 13485:2012 Note 2.1 |
31.3.2019 |
|
EN ISO 13485:2016/AC:2016 |
This is the first publication |
|
|
CEN |
EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing |
17.12.2002 |
|
|
CEN |
EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices |
17.12.2002 |
|
|
|
EN 13612:2002/AC:2002 |
2.12.2009 |
|
|
CEN |
EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents |
17.12.2002 |
|
|
CEN |
EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices — Statistical aspects |
21.11.2003 |
|
|
CEN |
EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures |
15.11.2006 |
|
|
CEN |
EN 14254:2004 In vitro diagnostic medical devices — Single-use receptacles for the collection of specimens, other than blood, from humans |
28.4.2005 |
|
|
CEN |
EN 14820:2004 Single-use containers for human venous blood specimen collection |
28.4.2005 |
|
|
CEN |
EN ISO 14937:2009 Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) |
7.7.2010 |
EN ISO 14937:2000 Note 2.1 |
30.4.2010 |
CEN |
EN ISO 14971:2012 Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
30.8.2012 |
EN ISO 14971:2009 Note 2.1 |
30.8.2012 |
CEN |
EN ISO 15193:2009 In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures (ISO 15193:2009) |
7.7.2010 |
|
|
CEN |
EN ISO 15194:2009 In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009) |
7.7.2010 |
|
|
CEN |
EN ISO 15197:2015 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013) |
13.5.2016 |
EN ISO 15197:2013 Note 2.1 |
31.7.2016 |
For blood glucose test strips and control solutions, the date of cessation of presumption of conformity of the superseded standard shall be 30.6.2017. |
||||
CEN |
EN ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements (ISO 15223-1:2016, Corrected version 2016-12-15) |
This is the first publication |
EN 980:2008 Note 2.1 |
31.12.2017 |
CEN |
EN ISO 17511:2003 In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003) |
28.4.2005 |
|
|
CEN |
EN ISO 18113-1:2011 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
27.4.2012 |
EN ISO 18113-1:2009 Note 2.1 |
30.4.2012 |
CEN |
EN ISO 18113-2:2011 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009) |
27.4.2012 |
EN ISO 18113-2:2009 Note 2.1 |
30.4.2012 |
CEN |
EN ISO 18113-3:2011 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009) |
27.4.2012 |
EN ISO 18113-3:2009 Note 2.1 |
30.4.2012 |
CEN |
EN ISO 18113-4:2011 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009) |
27.4.2012 |
EN ISO 18113-4:2009 Note 2.1 |
30.4.2012 |
CEN |
EN ISO 18113-5:2011 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009) |
27.4.2012 |
EN ISO 18113-5:2009 Note 2.1 |
30.4.2012 |
CEN |
EN ISO 18153:2003 In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003) |
21.11.2003 |
|
|
CEN |
EN ISO 20776-1:2006 Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006) |
9.8.2007 |
|
|
CEN |
EN ISO 23640:2015 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011) |
13.5.2016 |
EN 13640:2002 Note 2.1 |
30.6.2017 |
Cenelec |
EN 61010-2-101:2002 Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment IEC 61010-2-101:2002 (Modified) |
17.12.2002 |
|
|
Cenelec |
EN 61326-2-6:2006 Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-6: Particular requirements — In vitro diagnostic (IVD) medical equipment IEC 61326-2-6:2005 |
27.11.2008 |
|
|
Cenelec |
EN 62304:2006 Medical device software — Software life-cycle processes IEC 62304:2006 |
27.11.2008 |
|
|
|
EN 62304:2006/AC:2008 |
18.1.2011 |
|
|
Cenelec |
EN 62366:2008 Medical devices — Application of usability engineering to medical devices IEC 62366:2007 |
27.11.2008 |
|
|
Note 1: |
Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. |
Note 2.1: |
The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
Note 2.2: |
The new standard has a broader scope than the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
Note 2.3: |
The new standard has a narrower scope than the superseded standard. On the date stated, the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected. |
Note 3: |
In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
NOTE:
— |
Any information concerning the availability of the standards can be obtained either from the European standardisation organisations or from the national standardisation bodies the list of which is published in the Official Journal of the European Union according to Article 27 of the Regulation (EU) No 1025/2012 (2). |
— |
Standards are adopted by the European standardisation organisations in English (CEN and Cenelec also publish in French and German). Subsequently, the titles of the standards are translated into all other required official languages of the European Union by the national standardisation bodies. The European Commission is not responsible for the correctness of the titles which have been presented for publication in the Official Journal. |
— |
References to Corrigenda ‘…/AC:YYYY’ are published for information only. A Corrigendum removes printing, linguistic or similar errors from the text of a standard and may relate to one or more language versions (English, French and/or German) of a standard as adopted by a European standardisation organisation. |
— |
Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the official languages of the European Union. |
— |
This list replaces all the previous lists published in the Official Journal of the European Union. The European Commission ensures the updating of this list. |
— |
More information about harmonised standards and other European standards on the Internet at http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/index_en.htm |
(1) ESO: European standardisation organisation:
— |
CEN: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5500811; fax + 32 2 5500819 (http://www.cen.eu) |
— |
CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5196871; fax + 32 2 5196919 (http://www.cenelec.eu) |
— |
ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. +33 492 944200; fax +33 493 654716, (http://www.etsi.eu) |
(2) OJ C 338, 27.9.2014, p. 31.
17.11.2017 |
EN |
Official Journal of the European Union |
C 389/68 |
Commission communication in the framework of the implementation of Directive 1999/5/EC of the European Parliament and of the Council on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity and Directive 2014/53/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC
(Publication of titles and references of harmonised standards under Union harmonisation legislation)
(Text with EEA relevance)
(2017/C 389/05)
Directive 1999/5/EC
In accordance with the transitional provision of Article 48 of Directive 2014/53/EU (1), Member States shall not impede the making available on the market or putting into service of radio equipment covered by Directive 2014/53/EU which is in conformity with Directive 1999/5/EC (2) and which was placed on the market before 13 June 2017. Accordingly, harmonised standards the references to which have been published under Directive 1999/5/EC, as lastly listed in Commission Communication published in the Official Journal of the European Union C 249 of 8 July 2016, p. 1 , and corrected by Corrigendum published in the Official Journal of the European Union C 342 of 17 September 2016, p. 15 , and Corrigendum published in the Official Journal of the European Union C 403 of 1 November 2016, p. 26 , continue to confer a presumption of conformity with that Directive until 12 June 2017.
