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Document 02014L0068-20140717
Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (recast) (Text with EEA relevance)
Consolidated text: Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (recast) (Text with EEA relevance)
Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (recast) (Text with EEA relevance)
02014L0068 — EN — 17.07.2014 — 000.002
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DIRECTIVE 2014/68/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (recast) (OJ L 189 27.6.2014, p. 164) |
Corrected by:
DIRECTIVE 2014/68/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 15 May 2014
on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment
(recast)
(Text with EEA relevance)
CHAPTER 1
GENERAL PROVISIONS
Article 1
Scope
This Directive shall not apply to:
pipelines comprising piping or a system of piping designed for the conveyance of any fluid or substance to or from an installation (onshore or offshore) starting from and including the last isolation device located within the confines of the installation, including all the annexed equipment designed specifically for pipelines; this exclusion shall not apply to standard pressure equipment such as may be found in pressure reduction stations or compression stations;
networks for the supply, distribution and discharge of water and associated equipment and headraces such as penstocks, pressure tunnels, pressure shafts for hydroelectric installations and their related specific accessories;
simple pressure vessels covered by Directive 2014/29/EU of the European Parliament and of the Council ( 13 );
aerosol dispensers covered by Council Directive 75/324/EEC ( 14 );
equipment intended for the functioning of vehicles defined by the following legal acts:
Directive 2007/46/EC of the European Parliament and of the Council ( 15 );
Regulation (EU) No 167/2013 of the European Parliament and of the Council ( 16 );
Regulation (EU) No 168/2013 of the European Parliament and of the Council ( 17 );
equipment classified as no higher than category I under Article 13 of this Directive and covered by one of the following Directives:
Directive 2006/42/EC of the European Parliament and of the Council ( 18 );
Directive 2014/33/EU of the European Parliament and of the Council ( 19 );
Directive 2014/35/EU of the European Parliament and of the Council ( 20 );
Council Directive 93/42/EEC ( 21 );
Directive 2009/142/EC of the European Parliament and of the Council ( 22 );
Directive 2014/34/EU of the European Parliament and of the Council ( 23 );
equipment covered by point (b) of Article 346(1) TFEU;
items specifically designed for nuclear use, failure of which may cause an emission of radioactivity;
well-control equipment used in the petroleum, gas or geothermal exploration and extraction industry and in underground storage which is intended to contain and/or control well pressure; this shall comprise the wellhead (Christmas tree), the blow out preventers (BOP), the piping manifolds and all their equipment upstream;
equipment comprising casings or machinery where the dimensioning, choice of material and manufacturing rules are based primarily on requirements for sufficient strength, rigidity and stability to meet the static and dynamic operational effects or other operational characteristics and for which pressure is not a significant design factor; such equipment may include:
engines including turbines and internal combustion engines;
steam engines, gas/steam turbines, turbo-generators, compressors, pumps and actuating devices;
blast furnaces including the furnace cooling system, hot-blast recuperators, dust extractors and blast-furnace exhaust-gas scrubbers and direct reducing cupolas, including the furnace cooling, gas converters and pans for melting, re-melting, de-gassing and casting of steel, iron and non-ferrous metals;
enclosures for high-voltage electrical equipment such as switchgear, control gear, transformers, and rotating machines;
pressurised pipes for the containment of transmission systems, e.g. for electrical power and telephone cables;
ships, rockets, aircraft and mobile off-shore units, as well as equipment specifically intended for installation on board or the propulsion thereof;
pressure equipment consisting of a flexible casing, e.g. tyres, air cushions, balls used for play, inflatable craft, and other similar pressure equipment;
exhaust and inlet silencers;
bottles or cans for carbonated drinks for final consumption;
vessels designed for the transport and distribution of drinks having a PS·V of not more than 500 bar·L and a maximum allowable pressure not exceeding 7 bar;
equipment covered by Directive 2008/68/EC and Directive 2010/35/EU and equipment covered by the International Maritime Dangerous Goods Code and the Convention on International Civil Aviation;
radiators and pipes in warm water heating systems;
vessels designed to contain liquids with a gas pressure above the liquid of not more than 0,5 bar.
Article 2
Definitions
For the purposes of this Directive, the following definitions shall apply:
‘pressure equipment’ means vessels, piping, safety accessories and pressure accessories, including, where applicable, elements attached to pressurised parts, such as flanges, nozzles, couplings, supports, lifting lugs;
‘vessel’ means a housing designed and built to contain fluids under pressure including its direct attachments up to the coupling point connecting it to other equipment; a vessel may be composed of more than one chamber;
‘piping’ means piping components intended for the transport of fluids, when connected together for integration into a pressure system; piping includes in particular a pipe or system of pipes, tubing, fittings, expansion joints, hoses, or other pressure-bearing components as appropriate; heat exchangers consisting of pipes for the purpose of cooling or heating air shall be considered as piping;
‘safety accessories’ means devices designed to protect pressure equipment against the allowable limits being exceeded, including devices for direct pressure limitation, such as safety valves, bursting disc safety devices, buckling rods, controlled safety pressure relief systems (CSPRS), and limiting devices, which either activate the means for correction or provide for shutdown or shutdown and lockout, such as pressure switches or temperature switches or fluid level switches and safety related measurement control and regulation (SRMCR) devices;
‘pressure accessories’ means devices with an operational function and having pressure-bearing housings;
‘assemblies’ means several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole;
‘pressure’ means pressure relative to atmospheric pressure, i.e. gauge pressure. As a consequence, vacuum is designated by a negative value;
‘maximum allowable pressure PS’ means the maximum pressure for which the equipment is designed, as specified by the manufacturer, and defined at a location specified by him, being either the connection of protective and/or limiting devices, or the top of equipment or, if not appropriate, any point specified;
‘maximum/minimum allowable temperature TS’ means the maximum/minimum temperatures for which the equipment is designed, as specified by the manufacturer;
‘volume (V)’ means the internal volume of a chamber, including the volume of nozzles to the first connection or weld and excluding the volume of permanent internal parts;
‘nominal size (DN)’ means a numerical designation of size which is common to all components in a piping system other than components indicated by outside diameters or by thread size; it is a convenient round number for reference purposes and is only loosely related to manufacturing dimensions; the nominal size is designated by DN followed by a number;
‘fluids’ means gases, liquids and vapours in pure phase as well as mixtures thereof; fluids may contain a suspension of solids;
‘permanent joints’ means joints which cannot be disconnected except by destructive methods;
‘European approval for materials’ means a technical document defining the characteristics of materials intended for repeated use in the manufacture of pressure equipment which are not covered by any harmonised standard;
‘making available on the market’ means any supply of pressure equipment or assemblies for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
‘placing on the market’ means the first making available of pressure equipment or assemblies on the Union market;
‘putting into service’ means the first use of pressure equipment or an assembly by its user;
‘manufacturer’ means any natural or legal person who manufactures pressure equipment or an assembly or has such equipment or assembly designed or manufactured, and markets that pressure equipment or assembly under his name or trademark or uses it for his own purposes;
‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;
‘importer’ means any natural or legal person established within the Union who places pressure equipment or assemblies from a third country on the Union market;
‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes pressure equipment or assemblies available on the market;
‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;
‘technical specification’ means a document that prescribes technical requirements to be fulfilled by pressure equipment or assemblies;
‘harmonised standard’ means harmonised standard as defined in point (c) of Article 2(1) of Regulation (EU) No 1025/2012;
‘accreditation’ means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008;
‘national accreditation body’ means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;
‘conformity assessment’ means the process demonstrating whether the essential safety requirements of this Directive relating to pressure equipment or assemblies have been fulfilled;
‘conformity assessment body’ means a body that performs conformity assessment activities including calibration, testing, certification and inspection;
‘recall’ means any measure aimed at achieving the return of pressure equipment or assemblies that have already been made available to consumers or other users;
‘withdrawal’ means any measure aimed at preventing pressure equipment or assemblies in the supply chain from being made available on the market;
‘CE marking’ means a marking by which the manufacturer indicates that the pressure equipment or assembly is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing;
‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products.
Article 3
Making available on the market and putting into service
Article 4
Technical requirements
The following pressure equipment shall satisfy the essential safety requirements set out in Annex I:
vessels, except those referred to in point (b), for:
gases, liquefied gases, gases dissolved under pressure, vapours and also those liquids whose vapour pressure at the maximum allowable temperature is greater than 0,5 bar above normal atmospheric pressure (1 013 mbar) within the following limits:
liquids having a vapour pressure at the maximum allowable temperature of not more than 0,5 bar above normal atmospheric pressure (1 013 mbar) within the following limits:
fired or otherwise heated pressure equipment with the risk of overheating intended for generation of steam or super-heated water at temperatures higher than 110 °C having a volume greater than 2 L, and all pressure cookers (Annex II, table 5);
piping intended for:
gases, liquefied gases, gases dissolved under pressure, vapours and those liquids whose vapour pressure at the maximum allowable temperature is greater than 0,5 bar above normal atmospheric pressure (1 013 mbar) within the following limits:
liquids having a vapour pressure at the maximum allowable temperature of not more than 0,5 bar above normal atmospheric pressure (1 013 mbar) within the following limits:
safety and pressure accessories intended for equipment covered by points (a), (b), and (c) including where such equipment is incorporated into an assembly.
The following assemblies which include at least one item of pressure equipment covered by paragraph 1 shall satisfy the essential safety requirements set out in Annex I:
assemblies intended for generating steam or superheated water at a temperature higher than 110 °C comprising at least one item of fired or otherwise heated pressure equipment presenting a risk of overheating;
assemblies other than those referred to in point (a), if the manufacturer intends them to be made available on the market and put into service as assemblies.
By way of derogation from the first subparagraph, assemblies intended for generating warm water at temperatures not greater than 110 °C which are manually fed with solid fuels and have a PS·V greater than 50 bar·L shall comply with the essential safety requirements referred to in points 2.10, 2.11, 3.4, 5 (a) and 5 (d) of Annex I.
Without prejudice to other applicable Union harmonisation legislation providing for its affixing, such equipment or assemblies shall not bear the CE marking referred to in Article 18.
Article 5
Free movement
Member States shall not, on grounds of the risks due to pressure, prohibit, restrict or impede the making available on the market or the putting into service of pressure equipment or assemblies which comply with Article 4(3).
CHAPTER 2
OBLIGATIONS OF ECONOMIC OPERATORS
Article 6
Obligations of manufacturers
When placing their pressure equipment or assemblies referred to in Article 4(3) on the market or using them for their own purposes, manufacturers shall ensure that they have been designed and manufactured in accordance with the sound engineering practice of a Member State.
Where compliance of the pressure equipment or assemblies referred to in Article 4(1) and (2) with the applicable requirements has been demonstrated by the procedure referred to in the first subparagraph of this paragraph, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.
When deemed appropriate with regard to the risks presented by pressure equipment or assemblies, manufacturers shall, to protect the health and safety of consumers and other users, carry out sample testing of pressure equipment or assemblies made available on the market, investigate, and, if necessary, keep a register of complaints of non-conforming pressure equipment and assemblies and recalls of such equipment, and shall keep distributors informed of any such monitoring.
