PRELIMINARY OBSERVATIONS 1.The obligations arising from the essential requirements listed in this...2.The essential requirements laid down in the Directive are compulsory....3.The manufacturer is under an obligation to analyse the hazards...4.The essential requirements are to be interpreted and applied in...1.GENERAL 1.1.Pressure equipment must be designed, manufactured and checked, and if...1.2.In choosing the most appropriate solutions, the manufacturer must apply...1.3.Where the potential for misuse is known or can be...2.DESIGN 2.1.General 2.2.Design for adequate strength 2.2.1.The pressure equipment must be designed for loadings appropriate to...2.2.2.Design for adequate strength must be based on: 2.2.3.Calculation method (a)Pressure containment and other loading aspects (b)Resistance (c)Stability aspects 2.2.4.Experimental design method 2.3.Provisions to ensure safe handling and operation 2.4.Means of examination 2.5.Means of draining and venting 2.6.Corrosion or other chemical attack 2.7.Wear 2.8.Assemblies 2.9.Provisions for filling and discharge 2.10.Protection against exceeding the allowable limits of pressure equipment 2.11.Safety accessories 2.11.1.Safety accessories must: 2.11.2.Pressure limiting devices 2.11.3.Temperature monitoring devices 2.12.External fire 3.MANUFACTURING 3.1.Manufacturing procedures 3.1.1.Preparation of the component parts 3.1.2.Permanent joining 3.1.3.Non-destructive tests 3.1.4.Heat treatment 3.1.5.Traceability 3.2.Final assessment 3.2.1.Final inspection 3.2.2.Proof test 3.2.3.Inspection of safety devices 3.3.Marking and labelling 3.4.Operating instructions 4.MATERIALS 4.1.Materials for pressurized parts must: 4.2.The pressure equipment manufacturer must define in an appropriate manner...4.3.The equipment manufacturer must take appropriate measures to ensure that...SPECIFIC PRESSURE EQUIPMENT REQUIREMENTS 5.FIRED OR OTHERWISE HEATED PRESSURE EQUIPMENT WITH A RISK OF...6.PIPING AS REFERRED TO IN ARTICLE 3, SECTION 1.3 7.SPECIFIC QUANTITATIVE REQUIREMENTS FOR CERTAIN PRESSURE EQUIPMENT 7.1.Allowable stresses 7.1.1.Symbols 7.1.2.The permissible general membrane stress for predominantly static loads and...7.2.Joint coefficients 7.3.Pressure limiting devices, particularly for pressure vessels 7.4.Hydrostatic test pressure 7.5.Material characteristics 1.The references in the tables to categories of modules are...2.The safety accessories defined in Article 1, Section 2.1.3, and...3.The pressure accessories defined in Article 1, Section 2.1.4, and...4.The demarcation lines in the following conformity assessment tables indicate...Module A (internal production control) 1.This module describes the procedure whereby the manufacturer or his...2.The manufacturer must draw up the technical documentation described in...3.The technical documentation must enable an assessment to be made...4.The manufacturer, or his authorized representative established within the Community,...5.The manufacturer must take all measures necessary to ensure that...Module A1 (internal manufacturing checks with monitoring of the final...Module B (EC type-examination) 1.This module describes the part of the procedure by which...2.The application for EC type-examination must be lodged by the...3.The technical documentation must enable an assessment to be made...4.The notified body must: 4.1.examine the technical documentation, verify that the type has been...4.2.perform or have performed the appropriate examinations and necessary tests...4.3.perform or have performed the appropriate examinations and necessary tests...4.4.agree with the applicant the location where the examinations and...5.Where the type satisfies the provisions of the Directive which...6.The applicant must inform the notified body that holds the...7.Each notified body must communicate to the Member States the...8.The other notified bodies may receive copies of the EC...9.The manufacturer, or his authorized representative established within the Community,...Module B1 (EC design-examination) 1.This module describes the part of the procedure whereby a...2.The manufacturer, or his authorized representative established within the Community,...3.The technical documentation must enable an assessment to be made...4.The notified body must: 4.1.examine the technical documentation and identify the components which have...4.2.perform the necessary examinations to establish whether the solutions adopted...4.3.perform the necessary examinations to establish whether, where the manufacturer...5.Where the design meets the provisions of the Directive which...6.The applicant must inform the notified body that holds the...7.Each notified body must communicate to the Member States the...8.The other notified bodies may on request obtain the relevant...9.The manufacturer, or his authorized representative established within the Community,...Module C1 (conformity to type) 1.This module describes that part of the procedure whereby the...2.The manufacturer must take all measures necessary to ensure that...3.The manufacturer, or his authorized representative established within the Community,...4.Final assessment must be subject to monitoring in the form...Module D (production quality assurance) 1.This module describes the procedure whereby the manufacturer who satisfies...2.The manufacturer must operate an approved quality system for production,...3.Quality system 3.1.The manufacturer must lodge an application for assessment of his...3.2.The quality system must ensure compliance of the pressure equipment...3.3.The notified body must assess the quality system to determine...3.4.The manufacturer must undertake to fulfil the obligations arising out...4.Surveillance under the responsibility of the notified body 4.1.The purpose of surveillance is to make sure that the...4.2.The manufacturer must allow the notified body access for inspection...4.3.The notified body must carry out periodic audits to make...4.4.In addition the notified body may pay unexpected visits to...5.The manufacturer must, for a period of ten years after...6.Each notified body must communicate to the Member