ISSN 1977-091X

Official Journal

of the European Union

C 389

European flag  

English edition

Information and Notices

Volume 60
17 November 2017


Notice No

Contents

page

 

IV   Notices

 

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

 

European Commission

2017/C 389/01

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)  ( 1 )

1

2017/C 389/02

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)  ( 1 )

22

2017/C 389/03

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)  ( 1 )

29

2017/C 389/04

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)  ( 1 )

62

2017/C 389/05

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)  ( 1 )

68


 


 

(1)   Text with EEA relevance.

EN

 


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

 

 

 

EN 3-8:2006/AC:2007

12.8.2016

 

 

CEN

EN 19:2016

Industrial valves — Marking of metallic valves

12.8.2016

 

 

CEN

EN 267:2009+A1:2011

Automatic forced draught burners for liquid fuels

12.8.2016

 

 

CEN

EN 334:2005+A1:2009

Gas pressure regulators for inlet pressures up to 100 bar

12.8.2016

 

 

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

 

 

CEN

EN 676:2003+A2:2008

Automatic forced draught burners for gaseous fuels

12.8.2016

 

 

 

EN 676:2003+A2:2008/AC:2008

12.8.2016

 

 

CEN

EN 764-4:2014

Pressure equipment — Part 4: Establishment of technical delivery conditions for metallic materials

12.8.2016

 

 

CEN

EN 764-5:2014

Pressure equipment — Part 5: Inspection documentation of metallic materials and compliance with the material specification

12.8.2016

 

 

CEN

EN 764-7:2002

Pressure equipment — Part 7: Safety systems for unfired pressure equipment

12.8.2016

 

 

 

EN 764-7:2002/AC:2006

12.8.2016

 

 

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

 

 

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

 

 

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

 

 

 

EN 1092-3:2003/AC:2007

12.8.2016

 

 

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

 

 

CEN

EN 1171:2015

Industrial valves — Cast iron gate valves

12.8.2016

 

 

CEN

EN 1252-2:2001

Cryogenic vessels — Materials — Part 2: Toughness requirements for temperatures between - 80 oC and - 20 oC

12.8.2016

 

 

CEN

EN 1349:2009

Industrial process control valves

12.8.2016

 

 

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

 

 

CEN

EN 1562:2012

Founding — Malleable cast irons

12.8.2016

 

 

CEN

EN 1563:2011

Founding — Spheroidal graphite cast irons

12.8.2016

 

 

CEN

EN 1564:2011

Founding — Ausferritic spheroidal graphite cast irons

12.8.2016

 

 

CEN

EN 1591-1:2013

Flanges and their joints — Design rules for gasketed circular flange connections — Part 1: Calculation

12.8.2016

 

 

CEN

EN 1626:2008

Cryogenic vessels — Valves for cryogenic service

12.8.2016

 

 

CEN

EN 1653:1997

Copper and copper alloys — Plate, sheet and circles for boilers, pressure vessels and hot water storage units

12.8.2016

 

 

 

EN 1653:1997/A1:2000

12.8.2016

Note 3

 

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

 

 

 

EN 1759-3:2003/AC:2004

12.8.2016

 

 

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

 

 

CEN

EN 1797:2001

Cryogenic vessels — Gas/material compatibility

12.8.2016

 

 

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

 

 

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

 

 

CEN

EN 1983:2013

Industrial valves — Steel ball valves

12.8.2016

 

 

CEN

EN 1984:2010

Industrial valves — Steel gate valves

12.8.2016

 

 

CEN

EN ISO 4126-1:2013

Safety devices for protection against excessive pressure — Part 1: Safety valves (ISO 4126-1:2013)

12.8.2016

 

 

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

 

 

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

 

 

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

 

 

CEN

EN ISO 4126-7:2013

Safety devices for protection against excessive pressure — Part 7: Common data (ISO 4126-7:2013)

12.8.2016

 

 

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

 

 

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

 

 

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

 

 

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

 

 

CEN

EN ISO 9712:2012

Non-destructive testing — Qualification and certification of NDT personnel (ISO 9712:2012)

12.8.2016

 

 

CEN

EN 10028-1:2007+A1:2009

Flat products made of steels for pressure purposes — Part 1: General requirements

12.8.2016

 

 

 

EN 10028-1:2007+A1:2009/AC:2009

12.8.2016

 

 

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

 

 

CEN

EN 10028-3:2009

Flat products made of steels for pressure purposes — Part 3: Weldable fine grain steels, normalized

12.8.2016

 

 

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

 

 

CEN

EN 10028-5:2009

Flat products made of steels for pressure purposes — Part 5: Weldable fine grain steels, thermomechanically rolled

12.8.2016

 

 

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

 

 

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

 

 

CEN

EN 10213:2007+A1:2016

Steel castings for pressure purposes

12.8.2016

 

 

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

 

 

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

 

 

CEN

EN 10216-3:2013

Seamless steel tubes for pressure purposes — Technical delivery conditions — Part 3: Alloy fine grain steel tubes

12.8.2016

 

 

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

 

 

CEN

EN 10216-5:2013

Seamless steel tubes for pressure purposes — Technical delivery conditions — Part 5: Stainless steel tubes

12.8.2016

 

 

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

 

 

 

EN 10217-1:2002/A1:2005

12.8.2016

Note 3

 

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

 

 

 

EN 10217-2:2002/A1:2005

12.8.2016

Note 3

 

CEN

EN 10217-3:2002

Welded steel tubes for pressure purposes — Technical delivery conditions — Part 3: Alloy fine grain steel tubes

12.8.2016

 

 

 

EN 10217-3:2002/A1:2005

12.8.2016

Note 3

 

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

 

 

 

EN 10217-4:2002/A1:2005

12.8.2016

Note 3

 

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

 

 

 

EN 10217-5:2002/A1:2005

12.8.2016

Note 3

 

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

 

 

 

EN 10217-6:2002/A1:2005

12.8.2016

Note 3

 

CEN

EN 10217-7:2014

Welded steel tubes for pressure purposes — Technical delivery conditions — Part 7: Stainless steel tubes

12.8.2016

 

 

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

 

 

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

 

 

 

EN 10253-4:2008/AC:2009

12.8.2016

 

 

CEN

EN 10269:2013

Steels and nickel alloys for fasteners with specified elevated and/or low temperature properties

12.8.2016

 

 

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

 

 

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

 

 

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

 

 

 

EN ISO 10931:2005/A1:2015

12.8.2016

Note 3

 

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

 

 

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

 

 

CEN

EN 12284:2003

Refrigerating systems and heat pumps — Valves — Requirements, testing and marking

12.8.2016

 

 

CEN

EN 12288:2010

Industrial valves — Copper alloy gate valves

12.8.2016

 

 

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

 

 

CEN

EN 12420:2014

Copper and copper alloys — Forgings

12.8.2016

 

 

CEN

EN 12434:2000

Cryogenic vessels — Cryogenic flexible hoses

12.8.2016

 

 

 

EN 12434:2000/AC:2001

12.8.2016

 

 

CEN

EN 12451:2012

Copper and copper alloys — Seamless, round tubes for heat exchangers

12.8.2016

 

 

CEN

EN 12452:2012

Copper and copper alloys — Rolled, finned, seamless tubes for heat exchangers

12.8.2016

 

 

CEN

EN 12516-1:2014

Industrial valves — Shell design strength — Part 1: Tabulation method for steel valve shells

12.8.2016

 

 

CEN

EN 12516-2:2014

Industrial valves — Shell design strength — Part 2: Calculation method for steel valve shells

12.8.2016

 

 

CEN

EN 12516-3:2002

Valves — Shell design strength — Part 3: Experimental method

12.8.2016

 

 

 

EN 12516-3:2002/AC:2003

12.8.2016

 

 

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

 

 

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

 

 

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

 

 

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

 

 

CEN

EN 12778:2002

Cookware — Pressure cookers for domestic use

12.8.2016

 

 

 

EN 12778:2002/AC:2003

12.8.2016

 

 

 

EN 12778:2002/A1:2005

12.8.2016

Note 3

 

CEN

EN 12952-1:2015

Water-tube boilers and auxiliary installations — Part 1: General

12.8.2016

 

 

CEN

EN 12952-2:2011

Water-tube boilers and auxiliary installations — Part 2: Materials for pressure parts of boilers and accessories

12.8.2016

 

 

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

 

 

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

 

 

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

 

 

CEN

EN 12952-7:2012

Water-tube boilers and auxiliary installations — Part 7: Requirements for equipment for the boiler

12.8.2016

 

 

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

 

 

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

 

 

CEN

EN 12952-10:2002

Water-tube boilers and auxiliary installations — Part 10: Requirements for safeguards against excessive pressure

12.8.2016

 

 

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

 

 

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

 

 

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

 

 

CEN

EN 12952-18:2012

Water-tube boilers and auxiliary installations — Part 18: Operating instructions

12.8.2016

 

 

CEN

EN 12953-1:2012

Shell boilers — Part 1: General

12.8.2016

 

 

CEN

EN 12953-2:2012

Shell boilers — Part 2: Materials for pressure parts of boilers and accessories

12.8.2016

 

 

CEN

EN 12953-3:2016

Shell boilers — Part 3: Design and calculation for pressure parts

12.8.2016

 

 

CEN

EN 12953-4:2002

Shell boilers — Part 4: Workmanship and construction of pressure parts of the boiler

12.8.2016

 

 

CEN

EN 12953-5:2002

Shell boilers — Part 5: Inspection during construction, documentation and marking of pressure parts of the boiler

12.8.2016

 

 

CEN

EN 12953-6:2011

Shell Boilers — Part 6: Requirements for equipment for the boiler

12.8.2016

 

 

CEN

EN 12953-7:2002

Shell boilers — Part 7: Requirements for firing systems for liquid and gaseous fuels for the boilers

12.8.2016

 

 

CEN

EN 12953-8:2001

Shell boilers — Part 8: Requirements for safeguards against excessive pressure

12.8.2016

 

 

 

EN 12953-8:2001/AC:2002

12.8.2016

 

 

CEN

EN 12953-9:2007

Shell boilers — Part 9: Requirements for limiting devices of the boiler and accessories

12.8.2016

 

 

CEN

EN 12953-12:2003

Shell boilers — Part 12: Requirements for grate firing systems for solid fuels for the boiler

12.8.2016

 

 

CEN

EN 12953-13:2012

Shell boilers — Part 13: Operating instructions

12.8.2016

 

 

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

 

 

CEN

EN 13121-2:2003

GRP tanks and vessels for use above ground — Part 2: Composite materials — Chemical resistance

12.8.2016

 

 

CEN

EN 13121-3:2016

GRP tanks and vessels for use above ground — Part 3: Design and workmanship

12.8.2016

 

 

CEN

EN 13134:2000

Brazing — Procedure approval

12.8.2016

 

 

CEN

EN 13136:2013

Refrigerating systems and heat pumps — Pressure relief devices and their associated piping — Methods for calculation

12.8.2016

 

 

CEN

EN 13175:2014

LPG Equipment and accessories — Specification and testing for Liquefied Petroleum Gas (LPG) pressure vessel valves and fittings

12.8.2016

 

 

CEN

EN 13348:2016

Copper and copper alloys — Seamless, round copper tubes for medical gases or vacuum

12.8.2016

 

 

CEN

EN 13371:2001

Cryogenic vessels — Couplings for cryogenic service

12.8.2016

 

 

CEN

EN 13397:2001

Industrial valves — Diaphragm valves made of metallic materials

12.8.2016

 

 

CEN

EN 13445-1:2014

Unfired pressure vessels — Part 1: General

12.8.2016

 

 

 

EN 13445-1:2014/A1:2014

12.8.2016

Note 3

 

CEN

EN 13445-2:2014

Unfired pressure vessels — Part 2: Materials

12.8.2016

 

 

 

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

 

 

 

EN 13445-3:2014/A1:2015

12.8.2016

Note 3

 

 

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

 

 

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

 

 

CEN

EN 13445-8:2014

Unfired pressure vessels — Part 8: Additional requirements for pressure vessels of aluminium and aluminium alloys

12.8.2016

 

 

 

EN 13445-8:2014/A1:2014

12.8.2016

Note 3

 

CEN

EN 13458-1:2002

Cryogenic vessels — Static vacuum insulated vessels — Part 1: Fundamental requirements

12.8.2016

 

 

CEN

EN 13458-2:2002

Cryogenic vessels — Static vacuum insulated vessels — Part 2: Design, fabrication, inspection and testing

12.8.2016

 

 

 

EN 13458-2:2002/AC:2006

12.8.2016

 

 

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

 

 

 

EN 13480-4:2012/A1:2013

12.8.2016

Note 3

 

 

EN 13480-4:2012/A2:2015

12.8.2016

Note 3

 

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

 

 

CEN

EN ISO 13585:2012

Brazing — Qualification test of brazers and brazing operators (ISO 13585:2012)

12.8.2016

 

 

CEN

EN 13648-1:2008

Cryogenic vessels — Safety devices for protection against excessive pressure — Part 1: Safety valves for cryogenic service

12.8.2016

 

 

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

 

 

CEN

EN 13709:2010

Industrial valves — Steel globe and globe stop and check valves

12.8.2016

 

 

CEN

EN 13789:2010

Industrial valves — Cast iron globe valves

12.8.2016

 

 

CEN

EN 13831:2007

Closed expansion vessels with built in diaphragm for installation in water

12.8.2016

 

 

CEN

EN 13835:2012

Founding — Austenitic cast irons

12.8.2016

 

 

CEN

EN 13923:2005

Filament-wound FRP pressure vessels — Materials, design, manufacturing and testing

12.8.2016

 

 

CEN

EN 14129:2014

LPG Equipment and accessories — Pressure relief valves for LPG pressure vessels

12.8.2016

 

 

CEN

EN 14197-1:2003

Cryogenic vessels — Static non-vacuum insulated vessels — Part 1: Fundamental requirements

12.8.2016

 

 

CEN

EN 14197-2:2003

Cryogenic vessels — Static non-vacuum insulated vessels — Part 2: Design, fabrication, inspection and testing

12.8.2016

 

 

 

EN 14197-2:2003/A1:2006

12.8.2016

Note 3

 

 

EN 14197-2:2003/AC:2006

12.8.2016

 

 

CEN

EN 14197-3:2004

Cryogenic vessels — Static non-vacuum insulated vessels — Part 3: Operational requirements

12.8.2016

 

 

 

EN 14197-3:2004/A1:2005

12.8.2016

Note 3

 

 

EN 14197-3:2004/AC:2004

12.8.2016

 

 

CEN

EN 14222:2003

Stainless steel shell boilers

12.8.2016

 

 

CEN

EN 14276-1:2006+A1:2011

Pressure equipment for refrigerating systems and heat pumps — Part 1: Vessels — General requirements

12.8.2016

 

 

CEN

EN 14276-2:2007+A1:2011

Pressure equipment for refrigerating systems and heat pumps — Part 2: Piping — General requirements

12.8.2016

 

 

CEN

EN 14359:2006+A1:2010

Gas-loaded accumulators for fluid power applications

12.8.2016

 

 

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

 

 

 

EN 14382:2005+A1:2009/AC:2009

12.8.2016

 

 

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

 

 

CEN

EN 14570:2014

LPG equipment and accessories — Equipping of overground and underground LPG vessels

12.8.2016

 

 

CEN

EN 14585-1:2006

Corrugated metal hose assemblies for pressure applications — Part 1: Requirements

12.8.2016

 

 

CEN

EN 14917:2009+A1:2012

Metal bellows expansion joints for pressure applications

12.8.2016

 

 

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

 

 

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

 

 

 

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

 

 

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

 

 

 

EN ISO 15614-1:2004/A1:2008

12.8.2016

Note 3

 

 

EN ISO 15614-1:2004/A2:2012

12.8.2016

Note 3

 

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

 

 

 

EN ISO 15614-2:2005/AC:2009

12.8.2016

 

 

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

 

 

 

EN ISO 15614-4:2005/AC:2007

12.8.2016

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

CEN

EN ISO 15620:2000

Welding — Friction welding of metallic materials (ISO 15620:2000)

12.8.2016

 

 

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

 

 

CEN

EN ISO 16135:2006

Industrial valves — Ball valves of thermoplastics materials (ISO 16135:2006)

12.8.2016

 

 

CEN

EN ISO 16136:2006

Industrial valves — Butterfly valves of thermoplastics materials (ISO 16136:2006)

12.8.2016

 

 

CEN

EN ISO 16137:2006

Industrial valves — Check valves of thermoplastics materials (ISO 16137:2006)

12.8.2016

 

 

CEN

EN ISO 16138:2006

Industrial valves — Diaphragm valves of thermoplastics materials (ISO 16138:2006)

12.8.2016

 

 

CEN

EN ISO 16139:2006

Industrial valves — Gate valves of thermoplastics materials (ISO 16139:2006)

12.8.2016

 

 

CEN

EN 16767:2016

Industrial valves — Steel and cast iron check valves

12.8.2016

 

 

CEN

EN ISO 21009-2:2015

Cryogenic vessels — Static vacuum insulated vessels — Part 2: Operational requirements (ISO 21009-2:2015)

12.8.2016

 

 

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

 

 

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

 

 

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

 

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 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

 

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

 

 

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

 

 

 

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 10993-16:2010

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

 

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 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 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

 

 

 

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

 

 

 

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.

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.

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.

(2)  OJ L 91, 7.4.1999, p. 10.

(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.