Manufacturers shall ensure that the pressure equipment or assemblies referred to in Article 4(3) are accompanied by instructions and safety information in accordance with Article 4(3), in a language which can be easily understood by consumers and other users, as determined by the Member State concerned. Such instructions and safety information shall be clear, understandable and intelligible.
Article 7
Authorised representatives
The obligations laid down in Article 6(1) and the obligation to draw up technical documentation referred to in Article 6(2) shall not form part of the authorised representative’s mandate.
An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:
keep the EU declaration of conformity and the technical documentation at the disposal of national market surveillance authorities for 10 years after the pressure equipment or assembly has been placed on the market;
further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the pressure equipment or assembly;
cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by the pressure equipment or assembly covered by the authorised representative’s mandate.
Article 8
Obligations of importers
Before placing on the market the pressure equipment or assemblies referred to in Article 4(3), importers shall ensure that the manufacturer has drawn up the technical documentation and that pressure equipment or assemblies are accompanied by adequate instructions for use and that the manufacturer has complied with the requirements set out in Article 6(5) and (6).
Where an importer considers or has reason to believe that the pressure equipment or assembly is not in conformity with the essential safety requirements set out in Annex I, he shall not place the pressure equipment or assembly on the market until it has been brought into conformity. Furthermore, where the pressure equipment or assembly presents a risk, the importer shall inform the manufacturer and the market surveillance authorities to that effect.
Importers shall ensure that the pressure equipment or assembly referred to in Article 4(3) is accompanied by instructions and safety information in a language which can be easily understood by consumers and other users, as determined by the Member State concerned.
Article 9
Obligations of distributors
Where a distributor considers or has reason to believe that pressure equipment or assemblies are not in conformity with the essential safety requirements set out in Annex I, he shall not make the pressure equipment or assembly available on the market until it has been brought into conformity. Furthermore, where the pressure equipment or assembly presents a risk, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities.
Before making the pressure equipment or assembly referred to in Article 4(3) available on the market, distributors shall verify that that pressure equipment or assembly is accompanied by adequate instructions for use, in a language which can be easily understood by consumers and other users in the Member State in which that pressure equipment or assembly is to be made available on the market, and that the manufacturer and the importer have complied with the requirements set out in Article 6(5) and (6) and Article 8(3) respectively.
Article 10
Cases in which obligations of manufacturers apply to importers and distributors
An importer or distributor shall be considered a manufacturer for the purposes of this Directive and he shall be subject to the obligations of the manufacturer under Article 6, where he places pressure equipment or an assembly on the market under his name or trademark or modifies pressure equipment or an assembly already placed on the market in such a way that compliance with the requirements of this Directive may be affected.
Article 11
Identification of economic operators
Economic operators shall, on request, identify the following to the market surveillance authorities:
any economic operator who has supplied them with pressure equipment or an assembly;
any economic operator to whom they have supplied pressure equipment or an assembly.
Economic operators shall be able to present the information referred to in the first paragraph for 10 years after they have been supplied with the pressure equipment or assembly and for 10 years after they have supplied the pressure equipment or assembly.
CHAPTER 3
CONFORMITY AND CLASSIFICATION OF PRESSURE EQUIPMENT AND ASSEMBLIES
Article 12
Presumption of conformity
Article 13
Classification of pressure equipment
For the purposes of such classification fluids shall be divided into the following two groups:
group 1 consisting of substances and mixtures, as defined in points (7) and (8) of Article 2 of Regulation (EC) No 1272/2008, that are classified as hazardous in accordance with the following physical or health hazard classes laid down in Parts 2 and 3 of Annex I to that Regulation:
unstable explosives or explosives of Divisions 1.1, 1.2, 1.3, 1.4 and 1.5;
flammable gases, category 1 and 2;
oxidising gases, category 1;
flammable liquids, category 1 and 2;
flammable liquids, category 3 where the maximum allowable temperature is above the flashpoint;
flammable solids, category 1 and 2;
self-reactive substances and mixtures, type A to F;
pyrophoric liquids, category 1;
pyrophoric solids, category 1;
substances and mixtures which in contact with water emit flammable gases, category 1, 2 and 3;
oxidising liquids, category 1, 2 and 3;
oxidising solids, category 1, 2 and 3;
organic peroxides types A to F;
acute oral toxicity, category 1 and 2;
acute dermal toxicity, category 1 and 2;
acute inhalation toxicity, category 1, 2 and 3;
specific target organ toxicity – single exposure, category 1.
Group 1 comprises also substances and mixtures contained in pressure equipment with a maximum allowable temperature TS which exceeds the flashpoint of the fluid;
group 2 consisting of substances and mixtures not referred to in point (a).
Article 14
Conformity assessment procedures
The conformity assessment procedures to be applied for the various categories are the following:
category I:
category II:
category III:
category IV:
The conformity assessment procedures are set out in Annex III.
Assemblies referred to in Article 4(2) shall be subject to a global conformity assessment procedure comprising the following assessments:
the assessment of each item of pressure equipment making up the assembly and referred to in Article 4(1) which has not been previously subjected to a conformity assessment procedure and to a separate CE marking; the assessment procedure shall be determined by the category of each item of equipment;
the assessment of the integration of the various components of the assembly as referred to in points 2.3, 2.8 and 2.9 of Annex I which shall be determined by the highest category applicable to the equipment concerned other than that applicable to any safety accessories;
the assessment of the protection of an assembly against exceeding the permissible operating limits as referred to in points 2.10 and 3.2.3 of Annex I shall be conducted in the light of the highest category applicable to the items of equipment to be protected.
Article 15
European approval for materials
The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 44(3).
Article 16
User inspectorates
Article 17
EU declaration of conformity
Article 18
General principles of the CE marking
The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
Article 19
Rules and conditions for affixing the CE marking
The CE marking shall be affixed visibly, legibly and indelibly to any of the following:
each item of pressure equipment referred to in Article 4(1) or its dataplate;
each assembly referred to in Article 4(2) or its dataplate.
Where the affixing of the CE marking is not possible or not warranted on account of the nature of the equipment or assembly, it shall be affixed to the packaging and to the accompanying documents.
The item or assembly referred to in points (a) and (b) of the first subparagraph shall be complete or shall be in a state permitting final assessment as described in point 3.2 of Annex I.
The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative.
CHAPTER 4
NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
Article 20
Notification
Member States shall notify the Commission and the other Member States of the notified bodies and the user inspectorates authorised to carry out conformity assessment tasks in accordance with Article 14, Article 15 or Article 16 and of the third-party organisations they have recognised, for the purposes of the tasks referred to in points 3.1.2 and 3.1.3 of Annex I.
Article 21
Notifying authorities
Article 22
Requirements relating to notifying authorities
Article 23
Information obligation on notifying authorities
Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, recognised third-party organisations and user inspectorates, and of any changes thereto.
The Commission shall make that information publicly available.
Article 24
Requirements relating to notified bodies and recognised third-party organisations
A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of pressure equipment or assemblies which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.
A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of that pressure equipment or assembly, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.
Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.
At all times and for each conformity assessment procedure and each kind or category of pressure equipment in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary:
personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;
descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a conformity assessment body and other activities;
procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.
A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.
The personnel responsible for carrying out conformity assessment tasks shall have the following:
sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;
satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;
appropriate knowledge and understanding of the essential safety requirements set out in Annex I, of the applicable harmonised standards and of the relevant provisions of Union harmonisation legislation and of national legislation;
the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.
The remuneration of the top level management and personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.
Article 25
Requirements relating to user inspectorates
A user inspectorate, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of that pressure equipment or assembly, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.
At all times and for each conformity assessment procedure and each kind or category of pressure equipment in relation to which it has been notified, the user inspectorate shall have at its disposal the necessary:
personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;
descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a user inspectorate and other activities;
procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.
A user inspectorate shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.
The personnel responsible for carrying out conformity assessment tasks shall have the following:
sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;
satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;
appropriate knowledge and understanding of the essential safety requirements set out in Annex I, of the applicable harmonised standards and of the relevant provisions of Union harmonisation legislation and of national legislation;
the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.
The remuneration of the top level management and personnel responsible for carrying out conformity assessment tasks of a user inspectorate shall not depend on the number of assessments carried out or on the results of those assessments.
Article 26
Presumption of conformity of conformity assessment bodies
Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union it shall be presumed to comply with the requirements set out in Article 24 or Article 25 in so far as the applicable harmonised standards cover those requirements.
Article 27
Subsidiaries of and subcontracting by conformity assessment bodies
Article 28
Application for notification
Article 29
Notification procedure
Only such a body shall be considered a notified body, a recognised third-party organisation or a user inspectorate for the purposes of this Directive.
Article 30
Identification numbers and lists of notified bodies
It shall assign a single such number even where the body is notified under several Union acts.
The Commission shall ensure that the list is kept up to date.
Article 31
Lists of recognised third-party organisations and user inspectorates
The Commission shall make publicly available the list of the recognised third-party organisations and of the user inspectorates under this Directive and the tasks for which they have been recognised.
The Commission shall ensure that the list is kept up to date.
Article 32
Changes to notifications
Where a notifying authority has ascertained or has been informed that a user inspectorate no longer meets the requirements laid down in Article 25, or that it is failing to fulfil its obligations, the notifying authority shall as appropriate, restrict, suspend or withdraw the notification, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly.
Article 33
Challenge of the competence of notified bodies, recognised third party organisations and user inspectorates
That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 44(2).
Article 34
Operational obligations of notified bodies, user inspectorates and recognised third party organisations
Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the pressure equipment or assembly technology in question and the mass or serial nature of the production process.
In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the pressure equipment with the requirements of this Directive.
Article 35
Appeal against decisions of notified bodies, recognised third party organisations and user inspectorates
Member States shall ensure that appeal procedures against decisions of notified bodies, recognised third-party organisations and user inspectorates are available.
Article 36
Information obligation on notified bodies, recognised third party organisations and user inspectorates
Notified bodies, recognised third-party organisations and user inspectorates shall inform the notifying authority of the following:
any refusal, restriction, suspension or withdrawal of a certificate;
any circumstances affecting the scope of or conditions for notification;
any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
Article 37
Exchange of experience
The Commission shall provide for the organisation of exchange of experience between the Member States’ national authorities responsible for notification policy.
Article 38
Coordination of notified bodies, recognised third-party organisations and user inspectorates
The Commission shall ensure that appropriate coordination and cooperation between the conformity assessment bodies notified under this Directive are put in place and properly operated in the form of a sectoral group or groups of conformity assessment bodies.
Member States shall ensure that the conformity assessment bodies notified by them participate in the work of that or those group or groups, directly or by means of designated representatives.
CHAPTER 5
UNION MARKET SURVEILLANCE, CONTROL OF PRESSURE EQUIPMENT AND ASSEMBLIES ENTERING THE UNION MARKET, AND UNION SAFEGUARD PROCEDURE
Article 39
Union market surveillance and control of pressure equipment and assemblies entering the Union market
Article 15(3) and Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to pressure equipment and assemblies covered by Article 1 of this Directive.
Article 40
Procedure for dealing with pressure equipment or assemblies presenting a risk at national level
Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the equipment or assembly does not comply with the requirements laid down in this Directive, they shall without delay require the relevant economic operator to take all appropriate corrective actions to bring the pressure equipment or assembly into compliance with those requirements, to withdraw the equipment or assembly from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe.
The market surveillance authorities shall inform the relevant notified body accordingly.
Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph.
The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.
The information referred to in the second subparagraph of paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant equipment or assembly, the origin of the equipment or assembly, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to either of the following:
failure of the equipment or assembly to meet requirements relating to the health or safety of persons or to the protection of domestic animals or property; or
shortcomings in the harmonised standards referred to in Article 12 conferring a presumption of conformity.
Article 41
Union safeguard procedure
The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.
Article 42
Compliant pressure equipment or assemblies which present a risk
The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 44(3).
On duly justified imperative grounds of urgency relating to the protection of health and safety of persons, or of domestic animals or of property, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 44(4).
Article 43
Formal non-compliance
Without prejudice to Article 40, where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:
the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 19 of this Directive;
the CE marking has not been affixed;
the identification number of the notified body involved in the production control phase, has been affixed in violation of Article 19 or has not been affixed;
the marking and labelling referred to in point 3.3. of Annex I have not been affixed or have been affixed in violation of Article 19 or point 3.3 of Annex I;
the EU declaration of conformity has not been drawn up;
the EU declaration of conformity has not been drawn up correctly;
the technical documentation is either not available or not complete;
the information referred to in Article 6(6) or Article 8(3) is absent, false or incomplete;
any other administrative requirement provided for in Article 6 or Article 8 is not fulfilled.
CHAPTER 6
COMMITTEE PROCEDURE AND DELEGATED ACTS
Article 44
Committee procedure
The committee may furthermore examine any other matter concerning the application of this Directive raised either by its chair or by a representative of a Member State in accordance with its rules of procedure.
Article 45
Delegated power
In order to take into account emerging very serious safety reasons, the Commission shall be empowered to adopt delegated acts in accordance with Article 46 reclassifying pressure equipment or assemblies so as to:
make an item or family of pressure equipment referred to in Article 4(3) subject to the requirements of Article 4(1);
make an assembly or family of assemblies referred to in Article 4(3) subject to the requirements of Article 4(2);
classify an item or family of pressure equipment, by way of derogation from the requirements of Annex II, in another category.
Article 46
Exercise of the delegation
CHAPTER 7
TRANSITIONAL AND FINAL PROVISIONS
Article 47
Penalties
Member States shall lay down rules on penalties applicable to infringements by economic operators of the provisions of national law adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. Such rules may include criminal penalties for serious infringements.
The penalties referred to in the first paragraph shall be effective, proportionate and dissuasive.
Article 48
Transitional provisions
Article 49
Transposition
They shall apply those measures from 1 June 2015.
When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to Article 9 of Directive 97/23/EC shall be construed as references to Article 13 of this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated.
They shall apply those measures from 19 July 2016.
When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to the Directive repealed by this Directive shall be construed as references to this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated.
Article 50
Repeal
Article 9 of Directive 97/23/EC is deleted with effect from 1 June 2015, without prejudice to the obligations of the Member States relating to the time-limit for transposition into national law and the date of application of that Article, set out in Annex V, Part B.
Directive 97/23/EC, as amended by the acts listed in Annex V, Part A, is repealed with effect from 19 July 2016, without prejudice to the obligations of the Member States relating to the time-limit for transposition into national law and the date of application of the Directive set out in Annex V, Part B.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex VI.
Article 51
Entry into force and application
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 1, points 1 to 14 of Article 2, Articles 3, 4, 5, 14, 15 and 16, Article 19(1) and (2), and Articles 44, 45 and 46 shall apply from 19 July 2016.
Article 52
Addressees
This Directive is addressed to the Member States.
ANNEX I
ESSENTIAL SAFETY REQUIREMENTS
PRELIMINARY OBSERVATIONS
1. The obligations arising from the essential safety requirements listed in this Annex for pressure equipment also apply to assemblies where the corresponding hazard exists.
2. The essential safety requirements laid down in this Directive are compulsory. The obligations following from those essential safety requirements apply only if the corresponding hazard exists for the pressure equipment in question when it is used under conditions which are reasonably foreseeable by the manufacturer.
3. The manufacturer is under an obligation to analyse the hazards and risks in order to identify those which apply to his equipment on account of pressure; he shall then design and construct it taking account of his analysis.
4. The essential safety requirements are to be interpreted and applied in such a way as to take account of the state of the art and current practice at the time of design and manufacture as well as of technical and economic considerations which are consistent with a high degree of health and safety protection.
1. GENERAL
1.1. Pressure equipment shall be designed, manufactured and checked, and if applicable equipped and installed, in such a way as to ensure its safety when put into service in accordance with the manufacturer’s instructions, or in reasonably foreseeable conditions.
1.2. In choosing the most appropriate solutions, the manufacturer shall apply the principles set out below in the following order:
1.3. Where the potential for misuse is known or can be clearly foreseen, the pressure equipment shall be designed to prevent risks from such misuse or, if that is not possible, adequate warning given that the pressure equipment shall not be used in that way.
2. DESIGN
2.1. General
The pressure equipment shall be properly designed taking all relevant factors into account in order to ensure that the equipment will be safe throughout its intended life.
The design shall incorporate appropriate safety coefficients using comprehensive methods which are known to incorporate adequate safety margins against all relevant failure modes in a consistent manner.
2.2. Design for adequate strength
2.2.1. |
The pressure equipment shall be designed for loadings appropriate to its intended use and other reasonably foreseeable operating conditions. In particular, the following factors shall be taken into account:
—
internal/external pressure,
—
ambient and operational temperatures,
—
static pressure and mass of contents in operating and test conditions,
—
traffic, wind, earthquake loading,
—
reaction forces and moments which result from the supports, attachments, piping, etc.,
—
corrosion and erosion, fatigue, etc.,
—
decomposition of unstable fluids.
Various loadings which can occur at the same time shall be considered, taking into account the probability of their simultaneous occurrence. |
2.2.2. |
Design for adequate strength shall be based on either of the following:
—
as a general rule, a calculation method, as described in point 2.2.3, and supplemented if necessary by an experimental design method as described in point 2.2.4,
—
an experimental design method without calculation, as described in point 2.2.4, when the product of the maximum allowable pressure PS and the volume V is less than 6 000 bar·L or the product PS·DN less than 3 000 bar.
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2.2.3. |
Calculation method
(a) The allowable stresses for pressure equipment shall be limited having regard to reasonably foreseeable failure modes under operating conditions. To this end, safety factors shall be applied to eliminate fully any uncertainty arising out of manufacture, actual operational conditions, stresses, calculation models and the properties and behaviour of the material. These calculation methods shall provide sufficient safety margins consistent, where applicable, with the requirements of point 7. The requirements set out above may be met by applying one of the following methods, as appropriate, if necessary as a supplement to or in combination with another method:
—
design by formula,
—
design by analysis,
—
design by fracture mechanics.
(b) Appropriate design calculations shall be used to establish the resistance of the pressure equipment concerned. In particular:
—
the calculation pressures shall not be less than the maximum allowable pressures and take into account static head and dynamic fluid pressures and the decomposition of unstable fluids. Where a vessel is separated into individual pressure-containing chambers, the partition wall shall be designed on the basis of the highest possible chamber pressure relative to the lowest pressure possible in the adjoining chamber,
—
the calculation temperatures shall allow for appropriate safety margins,
—
the design shall take appropriate account of all possible combinations of temperature and pressure which might arise under reasonably foreseeable operating conditions for the equipment,
—
the maximum stresses and peak stress concentrations shall be kept within safe limits,
—
the calculation for pressure containment shall utilise the values appropriate to the properties of the material, based on documented data, having regard to the provisions set out in point 4 together with appropriate safety factors. Material characteristics to be considered, where applicable, include:
—
yield strength, 0,2 % or 1,0 % proof strength as appropriate at calculation temperature,
—
tensile strength,
—
time-dependent strength, i.e. creep strength,
—
fatigue data,
—
Young’s modulus (modulus of elasticity),
—
appropriate amount of plastic strain,
—
bending rupture energy,
—
fracture toughness.
—
appropriate joint factors shall be applied to the material properties depending, for example, on the type of non-destructive testing, the materials joined and the operating conditions envisaged,
—
the design shall take appropriate account of all reasonably foreseeable degradation mechanisms (e.g. corrosion, creep, fatigue) commensurate with the intended use of the equipment. Attention shall be drawn, in the instructions referred to in point 3.4, to particular features of the design which are relevant to the life of the equipment, for example:
—
for creep: design hours of operation at specified temperatures,
—
for fatigue: design number of cycles at specified stress levels,
—
for corrosion: design corrosion allowance.
(c) Where the calculated thickness does not allow for adequate structural stability, the necessary measures shall be taken to remedy the situation taking into account the risks from transport and handling. |
2.2.4. |
Experimental design method
The design of the equipment may be validated, in all or in part, by an appropriate test programme carried out on a sample representative of the equipment or the category of equipment. The test programme shall be clearly defined prior to testing and accepted by the notified body responsible for the design conformity assessment module, where it exists. This programme shall define test conditions and criteria for acceptance or refusal. The actual values of the essential dimensions and characteristics of the materials which constitute the equipment tested shall be measured before the test. Where appropriate, during tests, it shall be possible to observe the critical zones of the pressure equipment with adequate instrumentation capable of registering strains and stresses with sufficient precision. The test programme shall include:
(a)
A pressure strength test, the purpose of which is to check that, at a pressure with a defined safety margin in relation to the maximum allowable pressure, the equipment does not exhibit significant leaks or deformation exceeding a determined threshold. The test pressure shall be determined on the basis of the differences between the values of the geometrical and material characteristics measures under test conditions and the values used for design purposes; it shall take into account the differences between the test and design temperatures;
(b)
where the risk of creep or fatigue exists, appropriate tests determined on the basis of the service conditions laid down for the equipment, for instance hold time at specified temperatures, number of cycles at specified stress-levels;
(c)
where necessary, additional tests concerning other factors referred to in point 2.2.1 such as corrosion, external damage. |
2.3. Provisions to ensure safe handling and operation
The method of operation specified for pressure equipment shall be such as to preclude any reasonably foreseeable risk in operation of the equipment. Particular attention shall be paid, where appropriate, to:
In particular, pressure equipment fitted with an access door shall be equipped with an automatic or manual device enabling the user easily to ascertain that the opening will not present any risk. Furthermore, where the opening can be operated quickly, the pressure equipment shall be fitted with a device to prevent it being opened whenever the pressure or temperature of the fluid presents a risk.
2.4. Means of examination
(a) Pressure equipment shall be designed and constructed so that all necessary examinations to ensure safety can be carried out;
(b) Means of determining the internal condition of the equipment shall be available, where it is necessary to ensure the continued safety of the equipment, such as access openings allowing physical access to the inside of the pressure equipment so that appropriate examinations can be carried out safely and ergonomically;
(c) Other means of ensuring the safe condition of the pressure equipment may be applied in any of the following situations:
2.5. Means of draining and venting
Adequate means shall be provided for the draining and venting of pressure equipment where necessary:
2.6. Corrosion or other chemical attack
Where necessary, adequate allowance or protection against corrosion or other chemical attack shall be provided, taking due account of the intended and reasonably foreseeable use.
2.7. Wear
Where severe conditions of erosion or abrasion may arise, adequate measures shall be taken to:
2.8. Assemblies
Assemblies shall be so designed that:
2.9. Provisions for filling and discharge
Where appropriate, the pressure equipment shall be so designed and provided with accessories, or provision made for their fitting, as to ensure safe filling and discharge in particular with respect to risks such as:
on filling:
on discharge: the uncontrolled release of the pressurised fluid;
on filling or discharge: unsafe connection and disconnection.
2.10. Protection against exceeding the allowable limits of pressure equipment
Where, under reasonably foreseeable conditions, the allowable limits could be exceeded, the pressure equipment shall be fitted with, or provision made for the fitting of, suitable protective devices, unless the equipment is intended to be protected by other protective devices within an assembly.
The suitable device or combination of such devices shall be determined on the basis of the particular characteristics of the equipment or assembly.
Suitable protective devices and combinations thereof comprise:
safety accessories as defined in point 4 of Article 2,
where appropriate, adequate monitoring devices such as indicators and/or alarms which enable adequate action to be taken either automatically or manually to keep the pressure equipment within the allowable limits.
2.11. Safety accessories
2.11.1. |
Safety accessories shall:
—
be so designed and constructed as to be reliable and suitable for their intended duty and take into account the maintenance and testing requirements of the devices, where applicable,
—
be independent of other functions, unless their safety function cannot be affected by such other functions,
—
comply with appropriate design principles in order to obtain suitable and reliable protection. These principles include, in particular, fail-safe modes, redundancy, diversity and self-diagnosis.
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2.11.2. |
Pressure limiting devices
These devices shall be so designed that the pressure will not permanently exceed the maximum allowable pressure PS; however a short duration pressure surge in keeping with the specifications laid down in point 7.3 is allowable, where appropriate. |
2.11.3. |
Temperature monitoring devices
These devices shall have an adequate response time on safety grounds, consistent with the measurement function. |
2.12. External fire
Where necessary, pressure equipment shall be so designed and, where appropriate, fitted with suitable accessories, or provision made for their fitting, to meet damage-limitation requirements in the event of external fire, having particular regard to its intended use.
3. MANUFACTURING
3.1. Manufacturing procedures
The manufacturer shall ensure the competent execution of the provisions set out at the design stage by applying the appropriate techniques and relevant procedures, especially with a view to the aspects set out below.
3.1.1. Preparation of the component parts
Preparation of the component parts (e.g. forming and chamfering) shall not give rise to defects or cracks or changes in the mechanical characteristics likely to be detrimental to the safety of the pressure equipment.
3.1.2. Permanent joining
Permanent joints and adjacent zones shall be free of any surface or internal defects detrimental to the safety of the equipment.
The properties of permanent joints shall meet the minimum properties specified for the materials to be joined unless other relevant property values are specifically taken into account in the design calculations.
For pressure equipment, permanent joining of components which contribute to the pressure resistance of equipment and components which are directly attached to them shall be carried out by suitably qualified personnel according to suitable operating procedures.
For pressure equipment in categories II, III and IV, operating procedures and personnel shall be approved by a competent third party which, at the manufacturer’s discretion, may be:
To carry out these approvals the third party must perform examinations and tests as set out in the appropriate harmonised standards or equivalent examinations and tests or shall have them performed.
3.1.3. Non-destructive tests
For pressure equipment, non-destructive tests of permanent joints shall be carried out by suitable qualified personnel. For pressure equipment in categories III and IV, the personnel shall be approved by a third-party organisation recognised by a Member State pursuant to Article 20.
3.1.4. Heat treatment
Where there is a risk that the manufacturing process will change the material properties to an extent which would impair the safety of the pressure equipment, suitable heat treatment shall be applied at the appropriate stage of manufacture.
3.1.5. Traceability
Suitable procedures shall be established and maintained for identifying the material making up the components of the equipment which contribute to pressure resistance by suitable means from receipt, through production, up to the final test of the manufactured pressure equipment.
3.2. Final assessment
Pressure equipment shall be subjected to final assessment as described below.
3.2.1. Final inspection
Pressure equipment shall undergo a final inspection to assess visually and by examination of the accompanying documents compliance with the requirements of this Directive. Test carried out during manufacture may be taken into account. As far as is necessary on safety grounds, the final inspection shall be carried out internally and externally on every part of the equipment, where appropriate in the course of manufacture (e.g. where examination during the final inspection is no longer possible).
3.2.2. Proof test
Final assessment of pressure equipment shall include a test for the pressure containment aspect, which will normally take the form of a hydrostatic pressure test at a pressure at least equal, where appropriate, to the value laid down in point 7.4.
For category I series-produced pressure equipment, this test may be performed on a statistical basis.
Where the hydrostatic pressure test is harmful or impractical, other tests of a recognised value may be carried out. For tests other than the hydrostatic pressure test, additional measures, such as non-destructive tests or other methods of equivalent validity, shall be applied before those tests are carried out.
3.2.3. Inspection of safety devices
For assemblies, the final assessment shall also include a check of the safety devices intended to check full compliance with the requirements referred to in point 2.10.
3.3. Marking and labelling
In addition to the CE marking referred to in Articles 18 and 19 and the information to be provided in accordance with Article 6(6) and Article 8(3), the following information shall be provided:
for all pressure equipment:
depending on the type of pressure equipment, further information necessary for safe installation, operation or use and, where applicable, maintenance and periodic inspection such as:
where necessary, warnings fixed to the pressure equipment drawing attention to misuse which experience has shown might occur.
The information referred to in points (a), (b) and (c) shall be given on the pressure equipment or on a dataplate firmly attached to it, with the following exceptions:
3.4. Operating instructions
(a) When pressure equipment is made available on the market, it shall be accompanied, as far as relevant, with instructions for the user, containing all the necessary safety information relating to:
(b) Instructions shall cover information affixed to the pressure equipment in accordance with point 3.3, with the exception of serial identification, and shall be accompanied, where appropriate, by the technical documents, drawings and diagrams necessary for a full understanding of these instructions.
(c) If appropriate, these instructions shall also refer to risks arising from misuse in accordance with point 1.3 and particular features of the design in accordance with point 2.2.3.
4. MATERIALS
Materials used for the manufacture of pressure equipment shall be suitable for such application during the scheduled lifetime unless replacement is foreseen.
Welding consumables and other joining materials need to fulfil only the relevant requirements of points 4.1, 4.2(a) and the first paragraph of point 4.3, in an appropriate way, both individually and in a joined structure.
4.1. Materials for pressurised parts shall:
have appropriate properties for all operating conditions which are reasonably foreseeable and for all test conditions, and in particular they should be sufficiently ductile and tough. Where appropriate, the characteristics of the materials shall comply with the requirements of point 7.5. Moreover, due care should be exercised in particular in selecting materials in order to prevent brittle-type fracture where necessary; where for specific reasons brittle material has to be used appropriate measures shall be taken;
be sufficiently chemically resistant to the fluid contained in the pressure equipment; the chemical and physical properties necessary for operational safety shall not be significantly affected within the scheduled lifetime of the equipment;
not be significantly affected by ageing;
be suitable for the intended processing procedures;
be selected in order to avoid significant undesirable effects when the various materials are put together.
4.2. The pressure equipment manufacturer shall:
define in an appropriate manner the values necessary for the design calculations referred to in point 2.2.3 and the essential characteristics of the materials and their treatment referred to in point 4.1;
provide in his technical documentation elements relating to compliance with the materials specifications of this Directive in one of the following forms:
for pressure equipment in categories III and IV, a specific assessment of the particular material appraisal shall be performed by the notified body in charge of conformity assessment procedures for the pressure equipment.
4.3. The equipment manufacturer shall take appropriate measures to ensure that the material used conforms with the required specification. In particular, documentation prepared by the material manufacturer affirming compliance with a specification shall be obtained for all materials.
For the main pressure-bearing parts of equipment in categories II, III and IV, this shall take the form of a certificate of specific product control.
Where a material manufacturer has an appropriate quality-assurance system, certified by a competent body established within the Union and having undergone a specific assessment for materials, certificates issued by the manufacturer are presumed to certify conformity with the relevant requirements of this point.
SPECIFIC PRESSURE EQUIPMENT REQUIREMENTS
In addition to the applicable requirements of points 1 to 4, the following requirements apply to the pressure equipment covered by points 5 and 6.
5. FIRED OR OTHERWISE HEATED PRESSURE EQUIPMENT WITH A RISK OF OVERHEATING AS REFERRED TO IN ARTICLE 4(1)
This pressure equipment includes:
This pressure equipment shall be calculated, designed and constructed so as to avoid or minimise risks of a significant loss of containment from overheating. In particular it shall be ensured, where applicable, that:
appropriate means of protection are provided to restrict operating parameters such as heat input, heat take-off and, where applicable, fluid level so as to avoid any risk of local and general overheating;
sampling points are provided where required to allow evaluation of the properties of the fluid so as to avoid risks related to deposits and/or corrosion;
adequate provisions are made to eliminate risks of damage from deposits;
means of safe removal of residual heat after shutdown are provided;
steps are taken to avoid a dangerous accumulation of ignitable mixtures of combustible substances and air, or flame blowback.
6. PIPING AS REFERRED TO IN ARTICLE 4(1)(c)
Design and construction shall ensure:
that the risk of overstressing from inadmissible free movement or excessive forces being produced, e.g. on flanges, connections, bellows or hoses, is adequately controlled by means such as support, constraint, anchoring, alignment and pre-tension;
that where there is a possibility of condensation occurring inside pipes for gaseous fluids, means are provided for drainage and removal of deposits from low areas to avoid damage from water hammer or corrosion;
that due consideration is given to the potential damage from turbulence and formation of vortices; the relevant parts of point 2.7 are applicable;
that due consideration is given to the risk of fatigue due to vibrations in pipes;
that, where fluids of Group 1 are contained in the piping, appropriate means are provided to isolate ‘take-off’ pipes the size of which represents a significant risk;
that the risk of inadvertent discharge is minimised; the take-off points shall be clearly marked on the permanent side, indicating the fluid contained;
that the position and route of underground piping is at least recorded in the technical documentation to facilitate safe maintenance, inspection or repair.
7. SPECIFIC QUANTITATIVE REQUIREMENTS FOR CERTAIN PRESSURE EQUIPMENT
The following provisions apply as a general rule. However, where they are not applied, including in cases where materials are not specifically referred to and no harmonised standards are applied, the manufacturer shall demonstrate that appropriate measures have been taken to achieve an equivalent overall level of safety.
The provisions laid down in this section supplement the essential safety requirements of points 1 to 6 for the pressure equipment to which they apply.
7.1. Allowable stresses
7.1.1. Symbols
Re/t, yield limit, indicates the value at the calculation temperature of:
Rm/20 indicates the minimum value of the ultimate tensile strength at 20 °C.
Rm/t designates the ultimate tensile strength at the calculation temperature.
7.1.2. |
The permissible general membrane stress for predominantly static loads and for temperatures outside the range in which creep is significant shall not exceed the smaller of the following values, according to the material used:
—
in the case of ferritic steel including normalised (normalised rolled) steel and excluding fine-grained steel and specially heat-treated steel, 2/3 of Re/t and 5/12 of Rm/20,
—
in the case of austenitic steel:
—
if its elongation after rupture exceeds 30 %, 2/3 of Re/t
—
or, alternatively, and if its elongation after rupture exceeds 35 %, 5/6 of Re/t and 1/3 of Rm/t,
—
in the case of non-alloy or low-alloy cast steel, 10/19 of Re/t and 1/3 of Rm/20,
—
in the case of aluminium, 2/3 of Re/t,
—
in the case of aluminium alloys excluding precipitation hardening alloys 2/3 of Re/t and 5/12 of Rm/20.
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7.2. Joint coefficients
For welded joints, the joint coefficient shall not exceed the following values:
If necessary, the type of stress and the mechanical and technological properties of the joint shall also be taken into account.
7.3. Pressure limiting devices, particularly for pressure vessels
The momentary pressure surge referred to in point 2.11.2 shall be kept to 10 % of the maximum allowable pressure.
7.4. Hydrostatic test pressure
For pressure vessels, the hydrostatic test pressure referred to in point 3.2.2 shall be no less than either of the following:
7.5. Material characteristics
Unless other values are required in accordance with other criteria that shall be taken into account, a steel is considered as sufficiently ductile to satisfy point 4.1(a) if, in a tensile test carried out by a standard procedure, its elongation after rupture is no less than 14 % and its bending rupture energy measured on an ISO V test-piece is no less than 27 J, at a temperature not greater than 20 °C but not higher than the lowest scheduled operating temperature.
ANNEX II
CONFORMITY ASSESSMENT TABLES
1. The references in the tables to categories of modules are the following:
I |
= |
Module A |
II |
= |
Modules A2, D1, E1 |
III |
= |
Modules B (design type) + D, B (design type) + F, B (production type) + E, B (production type) + C2, H |
IV |
= |
Modules B (production type) + D, B (production type) + F, G, H1 |
2. The safety accessories defined in point 4 of Article 2, and referred to in Article 4(1)(d), are classified in category IV. However, by way of exception, safety accessories manufactured for specific equipment may be classified in the same category as the equipment they protect.
3. The pressure accessories defined in point 5 of Article 2, and referred to in Article 4(1)(d), are classified on the basis of:
The appropriate table for vessels or piping is to be used to determine the conformity assessment category.
Where both the volume and the nominal size are considered appropriate in the second indent of the first subparagraph, the pressure accessory shall be classified in the highest category.
4. The demarcation lines in the following conformity assessment tables indicate the upper limit for each category.
Table 1
Vessels referred to in Article 4(1)(a)(i), first indent
Exceptionally, vessels intended to contain an unstable gas and falling within categories I or II on the basis of table 1 shall be classified in category III.
Table 2
Vessels referred to in Article 4(1)(a)(i), second indent
Exceptionally, portable extinguishers and bottles for breathing equipment shall be classified at least in category III.
Table 3
Vessels referred to in Article 4(1)(a)(ii), first indent
Table 4
Vessels referred to in Article 4(1)(a)(ii), second indent
Exceptionally, assemblies intended for generating warm water as referred to in the second subparagraph of Article 4(2), shall be subject either to an EU-type examination (Module B — design type) with respect to their conformity with the essential requirements referred to in points 2.10, 2.11, 3.4, 5(a) and 5(d) of Annex I, or to full quality assurance (Module H).
Table 5
Pressure equipment referred to in Article 4(1)(b)
Exceptionally, the design of pressure-cookers shall be subject to a conformity assessment procedure equivalent to at least one of the category III modules.
Table 6
Piping referred to in Article 4(1)(c)(i), first indent
Exceptionally, piping intended for unstable gases and falling within categories I or II on the basis of Table 6 shall be classified in category III.
Table 7
Piping referred to in Article 4(1)(c)(i), second indent
Exceptionally, all piping containing fluids at a temperature greater than 350 °C and falling within category II on the basis of Table 7 shall be classified in category III.
Table 8
Piping referred to in Article 4(1)(c)(ii), first indent
Table 9
Piping referred to in Article 4(1)(c)(ii), second indent
ANNEX III
CONFORMITY ASSESSMENT PROCEDURES
The obligations arising from the provisions on pressure equipment in this Annex also apply to assemblies.
1. MODULE A: (INTERNAL PRODUCTION CONTROL)
1. |
Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfy the requirements of this Directive. |
2. |
Technical documentation
The manufacturer shall establish the technical documentation. The technical documentation shall make it possible to assess the conformity of the pressure equipment to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the pressure equipment. The technical documentation shall, wherever applicable, contain at least the following elements:
—
a general description of the pressure equipment,
—
conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,
—
descriptions and explanations necessary for an understanding of those drawings and diagrams and the operation of the pressure equipment,
—
a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and a description of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
—
results of design calculations made, examinations carried out, etc.,
—
test reports.
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3. |
Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured pressure equipment with the technical documentation referred to in point 2 and with the requirements of this Directive. |
4. |
CE marking and EU declaration of conformity
4.1. The manufacturer shall affix the CE marking to each individual pressure equipment that satisfies the applicable requirements of this Directive. 4.2. The manufacturer shall draw up a written EU declaration of conformity for the pressure equipment model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. |
5. |
Authorised representative
The manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. |
2. MODULE A2: INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRESSURE EQUIPMENT CHECKS AT RANDOM INTERVALS
1. |
Internal production control plus supervised pressure equipment checks at random intervals is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 4 and 5, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfy the requirements of this Directive. |
2. |
Technical documentation
The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the conformity of the pressure equipment with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the pressure equipment. The technical documentation shall contain, wherever applicable, at least the following elements:
—
a general description of the pressure equipment,
—
conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,
—
descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment,
—
a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
—
results of design calculations made, examinations carried out, etc., and
—
test reports.
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3. |
Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured pressure equipment with the technical documentation referred to in point 2 and with the requirements of this Directive that apply to it. |
4. |
Final assessment and pressure equipment checks
The manufacturer shall perform a final assessment of the pressure equipment, monitored by means of unexpected visits by a notified body chosen by the manufacturer. The notified body shall carry out product checks or have them carried out at random intervals determined by the body, in order to verify the quality of the internal checks of the pressure equipment, taking into account, inter alia, the technological complexity of the pressure equipment and the quantity of production. During its unexpected visits, the notified body shall:
—
establish that the manufacturer actually performs final assessment in accordance with point 3.2 of Annex I.
—
take samples of pressure equipment at the manufacturing or storage premises in order to conduct checks. The notified body assesses the number of items of equipment to sample and whether it is necessary to perform, or have performed, all or part of the final assessment of the pressure equipment samples.
The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the pressure equipment performs within acceptable limits, with a view to ensuring conformity of the pressure equipment. Should one or more of the items of pressure equipment or assembly not conform, the notified body shall take appropriate measures. The manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process. |
5. |
CE marking and EU declaration of conformity
5.1. The manufacturer shall affix the CE marking to each individual pressure equipment that satisfies the applicable requirements of this Directive. 5.2. The manufacturer shall draw up a written EU declaration of conformity for the pressure equipment model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. |
6. |
Authorised representative
The manufacturer’s obligations set out in point 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. |
3. MODULE B: EU-TYPE EXAMINATION
3.1. EU-Type examination – production type
1. EU-type examination — production type is the part of a conformity assessment procedure in which a notified body examines the technical design of the pressure equipment and verifies and attests that the technical design of the pressure equipment meets the requirements of this Directive.
2. EU-type examination — production type shall consist of an assessment of the adequacy of the technical design of the pressure equipment through examination of the technical documentation and supporting evidence referred to in point 3, plus examination of a specimen, representative of the production envisaged, of the complete pressure equipment.
3. The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice.
The application shall include:
The specimen may cover several versions of the pressure equipment provided that the differences between the versions do not affect the level of safety.
The notified body may request further specimens if needed for carrying out the test programme;
4. The notified body shall:
examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the pressure equipment and the manufacturing procedures.
In particular, the notified body shall:
verify that the specimen(s) have been manufactured in conformity with the technical documentation and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards as well as the elements which have been designed using other relevant technical specifications without applying the relevant provisions of those standards.
carry out appropriate examinations and necessary tests to check whether when the manufacturer has chosen to apply the solutions in the relevant harmonised standards, these have been applied correctly.
carry out appropriate examinations and necessary tests to check whether, where the solutions in the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential safety requirements of this Directive.
agree with the manufacturer on a location where the examinations and tests will be carried out.
5. The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis the notifying authority, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.
6. Where the type meets the requirements of this Directive, the notified body shall issue an EU-type examination certificate – production type to the manufacturer. Without prejudice to point 7, the certificate shall be valid for 10 years and be renewable and shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type.
A list of the relevant parts of the technical documentation shall be annexed to the certificate and a copy kept by the notified body.
The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured pressure equipment with the examined type to be evaluated and to allow for in-service control.
Where the type does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue an EU-type examination certificate – production type and shall inform the applicant accordingly, giving detailed reasons for its refusal. Provision shall be made for an appeals procedure.
7. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of this Directive, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.
The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate – production type of all modifications to the approved type that may affect the conformity of the pressure equipment with the essential safety requirements of this Directive or the conditions for validity of the certificate. Such modifications shall require additional approval in the form of an addition to the original EU- type examination certificate – production type.
8. Each notified body shall inform its notifying authority concerning the EU-type examination certificates – production type and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.
Each notified body shall inform the other notified bodies concerning the EU-type examination certificates – production type and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates – production type and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate – production type, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.
9. The manufacturer shall keep a copy of the EU-type examination certificate – production type, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market.
10. The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.
3.2. EU-Type examination – design type
1. EU-type examination – design type is the part of a conformity assessment procedure in which a notified body examines the technical design of the pressure equipment and verifies and attests that the technical design of the pressure equipment meets the requirements of this Directive.
2. The EU-type examination – design type shall consist of an assessment of the adequacy of the technical design of the pressure equipment through examination of the technical documentation and supporting evidence referred to in point 3, without examination of a specimen.
The experimental design method provided for in point 2.2.4 of Annex I shall not be used in the context of this module.