States the...Module D1 (production quality assurance) 1.This module describes the procedure whereby the manufacturer who satisfies...2.The manufacturer must draw up the technical documentation described below....3.The manufacturer must operate an approved quality system for production,...4.Quality system 4.1.The manufacturer must lodge an application for assessment of his...4.2.The quality system must ensure compliance of the pressure equipment...4.3.The notified body must assess the quality system to determine...4.4.The manufacturer must undertake to fulfil the obligations arising out...5.Surveillance under the responsibility of the notified body 5.1.The purpose of surveillance is to make sure that the...5.2.The manufacturer must allow the notified body access for inspection...5.3.The notified body must carry out periodic audits to make...5.4.In addition the notified body may pay unexpected visits to...6.The manufacturer must, for a period of ten years after...7.Each notified body must communicate to the Member States the...Module E (product quality assurance) 1.This module describes the procedure whereby the manufacturer who satisfies...2.The manufacturer must operate an approved quality system for the...3.Quality system 3.1.The manufacturer must lodge an application for assessment of his...3.2.Under the quality system, each item of pressure equipment must...3.3.The notified body must assess the quality system to determine...3.4.The manufacturer must undertake to discharge the obligations arising from...4.Surveillance under the responsibility of the notified body 4.1.The purpose of surveillance is to make sure that the...4.2.The manufacturer must allow the notified body access for inspection...4.3.The notified body must carry out periodic audits to make...4.4.In addition the notified body may pay unexpected visits to...5.The manufacturer must, for a period of ten years after...6.Each notified body must communicate to the Member States the...Module E1 (product quality assurance) 1.This module describes the procedure whereby the manufacturer who satisfies...2.The manufacturer must draw up the technical documentation described below....3.The manufacturer must operate an approved quality system for the...4.Quality system 4.1.The manufacturer must lodge an application for assessment of his...4.2.Under the quality system, each item of pressure equipment must...4.3.The notified body must assess the quality system to determine...4.4.The manufacturer must undertake to discharge the obligations arising from...5.Surveillance under the responsibility of the notified body 5.1.The purpose of surveillance is to make sure that the...5.2.The manufacturer must allow the notified body access for inspection...5.3.The notified body must carry out periodic audits to make...5.4.In addition the notified body may pay unexpected visits to...6.The manufacturer must, for a period of ten years after...7.Each notified body must communicate to the Member States the...Module F (product verification) 1.This module describes the procedure whereby a manufacturer, or his...2.The manufacturer must take all measures necessary to ensure that...3.The notified body must perform the appropriate examinations and tests...4.Verification by examination and testing of each item of pressure...4.1.Each item of pressure equipment must be individually examined and...4.2.The notified body must affix its identification number or have...4.3.The manufacturer, or his authorized representative established within the Community,...Module G (EC unit verification) 1.This module describes the procedure whereby the manufacturer ensures and...2.The manufacturer must apply to a notified body of his...3.The technical documentation must enable the conformity of the pressure...4.The notified body must examine the design and construction of...4.1.The notified body must affix its identification number or have...4.2.The manufacturer, or his authorized representative established within the Community,...Module H (full quality assurance) 1.This module describes the procedure whereby the manufacturer who satisfies...2.The manufacturer must implement an approved quality system for design,...3.Quality system 3.1.The manufacturer must lodge an application for assessment of his...3.2.The quality system must ensure compliance of the pressure equipment...3.3.The notified body must assess the quality system to determine...3.4.The manufacturer must undertake to fulfil the obligations arising out...4.Surveillance under the responsibility of the notified body 4.1.The purpose of this surveillance is to make sure that...4.2.The manufacturer must allow the notified body access for inspection...4.3.The notified body must carry out periodic audits to make...4.4.In addition the notified body may pay unexpected visits to...5.The manufacturer must, for a period of ten years after...6.Each notified body must communicate to the Member States the...Module H1 (full quality assurance with design examination and special...1.In addition to the requirements of module H, the following...2.Final assessment as referred to in section 3.2 of Annex...1.The body, its director and the personnel responsible for carrying...2.The body and its personnel must carry out the assessments...3.The body must have at its disposal the necessary personnel...4.The personnel responsible for inspection must have: 5.The impartiality of the inspection personnel must be guaranteed. Their...6.The body must take out liability insurance unless its liability...7.The personnel of the body must observe professional secrecy with...1.The user inspectorate must be organizationally identifiable and have reporting...2.The user inspectorate and its personnel must carry out the...3.The user inspectorate must have at its disposal the necessary...4.The personnel responsible for inspection must have: 5.The impartiality of inspection personnel must be guaranteed. Their remuneration...6.The user inspectorate must have adequate liability insurance unless liability...7.The personnel of the user inspectorate must observe professional secrecy...