Directive 2014/53/EU
(Publication of titles and references of harmonised standards under Union harmonisation legislation)
ESO (3) |
Reference and title of the standard (and reference document) |
First publication OJ |
Reference of superseded standard |
Date of cessation of presumption of conformity of superseded standard Note 1 |
Standard aims to cover Article(s) of Directive 2014/53/EU |
(1) |
(2) |
(3) |
(4) |
(5) |
(6) |
Cenelec |
EN 50360:2017 Product standard to demonstrate the compliance of wireless communication devices, with the basic restrictions and exposure limit values related to human exposure to electromagnetic fields in the frequency range from 300 MHz to 6 GHz: devices used next to the ear |
This is the first publication |
|
|
Article 3(1)(a) |
Cenelec |
EN 50385:2017 Product standard to demonstrate the compliance of base station equipment with radiofrequency electromagnetic field exposure limits (110 MHz — 100 GHz), when placed on the market |
This is the first publication |
|
|
Article 3(1)(a) |
Cenelec |
EN 50401:2017 Product standard to demonstrate the compliance of base station equipment with radiofrequency electromagnetic field exposure limits (110 MHz — 100 GHz), when put into service |
This is the first publication |
|
|
Article 3(1)(a) |
Cenelec |
EN 50566:2017 Product standard to demonstrate the compliance of wireless communication devices with the basic restrictions and exposure limit values related to human exposure to electromagnetic fields in the frequency range from 30 MHz to 6 GHz: hand-held and body mounted devices in close proximity to the human body |
This is the first publication |
|
|
Article 3(1)(a) |
Cenelec |
EN 55035:2017 Electromagnetic compatibility of multimedia equipment — Immunity requirements CISPR 35:2016 (Modified) |
This is the first publication |
|
|
Article 3(1)(b) |
ETSI |
EN 300 065 V2.1.2 Narrow-band direct-printing telegraph equipment for receiving meteorological or navigational information (NAVTEX); Harmonised Standard covering the essential requirements of articles 3.2 and 3.3(g) of the Directive 2014/53/EU |
8.7.2016 |
|
|
Article 3(2); Article 3(3)(g) |
ETSI |
EN 300 086 V2.1.2 Land Mobile Service; Radio equipment with an internal or external RF connector intended primarily for analogue speech; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
9.12.2016 |
|
|
Article 3(2) |
ETSI |
EN 300 113 V2.2.1 Land Mobile Service; Radio equipment intended for the transmission of data (and/or speech) using constant or non-constant envelope modulation and having an antenna connector; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 300 219 V2.1.1 Land Mobile Service; Radio equipment transmitting signals to initiate a specific response in the receiver; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 300 220-2 V3.1.1 Short Range Devices (SRD) operating in the frequency range 25 MHz to 1 000 MHz; Part 2: Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU for non specific radio equipment |
10.3.2017 |
|
|
Article 3(2) |
ETSI |
EN 300 220-3-1 V2.1.1 Short Range Devices (SRD) operating in the frequency range 25 MHz to 1 000 MHz; Part 3-1: Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU; Low duty cycle high reliability equipment, social alarms equipment operating on designated frequencies (869,200 MHz to 869,250 MHz) |
10.3.2017 |
|
|
Article 3(2) |
ETSI |
EN 300 220-3-2 V1.1.1 Short Range Devices (SRD) operating in the frequency range 25 MHz to 1 000 MHz; Part 3-2: Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU; Wireless alarms operating in designated LDC/HR frequency bands 868,60 MHz to 868,70 MHz, 869,25 MHz to 869,40 MHz, 869,65 MHz to 869,70 MHz |
10.3.2017 |
|
|
Article 3(2) |
ETSI |
EN 300 220-4 V1.1.1 Short Range Devices (SRD) operating in the frequency range 25 MHz to 1 000 MHz; Part 4: Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU; Metering devices operating in designated band 169,400 MHz to 169,475 MHz |
10.3.2017 |
|
|
Article 3(2) |
ETSI |
EN 300 224 V2.1.1 Land Mobile Service; Radio Equipment for use in a Paging Service operating within the frequency range 25 MHz — 470 MHz; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
13.10.2017 |
EN 300 224-2 V1.1.1 Note 2.1 |
28.2.2019 |
Article 3(2) |
ETSI |
EN 300 224-2 V1.1.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); On-site paging service; Part 2: Harmonized EN under article 3.2 of the R&TTE Directive |
8.6.2017 |
|
|
Article 3(2) |
This harmonised standard does not address requirements relating to receiver performance parameters and does not confer a presumption of conformity as regards those parameters. |
|||||
ETSI |
EN 300 296 V2.1.1 Land Mobile Service; Radio equipment using integral antennas intended primarily for analogue speech; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 300 328 V2.1.1 Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
13.1.2017 |
|
|
Article 3(2) |
ETSI |
EN 300 330 V2.1.1 Short Range Devices (SRD); Radio equipment in the frequency range 9 kHz to 25 MHz and inductive loop systems in the frequency range 9 kHz to 30 MHz; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
10.3.2017 |
|
|
Article 3(2) |
ETSI |
EN 300 341 V2.1.1 Land Mobile Service; Radio equipment using an integral antenna transmitting signals to initiate a specific response in the receiver; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 300 390 V2.1.1 Land Mobile Service; Radio equipment intended for the transmission of data (and speech) and using an integral antenna; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 300 422-1 V2.1.2 Wireless Microphones; Audio PMSE up to 3 GHz; Part 1: Class A Receivers; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
10.2.2017 |
|
|
Article 3(2) |
ETSI |
EN 300 422-2 V2.1.1 Wireless Microphones; Audio PMSE up to 3 GHz; Part 2: Class B Receivers; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
10.3.2017 |
|
|
Article 3(2) |
ETSI |
EN 300 422-3 V2.1.1 Wireless Microphones; Audio PMSE up to 3 GHz; Part 3: Class C Receivers; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
10.3.2017 |
|
|
Article 3(2) |
ETSI |
EN 300 433 V2.1.1 Citizens' Band (CB) radio equipment; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 300 440 V2.1.1 Short Range Devices (SRD); Radio equipment to be used in the 1 GHz to 40 GHz frequency range; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
14.7.2017 |
EN 300 440-2 V1.4.1 Note 2.1 |
31.12.2018 |
Article 3(2) |