3. The manufacturer shall lodge an application for EU-type examination — design type with a single notified body of his choice.
The application shall include:
The application may cover several versions of the pressure equipment provided that the differences between the versions do not affect the level of safety.
4. The notified body shall:
examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the product.
In particular, the notified body shall:
carry out appropriate examinations to check whether where the manufacturer has chosen to apply the solutions in the relevant harmonised standards these have been applied correctly.
carry out appropriate examinations to check whether, where the solutions in the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer meet the corresponding essential safety requirements of this Directive.
5. The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.
6. Where the design meets the requirements of this Directive, the notified body shall issue an EU-type examination certificate — design type to the manufacturer. Without prejudice to point 7, the certificate shall be valid for 10 years and be renewable and shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved design.
A list of the relevant parts of the technical documentation shall be annexed to the certificate and a copy kept by the notified body.
The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured pressure equipment with the examined design to be evaluated and to allow for in-service control.
Where the design does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue an EU-type examination certificate — design type and shall inform the applicant accordingly, giving detailed reasons for its refusal.
7. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of this Directive, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.
The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate — design type of all modifications to the approved design that may affect the conformity of the pressure equipment with the essential safety requirements of this Directive or the conditions for validity of the certificate. Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate — design type.
8. Each notified body shall inform its notifying authorities concerning the EU-type examination certificates — design type and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.
Each notified body shall inform the other notified bodies concerning the EU-type examination certificates — design type and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates — design type and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate — design type, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.
9. The manufacturer shall keep a copy of the EU-type examination certificate — design type, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market.
10. The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.
4. MODULE C2: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRESSURE EQUIPMENT CHECKS AT RANDOM INTERVALS
1. |
Conformity to type based on internal production control plus supervised pressure equipment checks at random intervals is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the pressure equipment concerned is in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to it. |
2. |
Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured pressure equipment with the type described in the EU-type examination certificate and with the requirements of this Directive that apply to them. |
3. |
Final assessment and pressure equipment checks
A notified body, chosen by the manufacturer, shall carry out checks or have them carried out at random intervals determined by the body, in order to verify the quality of the final assessment and of the internal checks on the pressure equipment, taking into account, inter alia, the technological complexity of the pressure equipment and the quantity of production. The notified body shall establish that the manufacturer actually performs final assessment in accordance with point 3.2 of Annex I. An adequate sample of the final pressure equipment, taken on site by the notified body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the harmonised standards, and/or equivalent tests applying other technical specifications, shall be carried out to check the conformity of the pressure equipment with the relevant requirements of this Directive. The notified body shall assess the number of items of equipment to sample and whether it is necessary to perform, or have performed, all or part of final assessment on the pressure equipment samples. Where a sample does not conform to the acceptable quality level, the body shall take appropriate measures. The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the pressure equipment performs within acceptable limits, with a view to ensuring conformity of the pressure equipment. Where the tests are carried out by a notified body, the manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process. |
4. |
CE marking and EU declaration of conformity
4.1. The manufacturer shall affix the CE marking to each individual pressure equipment or assembly that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive. 4.2. The manufacturer shall draw up a written EU declaration of conformity for a pressure equipment model and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. |
5. |
Authorised representative
The manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. |
5. MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS
1. |
Conformity to type based on quality assurance of the production process is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the pressure equipment or assembly concerned is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of this Directive that apply to it. |
2. |
Manufacturing
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the pressure equipment concerned as specified in point 3 and shall be subject to surveillance as specified in point 4. |
3. |
Quality system
3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice for the pressure equipment concerned. The application shall include:
—
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,
—
a written declaration that the same application has not been lodged with any other notified body,
—
all relevant information on the pressure equipment type envisaged,
—
the documentation concerning the quality system,
—
the technical documentation of the approved type and a copy of the EU-type examination certificate.
3.2. The quality system shall ensure that the pressure equipment is in conformity with the type described in the EU-type examination certificate and comply with the requirements of this Directive that apply to it. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of:
—
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment,
—
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used, particularly the procedures used for the permanent joining of parts as approved in accordance with point 3.1.2 of Annex I,
—
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
—
the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the non-destructive tests in accordance with points 3.1.2 and 3.1.3 of Annex I, etc., and
—
the means of monitoring the achievement of the required quality and the effective operation of the quality system.
3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant pressure equipment field and pressure equipment technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an inspection visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 3.1, fifth indent, to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. 3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate the proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
4. |
Surveillance under the responsibility of the notified body
4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:
—
the quality system documentation,
—
the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.
4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits shall be such that a full reassessment is carried out every three years. 4.4. In addition the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors shall be considered in the visit control system:
—
the category of the pressure equipment,
—
the results of previous surveillance visits,
—
the need to follow up corrective actions,
—
special conditions linked to the approval of the system, where applicable,
—
significant changes in manufacturing organisation, policy or techniques.
During such visits the notified body may, if necessary, carry out product tests or have them carried out in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. |
5. |
CE marking and EU declaration of conformity
5.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual pressure equipment that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive. 5.2. The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. |
6. |
The manufacturer shall, for a period ending 10 years after the pressure equipment has been placed on the market, keep at the disposal of the national authorities:
—
the documentation referred to point 3.1,
—
the change referred to in point 3.5, as approved,
—
the decisions and reports of the notified body referred to in points 3.3, 3.5, 4.3 and 4.4.
|
7. |
Each notified body shall inform its notifying authorities of the quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies of the quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued. |
8. |
Authorised representative
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. |
6. MODULE D1: QUALITY ASSURANCE OF THE PRODUCTION PROCESS
1. |
Quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 4 and 7, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfy the requirements of this Directive that apply to it. |
2. |
Technical documentation
The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the conformity of the pressure equipment with the relevant requirements and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall, wherever applicable, contain at least the following elements:
—
a general description of the pressure equipment,
—
conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,
—
descriptions and explanations necessary for an understanding of those drawings and diagrams and the operation of the pressure equipment,
—
a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
—
results of design calculations made, examinations carried out, etc., and
—
test reports.
|
3. |
The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the pressure equipment has been placed on the market. |
4. |
Manufacturing
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the pressure equipment concerned as specified in point 5, and shall be subject to surveillance as specified in point 6. |
5. |
Quality system
5.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice for the pressure equipment concerned. The application shall include:
—
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,
—
a written declaration that the same application has not been lodged with any other notified body,
—
all relevant information on the pressure equipment type envisaged,
—
the documentation concerning the quality system,
—
the technical documentation referred to in point 2.
5.2. The quality system shall ensure compliance of the pressure equipment with the requirements of this Directive that apply to it. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of:
—
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment,
—
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic measures that will be used, particularly the procedures used for the permanent joining of parts as approved in accordance with point 3.1.2 of Annex I,
—
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
—
the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts in accordance with point 3.1.2 of Annex I, etc.,
—
the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
5.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 5.2. The elements of the quality system which conform to the relevant harmonised standard are presumed to comply with the corresponding requirements referred to in point 5.2. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the pressure equipment technology concerned, and the knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 2 in order to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the pressure equipment with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 5.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. 5.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 5.2 or whether a reassessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
6. |
Surveillance under the responsibility of the notified body
6.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 6.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:
—
the quality system documentation,
—
the technical documentation referred to in point 2,
—
the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.
6.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits shall be such that a full reassessment is carried out every three years. 6.4. In addition the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors shall be considered in the visit control system:
—
the category of the pressure equipment,
—
the results of previous surveillance visits,
—
the need to follow up corrective action(s),
—
special conditions linked to the approval of the system, where applicable,
—
significant changes in manufacturing organisation, policy or techniques.
During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. |
7. |
CE marking and EU declaration of conformity
7.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 5.1, the latter’s identification number to each individual pressure equipment that satisfies the applicable requirements of this Directive. 7.2. The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the product model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. |
8. |
The manufacturer shall, for a period ending 10 years after the pressure equipment has been placed on the market, keep at the disposal of the national authorities:
—
the documentation referred to in point 5.1,
—
the change referred to in point 5.5,
—
the decisions and reports of the notified body referred to in points 5.5, 6.3 and 6.4.
|
9. |
Each notified body shall inform its notifying authorities of the quality system approvals issued or withdrawn, and shall periodically, or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended, or withdrawn, and upon request, of quality system approvals which it has issued. |
10. |
Authorised representative
The manufacturer’s obligations set out in points 3, 5.1, 5.5, 7 and 8 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. |
7. MODULE E: CONFORMITY TO TYPE BASED ON PRESSURE EQUIPMENT QUALITY ASSURANCE
1. |
Conformity to type based on pressure equipment quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the pressure equipment concerned is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of this Directive that apply to it. |
2. |
Manufacturing
The manufacturer shall operate an approved quality system for the final product inspection and testing of the pressure equipment concerned as specified in point 3 and shall be subject to surveillance as specified in point 4. |
3. |
Quality system
3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the pressure equipment concerned. The application shall include:
—
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,
—
a written declaration that the same application has not been lodged with any other notified body,
—
all relevant information on the pressure equipment type envisaged,
—
the documentation concerning the quality system,
—
the technical documentation of the approved type and a copy of the EU-type examination certificate.
3.2. The quality system shall ensure compliance of the products with the type described in the EU-type examination certificate and with the applicable requirements of this Directive. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of:
—
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,
—
the examinations and tests that will be carried out after manufacture,
—
the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the non-destructive tests in accordance with points 3.1.2 and 3.1.3 of Annex I,
—
the means of monitoring the effective operation of the quality system.
3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant pressure equipment field and pressure equipment technology concerned and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 3.1, fifth indent, in order to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the pressure equipment with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. 3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
4. |
Surveillance under the responsibility of the notified body
4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:
—
the quality system documentation,
—
the technical documentation,
—
the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel concerned, etc.
4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years. 4.4. In addition the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors shall be considered in the visit control system:
—
the category of the pressure equipment,
—
the results of previous surveillance visits,
—
the need to follow up corrective actions,
—
special conditions linked to the approval of the system, where applicable,
—
significant changes in manufacturing organisation, policy or techniques.
During such visits, the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. |
5. |
CE marking and EU declaration of conformity
5.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual pressure equipment that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive. 5.2. The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the product model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. |
6. |
The manufacturer shall, for a period ending 10 years after the pressure equipment has been placed on the market, keep at the disposal of the national authorities:
—
the documentation referred to in point 3.1,
—
the change referred to in point 3.5, as approved,
—
the decisions and reports from the notified body which are referred to in points 3.3, 3.5, 4.3 and 4.4.
|
7. |
Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued. |
8. |
Authorised representative
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. |
8. MODULE E1: QUALITY ASSURANCE OF FINAL PRESSURE EQUIPMENT INSPECTION AND TESTING
1. |
Quality assurance of final pressure equipment inspection and testing is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 4 and 7, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfy the requirements of this Directive that apply to it. |
2. |
Technical documentation
The manufacturer shall establish the technical documentation. The technical documentation shall make it possible to assess the conformity of the pressure equipment with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s) The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the pressure equipment. The technical documentation shall, wherever applicable, contain at least the following elements:
—
a general description of the pressure equipment,
—
conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,
—
descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment,
—
a list of the harmonised standards, the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
—
results of design calculations made, examinations carried out, etc., and
—
test reports.
|
3. |
The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the pressure equipment has been placed on the market. |
4. |
Manufacturing
The manufacturer shall operate an approved quality system for the final product inspection and testing of the pressure equipment as specified in point 5 and shall be subject to surveillance as specified in point 6. |
5. |
Quality system
5.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the pressure equipment concerned. The application shall include:
—
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,
—
a written declaration that the same application has not been lodged with any other notified body,
—
all relevant information on the pressure equipment type envisaged,
—
the documentation concerning the quality system, and
—
the technical documentation referred to in point 2.
5.2. The quality system shall ensure compliance of the pressure equipment with the requirements of this Directive that apply to it. Under the quality system, each item of pressure equipment shall be examined and appropriate tests as set out in the relevant standard(s) referred to in Article 12, or equivalent tests, and particularly final assessment as referred to in point 3.2 of Annex I, shall be carried out in order to ensure its conformity with the requirements of this Directive which apply to it. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of:
—
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment,
—
the procedures used for the permanent joining of parts as approved in accordance with point 3.1.2 of Annex I,
—
the examinations and tests that will be carried out after manufacture,
—
the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts in accordance with point 3.1.2 of Annex I,
—
the means of monitoring the effective operation of the quality system.
5.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 5.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant pressure equipment field and pressure equipment technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 2 in order to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the pressure equipment with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 5.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. 5.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 5.2 or whether a reassessment is required. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
6. |
Surveillance under the responsibility of the notified body
6.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 6.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:
—
the quality system documentation,
—
the technical documentation referred to in point 2,
—
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
6.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits shall be such that a full reassessment is carried out every three years. 6.4. In addition the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors shall be considered in the visit control system:
—
the category of the equipment,
—
the results of previous surveillance visits,
—
the need to follow up corrective action(s),
—
special conditions linked to the approval of the system, where applicable,
—
significant changes in manufacturing organisation, policy or techniques.
During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. |
7. |
CE marking and EU declaration of conformity
7.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 5.1, the latter’s identification number to each individual item of pressure equipment that satisfies the applicable requirements of this Directive. 7.2. The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. |
8. |
The manufacturer shall, for a period ending 10 years after the pressure equipment has been placed on the market, keep at the disposal of the national authorities:
—
the documentation referred to in point 5.1,
—
the change referred to in point 5.5, as approved,
—
the decisions and reports of the notified body referred to in points 5.3, 5.5, 6.3 and 6.4.
|
9. |
Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn and shall periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued. |
10. |
Authorised representative
The manufacturer’s obligations set out in points 3, 5.1, 5.5, 7 and 8 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. |
9. MODULE F: CONFORMITY TO TYPE BASED ON PRESSURE EQUIPMENT VERIFICATION
1. |
Conformity to type based on pressure equipment verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the pressure equipment concerned, which has been subject to the provisions of point 3, is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of this Directive which apply to it. |
2. |
Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the approved type described in the EU-type examination certificate and with the requirements of this Directive which apply to them. |
3. |
Verification
A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests in order to check the conformity of the pressure equipment with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Directive. The examinations and tests to check the conformity of the pressure equipment with the appropriate requirements shall be carried out by examination and testing of every product as specified in point 4. |
4. |
Verification of conformity by examination and testing of every item of pressure equipment
4.1. All pressure equipment shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) or equivalent tests shall be carried out in order to verify conformity with the approved type and described in the EU-type examination certificate and with the appropriate requirements of this Directive. In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out. In particular, the notified body shall:
—
verify that the personnel undertaking the permanent joining of parts and the non-destructive tests are qualified or approved in accordance with points 3.1.2 and 3.1.3 of Annex I,
—
verify the certificate issued by the materials manufacturer in accordance with point 4.3 of Annex I,
—
carry out or have carried out the final inspection and proof test referred to in point 3.2 of Annex I and examine the safety devices, if applicable.
4.2. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number or have it affixed under its responsibility to each approved item of pressure equipment. The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the pressure equipment has been placed on the market. |
5. |
CE marking and EU declaration of conformity
5.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3, the latter’s identification number to each individual item of pressure equipment that is in conformity with the approved type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive. 5.2. The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities, for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. If the notified body referred to in point 3 agrees and under its responsibility, the manufacturer may also affix the notified body’s identification number to the pressure equipment. |
6. |
If the notified body agrees and under its responsibility, the manufacturer may affix the notified body’s identification number to the pressure equipment during the manufacturing process. |
7. |
Authorised representative
The manufacturer’s obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer’s obligations set out in point 2. |
10. MODULE G: CONFORMITY BASED ON UNIT VERIFICATION
1. |
Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 5, and ensures and declares on his sole responsibility that the pressure equipment concerned, which has been subject to the provisions of point 4, is in conformity with the requirements of this Directive that apply to it. |
2. |
Technical documentation
The manufacturer shall establish the technical documentation and make it available to the notified body referred to in point 4. The documentation shall make it possible to assess the conformity of the pressure equipment with the relevant requirements and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the pressure equipment. The technical documentation shall, wherever applicable, contain at least the following elements:
—
a general description of the pressure equipment,
—
conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,
—
descriptions and explanations necessary for an understanding of those drawings and diagrams and the operation of the pressure equipment,
—
a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards, have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
—
results of design calculations made, examinations carried out, etc.,
—
test reports,
—
appropriate details relating to the approval of the manufacturing and test procedures and of the qualifications or approvals of the personnel concerned in accordance with points 3.1.2 and 3.1.3 of Annex I.
The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the pressure equipment has been placed on the market. |
3. |
Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured pressure equipment with the applicable requirements of this Directive. |
4. |
Verification
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant harmonised standard(s) and/or equivalent tests, to check the conformity of the pressure equipment with the applicable requirements of this Directive, or have them carried out. In the absence of such a harmonised standard the notified body concerned shall decide on the appropriate tests to be carried out applying other technical specifications. In particular the notified body shall:
—
examine the technical documentation with respect to the design and the manufacturing procedures,
—
assess the materials used where these are not in conformity with the relevant harmonised standards or with a European approval for pressure equipment materials, and check the certificate issued by the material manufacturer in accordance with point 4.3 of Annex I,
—
approve the procedures for the permanent joining of parts or check that they have been previously approved in accordance with point 3.1.2 of Annex I,
—
verify the qualifications or approvals required under points 3.1.2 and 3.1.3 of Annex I,
—
carry out the final inspection referred to in point 3.2.1 of Annex I, perform or have performed the proof test referred to in point 3.2.2 of Annex I, and examine the safety devices, if applicable.
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved pressure equipment, or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. |
5. |
CE marking and EU declaration of conformity
5.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 4, the latter’s identification number to each item of pressure equipment that satisfies the applicable requirements of this Directive. 5.2. The manufacturer shall draw up a written EU declaration of conformity and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. |
6. |
Authorised representative
The manufacturer’s obligations set out in points 2 and 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. |
11. MODULE H: CONFORMITY BASED ON FULL QUALITY ASSURANCE
1. |
Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfies the requirements of this Directive that apply to it. |
2. |
Manufacturing
The manufacturer shall operate an approved quality system for design, manufacture, final product inspection and testing of the pressure equipment as specified in point 3 and shall be subject to surveillance as specified in point 4. |
3. |
Quality system
3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the pressure equipment concerned. The application shall include:
—
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,
—
the technical documentation for one model of each type of pressure equipment intended to be manufactured. The technical documentation shall, wherever applicable, contain at least the following elements:
—
a general description of the pressure equipment,
—
conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,
—
descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment,
—
a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
—
results of design calculations made, examinations carried out, etc.,
—
test reports,
—
the documentation concerning the quality system, and
—
a written declaration that the same application has not been lodged with any other notified body.
3.2. The quality system shall ensure compliance of the pressure equipment with the requirements of this Directive that apply to it. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. That quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of:
—
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality,
—
the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards will not be applied in full, the means that will be used to ensure that the essential requirements of this Directive that apply to the pressure equipment will be met,
—
the design control and design verification techniques, processes and systematic actions that will be used when designing the pressure equipment, pertaining to the product type covered, particularly with regard to materials in accordance with point 4 of Annex I,
—
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used, particularly the procedures for the permanent joining of parts as approved in accordance with point 3.1.2 of Annex I,
—
the examinations and tests to be carried out before, during, and after manufacture, and the frequency with which they will be carried out,
—
the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the non-destructive tests in accordance with points 3.1.2 and 3.1.3 of Annex I, etc.,
—
the means of monitoring the achievement of the required design and pressure equipment quality and the effective operation of the quality system.
3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member experienced as assessor in the pressure equipment technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 3.1, second indent, to verify the manufacturer’s ability to identify the applicable requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the pressure equipment with those requirements. The manufacturer or his authorised representative shall be notified of the decision. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. 3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
4. |
Surveillance under the responsibility of the notified body
4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:
—
the quality system documentation,
—
the quality records provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.,
—
the quality records provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. The frequency of periodic audits shall be such that a full reassessment is carried out every three years. 4.4. In addition, the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors shall be considered in the visit control system:
—
the category of the equipment,
—
the results of previous surveillance visits,
—
the need to follow up corrective action(s),
—
special conditions linked to the approval of the system, where applicable,
—
significant changes in manufacturing organisation, policy or techniques.
During such visits, the notified body may, if necessary, carry out product tests, or have them carried out, in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. |
5. |
CE marking and EU declaration of conformity
5.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual item of pressure equipment that satisfies the applicable requirements of this Directive. 5.2. The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. |
6. |
The manufacturer shall, for a period ending 10 years after the pressure equipment has been placed on the market, keep at the disposal of the national authorities:
—
the technical documentation referred to in point 3.1,
—
the documentation concerning the quality system referred to in point 3.1,
—
the change referred to point 3.4, as approved,
—
the decisions and reports of the notified body referred to in points 3.3, 3.4, 4.3 and 4.4.
|
7. |
Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued. |
8. |
Authorised representative
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. |
12. MODULE H1: CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION
1. |
Conformity based on full quality assurance plus design examination and special surveillance of the final assessment is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 6, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfy the requirements of the Directive that apply to it. |
2. |
Manufacturing
The manufacturer shall operate an approved quality system for design, manufacture and final product inspection and testing of the products concerned as specified in point 3 and shall be subject to surveillance as specified in point 5. The adequacy of the technical design of the pressure equipment shall have been examined in accordance with point 4. |
3. |
Quality system
3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the pressure equipment concerned. The application shall include:
—
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,
—
the technical documentation for one model of each type of pressure equipment intended to be manufactured. The technical documentation shall, wherever applicable, contain at least the following elements:
—
a general description of the pressure equipment,
—
conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,
—
descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment,
—
a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
—
results of design calculations made, examinations carried out, etc.,
—
test reports,
—
the documentation concerning the quality system,
—
a written declaration that the same application has not been lodged with any other notified body.
3.2. The quality system shall ensure compliance of the pressure equipment with the requirements of this Directive that apply to it. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of:
—
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality,
—
the technical design specifications, including standards, that will be applied and, where relevant harmonised standards will not be applied in full, the means that will be used to ensure that the essential safety requirements of the Directive that apply to the pressure equipment will be met,
—
the design control and design verification techniques, processes and systematic actions that will be used when designing the pressure equipment pertaining to the pressure equipment type covered, particularly with regard to materials in accordance with point 4 of Annex I,
—
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used, particularly the procedures for the permanent joining of parts as approved in accordance with point 3.1.2 of Annex I,
—
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
—
the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the non-destructive tests in accordance with points 3.1.2 and 3.1.3 of Annex I, etc.,
—
the means of monitoring the achievement of the required design and pressure equipment quality and the effective operation of the quality system.
3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant pressure equipment field and pressure equipment technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 3.1, second indent, to verify the manufacturer’s ability to identify the applicable requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the pressure equipment with those requirements. The manufacturer or his authorised representative shall be notified of the decision. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. 3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a re-assessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. 3.6. Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued. |
4. |
Design examination
4.1. The manufacturer shall lodge an application for examination of the design of each item of pressure equipment not covered by a previous design examination with the notified body referred to in point 3.1. 4.2. The application shall make it possible to understand the design, manufacture and operation of the pressure equipment, and to assess the conformity with the requirements of this Directive that apply to it. It shall include:
—
the name and address of the manufacturer,
—
a written declaration that the same application has not been lodged with any other notified body,
—
the technical documentation. The documentation shall make it possible to assess the conformity of the pressure equipment with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design and operation of the pressure equipment. The technical documentation shall, wherever applicable, contain at least the following elements:
—
a general description of the pressure equipment,
—
conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,
—
descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment,
—
a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive, where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
—
results of design calculations made, examinations carried out, etc., and
—
test reports,
—
the supporting evidence for the adequacy of the technical design. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards have not been applied in full, and shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer or by another testing laboratory on his behalf and under his responsibility.
4.3. The notified body shall examine the application, and where the design meets the requirements of this Directive that apply to the pressure equipment it shall issue an EU design examination certificate to the manufacturer. The certificate shall give the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for identification of the approved design. The certificate may have one or more annexes attached. The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured products with the examined design to be evaluated, and to allow for in-service control, where applicable. Where the design does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue a design examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal. 4.4. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of this Directive, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. The manufacturer shall keep the notified body that has issued the EU design examination certificate informed of any modification to the approved design that may affect the conformity with the essential safety requirements of this Directive or the conditions for validity of the certificate. Such modifications shall require additional approval — from the notified body that issued the EU design examination certificate — in the form of an addition to the original EU design examination certificate. 4.5. Each notified body shall inform its notifying authorities of the EU design examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies of the EU design examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or additions thereto which it has issued. The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU design examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and of the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU design examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer until the expiry of the validity of the certificate. 4.6. The manufacturer shall keep a copy of the EU design examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. |
5. |
Surveillance under the responsibility of the notified body
|
6. |
CE marking and EU declaration of conformity
6.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual item of pressure equipment that satisfies the applicable requirements of this Directive. 6.2. The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment model for which it has been drawn up and shall mention the number of the design examination certificate. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. |
7. |
The manufacturer shall, for a period ending 10 years after the pressure equipment has been placed on the market, keep at the disposal of the national authorities:
—
the documentation concerning the quality system referred to in point 3.1,
—
the change referred to in point 3.5, as approved,
—
the decisions and reports of the notified body referred to in points 3.5, 5.3 and 5.4.
|
8. |
Authorised representative
The manufacturer’s authorised representative may lodge the application referred to in points 4.1 and 4.2 and fulfil the obligations set out in points 3.1, 3.5, 4.4, 4.6, 6 and 7, on his behalf and under his responsibility, provided that they are specified in the mandate. |
ANNEX IV
EU DECLARATION OF CONFORMITY (No XXXX) ( 24 )
1. Pressure equipment or assembly (product, type, batch or serial number):
2. Name and address of the manufacturer and, where applicable, his authorised representative:
3. This declaration of conformity is issued under the sole responsibility of the manufacturer.
4. Object of the declaration (identification of pressure equipment or assembly allowing traceability; it may, where necessary for the identification of the pressure equipment or assembly, include an image):
5. The object of the declaration described above is in conformity with the relevant Union harmonisation legislation:
6. References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared:
7. Where appropriate, the name, address and number of the notified body which carried out the conformity assessment and the number of the certificate issued, and a reference to the EU-type examination certificate – production type, EU-type examination certificate – design type, EU design examination certificate or certificate of conformity.
8. Additional information:
Signed for and on behalf of:
ANNEX V
PART A
Repealed Directive with list of the successive amendments thereto
(referred to in Article 50)
Directive 97/23/EC of the European Parliament and of the Council (OJ L 181, 9.7.1997, p. 1). |
|
Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). |
Only point 13 of Annex I |
Regulation (EU) No 1025/2012 of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12). |
Only point (f) of Article 26(1) |
PART B
Time-limit for transposition into national law and date of application
(referred to in Article 49)
Directive |
Time-limit for transposition |
Date of application |
97/23/EC |
29 May 1999 |
29 November 1999 (1) |
(1)
In accordance with Article 20(3) of Directive 97/23/EC, Member States shall permit the putting into service of pressure equipment and assemblies which comply with the regulations in force in their territory at the date of application of the Directive beyond that date. |
ANNEX VI
CORRELATION TABLE
Directive 97/23/EC |
This Directive |
Article 1(1) |
Article 1(1) |
Article 1(2) |
Article 2(1) to (14) |
Article 1(3) |
Article 1(2) |
— |
Article 2(15) to (32) |
Article 2 |
Article 3 |
Article 3 |
Article 4 |
Article 4(1) |
Article 5(1) |
Article 4(2) |
Article 5(3) |
— |
Article 6 |
— |
Article 7 |
— |
Article 8 |
— |
Article 9 |
— |
Article 10 |
— |
Article 11 |
Article 5 |
— |
Article 6 |
— |
— |
Article 12(1) |
Article 7(1) |
Article 45 |
Article 7(2) |
Article 44(1) |
Article 7(3) |
— |
Article 7(4) |
Article 44(5), second subparagraph |
Article 8 |
— |
Article 9(1) |
Article 13(1), introductory sentence |
Article 9(2) point 1 |
— |
— |
Article 13(1)(a) |
Article 9(2) point 2 |
Article 13(1)(b) |
Article 9(3) |
Article 13(2) |
Article 10 |
Article 14 |
Article 11(1) |
Article 15(1) |
Article 11(2) |
Article 15(2) |
Article 11(3) |
Article 15(3) |
Article 11(4) |
Article 12(2) |
— |
Article 15(4) |
Article 11(5) |
Article 15(5) |
— |
Article 15(6) |
Article 12 |
— |
Article 13 |
— |
Article 14(1) |
Article 16(1) |
Article 14(2) |
Article 5(2) |
Article 14(3) to (8) |
Article 16(2) to (7) |
Article 14(9) and (10) |
— |
— |
Article 17 |
— |
Article 18 |
Article 15(1) |
— |
Article 15(2) |
Article 19(1) |
Article 15(3) |
Article 19(2) |
Article 15(4) and (5) |
— |
— |
Article 19(3) to (6) |
— |
Article 20 |
— |
Article 21 |
— |
Article 22 |
— |
Article 23 |
— |
Article 24 |
— |
Article 25 |
— |
Article 26 |
— |
Article 27 |
— |
Article 28 |
— |
Article 29 |
— |
Article 30 |
— |
Article 31 |
— |
Article 32 |
— |
Article 33 |
— |
Article 34 |
— |
Article 35 |
— |
Article 36 |
— |
Article 37 |
— |
Article 38 |
Article 16 |
— |
Article 17 |
— |
Article 18 |
— |
— |
Article 39 |
— |
Article 40 |
— |
Article 41 |
— |
Article 42 |
— |
Article 43 |
— |
Article 44(2) to (4) |
— |
Article 44(5), first subparagraph |
— |
Article 46 |
— |
Article 47 |
Article 19 |
— |
Article 20(1) to (2) |
— |
Article 20(3) |
Article 48(1) |
— |
Article 48(2) and (3) |
— |
Article 49 |
— |
Article 50 |
— |
Article 51 |
Article 21 |
Article 52 |
Annex I |
Annex I |
Annex II |
Annex II |
Annex III, introductory wording |
Annex III, introductory wording |
Annex III, Module A |
Annex III, point 1, Module A |
Annex III, Module A1 |
Annex III, point 2, Module A2 |
Annex III, Module B |
Annex III, point 3.1, Module B, EU-type examination – production type |
Annex III, Module B1 |
Annex III, point 3.2, Module B, EU-type examination – design type |
Annex III, Module C1 |
Annex III, point 4, Module C2 |
Annex III, Module D |
Annex III, point 5, Module D |
Annex III, Module D1 |
Annex III, point 6, Module D1 |
Annex III, Module E |
Annex III, point 7, Module E |
Annex III, Module E1 |
Annex III, point 8, Module E1 |
Annex III, Module F |
Annex III, point 9, Module F |
Annex III, Module G |
Annex III, point 10, Module G |
Annex III, Module H |
Annex III, point 11, Module H |
Annex III, Module H1 |
Annex III, point 12, Module H1 |
Annex IV |
— |
Annex V |
— |
Annex VI |
— |
Annex VII |
Annex IV |
— |
Annex V |
— |
Annex VI |
( 1 ) OJ C 67, 6.3.2014, p. 101.
( 2 ) Position of the European Parliament of 15 April 2014 (not yet published in the Official Journal) and decision of the Council of 13 May 2014.
( 3 ) Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment (OJ L 181, 9.7.1997, p. 1).
( 4 ) See Annex V, Part A.
( 5 ) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
( 6 ) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
( 7 ) Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p. 13).
( 8 ) Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165, 30.6.2010, p. 1).
( 9 ) Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ 196, 16.8.1967, p. 1).
( 10 ) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
( 11 ) Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
( 12 ) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
( 13 ) Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels (OJ L 96, 29.3.2014, p. 45).
( 14 ) Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers (OJ L 147, 9.6.1975, p. 40).
( 15 ) Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework Directive) (OJ L 263, 9.10.2007, p. 1).
( 16 ) Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1).
( 17 ) Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52).
( 18 ) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).
( 19 ) Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251).
( 20 ) Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357).
( 21 ) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).
( 22 ) Directive 2009/142/EC of the European Parliament and of the Council of 30 November 2009 relating to appliances burning gaseous fuels (OJ L 330, 16.12.2009, p. 10).
( 23 ) Directive 2014/34/EU of the European Parliament and the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (OJ L 96, 29.3.2014, p. 309).
( 24 ) It is optional for the manufacturer to assign a number to the declaration of conformity.