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 (repealed)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof,

Having regard to the proposals from the Commission1,

Having regard to the Opinion of the Economic and Social Committee2,

Acting in accordance with the procedure laid down in Article 189b of the Treaty3, in the light of the joint text approved by the Conciliation Committee on 4 February 1997,

1.

Whereas the internal market is an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;

2.

Whereas there are differences in the content and scope of the laws, regulations and administrative provisions in force in the Member States with regard to the safety and protection of health of persons and, where appropriate, domestic animals or property, where pressure equipment not covered by present Community legislation is concerned; whereas the certification and inspection procedures for such equipment differ from one Member State to another; whereas such disparities may well constitute barriers to trade within the Community;

3.

Whereas the harmonization of national legislation is the only means of removing these barriers to free trade; whereas this objective cannot be achieved satisfactorily by the individual Member States; whereas this Directive only lays down indispensable requirements for the free circulation of the equipment to which it is applicable;

4.

Whereas equipment subject to a pressure of not more than 0,5 bar does not pose a significant hazard due to pressure; whereas there should not therefore be any obstacle to its free movement within the Community; whereas this Directive applies to equipment subject to a maximum allowable pressure PS exceeding 0,5 bar;

5.

Whereas this Directive relates also to assemblies composed of several pieces of pressure equipment assembled to constitute an integrated and functional whole; whereas these assemblies may range from simple assemblies such as pressure cookers to complex assemblies such as watertube boilers; whereas, if the manufacturer of an assembly intends it to be placed on the market and put into service as an assembly — and not in the form of its constituent non-assembled elements — that assembly must conform to this Directive; whereas, on the other hand, this Directive does not cover the assembly of pressure equipment on the site and under the responsibility of the user, as in the case of industrial installations;

6.

Whereas this Directive harmonizes national provisions on hazards due to pressure; whereas the other hazards which this equipment may present accordingly may fall within the scope of other Directives dealing with such hazards; whereas, however, pressure equipment may be included among products covered by other Directives based on Article 100a of the Treaty; whereas the provisions laid down in some of those Directives deal with the hazard due to pressure; whereas those provisions are considered adequate to provide appropriate protection where the hazard due to pressure associated with such equipment remains small; whereas, therefore, there are grounds for excluding such equipment from the scope of this Directive;

7.

Whereas, for pressure equipment covered by international Conventions, transport and pressure hazards are due to be dealt with as soon as possible by forthcoming Community Directives based on such Conventions or by supplements to existing Directives; whereas such equipment is accordingly excluded from the scope of this Directive;

8.

Whereas certain types of pressure equipment, although subject to a maximum allowable pressure PS higher than 0,5 bar, do not present any significant hazard due to pressure, and therefore the freedom of movement of such equipment in the Community should not be hindered if it has been legally manufactured or placed on the market in a Member State; whereas it is not necessary in order to ensure free movement of such equipment to include it in the scope of this Directive; whereas consequently it is expressly excluded from its scope;

9.

Whereas other pressure equipment subject to a maximum allowable pressure higher than 0,5 bar and presenting a significant hazard due to pressure, but in respect of which free movement and an appropriate level of safety are guaranteed, is excluded from the scope of this Directive; whereas such exclusions should, however, be regularly reviewed in order to ascertain whether it is necessary to take action at Union level;

10.

Whereas regulations to remove technical barriers to trade must follow the new approach provided for in the Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards4, which requires a definition of the essential requirements regarding safety and other requirements of society without reducing existing, justified levels of protection within the Member States; whereas that Resolution provides that a very large number of products be covered by a single Directive in order to avoid frequent amendments and the proliferation of Directives;

11.

Whereas the existing Community Directives on the approximation of the laws of the Member States relating to pressure equipment have made positive steps towards removing barriers to trade in this area; whereas those Directives cover that sector only to a minor extent; whereas Council Directive 87/404/EEC of 25 June 1987 on the harmonization of the laws of the Member States relating to simple pressure vessels5 is the first case of application of the new approach to the sector of pressure equipment; whereas the present Directive will not apply to the area covered by Directive 87/404/EEC; whereas, no later than three years after the present Directive enters into force, a review will be carried out of the application of Directive 87/404/EEC in order to ascertain the need for the integration thereof into the present Directive;

12.