This harmonised standard does not address, for receiver categories 2 and 3 as defined in Table 5, the requirements relating to receiver performance parameters and does not confer a presumption of conformity as regards those parameters. |
|||||
ETSI |
EN 300 440-2 V1.4.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Short range devices; Radio equipment to be used in the 1 GHz to 40 GHz frequency range; Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive |
8.6.2017 |
|
|
Article 3(2) |
This harmonised standard does not address requirements relating to receiver performance parameters and does not confer a presumption of conformity as regards those parameters. |
|||||
ETSI |
EN 300 454-2 V1.1.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Wide band audio links; Part 2: Harmonized EN under article 3.2 of the R&TTE Directive |
8.6.2017 |
|
|
Article 3(2) |
This harmonised standard does not address requirements relating to receiver performance parameters and does not confer a presumption of conformity as regards those parameters. |
|||||
ETSI |
EN 300 487 V2.1.2 Satellite Earth Stations and Systems (SES); Harmonised Standard for Receive-Only Mobile Earth Stations (ROMES) providing data communications operating in the 1,5 GHz frequency band; Radio Frequency (RF) specifications covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
13.1.2017 |
|
|
Article 3(2) |
ETSI |
EN 300 676-2 V2.1.1 Ground-based VHF hand-held, mobile and fixed radio transmitters, receivers and transceivers for the VHF aeronautical mobile service using amplitude modulation; Part 2: Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
8.7.2016 |
|
|
Article 3(2) |
ETSI |
EN 300 698 V2.1.1 Radio telephone transmitters and receivers for the maritime mobile service operating in the VHF bands used on inland waterways; Harmonised Standard covering the essential requirements of articles 3.2 and 3.3(g) of the Directive 2014/53/EU |
13.1.2017 |
|
|
Article 3(2); Article 3(3)(g) |
ETSI |
EN 300 718-2 V1.1.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Avalanche Beacons; Transmitter-receiver systems; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive |
8.6.2017 |
|
|
Article 3(2) |
This harmonised standard does not address requirements relating to receiver performance parameters and does not confer a presumption of conformity as regards those parameters. |
|||||
ETSI |
EN 300 718-3 V1.2.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Avalanche Beacons; Transmitter-receiver systems; Part 3: Harmonized EN covering essential requirements of article 3.3e of the R&TTE Directive |
8.6.2017 |
|
|
Article 3(3)(g) |
ETSI |
EN 300 720 V2.1.1 Ultra-High Frequency (UHF) on-board vessels communications systems and equipment; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
10.3.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 025 V2.1.1 VHF radiotelephone equipment for general communications and associated equipment for Class ‘D’ Digital Selective Calling (DSC); Harmonised Standard covering the essential requirements of articles 3.2 and 3.3(g) of the Directive 2014/53/EU |
12.8.2016 |
|
|
Article 3(2); Article 3(3)(g) |
ETSI |
EN 301 025 V2.2.1 VHF radiotelephone equipment for general communications and associated equipment for Class ‘D’ Digital Selective Calling (DSC); Harmonised Standard covering the essential requirements of articles 3.2 and 3.3(g) of Directive 2014/53/EU |
12.4.2017 |
EN 301 025 V2.1.1 Note 2.1 |
30.11.2018 |
Article 3(2); Article 3(3)(g) |
ETSI |
EN 301 091-2 V1.3.2 Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices; Road Transport and Traffic Telematics (RTTT); Radar equipment operating in the 76 GHz to 77 GHz range; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive |
8.6.2017 |
|
|
Article 3(2) |
This harmonised standard does not address requirements relating to receiver performance parameters and does not confer a presumption of conformity as regards those parameters. |
|||||
ETSI |
EN 301 166 V2.1.1 Land Mobile Service; Radio equipment for analogue and/or digital communication (speech and/or data) and operating on narrow band channels and having an antenna connector; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
10.2.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 178 V2.2.2 Portable Very High Frequency (VHF) radiotelephone equipment for the maritime mobile service operating in the VHF bands (for non-GMDSS applications only); Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
12.5.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 357 V2.1.1 Cordless audio devices in the range 25 MHz to 2 000 MHz; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
14.7.2017 |
EN 301 357-2 V1.4.1 Note 2.1 |
28.2.2019 |
Article 3(2) |
ETSI |
EN 301 357-2 V1.4.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Cordless audio devices in the range 25 MHz to 2 000 MHz; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive |
8.6.2017 |
|
|
Article 3(2) |
This harmonised standard does not address requirements relating to receiver performance parameters and does not confer a presumption of conformity as regards those parameters. |
|||||
ETSI |
EN 301 360 V2.1.1 Satellite Earth Stations and Systems (SES); Harmonised Standard for Satellite Interactive Terminals (SIT) and Satellite User Terminals (SUT) transmitting towards satellites in geostationary orbit, operating in the 27,5 GHz to 29,5 GHz frequency bands covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
11.11.2016 |
|
|
Article 3(2) |
ETSI |
EN 301 406 V2.2.2 Digital Enhanced Cordless Telecommunications (DECT); Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
11.11.2016 |
|
|
Article 3(2) |
ETSI |
EN 301 426 V2.1.2 Satellite Earth Stations and Systems (SES); Harmonised Standard for Low data rate Land Mobile satellite Earth Stations (LMES) and Maritime Mobile satellite Earth Stations (MMES) not intended for distress and safety communications operating in the 1,5 GHz/1,6 GHz frequency bands covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
13.1.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 427 V2.1.1 Satellite Earth Stations and Systems (SES); Harmonised Standard for low data rate Mobile satellite Earth Stations (MES) except aeronautical mobile satellite earth stations, operating in the 11/12/14 GHz frequency bands covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 428 V2.1.2 Satellite Earth Stations and Systems (SES); Harmonised Standard for Very Small Aperture Terminal (VSAT); Transmit-only, transmit/receive or receive-only satellite earth stations operating in the 11/12/14 GHz frequency bands covering the essential requirements of article 3.2 of Directive 2014/53/EU |
8.6.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 430 V2.1.1 Satellite Earth Stations and Systems (SES); Harmonised Standard for Satellite News Gathering Transportable Earth Stations (SNG TES) operating in the 11 GHz to 12 GHz/13 GHz to 14 GHz frequency bands covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
14.10.2016 |
|
|
Article 3(2) |
ETSI |
EN 301 441 V2.1.1 Satellite Earth Stations and Systems (SES); Harmonised Standard for Mobile Earth Stations (MES), including handheld earth stations, for Satellite Personal Communications Networks (S-PCN) operating in the 1,6 GHz/2,4 GHz frequency band under the Mobile Satellite Service (MSS) covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 442 V2.1.1 Satellite Earth Stations and Systems (SES); Harmonised Standard for NGSO Mobile Earth Stations (MES) including handheld earth stations, for Satellite Personal Communications Networks (S-PCN) operating in the 1 980 MHz to 2 010 MHz (earth-to-space) and 2 170 MHz to 2 200 MHz (space-to-earth) frequency bands under the Mobile Satellite Service (MSS) covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 443 V2.1.1 Satellite Earth Stations and Systems (SES); Harmonised Standard for Very Small Aperture Terminal (VSAT); Transmit-only, transmit-and-receive, receive-only satellite earth stations operating in the 4 GHz and 6 GHz frequency bands covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 444 V2.1.2 Satellite Earth Stations and Systems (SES); Harmonised Standard for Land Mobile Earth Stations (LMES) providing voice and/or data communications, operating in the 1,5 GHz and 1,6 GHz frequency bands covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
13.1.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 447 V2.1.1 Satellite Earth Stations and Systems (SES); Harmonised Standard for satellite Earth Stations on board Vessels (ESVs) operating in the 4/6 GHz frequency bands allocated to the Fixed Satellite Service (FSS) covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 459 V2.1.1 Satellite Earth Stations and Systems (SES); Harmonised Standard for Satellite Interactive Terminals (SIT) and Satellite User Terminals (SUT) transmitting towards satellites in geostationary orbit, operating in the 29,5 GHz to 30,0 GHz frequency bands covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
14.10.2016 |
|
|
Article 3(2) |
ETSI |
EN 301 473 V2.1.2 Satellite Earth Stations and Systems (SES); Harmonised Standard for Aircraft Earth Stations (AES) providing Aeronautical Mobile Satellite Service (AMSS)/Mobile Satellite Service (MSS) and/or the Aeronautical Mobile Satellite on Route Service (AMS(R)S)/Mobile Satellite Service (MSS), operating in the frequency band below 3 GHz covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
13.1.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 502 V12.5.2 Global System for Mobile communications (GSM); Base Station (BS) equipment; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 511 V9.0.2 Global System for Mobile communications (GSM); Harmonized EN for mobile stations in the GSM 900 and GSM 1800 bands covering essential requirements under article 3.2 of the R&TTE directive (1999/5/EC) |
12.4.2017 |
|
|
Article 3(2) |
Notice: This harmonised standard provides presumption of conformity with the essential requirements of Directive 2014/53/EU if also the receiving parameters in clause(s) 4.2.20, 4.2.21 and 4.2.26 are applied |
|||||
ETSI |
EN 301 559 V2.1.1 Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) and associated Peripherals (LP-AMI-P) operating in the frequency range 2 483,5 MHz to 2 500 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
13.1.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 598 V1.1.1 White Space Devices (WSD); Wireless Access Systems operating in the 470 MHz to 790 MHz TV broadcast band; Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive |
8.6.2017 |
|
|
Article 3(2) |
This harmonised standard does not address requirements relating to receiver performance parameters and does not confer a presumption of conformity as regards those parameters. |
|||||
ETSI |
EN 301 681 V2.1.2 Satellite Earth Stations and Systems (SES); Harmonised Standard for Mobile Earth Stations (MES) of Geostationary mobile satellite systems, including handheld earth stations, for Satellite Personal Communications Networks (S-PCN) under the Mobile Satellite Service (MSS), operating in the 1,5 GHz and 1,6 GHz frequency bands covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
13.1.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 721 V2.1.1 Satellite Earth Stations and Systems (SES); Harmonised Standard for Mobile Earth Stations (MES) providing Low Bit Rate Data Communications (LBRDC) using Low Earth Orbiting (LEO) satellites operating below 1 GHz frequency band covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 783 V2.1.1 Commercially available amateur radio equipment; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
8.7.2016 |
|
|
Article 3(2) |
ETSI |
EN 301 839 V2.1.1 Ultra Low Power Active Medical Implants (ULP-AMI) and associated Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
8.7.2016 |
|
|
Article 3(2) |
ETSI |
EN 301 841-3 V2.1.1 VHF air-ground Digital Link (VDL) Mode 2; Technical characteristics and methods of measurement for ground-based equipment; Part 3: Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
13.1.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 842-5 V2.1.1 VHF air-ground Digital Link (VDL) Mode 4 radio equipment; Technical characteristics and methods of measurement for ground-based equipment; Part 5: Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
13.1.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 893 V1.8.1 Broadband Radio Access Networks (BRAN); 5 GHz high performance RLAN; Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive |
8.6.2017 |
|
|
Article 3(2) |
This harmonised standard does not address requirements relating to receiver performance parameters and does not confer a presumption of conformity as regards those parameters. |
|||||
ETSI |
EN 301 893 V2.1.1 5 GHz RLAN; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
8.6.2017 |
EN 301 893 V1.8.1 Note 2.1 |
12.6.2018 |
Article 3(2) |
As regards adaptivity, until 12.6.2018, either clause 4.2.7 of this harmonised standard or clause 4.8 of harmonised standard EN 301 893 v1.8.1 may be used; after that date, only clause 4.2.7 of this harmonised standard may be used. |
|||||
ETSI |
EN 301 908-1 V11.1.1 IMT cellular networks; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU; Part 1: Introduction and common requirements |
9.12.2016 |
|
|
Article 3(2) |
ETSI |
EN 301 908-2 V11.1.1 IMT cellular networks; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU; Part 2: CDMA Direct Spread (UTRA FDD) User Equipment (UE) |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 908-2 V11.1.2 IMT cellular networks; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU; Part 2: CDMA Direct Spread (UTRA FDD) User Equipment (UE) |
13.10.2017 |
EN 301 908-2 V11.1.1 Note 2.1 |
28.2.2019 |
Article 3(2) |
ETSI |
EN 301 908-3 V11.1.3 IMT cellular networks; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU; Part 3: CDMA Direct Spread (UTRA FDD) Base Stations (BS) |
12.5.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 908-10 V4.2.2 Electromagnetic compatibility and Radio spectrum Matters (ERM); Base Stations (BS), Repeaters and User Equipment (UE) for IMT-2000 Third-Generation cellular networks; Part 10: Harmonised Standard for IMT-2000, FDMA/TDMA (DECT) covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
13.1.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 908-11 V11.1.2 IMT cellular networks; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU; Part 11: CDMA Direct Spread (UTRA FDD) Repeaters |
10.2.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 908-12 V7.1.1 IMT cellular networks; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU; Part 12: CDMA Multi-Carrier (cdma2000) Repeaters |
9.9.2016 |
|
|
Article 3(2) |
ETSI |
EN 301 908-13 V11.1.1 IMT cellular networks; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU; Part 13: Evolved Universal Terrestrial Radio Access (E-UTRA) User Equipment (UE) |
12.5.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 908-13 V11.1.2 IMT cellular networks; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU; Part 13: Evolved Universal Terrestrial Radio Access (E-UTRA) User Equipment (UE) |
13.10.2017 |
EN 301 908-13 V11.1.1 Note 2.1 |
28.2.2019 |
Article 3(2) |
ETSI |
EN 301 908-14 V11.1.2 IMT cellular networks; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU; Part 14: Evolved Universal Terrestrial Radio Access (E-UTRA) Base Stations (BS) |
12.5.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 908-15 V11.1.2 IMT cellular networks; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU; Part 15: Evolved Universal Terrestrial Radio Access (E-UTRA FDD) Repeaters |
10.2.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 908-18 V11.1.2 IMT cellular networks; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU; Part 18: E-UTRA, UTRA and GSM/EDGE Multi-Standard Radio (MSR) Base Station (BS) |
12.5.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 908-19 V6.3.1 IMT cellular networks; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU; Part 19: OFDMA TDD WMAN (Mobile WiMAXTM) TDD User Equipment (UE) |
8.6.2017 |
|
|
Article 3(2) |
ETSI |
EN 301 908-20 V6.3.1 IMT cellular networks; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU; Part 20: OFDMA TDD WMAN (Mobile WiMAXTM) TDD Base Stations (BS) |
14.10.2016 |
|
|
Article 3(2) |
ETSI |
EN 301 908-21 V6.1.1 IMT cellular networks; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU; Part 21: OFDMA TDD WMAN (Mobile WiMAXTM) FDD User Equipment (UE) |
14.10.2016 |
|
|
Article 3(2) |
ETSI |
EN 301 908-22 V6.1.1 IMT cellular networks; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU; Part 22: OFDMA TDD WMAN (Mobile WiMAXTM) FDD Base Stations (BS) |
9.12.2016 |
|
|
Article 3(2) |
ETSI |
EN 301 929 V2.1.1 VHF transmitters and receivers as Coast Stations for GMDSS and other applications in the maritime mobile service; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 017 V2.1.1 Transmitting equipment for the Amplitude Modulated (AM) sound broadcasting service; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
12.5.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 018 V2.1.1 Transmitting equipment for the Frequency Modulated (FM) sound broadcasting service; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
8.6.2017 |
EN 302 018-2 V1.2.1 Note 2.1 |
31.12.2018 |
Article 3(2) |
ETSI |
EN 302 018-2 V1.2.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Transmitting equipment for the Frequency Modulated (FM) sound broadcasting service; Part 2: Harmonized EN under article 3.2 of the R&TTE Directive |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 054-2 V1.2.1 Meteorological Aids (Met Aids); Radiosondes to be used in the 400,15 MHz to 406 MHz frequency range with power levels ranging up to 200 mW; Part 2: Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
13.1.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 064-2 V1.1.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Wireless Video Links (WVL) operating in the 1,3 GHz to 50 GHz frequency band; Part 2: Harmonized EN under article 3.2 of the R&TTE Directive |
8.6.2017 |
|
|
Article 3(2) |
This harmonised standard does not address requirements relating to receiver performance parameters and does not confer a presumption of conformity as regards those parameters. |
|||||
ETSI |
EN 302 065-1 V2.1.1 Short Range Devices (SRD) using Ultra Wide Band technology (UWB); Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU; Part 1: Requirements for Generic UWB applications |
10.3.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 065-2 V2.1.1 Short Range Devices (SRD) using Ultra Wide Band technology (UWB); Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU; Part 2: Requirements for UWB location tracking |
10.3.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 065-3 V2.1.1 Short Range Devices (SRD) using Ultra Wide Band technology (UWB); Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU; Part 3: Requirements for UWB devices for ground based vehicular applications |
10.3.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 065-4 V1.1.1 Short Range Devices (SRD) using Ultra Wide Band technology (UWB); Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU; Part 4: Material Sensing devices using UWB technology below 10,6 GHz |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 066-2 V1.2.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Ground- and Wall-Probing Radar applications (GPR/WPR) imaging systems; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive |
8.6.2017 |
|
|
Article 3(2) |
This harmonised standard does not address requirements relating to receiver performance parameters and does not confer a presumption of conformity as regards those parameters. |
|||||
ETSI |
EN 302 077-2 V1.1.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Transmitting equipment for the Terrestrial — Digital Audio Broadcasting (T-DAB) service; Part 2: Harmonized EN under article 3.2 of the R&TTE Directive |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 186 V2.1.1 Satellite Earth Stations and Systems (SES); Harmonised Standard for satellite mobile Aircraft Earth Stations (AESs) operating in the 11/12/14 GHz frequency bands covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 194-2 V1.1.2 Electromagnetic compatibility and Radio spectrum Matters (ERM); Navigation radar used on inland waterways; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive |
8.6.2017 |
|
|
Article 3(2) |
This harmonised standard does not address requirements relating to receiver performance parameters and does not confer a presumption of conformity as regards those parameters. |
|||||
ETSI |
EN 302 195 V2.1.1 Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and accessories (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
11.11.2016 |
|
|
Article 3(2) |
ETSI |
EN 302 208 V3.1.1 Radio Frequency Identification Equipment operating in the band 865 MHz to 868 MHz with power levels up to 2 W and in the band 915 MHz to 921 MHz with power levels up to 4 W; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 217-2 V3.1.1 Fixed Radio Systems; Characteristics and requirements for point-to-point equipment and antennas; Part 2: Digital systems operating in frequency bands from 1 GHz to 86 GHz; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
8.6.2017 |
EN 302 217-2-2 V2.2.1 Note 2.1 |
31.12.2018 |
Article 3(2) |
ETSI |
EN 302 217-2-2 V2.2.1 Fixed Radio Systems; Characteristics and requirements for point-to-point equipment and antennas; Part 2-2: Digital systems operating in frequency bands where frequency coordination is applied; Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive |
12.4.2017 |
|
|
Article 3(2) |
Notice: This harmonised standard provides presumption of conformity with the essential requirements of Directive 2014/53/EU if also the receiving parameters in clause(s) 4.3.1, 4.3.2, 4.3.3 and 4.3.4 are applied |
|||||
ETSI |
EN 302 245-2 V1.1.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Transmitting equipment for the Digital Radio Mondiale (DRM) broadcasting service Part 2: Harmonized EN under article 3.2 of the R&TTE Directive |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 248 V2.1.1 Navigation radar for use on non-SOLAS vessels; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
10.3.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 264-2 V1.1.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices; Road Transport and Traffic Telematics (RTTT); Short Range Radar equipment operating in the 77 GHz to 81 GHz band; Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive |
8.6.2017 |
|
|
Article 3(2) |
This harmonised standard does not address requirements relating to receiver performance parameters and does not confer a presumption of conformity as regards those parameters. |
|||||
ETSI |
EN 302 288-2 V1.6.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices; Road Transport and Traffic Telematics (RTTT); Short range radar equipment operating in the 24 GHz range; Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive |
8.6.2017 |
|
|
Article 3(2) |
This harmonised standard does not address requirements relating to receiver performance parameters and does not confer a presumption of conformity as regards those parameters. |
|||||
ETSI |
EN 302 296-2 V1.2.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Transmitting equipment for the digital television broadcast service, Terrestrial (DVB-T); Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 326-2 V1.2.2 Fixed Radio Systems; Multipoint Equipment and Antennas; Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive for Digital Multipoint Radio Equipment |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 340 V2.1.1 Satellite Earth Stations and Systems (SES); Harmonised Standard for satellite Earth Stations on board Vessels (ESVs) operating in the 11/12/14 GHz frequency bands allocated to the Fixed Satellite Service (FSS) covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 372 V2.1.1 Short Range Devices (SRD); Tank Level Probing Radar (TLPR) equipment operating in the frequency ranges 4,5 GHz to 7 GHz, 8,5 GHz to 10,6 GHz, 24,05 GHz to 27 GHz, 57 GHz to 64 GHz, 75 GHz to 85 GHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
10.3.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 448 V2.1.1 Satellite Earth Stations and Systems (SES); Harmonised Standard for tracking Earth Stations on Trains (ESTs) operating in the 14/12 GHz frequency bands covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 454-2 V1.2.1 Meteorological Aids (Met Aids); Radiosondes to be used in the 1 668,4 MHz to 1 690 MHz frequency range; Part 2: Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
13.1.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 480 V2.1.2 Mobile Communication On Board Aircraft (MCOBA) systems; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
10.3.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 502 V2.1.1 Wireless Access Systems (WAS); 5,8 GHz fixed broadband data transmitting systems; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
12.5.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 510-2 V1.1.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 30 MHz to 37,5 MHz for Ultra Low Power Active Medical Membrane Implants and Accessories; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive |
8.6.2017 |
|
|
Article 3(2) |
This harmonised standard does not address requirements relating to receiver performance parameters and does not confer a presumption of conformity as regards those parameters. |
|||||
ETSI |
EN 302 536-2 V1.1.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Radio equipment in the frequency range 315 kHz to 600 kHz; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive |
8.6.2017 |
|
|
Article 3(2) |
This harmonised standard does not address requirements relating to receiver performance parameters and does not confer a presumption of conformity as regards those parameters. |
|||||
ETSI |
EN 302 537 V2.1.1 Ultra Low Power Medical Data Service (MEDS) Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
13.1.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 561 V2.1.1 Land Mobile Service; Radio equipment using constant or non-constant envelope modulation operating in a channel bandwidth of 25 kHz, 50 kHz, 100 kHz or 150 kHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 567 V1.2.1 Broadband Radio Access Networks (BRAN); 60 GHz Multiple-Gigabit WAS/RLAN Systems; Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive |
8.6.2017 |
|
|
Article 3(2) |
This harmonised standard does not address requirements relating to receiver performance parameters and does not confer a presumption of conformity as regards those parameters. |
|||||
ETSI |
EN 302 571 V2.1.1 Intelligent Transport Systems (ITS); Radiocommunications equipment operating in the 5 855 MHz to 5 925 MHz frequency band; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
8.6.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 574-1 V2.1.2 Satellite Earth Stations and Systems (SES); Harmonised Standard for Mobile Earth Stations (MES) operating in the 1 980 MHz to 2 010 MHz (earth-to-space) and 2 170 MHz to 2 200 MHz (space-to-earth) frequency bands covering the essential requirements of article 3.2 of the Directive 2014/53/EU; Part 1: Complementary Ground Component (CGC) for wideband systems |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 574-2 V2.1.2 Satellite Earth Stations and Systems (SES); Harmonised Standard for Mobile Earth Stations (MES) operating in the 1 980 MHz to 2 010 MHz (earth-to-space) and 2 170 MHz to 2 200 MHz (space-to-earth) frequency bands covering the essential requirements of article 3.2 of the Directive 2014/53/EU; Part 2: User Equipment (UE) for wideband systems |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 574-3 V2.1.1 Satellite Earth Stations and Systems (SES); Harmonised Standard for Mobile Earth Stations (MES) operating in the 1 980 MHz to 2 010 MHz (earth-to-space) and 2 170 MHz to 2 200 MHz (space-to-earth) frequency bands covering the essential requirements of article 3.2 of the Directive 2014/53/EU; Part 3: User Equipment (UE) for narrowband systems |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 608 V1.1.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Radio equipment for Eurobalise railway systems; Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive |
8.6.2017 |
|
|
Article 3(2) |
This harmonised standard does not address requirements relating to receiver performance parameters and does not confer a presumption of conformity as regards those parameters. |
|||||
ETSI |
EN 302 609 V2.1.1 Short Range Devices (SRD); Radio equipment for Euroloop railway systems; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
8.6.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 617-2 V2.1.1 Ground-based UHF radio transmitters, receivers and transceivers for the UHF aeronautical mobile service using amplitude modulation; Part 2: Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
13.1.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 686 V1.1.1 Intelligent Transport Systems (ITS); Radiocommunications equipment operating in the 63 GHz to 64 GHz frequency band; Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive |
8.6.2017 |
|
|
Article 3(2) |
This harmonised standard does not address requirements relating to receiver performance parameters and does not confer a presumption of conformity as regards those parameters. |
|||||
ETSI |
EN 302 729 V2.1.1 Short Range Devices (SRD); Level Probing Radar (LPR) equipment operating in the frequency ranges 6 GHz to 8,5 GHz, 24,05 GHz to 26,5 GHz, 57 GHz to 64 GHz, 75 GHz to 85 GHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
12.5.2017 |
|
|
Article 3(2) |
ETSI |
EN 302 752 V1.1.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Active radar target enhancers; Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive |
8.6.2017 |
|
|
Article 3(2) |
This harmonised standard does not address requirements relating to receiver performance parameters and does not confer a presumption of conformity as regards those parameters. |
|||||
ETSI |
EN 302 858-2 V1.3.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Road Transport and Traffic Telematics (RTTT); Automotive radar equipment operating in the 24,05 GHz up to 24,25 GHz or 24,50 GHz frequency range; Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive |
8.6.2017 |
|
|
Article 3(2) |
This harmonised standard does not address requirements relating to receiver performance parameters and does not confer a presumption of conformity as regards those parameters. |
|||||
ETSI |
EN 302 885 V2.1.1 Portable Very High Frequency (VHF) radiotelephone equipment for the maritime mobile service operating in the VHF bands with integrated handheld class D DSC; Harmonised Standard covering the essential requirements of articles 3.2 and 3.3(g) of the Directive 2014/53/EU |
13.1.2017 |
|
|
Article 3(2); Article 3(3)(g) |
ETSI |
EN 302 885 V2.2.2 Portable Very High Frequency (VHF) radiotelephone equipment for the maritime mobile service operating in the VHF bands with integrated handheld class H DSC; Harmonised Standard covering the essential requirements of articles 3.2 and 3.3(g) of Directive 2014/53/EU |
12.4.2017 |
EN 302 885 V2.1.1 Note 2.1 |
31.12.2018 |
Article 3(2); Article 3(3)(g) |
ETSI |
EN 302 885 V2.2.3 Portable Very High Frequency (VHF) radiotelephone equipment for the maritime mobile service operating in the VHF bands with integrated handheld class H DSC; Harmonised Standard covering the essential requirements of articles 3.2 and 3.3(g) of Directive 2014/53/EU |
12.5.2017 |
EN 302 885 V2.2.2 Note 2.1 |
31.1.2019 |
Article 3(2); Article 3(3)(g) |
ETSI |
EN 302 961 V2.1.2 Maritime Personal Homing Beacon intended for use on the frequency 121,5 MHz for search and rescue purposes only; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
11.11.2016 |
|
|
Article 3(2) |
ETSI |
EN 302 977 V2.1.1 Satellite Earth Stations and Systems (SES); Harmonised Standard for Vehicle-Mounted Earth Stations (VMES) operating in the 14/12 GHz frequency bands covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 303 039 V2.1.2 Land Mobile Service; Multichannel transmitter specification for the PMR Service; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
11.11.2016 |
|
|
Article 3(2) |
ETSI |
EN 303 084 V2.1.1 Ground Based Augmentation System (GBAS) VHF ground-air Data Broadcast (VDB); Technical characteristics and methods of measurement for ground-based equipment; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
11.11.2016 |
|
|
Article 3(2) |
ETSI |
EN 303 098 V2.1.1 Maritime low power personal locating devices employing AIS; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
13.1.2017 |
|
|
Article 3(2) |
ETSI |
EN 303 132 V1.1.1 Maritime low power VHF personal locating beacons employing Digital Selective Calling (DSC); Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
12.5.2017 |
|
|
Article 3(2) |
ETSI |
EN 303 135 V2.1.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Coastal Surveillance, Vessel Traffic Services and Harbour Radars (CS/VTS/HR); Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
13.1.2017 |
|
|
Article 3(2) |
ETSI |
EN 303 203 V2.1.1 Short Range Devices (SRD); Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
12.8.2016 |
|
|
Article 3(2) |
ETSI |
EN 303 204 V2.1.2 Network Based Short Range Devices (SRD); Radio equipment to be used in the 870 MHz to 876 MHz frequency range with power levels ranging up to 500 mW; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
11.11.2016 |
|
|
Article 3(2) |
ETSI |
EN 303 213-6-1 V2.1.1 Advanced Surface Movement Guidance and Control System (A-SMGCS); Part 6: Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU for deployed surface movement radar sensors; Sub-part 1: X-band sensors using pulsed signals and transmitting power up to 100 kW |
13.1.2017 |
|
|
Article 3(2) |
ETSI |
EN 303 339 V1.1.1 Broadband Direct Air-to-Ground Communications; Equipment operating in the 1 900 MHz to 1 920 MHz and 5 855 MHz to 5 875 MHz frequency bands; Fixed pattern antennas; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
11.11.2016 |
|
|
Article 3(2) |
ETSI |
EN 303 340 V1.1.2 Digital Terrestrial TV Broadcast Receivers; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
11.11.2016 |
|
|
Article 3(2) |
ETSI |
EN 303 354 V1.1.1 Amplifiers and active antennas for TV broadcast reception in domestic premises; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
12.5.2017 |
|
|
Article 3(2) |
ETSI |
EN 303 372-1 V1.1.1 Satellite Earth Stations and Systems (SES); Satellite broadcast reception equipment; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU; Part 1: Outdoor unit receiving in the 10,7 GHz to 12,75 GHz frequency band |
13.1.2017 |
|
|
Article 3(2) |
ETSI |
EN 303 372-2 V1.1.1 Satellite Earth Stations and Systems (SES); Satellite broadcast reception equipment; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU; Part 2: Indoor unit |
9.9.2016 |
|
|
Article 3(2) |
ETSI |
EN 303 402 V2.1.2 Maritime mobile transmitters and receivers for use in the MF and HF bands; Harmonised Standard covering the essential requirements of articles 3.2 and 3.3(g) of Directive 2014/53/EU |
13.10.2017 |
|
|
Article 3(2); Article 3(3)(g) |
ETSI |
EN 303 406 V1.1.1 Short Range Devices (SRD); Social Alarms Equipment operating in the frequency range 25 MHz to 1 000 MHz; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU |
12.4.2017 |
|
|
Article 3(2) |
ETSI |
EN 303 609 V12.5.1 Global System for Mobile communications (GSM); GSM Repeaters; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
13.1.2017 |
|
|
Article 3(2) |
ETSI |
EN 303 978 V2.1.2 Satellite Earth Stations and Systems (SES); Harmonised Standard for Earth Stations on Mobile Platforms (ESOMP) transmitting towards satellites in geostationary orbit, operating in the 27,5 GHz to 30,0 GHz frequency bands covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
11.11.2016 |
|
|
Article 3(2) |
ETSI |
EN 303 979 V2.1.2 Satellite Earth Stations and Systems (SES); Harmonised Standard for Earth Stations on Mobile Platforms (ESOMP) transmitting towards satellites in non-geostationary orbit, operating in the 27,5 GHz to 29,1 GHz and 29,5 GHz to 30,0 GHz frequency bands covering the essential requirements of article 3.2 of the Directive 2014/53/EU |
11.11.2016 |
|
|
Article 3(2) |
ETSI |
EN 305 550-2 V1.2.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Radio equipment to be used in the 40 GHz to 246 GHz frequency range; Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive |
8.6.2017 |
|
|
Article 3(2) |
This harmonised standard does not address requirements relating to receiver performance parameters and does not confer a presumption of conformity as regards those parameters. |
Note 1: |
Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. |
Note 2.1: |
The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
Note 2.2: |
The new standard has a broader scope than the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
Note 2.3: |
The new standard has a narrower scope than the superseded standard. On the date stated, the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected. |
Note 3: |
In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
NOTE:
— |
Any information concerning the availability of the standards can be obtained either from the European standardisation organisations or from the national standardisation bodies the list of which is published in the Official Journal of the European Union according to Article 27 of the Regulation (EU) No 1025/2012 (4). |
— |
Standards are adopted by the European standardisation organisations in English (CEN and Cenelec also publish in French and German). Subsequently, the titles of the standards are translated into all other required official languages of the European Union by the national standardisation bodies. The European Commission is not responsible for the correctness of the titles which have been presented for publication in the Official Journal. |
— |
References to Corrigenda ‘…/AC:YYYY’ are published for information only. A Corrigendum removes printing, linguistic or similar errors from the text of a standard and may relate to one or more language versions (English, French and/or German) of a standard as adopted by a European standardisation organisation. |
— |
Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the official languages of the European Union. |
— |
This list replaces all the previous lists published in the Official Journal of the European Union under Directive 1999/5/EC and Directive 2014/53/EU. The European Commission ensures the updating of this list. |
— |
More information about harmonised standards and other European standards on the Internet at: http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/index_en.htm |
(1) OJ L 153, 22.5.2014, p. 62.
(3) ESO: European standardisation organisation:
— |
CEN: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5500811; fax + 32 2 5500819 (http://www.cen.eu) |
— |
CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5196871; fax + 32 2 5196919 (http://www.cenelec.eu) |
— |
ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. +33 492 944200; fax +33 493 654716, (http://www.etsi.eu) |
(4) OJ C 338, 27.9.2014, p. 31.