Whereas the framework Directive, Council Directive 76/767/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to common provisions for pressure vessels and methods for inspecting them6 is optional; whereas it provides for a procedure for the bilateral recognition of testing and certification of pressure equipment which did not operate satisfactorily and which therefore must be replaced by effective Community measures;

13.

Whereas the scope of this Directive must be based on a general definition of the term ‘pressure equipment’ so as to allow for the technical development of products;

14.

Whereas compliance with the essential safety requirements is necessary in order to ensure the safety of pressure equipment; whereas those requirements have been subdivided into general and specific requirements which must be met by pressure equipment; whereas in particular the specific requirements are intended to take account of particular types of pressure equipment; whereas certain types of pressure equipment in categories III and IV must be subject to a final assessment comprising final inspection and proof tests;

15.

Whereas Member States should be in a position to allow the showing at trade fairs of pressure equipment which is not yet in conformity with the requirements of this Directive; whereas, during demonstrations, appropriate safety measures must be taken in accordance with the general safety rules of the Member State concerned to ensure the safety of persons;

16.

Whereas in order to ease the task of demonstrating compliance with the essential requirements, standards harmonized at European level are useful, especially with regard to the design, manufacture and testing of pressure equipment, compliance with which enables a product to be presumed to meet the said essential requirements; whereas standards harmonized at European level are drawn up by private bodies and must retain their non-mandatory status; whereas, for this purpose, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are recognized as being the bodies that are competent to adopt harmonized standards that follow the general guidelines for cooperation between the Commission and those two bodies signed on 13 November 1984;

17.

Whereas, for the purposes of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted by one or other of those bodies, or by both, at the request of the Commission pursuant to Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations7 and in accordance with the general guidelines referred to above; whereas, in relation to standardization, it would be advisable for the Commission to be assisted by the Committee set up pursuant to Directive 83/189/EEC; whereas the Committee will, if necessary, consult technical experts;

18.

Whereas manufacturing of pressure equipment calls for the utilization of safe materials; whereas in the absence of harmonized standards it is useful to define the characteristics of the materials intended for repeated use; whereas this definition is established by European approvals for materials, such approvals being issued by one of the notified bodies specifically designated for that task; whereas the materials conforming to the European approvals shall be presumed to satisfy the essential requirements of this Directive;

19.

Whereas, in view of the nature of the hazards involved in the use of pressure equipment it is necessary to establish procedures for assessing compliance with the basic requirements of the Directives; whereas these procedures must be devised in the light of the level of danger which is inherent in the pressure equipment; whereas, therefore, for each category of pressure equipment there must be an adequate procedure or a choice between different procedures of equivalent stringency; whereas the procedures adopted are as required by Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization Directives8; whereas the details added to these procedures are justified by the nature of the verification required for pressure equipment;

20.

Whereas Member States should be in a position to authorize user inspectorates to carry out certain tasks for conformity assessment in the framework of this Directive; whereas for that purpose this Directive sets out criteria for the authorization of user inspectorates by Member States;

21.

Whereas, under the conditions laid down by this Directive, certain procedures for conformity assessment may require each item to be inspected and tested by a notified body or a user inspectorate as part of the final assessment of the pressure equipment; whereas in other cases provision should be made to ensure that the final assessment may be monitored by a notified body by means of unexpected visits;

22.

Whereas pressure equipment will, as a general rule, bear the CE marking affixed either by the manufacturer or by his authorized representative established within the Community; whereas the CE marking means that the pressure equipment complies with the provisions of this Directive and those of other applicable Community directives on CE marking; whereas for pressure equipment defined in this Directive which presents only a minor pressure hazard and for which certification procedures are therefore not justified, the CE marking will not be affixed;

23.

Whereas it is appropriate that the Member States, as provided for by Article 100a of the Treaty, may take provisional measures to limit or prohibit the placing on the market, putting into service and use of pressure equipment in cases where it presents a particular risk to the safety of persons and, where appropriate, domestic animals or property, provided that the measures are subject to a Community control procedure;

24.

Whereas the addressees of any decision taken under this Directive must be aware of the reasons behind that decision and the means of appeal open to them;

25.

Whereas it is necessary to lay down a transitional arrangement enabling pressure equipment manufactured in compliance with the national regulations in force on the date of entry into force of this Directive to be marketed and put into service;

26.

Whereas the requirements laid down in the Annexes should be made as clear as possible so as to allow all users, including small and medium-sized enterprises (SMEs), to comply with them easily;

27.

Whereas an agreement on a modus vivendi between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the Treaty was reached on 20 December 19949,

HAVE ADOPTED THIS DIRECTIVE: