CELEX: 51993PC0319
Language: en
Date: 1993-07-14
Title: Proposal for a COUNCIL DIRECTIVE on the approximation of the laws of the Member States concerning pressure equipment

9 . 9 . 93                             Official Journal of the European Communities                                No C 246/1
                                                               n
                                                                          i
                                                      (Preparatory Acts)
                                                  COMMISSION
              Proposal for a Council Directive on the approximation of the laws of the Member States
                                                concerning pressure equipment
                                                        ( 93/C 246/01 )
                                              COM(93) 319 final — SYN 462
                                     (Submitted by the Commission on 15 July 1993)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                          another level by the individual Member States; whereas
                                                                  this Directive only lays down necessary and sufficient
Having regard to the Treaty establishing the European             requirements for the free circulation of the equipment to
Economic Community, and in particular Article 100a                which it is applicable;
thereof,
                                                                  Whereas regulations to remove technical barriers to trade
Having regard to the proposal from the Commission,                must follow the new approach provided for in the
                                                                  Council Resolution of 7 May 1985 (*), which requires a
In cooperation with the European Parliament,                      definition of the essential requirements regarding safety
                                                                  and other requirements of society without reducing
Having regard to the opinion of the Economic and Social           existing, justified levels of protection within the Member
Committee,                                                        States; whereas that resolution provides that a very large
                                                                  number of products be covered by a single directive
Whereas measures should be adopted for the progressive            in order to avoid frequent amendments and the
establishment of the internal market; whereas the internal        proliferation of directives;
market is an area without internal frontiers in which the
free movement of goods, persons, services and capital is
ensured;
                                                                  Whereas the existing Community directives on the
                                                                  approximation of the laws of the Member States relating
                                                                  to pressure equipment have made positive steps to
Whereas there are differences in the content and scope of         remove barriers to trade in this area; whereas these
the laws, regulations and administrative provisions in            Directives cover that sector only to a minor extent;
force in the Member States with regard to safety,                 whereas Directive 87/404/EEC relating to simple pressure
protection of health and, where appropriate, domestic             vessels (2) is the first case of application of the new
animals and property, where pressure equipment not                approach to a sector of pressure equipment; whereas this
covered by present Community legislation is concerned;            Directive will not apply to the area covered by Directive
whereas the protection of the environment must be                 87/404/EEC;       whereas      the     framework   Directive
considered with respect to risks from pressurized                 76/767/EEC ( 3 ) is optional;
hazardous fluids; whereas the certification and inspection
procedures for such equipment differ from one Member
State to another; whereas such disparities constitute             Whereas it provides for a procedure for the bilateral
barriers to trade within the Community;                           recognition of testing and certification of pressure
Whereas the harmonization of national legislation is the          O OJ No C 136, 4. 6. 1985, p. 1 .
only means of removing these obstacles to free trade;             (2) OJ No L 220, 8 . 8 . 1987, p. 48 .
whereas this objective cannot be achieved satisfactorily at       <3 ) OJ No L 262, 27. 9. 1976, p. 153 .
 ---pagebreak---   No C 246/2                                Official Journal of the European Communities                                  9 . 9 . 93
  equipment which did not operate satisfactorily and which             danger which is inherent in the pressure equipment;
  therefore must be replaced by effective Community                    whereas therefore each category of pressure equipment
  measures ;                                                           must be supplemented by an adequate procedure or a
                                                                       choice between different procedures of equivalent
                                                                       stringency; whereas the procedures adopted are as
  Whereas the field of application of this Directive must be           required by the Council Decision of 13 December
  based on a general definition of the term 'pressure                  1990 ( 3) concerning the modules for the various phases of
  equipment' so as to allow for the technical development              the conformity assessment procedures which are intended
  of products;                                                         to be used in the technical harmonization directives;
                                                                       whereas the details added to these procedures are
                                                                       justified by the nature of the verification required for
  Whereas compliance with the basic safety and other
                                                                       pressure equipment;
  requirements is essential in order to ensure the safety of
  pressure equipment; whereas those requirements have
  been subdivided into general and specific requirements               Whereas the decision referred to does not preclude under
  which must be met by pressure equipment; whereas in                  certain conditions the use of second-party inspection
  particular the specific requirements are intended to take            carried out by user inspectorates in the procedures for
  account of particular types of pressure equipment;                   conformity assessment; whereas second-party inspection
                                                                       is applied successfully in different Member States;
                                                                       whereas Member States should be in a position to
  Whereas in order to ease the task or proving compliance              authorize user inspectorates to carry out defined tasks for
  with the essential requirements, standards harmonized at             conformity assessment in the framework of this Directive;
  European level are useful, especially with regard to the             whereas for that purpose this Directive sets out criteria
  design, manufacture and testing of pressure equipment,               for authorizing user inspectorates;
  compliance with which enables a product to be presumed
  to meet the said essential requirements; whereas                     Whereas pressure equipment shall, as a general rule, bear
  standards harmonized at European level are drawn up by               the CE marking affixed either by the manufacturer or by
  private bodies and must retain their non-mandatory                   his authorized representative within the Community;
  status; whereas, for this purpose, the European                      whereas the CE marking means that the pressure
  Committee for Standardization ( CEN) and the European                equipment conforms to the provisions of this Directive
  Committee for Electrotechnical Standardization ( Cenelec )           and those of other Community directives which provide
  are recognized as being the bodies that are competent to             for CE marking and which are applied; whereas for
  adopt harmonized standards that follow the general                   pressure equipment which presents only a minor pressure
  guidelines for cooperation between the Commission and                risk and which is defined in this Directive and for which
  those two bodies signed on 13 November 1984;                         no certification procedures are therefore justified, the CE
                                                                       marking shall not be affixed; whereas that pressure
  Whereas the Community, confirming the interest of                    equipment is covered by national regulations and its free
                                                                       circulation must be ensured;
• an international standardization system capable or
  producing standards that are actually used by all partners
  in international trade and of meeting the requirements of            Whereas it is appropriate that the Member States, as
  Community policy, invites the European standards                     provided for by Article 100a of the Treaty, may take
  organizations to continue their cooperation with                     temporary measures to limit or prohibit the placing on
  international standards organizations;                               the market and putting into service and the use of
                                                                       pressure equipment in cases where they present a
                                                                       particular risk to the safety of persons, the environment
  Whereas, for the purposes of this Directive, a harmonized            and, where appropriate, domestic animals or property,
  standard is a technical specification ( European standard            provided that the measures are subject to a Community
  or harmonization document) adopted by one or other of                control procedure;
  those bodies, or by both, at the prompting of the
  Commission in pursuance of Council Directive                         Whereas the recipients of any decision taken under this
  83/189/EEC of 28 March 1983 providing for a procedure                Directive must be aware of the reasons behind that
  governing the provision of information on technical                  decision and the means of appeal open to them;
  standards and regulations ( x ) as last amended by Directive                            i                                          •
  88/182/EEC (2) and in pursuance of the general guidelines
  referred to above;                                                   Whereas Directive 76/767/EEC must be repealed, except
                                                                       as regards the application of Directive 84/525/EEC,
                                                                       84/526/EEC and 84/527/EEC;
  Whereas, in view of the nature of the risks involved in
  the use of pressure equipment it is necessary to establish           Whereas provision for a transitional arrangement
  procedures applying to the assessment of compliance with             enabling pressure equipment manufactured in compliance
  the basic requirements of the directives; whereas these              with the national regulations in force at the date of
  procedures must be devised in the light of the level of              adoption of this Directive to be marketed and put into
                                                                       service is necessary,
  O OJ No L 109, 26 . 4, 1983 , p . 8 .
  (2) OJ No L 81 , 26 . 3 . 1988 , p . 75 .                            (3) OJ No L 380, 31 . 12. 1990, p. 13 .
 ---pagebreak--- 9 . 9 . 93                                  Official Journal of the European Communities                              No C 246/3
HAS ADOPTED THIS DIRECTIVE :                                            2.  'pressure' means pressure relative to atmospheric
                                                                            pressure, i.e. gauge pressure. As a consequence,
                                                                            vacuum is designated by a negative value;
                             Article 1
                                                                        3.  'maximum allowable pressure PS' means the
                     Scope and definitions                                  maximum operating pressure at normal operating
                                                                            conditions, normally at the top of equipment,
                                                                            specified for safety reasons;
1 . This Directive applies to the design, manufacture
and conformity assessment of pressure equipment subject
to an allowable pressure PS greater than 0,5 bar or less
                                                                        4.  'maximum/minimum allowable temperature TS'
than -0,5 bar.                                                              means       the     maximum/minimum          operating
                                                                            temperatures at normal operating conditions
                                                                            specified for safety reasons;
2. For the purposes of this Directive the following
definitions shall apply:                                                5.  test pressure PT' means the pressure to which the
  1 , 'pressure     equipment5     includes     vessels,  piping,           equipment is subjected for test purposes;
       assemblies and accessories .
                                                                        6.  'volume (V)' means the internal volume of a
       Where applicable, the pressure equipment includes                    compartment, including the volume of nozzles to the
       components attached to and necessary for direct                      first flange or weld and excluding the volume of
       support;                                                             internal structures;
        1.1 'vessel' means the vessel proper, where                     7.  nominal size (DN): a numerical designation of size
            applicable, terminating at the connecting                       which is common to all components in a piping
            nozzles, such as 'welding' end, screwed end, or                 system other than components indicated by outside
            bolted flange and its attachments;                              diameters or by thread size. It is a convenient round
                                                                            number for reference purposes and is only loosely
        1.2 'piping' means a system of pipes, or a pipe                     related to manufacturing dimensions. It is designated
            which has been transformed for integration                      by DN followed by a number (ISO 6708-1980 );
            into such a system or into an assembly. Piping
            includes also hoses and bellows,
                                                                        8.  'fluids' means all gases, liquids, liquefied gases,
            'Piping' does not include:                                      liquids dissolved under pressure and vapours. They
                                                                            are subdivided into groups I, II and III according to
            (a) pipelines and their accessories specifically                their properties as given in Article 8 ;
                 designed for
                 — supply of oil, chemical products etc. to             9.  'liquid' means a fluid with a vapour pressure at
                     an    industrial    site   or    commercial            50 °C not exceeding 3 bar;
                     establishment,
                                                                       10 . 'hot water' means water which is at a temperature
                 — supply of gaseous and liquefied natural                  above 110 °C.
                     and petroleum gases to domestic and
                     industrial sites,
                                                                       3.    The following are excluded from the scope of this
                 — water supply,                                       Directive :
                 — the conveyance of district heating
                     fluids,                                            1 . equipment as covered by Directive 87/404/EEC;
                 — the conveyance of sewage fluids;
                                                                        2. equipment as covered by Directive 75/324/EEC;
            b)   stream waterways such as penstocks,
                 pressure tunnels, pressure shaft for                   3   equipment or vehicles covered by the EEC type­
                 hydroelectric installations and their related              approval procedures as laid down in Directives
                 specific accessories;                                      70/156/EEC, 74/150/EEC and 92/61/EEC, with the
                                                                            exception of pressure equipment for storage of
        1.3 'assemblies' means linked items of vessels and                  pressurized propulsion fuel;
            piping arranged and controlled so as to
            function as an integrated whole, as in shell                4. items for fluid power as covered in Annex I,
            boilers, water-tube boilers etc.;
                                                                            point 1.3.2 of Directive 89/392/EEC;
        1.4 'accessories '   means    devices   which    have   a
            safety-related function with respect to pressure            5 . equipment as covered by Directive 90/396/EEC;
            containment and/or control such as protective
            or limiting devices, regulating and monitoring              6. equipment covered by Article 223 ( 1 ) ( b) of the EEC
            devices, valves, indicators;                                    Treaty;
 ---pagebreak--- No C 246/4                                 Official Journal of the European Communities                                   9 . 9 . 93
  7. items specifically designed for nuclear use, failure of          purpose and when, where applicable, properly installed,
       which may cause an emission of radioactivity;                  maintained and periodically tested.
  8    equipment used for petroleum and natural gas
       extraction and underground storage caverns for gas,            2. This Directive shall not affect the authority of the
       oil and liquefied gas;                                         Member States to lay down, with due regard to the
                                                                      provisions of the Treaty, requirements which they
  9    casings and parts of machinery, e.g. for steam                 consider necessary for the protection of persons and in
       engines, gas/steam turbines, compressors, pumps and            particular of workers using the relevant pressure
       actuating devices etc. which are exposed to internal           equipment, provided this does not result in changes to
       pressure, but where the choice of material and                 pressure equipment with respect to the provisions of this
                                                                      Directive .
       dimensioning is based primarily on requirements for
       sufficient strength, rigidity and stability to meet the
       dynamic operational effects and is more than                   3.     At trade fairs, exhibitions, demonstrations, etc.,
       adequate for pressure containment;                             Member States shall not prevent the showing of pressure
             i
                                                                      equipment which does not conform to the provisions of
10     blast furnaces including the furnace cooling,                  this Directive, provided that *a visible sign clearly
       hot-blast recuperators, dust extractors and                    indicates that such pressure equipment does not conform
       blast-furnace exhaust-gas scrubbers and direct                 and that it is not for sale until it has been brought into
       reducing cupolas, including the furnace cooling, gas           conformity by the manufacturer or his authorized
       converters arid pans for melting, re-melting,                  representative established in the Community. "Where non
       de-gasing and casting of steel and non-ferrous                 conforming pressure equipment is to be pressurized
       metals;                                                        during a demonstration it shall only be pressurized with
                                                                      the agreement of a notified body.
11 .   enclosures for high-voltage electrical equipment such
       as switchgear, control gear, transformers, and
       rotating machines;
                                                                                                  Article 3
12, pressurized        pipes    for    the   containment      of
       transmission systems, e.g. for electrical power and
       telephone cables;                                                                  Essential requirements
13 : steam       condensors   under    vacuum    for  industrial
                                                                      1.     The following pressure equipment must satisfy the
       processes such as power plants;                                essential requirements set out in Annex I:
14. permanently fixed items for ships, rockets and
                                                                      1 . vessels for:
       aircraft;
15 . pneumatic tyres u$ed for the support or propulsion                   ( a) gases, liquefied gases and liquids at a temperature
       of vehicles;                                                            above their atmospheric-pressure boiling point,
     i
                                                                               including vapours, within the following limits;
16 . air cushions for transport vehicles including those                       — for fluids in Groups I and II with a product
       for rescue support and recovery in the event of                             of PS and V greater than 20 bar 1 and a
       accident and also those for protection of goods in                          volume greater than 0,2 1,
       transport;
                                                                                   for fluids in Group III with a product of PS
17. non-industrial exhaust and inlet silencers;                                    and V greater than 50 bar 1 and a volume
18 .   bottles or cans for carbonated drinks for final
                                                                                   greater than 0,2 1;
                                                                                    <
       consumption;                                                       (b) liquids     at a temperature below               their
                                                                               atmospheric-pressure boiling point:
19. vessels designed for the transport and distribution of
       beer;                                                                   — for fluids in Groups I and II with a product
                                                                                   of PS and V greater than 200 bar 1 and a
20. equipment for the transport of dangerous goods.                                volume greater than 1 1,
                                                                               — for fluids in Group III with a product of PS
                             Article 2                                             and V greater than 5 000 bar 1 and a volume
                                                                                   greater than 10 1;
                      Market surveillance                                                     i
                                                                          (c) vacuum conditions with a volume V greater than
                                                                               1 000 1;
1 . Member States shall take all appropriate measures
to ensure that pressure equipment covered by this                     2.  fired or otherwise heated pressure equipment with the
Directive may be placed on the market and put into                        risk of overheating intended for:
service only if it does not endanger the health or safety of                                    /             •
persons, the environment and, where appropriate,                          ( a) steam or hot-water generation with a volume
domestic animals or property when used for its intended                        greater than 2 1 and
 ---pagebreak--- 9 . 9 . 93                                 Official Journal of the European Communities                              No C 246/5
     ( b ) process heating for other than steam or hot                2.     Conformity of pressure equipment:
           water with a volume greater than 2 1;
                                                                        a   with the national standards which transpose the
3 . piping intended for:                                                    harmonized    standards the reference numbers      of
     (a ) gases, liquefied gases and liquids at a temperature               which have been published in the Official Journal of
           above their atmospheric-pressure boiling point                   the European Communities or
           including vapours and hot water with a DN
           greater than 32 and a product of PS and DN                 ( b ) with the national standards applicable to them
           greater than 1 000 bar;                                          referred to in paragraph 4 in so far as, in the areas
                                                                            covered by such standards, no harmonized standards
     ( b ) liquids at a temperature below                  their            exist,
           atmospheric-pressure boiling point:
           — for liquids in Groups I and II with a DN                 shall result in a presumption of conformity with the
               greater than 32 and a product of PS and DN             essential requirements referred to in Article 3 . Member
               greater than 2 000 bar,                                States shall publish the reference numbers of the national
                                                                      standards referred to in paragraph 2 (a ).
           — liquids in Group III with a DN greater than
               100 and a product of PS and DN greater than
               5 000 bar,                                             3 . Member States shall ensure that appropriate
                       \
                                                                      measures are taken to enable the social partners to have
     (c ) vacuum conditions with a DN greater than                    an influence at national level on the process of preparing
           1 000:                                                     and monitoring the harmonized standards.
4 . accessories for vessels, piping and assemblies.
                                                                      4.     Member      States  shall    communicate    to   the
                                                                      Commission the texts of their national standards as
2. Vessels, piping and assemblies below the limits
quoted in paragraph 1 , points 1 to 3 must be                         referred to in paragraph 2 ( b) which they regard as
manufactured in accordance with point 1 of Annex I and                complying with the essential requirements referred to in
                                                                      Article 3 . The Commission shall forward these national
with sound engineering practice of one of the Member
                                                                      standards to the other Member States . In accordance
States and bear markings as laid down in point 3.2.6 of
Annex I, with the exception of the CE marking referred                with the procedure provided for in Article 6 (2), it shall
to in Article 12 .                                                    notify the Member States of those national standards
                                                                      which are presumed to conform with the essential
                                                                      requirements referred to in Article 3 .
                            Article 4
                         Free circulation                                                       Article 6
1 . Member States shall not prohibit, restrict or impede                   Committee on Technical Standards and Regulations
the placing on the market or putting into service on their
territory of pressure equipment which complies with the
provisions of this Directive.                                         1.     Where    a   Member    State   or  the  Commission
                                                                      considers that the standards referred to in Article 5 (2 )
2. Member States shall not prohibit, restrict or impede               do not entirely meet the essential requirements referred to
the placing on the market of parts of pressure equipment              in Article 3 , the Commission or the Member State
which have been transformed with regard to the                        concerned shall bring the matter before the Standing
production of pressure equipment where the                            Committee set up under Directive 83/189/EEC,
manufacturer or his authorized representative established             hereinafter referred to as 'the Committee', giving the
in the Community declares in accordance with Annex VII                reasons therefor. The Committee shall deliver an opinion
that it is intended to be part of pressure equipment                  without delay.
within the meaning of Article 9 ( 1 ), point 1 .
                                                                      In the light of the Committee's opinion, the Commission
                                                                      shall inform the Member . States whether or not it is
                            Article 5                                 necessary to withdraw those standards from the
                                                                      publications referred to in Articles 5 (2) and 6 (2 ).
                  Presumption of conformity
                                                                      2. After receipt of the communication referred to in
1 . Member States shall regard pressure equipment                     Article 5 (4 ), the Commission shall consult the
bearing the CE marking provided for in Article 12 as                  Committee. Upon receipt of the latter's opinion, the
conforming to all the provisions of this Directive,                   Commission shall, within one month, inform the Member
including the evaluation of conformity provided , for in              States whether or not the national standard(s ) in question
Article 9 .                                                           are to enjoy the presumption of conformity; if they are,
                                         t
 ---pagebreak---                                                        t
No C 246/6                              Official Journal of the European Communities                                     9 . 9 . 93
the Member States shall publish the reference numbers of                                     Article 8
those standards. The Commission shall also publish them
in the Official Journal of the European Communities.                                      Classification
                                                                                                       i
                                                                   1.     The different types of pressure equipment, as
                                                                   referred to in Article 3 ( 1 ), shall be classified for
                           Article 7                               the specification of the attestation procedures. The
                                                                   classification is set out in the relevant conformity -
                                                                   assessment tables in Annex II.
                       Safeguard clause
                                                                   2. Where the properties of fluids are criteria for
1 . Where a Member State ascertains that pressure                  classification, the y shall be grouped as referred to in
equipment bearing the CE marking which is, where                   paragraph 2, points 1 to 3 .
applicable, correctly installed, maintained and used in                                                                      i
accordance with its intended purpose is liable to                  Very dangerous or dangerous fluids within the meaning
endanger the safety of persons, the environment, and,              of this Directive are substances or preparations according
where appropriate, domestic animals or property, it shall          to the definitions in Article 2 (2 ) of Directive 67/548/EEC
take all appropriate provisional measures to withdraw              as last amended by Directives 92/32/EEC and
such pressure equipment from the market, or to prohibit            88/379/EEC.
                                                                                                                i
or restrict placing on the market, putting into service or                                                    t
use .                                                              1 . Group I includes very dangerous and dangerous fluids
                                                                       such as those defined as :
The Member State shall immediately inform the                          — explosive,
Commission of any such measure, indicating the reasons
for its decision and, in particular, whether                           — extremely flammable,
non-conformity is due to:                                              — highly flammable,
(a) non-compliance with the essential requirements                     — very toxic,
      referred to in Article 3, where the pressure                     — toxic,
      equipment does not comply with the standards
      referred to in Article 5 (2 );                                   — carcinogenic,
                                                                       — mutagenic^
( b ) incorrect application of the standards referred to in            — toxic for reproduction.
      Article 5 (2 );
                                                                   2. Group II includes:
(c ) shortcomings in the standards referred to in Article 5
      (2 ) themselves.                                                 (a) dangerous and less dangerous fluids such as
                                                                            those defined as
2.     The Commission shall enter into consultation with                    — corrosive,
the parties concerned as soon as possible . Where, after
                                                                            — irritant,
such consultation, they Commission finds that any
measure as referred to in paragraph 1 is justified, it shall                ■— harmful,
immediately so inform the Member State that took the                        — oxidizing,
measure and the other Member States .
                                                                            — dangerous for the environment,
Where the measures referred to in paragraph 1 are                           — flammable,
attributed to shortcomings in the standards referred to in
                                                                            — sensitizing;
Article 5 (2 ), the Commission, after consulting the parties
concerned, shall bring the matter before the Committee                 ( b) steam and hot water for other than steam and
referred to in Article 6 ( 1 ) within two months if the                     hot-water generation and if aboveground and
Member State which has taken the measures intends to                        unshielded .
maintain them, and shall initiate the procedures referred
to in Article 6 .                                                  3 - Group III includes less dangerous and non-dangerous
                                                                       fluids .
3 . If a non-conforming item of pressure equipment
bears the CE marking the competent Member State shall                                        Article 9
take appropriate measures against whomsoever has
affixed that marking and shall inform the Commission
and the other Member States thereof.
                                                                                      Conformity assessment
                                                                                    i
                                                     i
                                                                   1 . The conformity assessment procedures to be applied
4.     The Commission shall ensure that the Member                 to an item of pressure equipment in order to affix the CE
States are informed of the application and results of this         marking are indicated in the tables in Annex II and are
procedure.                                                         set out in detail in Annex III .
 ---pagebreak--- 9 . 9 . 93                               Official Journal of the European Communities                               No C 246/7
1 . The CE marking shall be affixed to the completed                of the Member State where the body responsible for
      pressure equipment or to pressure equipment which is          carrying out these procedures is established or in a
      at least in a state permitting the tests, including that      language accepted by it.
      for pressure containment as referred to in point 3.2.5
      of Annex I, which shall ensure that the pressure
      equipment is adequate and safe for its duty.                                            Article 10
2 . Where, in the relevant table, more than one                                            Notified bodies
      conformity assessment procedure is allowed, the
      manufacturer can choose the one to be used.
                                                                    1.    Member States shall inform the Commission and
                                                                    the other Member States of the bodies designated by
2. Where equipment is manufactured to constitute an                 them to carry out the procedures referred to in Article 9
assembly of linked items as referred to in Article 1 (2),           and of the specific tasks for which the bodies have been
point 1.3 when placed on the market, the following shall            designated and the identification numbers assigned to the
apply:                                                              bodies by the Commission.
( a ) without prejudice to Article 3 (2 ) the conformity            The Commission shall publish in the Official Journal of
       assessment procedure to be applied to the assembly           the European Communities a list of the notified bodies
       shall be the most stringent procedure applicable to          containing their identification numbers and the tasks for
                                                                    which they have been notified. It shall ensure that the list
       any of the manufactured individual equipment, not
       taking into account already CE-marked items which            is kept up to date.
       might be integrated. In the framework of the
       procedure to be applied, the items already                   2.    Member States shall apply the minimum criteria set
       CE-marked shall only be checked concerning their             out in Annex IV for the designation of bodies. Bodies
       compatibility with the other items of pressure               that satisfy the criteria fixed by the relevant harmonized
       equipment and their suitable integration;                    standards shall be presumed to satisfy the relevant
                                                                    minimum criteria .
( b) where an assembly is constituted exclusively by
       already CE-marked items, the assembler shall                 3 . A Member State that has notified a body shall
                                                                    withdraw that notification if it finds that the body no
       — for assemblies for fluids in Groups I or II and for        longer meets the criteria referred to in paragraph 2. It
           assemblies in Groups I or II for steam or                shall immediately inform the other Member States and
                                                                    the Commission thereof.
           hot-water generation, apply Module B, restricted
           to the approval of technical documentation with
           respect to aspects of assembling such as referred        4.    The notified body and the manufacturer or his
           to in point 2.2.8 in Annex I and apply one of the        authorized representative established within the
           specific procedures for assembling, Module DA or         Community shall agree on the procedures and the time
           Module FA.                                               limit for the execution and completion of the evaluation
                                                                    and verification operations referred to in Annex III.
       — for assemblies for fluids in Group III and for
           steam or hot-water generator assemblies in
           Group III apply Module DA or Module FA.                                            Article 11
3 . Where the pressure equipment is subject to other                                     User inspectorates
directives covering other aspects which provide for the
affixing of the CE marking, the latter shall indicate that          1 . Member States may authorize second-party user
the pressure equipment in question is also presumed to              inspectorates to carry out the tasks normally assigned to
conform to the provisions of those other directives.                a third party exclusively in the framework of
                                                                    Modules A 1 , C I , F 4, FA and G as set out in
                                                                    Annex III.
However, should one or more of those directives allow
the manufacturer, during a transitional period, to choose           The user inspectorates shall act exclusively for their
which arrangements to apply, the CE marking shall                   parent organization.
indicate conformity only with the directives applied by
the manufacturer. In this case, the particulars of the said         2.    The Member States shall communicate the names
directives, as published in the Official Journal of the
European Communities, must be given in the documents,               and addresses of the user inspectorates they have
notices or instructions required by the directives and              authorized to the Commission, which will inform the
                                                                    other Member States thereof.
accompanying the pressure equipment.
                                                                    3 . Member States shall apply the criteria set out in
4. Records and correspondence relating to conformity                Annex V for the authorization of user inspectorates. User
assessment shall be drawn up in the official language(s )           inspectorates that satisfy the criteria fixed by the relevant
 ---pagebreak--- No C 246/8                             Official Journal of the European Communities                                    9 . 9 . 93
harmonized standards shall be presumed to satisfy the             ( b) where non-conformity continues, the Member State
relevant criteria .                                                    must take all appropriate measures to restrict or
                                                                       prohibit the placing on the market of the product in
4.     A  Member     State  that   has  authorized  a   user           question or to ensure that it is withdrawn from the
inspectorate shall withdraw that authorization if it finds             market in accordance with Article 7.
that the user inspectorate no longer meets the criteria
referred to in paragraph 3 . It shall immediately inform
the Commission thereof, which will inform the other                                         Article 14
Member States .
                                                                         Decisions resulting in a refusal or restriction
5 . The user inspectorate and the manufacturer shall                          r
agree on the procedures and the time limit for the                Any decision taken pursuant to this Directive which
execution and completion of the evaluation and                    includes any restriction on the placing on the market
verification operations referred to in paragraph 1 .              and/or putting into service of pressure equipment shall
                                                                  state the precise grounds on which it is based. It shall be
                                                                  notified without delay to the party concerned, which
                                                                  shall at the same time be informed of the legal remedies
                         Article 12                               available to it under the laws in force in the Member
                                                                  State in question and of the time limits to which such
                        CE marking                                remedies are subject.
1 . The CE marking shall consist of the initials ' CE'.
The form of the marking to be used is shown in                                              Article 15
Annex VI.
                                                                                       Repeal of Directive
The CE marking shall be followed by the identification                                                j '
number, referred to in Article 10 ( 1 ), of the body              Directive 76/767/EEC shall be repealed as from 1 July
involved in the production control phase.                         1996, except as regards the application of Directive
                                                                  84/525/EEC, 84/526/EEC and 84/527/EEC.
Where user inspectorates as referred to in Article 11 are
involved in the production phase, the CE marking shall                                      Article 16
also be affixed, but their identification shall be included
in the documents accompanying the pressure equipment.                     Coming into force, transitional provisions
2. The CE marking shall be affixed to pressure                    1 . Before 1 April 1996, Member States shall adopt
equipment distinctly and visibly.                                 and publish the laws, regulations and administrative
                                                                  provisions necessary to comply with this Directive and
3 . It is prohibited to affix any other mark, sign or             communicate them to the Commission .
indication which may be confused with the CE marking
in meaning or design.                                             Provisions adopted pursuant to the first paragraph shall
                                                                  refer explicitly to this Directive.
Any other mark, such as a mark of conformity with a
national or European standard or a mark of conformity             Member States shall apply such provisions as from 1 July
                                                                  1996 .
with traditional directives of the optional type, may be
affixed to a product, provided it cannot be confused with
the CE marking.                                                   2.    Member       States   shall       communicate  to      the
                                                                  Commission the texts of the provisions of national law
                                                                  which they adopt in the field covered by this Directive.
                          Article 13
                                                                  3 . Member States must, during the period up to 1 July
                                                                  1999, permit the placing on the market and/or the
                Unduly affixed CE marking                         putting into service of pressure equipment which
                                                                  complies with the regulations in force in the Member
Without prejudice to Article 7                                    States at the date of adoption of this Directive .
( a ) where a Member State establishes that the CE
      marking has been affixed unduly, the manufacturer                                     Article 17
      or his authorized representative established within
      the Community shall be obliged to make the product                           Addressees of the Directive
      comply and to end the infringement under the
      conditions imposed by the Member State;                     This Directive is addressed to the Member States .
 ---pagebreak--- 9 . 9 . 93                                 Official Journal of the European Communities                                    No C 246/9
                                                               ANNEX 1
                             ESSENTIAL REQUIREMENTS RELATING TO PRESSURE EQUIPMENT
                                                                            s
                         %
           PRELIMINARY OBSERVATION
                                                                                                           r
           The obligations laid down in these essential requirements apply only when the corresponding hazard exists
           for the pressure equipment concerned when it is used under the foreseeable conditions specified in the
           instructions for use .
           1.         General
           1.1        Pressure equipment shall be designed, calculated, manufactured, tested and if applicable equipped
                      and installed in such a way as to withstand all conditions to which it will reasonably foreseeably
                      be subjected during its normal use, when correctly operated, maintained and periodically
                      inspected where applicable.                 s
           1.2        Effective provisions shall be made to enable operation, adjustment, maintenance and inspection to
                      be carried out without putting persons and the environment at risk.
           1.3        Where the potential for misuse is known or can be clearly foreseen, the pressure equipment shall
                      be designed to prevent danger from such misuse or, if that is not possible, adequate warning shall
                      be given that the pressure equipment should not be used in that way.
                                                                                               4
           2.         Design and calculation
                      In the design of the pressure equipment all relevant factors are to be taken into account which
                      will influence :
                                  •                    i
                      — proper and safe operation,
                      — proper aind safe testing, and
                      — the assurance of stability,
                      e.g., where appropriate:
                      — internal/external pressure,
                      — ambient and operational temperatures,                                1                      V
                      — static pressure and mass of substance in operating and test conditions,
                      — traffic, wind, earthquake loading,
                      — reaction forces and moments which result from the supports, attachments, piping etc.
                      Various loadings which can occur at the same time are to be reasonably considered taking into
                      account the probability of their simultaneous occurrence.
           2.1        Determination of wall thickness and of supporting components
                      Normally the wall thickness shall be determined by calculation accompanied if need be by
                      experimental stress analysis as given in point 2.1.1 . The wall thickness may be determined by
                      experimental means as given in point 2.1.2 within the limits specified.
           2.1.1      Calculation method
                      (a) Pressure containment and other loading aspects
                            Appropriate design calculations for pressure containment and supporting components shall be
                            used to establish the safety of the pressure equipment concerned.
                            The minimum thickness to withstand pressure must be calculated with regard in particular
                            to :
                           — the calculation pressures which must not be less than the allowable pressures and take
                                 into account static head and dynamic fluid pressures. External loads not resulting from
                                 the duty shall be superimposed on the pressure load. Where a vessel is separated into
                                 individual pressure-containing compartments, the partition wall shall be calculated based
                                 on the higher compartment pressure relative to the lowest pressure possible in the
                                 adjoining compartment,
 ---pagebreak--- No C 246/10                          Official Journal of the European Communities                                          9 . 9 . 93
                        — the calculation temperatures allowing for appropriate safety margins and taking into
                           account the design lifetime of the pressure equipment, in particular where it is operated in
                           the creep range or . subject to fatigue,
                        — the maximum stresses and peak stress concentrations where necessary. These stresses shall
                           be established by specific calculations and if necessary accompanied by specific tests such
                           as strain gauges or photoelastic models in cases where the configuration makes the
                           calculations uncertain,
                        — appropriate joint factors applied to the material properties depending, for example, on the
                           type of joining, the amount and type of non-destructive testing, the materials joined and
                           the operating conditions envisaged.
                        The calculation for pressure containment and the associated supporting elements shall utilize
                        the appropriate data for the material selected having regard to the provisions set out in
                        points 4 and 4.1 together with appropriate safety factors. Material characteristics to be
                        considered, are, where applicable, for example:
                        — 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,
                                                               4                      '
                     - — Young's modulus (modulus of elasticity)
                        — appropriate amount of plastic strain,
                        — impact strength,
                        — fracture toughness.
                  ( b) Stability aspects
                        Where the calculated thickness would give rise to an unacceptable structural stability
                        adequate measures shall be taken to overcome it taking into account the risks from transport
                        and handling.
                                                                         »
           2.1.2  Experimental method
                  The wall thickness for a given allowable pressure PS of the pressure equipment may be established
                  by means of a test to a pressure as specified below and carried out on a unit representative of the
                  production. The test procedure shall be clearly laid down before the test and the critical
                  dimension relative to design tolerances and the actual material properties established before the
                  test is carried out.
                  The test shall be limited to pressure equipment within the following scope:
                  — creep or fatigue is not a feature affecting the design, unless the tests specifically relate to that
                       condition,
                                                                                           .         i
                  — the product of the allowable pressure PS and the volume V is < 6 000 bar 1. This value may be
                       greater in specific cases subject to the agreement of the notified body.
                  It shall be possible to observe either visually or by suitable instrumentation the critical areas of the
                  pressure equipment during the test where the failure would establish the pressure from which the
                  allowable pressure PS is determined.
                  The pressure specified for the test shall ensure that the design provides for an adequate safety
                  margin taking into account the relevant material characteristics, the differences between the test
                  and design temperatures, the differences between the actual and the minimum guaranteed material
                  characteristics   and the    differences   between  the   actual  and  the   minimum     allowed wall
                  thicknesses .
                                                                                «
                  It is not necessary to test to destruction provided the pressure equipment remains sound and no
             -•V,
                  significant permanent deformation has occurred up to the pressure specified for the test.
                                                                  I*
                  The criterion for failure rs considered to be when either the first leakage from the pressure
                  equipment occurs or the material has exceeded an allowable amount of plastic deformation.
                                                V.
 ---pagebreak---                                                      r
9 . 9 . 93                         Official Journal of the European Communities                                 No C 246/11
           2.2   Design       -
           2.2.1 Stress limitation
                 Stress concentrations due to the design, e.g. arising from the geometry and thermal expansion or
                 contraction, shall be kept within safe limits.
           2.2.2 Material selection
                 The materials shall comply with the provisions set out in point 4. Adverse effects of
                 incompatibility shall be avoided where different materials are joined.
           2.2.3 Provisions to ensure safe handling and operation
                 The means of operation of pressure equipment shall be such that no reasonably foreseeable risk
                 from operating that pressure equipment shall occur in particular regarding:
                 — quick actuating closures and openings,
                                                                                                          i
                 — inadvertent discharge of contents,
                                                   i
                 — dangerous discharge of pressure relief blow-off,
                 — avoiding access whilst pressure or vacuum exists,
                 — surface temperature taking into consideration the intended use.
           2.2.4 Means for internal examination
                 Where necessary to ensure the continued safety of pressure equipment, means of determining the
                 internal condition must be available such as :
                 (a) access openings which will allow cleaning, purging and physical access to the inside of the
                      pressure equipment so that visual examination can take place safely;
                 (b) other means of ensuring the safe condition of the pressure equipment can be applied
                      — where it is Joo small for physical internal access' or
                      — where the opening-up of the pressure equipment would adversely affect the inside, or
                      — where the substance to be contained has been proven not to be harmful to the material
                          from which the pressure equipment is made.
           2.2.5 Means of draining and venting
                 Adequate means shall be provided for the draining and venting of pressure equipment where
                 necessary
                 — to avoid harmful effects such as water hammer, vacuum collapse and corrosion; all stages of
                     operation and testing shall be considered,
                 — to permit cleaning and maintenance,
                 — to avoid weld-seam attack, as far as possible weld seams shall not be at the bottom of the
                     pressure equipment.
           2.2.6 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 use and the in-use inspections foreseen.
                                       >
           2.2.7 Wear
                 Where severe conditions of erosion or abrasion may arise adequate measures shall be taken to:
                 — minimize that effect by appropriate design, e.g. additional material thickness,
                 — permit replacement of parts which are most affected,
                 — draw attention, in the instructions referred to in point 3.2.7, to measures necessary for
                     continued safe use .
                                          v
           2.2.8 Assemblies
                 Assemblies shall be so designed that:
                 — the items to be linked are suitable and reliable for their duty,
                                                                                               m                           i
                                /
 ---pagebreak--- No C 246/12                              Official Journal of the European Communities                                   9 . 9 . 93
                    — protection against exceeding the allowable operational limits is ensured; where an item of the
                         assembly, such as a vessel or piping, can be isolated and where there is a risk that allowable
                         operational limits can be exceeded, that item shall be fitted with suitable protective and/or
                         limiting devices,
                    — provision is made for adequate integration of all items and their suitable joining.
           2.2.9    Provisions for filling and discharge
                    The pressure equipment shall be so designed and provided with accessories, or provision made for
                    their fitting, to ensure safe filling and discharge in particular with respect to risks such as
                    (a) for filling,
                          the overfilling or overpressurization having regard in particular to the filling ratio and to
                          vapour pressure at the reference temperature;
                    (b) for discharge,
                          the uncontrolled release of the pressurized fluid;
                    (c ) for filling and discharge:
                          — unsafe connection and disconnection, also with regard to protection of the environment,
                               e.g. from spillage, and to inadvertent drive-away where applicable.
           2.2.10   Protection against exceeding the allowable operating limits of pressure
                    equipment
                    Where, under reasonably foreseeable service conditions, the allowable operating limits may be
                    exceeded the pressure equipment must be fitted with, or provision must be made for, the fitting
                    of:
                    (a) where appropriate, manually or automatically operated regulatory devices to maintain
                          conditions during normal operation within the maximum/minimum allowable operating
                           limits;
                    (b) 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 operational limits;
                    (c) adequate protective and/or limiting devices which
                          — activate the means for correction, such as pressure switches, temperature switches,
                               measurement, control and regulation devices (MCR).
                          — provide for shutdown and lockout, such as pressure switches, temperature switches and
                               level switches,
                          — serve as ultimate protection to prevent the allowable operating limits from being
                               exceeded, such as safety valves, bursting disk safety devices, buckling rods etc.
                          The relevant combination of those devices shall be determined based on the particular
                           installation;
                                                                                            k
                    (d) for limiting devices or indicators, suitable facilities shall be provided for fitting test
                           instrumentation on the pressure equipment,
           2.2.11   Accessory design
             *      Accessories shall be reliable and suitable for their duty.
                                       f
           2.2.11.1 Limiting devices or their relevant components shall
                    — be either fail-safe, have redundancy or be self-monitoring,
                    — be independent of other functions and, if applicable of each other.
           2.2.11.2 Pressure limitation
                    Pressure-limiting devices shall be effective at a pressure such that pressure shall not exceed 1,1
                    times the maximum allowable pressure PS.
                    Bursting disk safety devices which are designed to be effective at the maximum allowable pressure
                    PS and whose performance tolerance is such that the requirement in the first paragraph is fulfilled
                    during their service life and safety valves are considered to comply with point 2.2.11.1 .
 ---pagebreak---   9 . 9 . 93                             Official Journal of the European Communities                                      No C 246/1 3
             2.2.11.3 Temperature safeguard
                      This device shall have an adequate response time .
                                                                                         /
                                                 *
             2.2.12   Electrical hazards
                                                                     s
                      Pressure equipment must be so designed and constructed as to avoid hazards of electrical origin.
                      In the area in which it applies, compliance with Directive 73/23/EEC shall be equivalent to
                      fulfilment of this requirement.
             2.2.13   External fire
\
                      Pressure equipment in particular for Group I and II fluids must be so designed and, where
                      appropriate, fitted with adequate accessories, or provisions made for their fitting, as to reduce the
                      consequences in the event of fire of external origin, having in particular regard to its
                      destination .
             2.2.14   Pressure equipment used for agro-foodstuffs and edible liquids
                      Without prejudice to the Community regulations in this area, materials and components used in
                      the construction of pressure equipment which may come into contact with agro-foodstuffs and
                      edible liquids must not impair their quality.
             2.2.15   Noise
                      Pressure equipment must be so designed and constructed that risks resulting from the emission of
                      airborne noise are reduced to the lowest level taking account of technical progress and the
                      availability of means of reducing noise, in particular at source.
             3.       Manufacturing
                                                                       %
             3.1 .    Qualification of manufacturer
                      The manufacturer shall have the technical capability and have at his disposal all appropriate
                      means to carry out satisfactorily the manufacture of pressure equipment and in particular properly
                      qualified personnel for the
                      — surveillance of the whole manufacturing process,
                      — joining of materials,
                      — appropriate testing.
             3.2 .    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:
             3.2.1 .  Preparation of the component parts
                      Preparation of the component parts (e.g. forming and chamfering) must not give rise to surface
                      defects or cracks or changes in the mechanical characteristics likely to be detrimental to the safety
                      of the pressure equipment.
             3.2.2 .  Joining
                      The joining of materials shall produce an effective seal, and be of adequate strength, ductility and
                      toughness.
             3.2.3 .  Heat treatment
                      Where there is a risk that the manufacturing process will change the material properties beyond
                      the limits which would impair the integrity of the pressure equipment, suitable heat treatment
                      shall be applied at the appropriate stage of manufacture.
             3.2.4    Traceability
                      Traceability of materials shall be ensured at least up to the final acceptance of the manufactured
                      pressure equipment.
             3.2.5    Final testing
                      (a) Pressure equipment shall be subject to an appropriate final test which shall ensure that it is
                           adequate and safe for its duty.
 ---pagebreak---                                                «
No C 246/14                           Official Journal of the European Communities                                        9 . 9 . 93
                  (b) The final test for pressure equipment and pressurized accessories shall include a test for the
                       pressure containment aspect and shall:
                       — where the pressure equipment is subject to a positive pressure, normally be a hydraulic
                           pressure test.
                       Other tests of proven validity can be applied especially in cases where a hydraulic pressure
                       test is detrimental or is not practical.
                       Where a pneumatic test is applied, complementary measures such as appropriate
                       non-destructive testing of relevant parts or other methods of equivalent validity shall be
                       applied prior to the pneumatic test,
                       — where subject to vacuum conditions, be a vacuum test which provides for an adequate
          <
                           safety margin or a test of equivalent validity.                      i
                        i
            3.2.6 Marking and / or labelling
                  In addition to the CE marking referred to in Article 13, the following information must be
                  provided: 1
                  (a) for all pressure equipment
                       — name and address or other means of identification of the manufacturer,
                       — identification of the pressure equipment, such as type, serial or batch identification,
                       — essential maximum/minimum allowable limits;
                                                                                  «
                  (b) 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:
                       — the capacity of the pressure equipment V in litres,
                       — the nominal size for piping DN,
                       — date of manufacturing,
                                  i
                       — the design code,
                                       i .
                       — the test pressure PT applied in bar and date,
                       — safety device set pressure in bar,
                       — output of the pressure equipment in kW,
                       — supply voltage in volts,
                       — intended use,
                       — filling ratio kg/1,
                       — maximum filling mass in kg, where appropriate,
                       — tare mass in kg;
                  (c) where necessary, warnings fixed to the pressure equipment shall draw attention to ways —
                       which experience has shown might occur — in which the pressure equipment shall not be
    /
                       used.
  i
                  The CE marking and the required information must be given on the pressure equipment or on a
                  data plate attached to it with the exceptions below:
                  — where, for piping, the layout is such that the marking on the piping would practically be
                      invisible, the piping shall carry at least the test pressure and date and a means of identification
                      relating to a separate documentation which contains all information necessary including that
                      of the CE marking,
                  — where the pressure equipment is too small, e.g. accessories, information referred to in (b ) may ,
                      be given on a loose label attached to that pressure equipment,
                                                                                                  y
                  — labelling or other adequate means may be used for the mass to be filled and the warnings
                      referred to in (c) provided it remains legible during the appropriate period of time.
            3.2.7 Instructions
                  When being placed on the market, pressure equipment must be accompanied, as far as relevant,
                  with adequate means of ensuring safe operation such as:
                  (a) a document giving the information with which the pressure equipment is marked (see
                       point 3.2.6 ), with the exception of serial identification;
 ---pagebreak--- 9 . 9 . 93                                Official Journal of the European Communities                                    No C 246/15
                      (b) where appropriate, instructions, including information, drawings and diagrams necessary for
                           safe:
                           — assembling, as referred to in point 2.2.8,
                           — putting into service,
                           — use ,
                           — maintenance
                           — periodic inspection;
                      (c) the instructions shall, where necessary, draw attention to ways — which experience has
                           shown might occur — in which the pressure equipment shall or shall not be used.
                    ,                           >                *
           3.2.8      Languages
                      Marking and instructions as referred to in points 3.2.6 and 3.2.7 must be in the official language
                      or languages of the Member State of destination.
               .  i
           4.         Materials
                      Materials used for the manufacturing of pressure equipment must be'suitable for such application
                      during the design lifetime unless replacement is foreseen.
           4.1        Materials for pressurized parts must:
                      (a) be sufficiently ductile and tough, so that an accidental rupture at minimum allowable
                           temperature does not give rise to either unacceptable fragmentation or brittle type fracture .
                           Where for specific reasons brittle material has to be used appropriate measures shall be
                           provided to compensate for this;
                      (b) be sufficiently chemical resistant against the fluid to be contained in the pressure equipment.
                           The mechanical properties of the material shall not be affected by the fluid within its design
                           lifetime;
                      (c) not be unduly affected by natural ageing;
                      (d) be suitable for the amount of forming foreseen.
           4.2        The properties of materials shall be properly ascertained and documented. The documentation
                      produced shall provide the necessary information to confirm the characteristics set out in the
                      design specification. Suitable means of ensuring adequate traceability of material shall be provided
                      in order to enable the pressure equipment manufacturer to comply with the requirements in
                      point 3.2.4 .
           4.3        Manufacture of basic materials
                                                                                                                v
                      'Basic materials' means materials in the unaltered state before any specific transformation with
                      regard to the production of pressure equipment, such as sheet material, tubes, weld or other
                      joining materials, jointing materials, bar material for such as bolts etc.
                      The materials used must be manufactured by manufacturers which:
                      — have facilities and qualified staff for proper manufacturing of the materials,
                      — have at their disposal facilities and qualified staff for the testing of the materials including
                          non-destructive testing to the extent that such tests are provided for in the material
                          specification,
                      — manufacture the materials in accordance with an appropriate process, which has to be
                          specified, and
                      — ensure proper manufacturing of the products and compliance with the requirements referred
                          to in the material specification by means of quality monitoring with corresponding records.
           SPECIFIC PRESSURE EQUIPMENT REQUIREMENTS
           In addition to the applicable requirements of point 1 to 4 the following requirements shall apply to the
           pressure equipment covered by points 5 and 6.
           5.         Fired or otherwise heated pressure equipment with the risk of overheating as referred to in
                      Article 3 ( 1 ), point 2.
                      This pressure equipment includes:
                      — steam and hot-water generators with a volume greater than 2 1 such as fired steam and hot
                          water boilers, superheaters and reheaters, waste-heat boilers, waste-incineration boilers,
 ---pagebreak---                    /
  No C 246/16                            Official Journal of the European Communities                                    9 . 9 . 93
                          electrode or immersion-type electrically heated boilers, pressure cookers, together with their
                          accessories and where applicable their heat-source controls and their system for treatment of
                          feedwater, feeding of fuels and for the removal and treatment of flue gases, and
                     — process-heating equipment for other than steam and hot water with a volume greater than 2 1
                          such as heaters for chemical and other similar processes, pressurized food-process equipment
                          together with their controls and other related accessories.
                     This pressure equipment shall be calculated, designed and constructed so as to minimize risks
                     from the transfer of heat. In particular it shall be fensured, where applicable, that:
                     (a ) heat imput and heat take-off and water level are adequately controlled so as to avoid local
                           and general overheating;
                     (b) the properties of the fluid are adequately controlled so as to avoid risks related to deposits
                           and/or corrosion;
                     (c ) adequate provisions are made to eliminate risks of damage from deposits;
                     (d) means of safe dissipation of residual heat after shutdown are provided;
                     (e) the combustion process is adequately controlled so as to avoid
                           — a dangerous accumulation of ignitable mixtures of combustible substances and air,
                           — flame blowback, and
             t
                           — unacceptable concentrations of substances harmful to health and the environment in the
                               combustion products.
               6.    Piping as referred to in Article 3
                     Calculation, design and construction shall ensure that:
               6.1   (a) the risk of overstressing from unacceptable free movement or excessive forces being
                           produced, e.g. on flanges, connections, bellows or hoses, shall be adequately controlled by
                           means such as support, constraint, anchoring, alignment and pre-tension;
                     (b) where there is a possibility of condensation occurring inside pipes for gaseous fluids, means
                           shall be provided for drainage and removal of deposits from low areas to avoid damage from
                           water hammer or corrosion;
                     (c ) due consideration is given to the potential damage from turbulence and formation of vortices;
                           the relevant parts of point 2.2.7 are applicable;
                     (d) due consideration is given to the risk of fatigue or noise from resonances in pipes;
                     (e ) where there is a risk of impact damage, it shall be adequately protected;
                     (f) where necessary for continued safe operation, means are provided for checking its integrity in
                           situ;
                                                                I                        /
                     (g) where fluids of Groups I or II are contained, means are provided to isolate 'take-off' pipes;
                     (h ) the risk of inadvertent discharge is minimized; the take-off points shall be clearly marked on
                           the permanent side indicating the fluid contained;
                     (i) the position and route of underground piping and pipelines is at least recorded in the
                           technical documentation to facilitate safe maintenance inspection or repair.
\
 ---pagebreak--- 9 . 9 . 93                                 Official Journal of the European Communities                                    No C 246/17
                                                                  ANNEX II
                                                 CONFORMITY ASSESSMENT TABLES
                                                                                           i
                                                                   TABLE 1
              Vessels for gases, liquefied gases and liquids at a temperature above their atmospheric-pressure boiling point
                               according to Article 3 ( 1 ), point 1 (a) and (c) and Article 3 ( 1 ), point 2 (b)
                                      v
                                                                                                                             Module
Fluids in Group I where             la      very toxic            PS > 0,5 bar and PS · V > 20 bar 1                   G or H 1
                                                                  or PS < - 0,5 bar and V > 1 000 1                    or B + D
                                                                                                                       or B + F 4
         I
PS > 0,5 bar                        lb      other fluids          PS · V > 1 000 bar 1                                 G or H 1
V > 0,2 1                                                                        t                                     or B + D
                                                                                                                       or B + F 4
                                                                                                             k
                                                                                                                                     j
or                                                                                                               •
PS < -0,5 bar                       Ic            .               20 < PS · V < 1 000 bar 1                            F 4 or
V > 1 000 1                                                       or PS < - 0,5 bar and V > 1 000 1                    B + C 1
Fluids in Group II where            Ha                            PS · V > 3 000 bar 1                                 G or H 1
                                                                                                                   t
                             /                           »
                                                                  and                                                  or B + D
                                                                  PS > 2 bar                                           or B + F 4
                                                                                                         «
PS > 0,5 bar                        IIb                           20 < PS · V < 3 000 bar 1 or                         F 4
V > 0,2 1                                                         PS · V > 3 000 bar 1 and PS < 2 bar                  or B + C 1
or PS < -0,5 bar                                                  or PS < -0,5 bar and                                 or B + E
V > 1 000 1                                                       V > 1 000 1
           I
                                              t
Fluids in Group III where           Illa                          PS · V > 3 000 bar 1 and                             G or H 1
                                                                  PS > 2 bar                                           or B + D
                                                                                                                       or B + F 4
PS > 0,5 bar                        IHb                           1 000 < PS · V < 3 000 bar 1                         F 4
V > 0,2 1                                                         or                                                   or B + C 2
                                                                  PS · V > 1 000 bar 1 and PS < 2 bar                  or B + F 4
or PS < -0,5 bar                    IIIc                          50 < PS · V < 1 000 bar 1                            A
V > 1 000 1                                                       or PS < - 0,5 bar and V > 1 000 1
                                     N>
 ---pagebreak--- No C 246/ 18                              Official Journal of the European Communities                                         9 . 9 . 93
                                                              TABLE 2
                 Vessels containing liquids below their atmospheric-pressure boiling point according to Article 3 ( 1 ),
                                                             point 2 (b)
                      -
                                                                                                                           Module
Fluids in Group I where           la      very toxic         PS · V > 200 bar 1                                      G or H 1
                                                                                                                     or B + F 4
                                            ■
                                                                                                                     or B + D
PS > 0,5 bar                      lb      other fluids       PS > 100 bar                                            G or H
V > 1 1                                                      and PS · V > 200 bar 1                                  or B + F 4
                                                                                                                     or B + D
                                                                                                                  X.
                                  Ic                         0,5 < PS < 100 bar                                      A 1
                                                             and PS · V > 200 bar 1                         s
                                                                                                                     or A 2
Fluids in Group II where          Ha                         PS > 500 bar                                            G or H 1
                                                                                                                     or B + F 4
  «
                                                                                                                     or B + D
PS > 0,5 bar                      IIb                        0,5 < PS ^ 500 bar                                      A 1
V > 1 1                                                      and PS · V > 200 bar 1                                  or A 2
Fluids in Group III where         Illa                       PS > 500 bar                                            A 1
                                                                                                                     or A 2
PS > 0,5 bar                      Hib                        0,5 < PS < 500 bar                                      A
V > 10 1                                                     and PS · V > 5 000 bar 1
                           s
Fluids in Groups I, II and III                                                                                       F 4
where                                                                                      •
                                                                                                                     or B + C 1
PS < -0,5 bar
and V > 1 000 1
 ---pagebreak--- 9 . 9 . 93                               Official Journal of the European Communities                             No C 246/19
                                                              TABLE 3
                               Steam or hot-wat^r generators according to Article 3 ( 1 ), point 2 (a)
                                                                                                                       »
                                                                                                             Module
              ·>
                                                                                                                         •
Group I
1 < PS < 32 bar and V > 10 1 and TS > 120 °C                                                           G or HI
or                                                                                                     or B + F 4
PS > 32 bar                                                                                            or B + D
Group II
0,5 < PS < 1 bar and V > 10 1 and TS > 120 °C                                                          G or H 1
or                                                         *·
                                                                                                       or B + C 1
TS < 120 °C and V > 10 1 and 0,5 < PS < 32 bar                                                         or B + E
                                                                                            i
                                                                                  v
Group III
0,5 < PS < 32 bar and 2 < V < 10 1                                                                     A 1 or A 2
                   For temperatures less than 120 °C                   For temperatures more than 120 °C
 ---pagebreak--- No C 246/20                                Official Journal of the European Communities                                        9 . 9 . 93
                                                                  TABLE 4
              Piping for gases, liquefied gases and liquids at a temperature above their atmospheric-pressure boiling point
                                               according to Article 3 ( 1 ), point 3 (a) and (c)
                                                                                              >
                                                   \
                                                                          I                                                 Module
     \
Fluids in Group I                  la       very toxic          PS > 0,5 bar and                                      G or H 1
                                                                PS · DN > 1 000 bar or
                                                                PS < - 0,5 bar and DN > 1 000
DN > 32                            lb       other fluids        PS > 0,5 bar and                                      G or H 1
                                                                PS · DN > 2 000 bar
                                   Ic                           PS > 0,5 bar and                                      A 1
                                                                1 000 < PS · DN < 2 000 bar or
                                                                PS < -0,5 bar and DN > 1 000
Fluids in Group II                 Ha                           PS > 0,5 bar and                                      G or H 1
                                                                PS-DN > 3 500 bar
DN > 32                            IIb                          PS > 0,5 bar and                                      A 1
                                                                1 000 . < PS-DN < 3 500 bar or
   t
                                                                PS < -0,5 bar and DN > 1 000
Fluids in Group III                Illa
                                                     I
                                                                PS > 0,5 bar and                                      A 1
                                                                PS · DN > 3 500 bar
                                                       t
DN > 32                            mb                           PS > 0,5 bar and                                      A
                                                                1 000 < PS · DN :£ 3 500 bar or
          r
                                                                PS < - 0,5 bar and DN > 1 000
 ---pagebreak---            /
9 . 9 . 93                                Official Journal of the European Communities                                       No C 246/21
                                                                TABLE 5
              Piping for liquids at a temperature below their atmospheric-pressure boiling point according to Article 3 ( 1 ),
                                                           point 3 (b) and (c)
                                              #
                                                                                                                               Module
Fluids in Group I                   la     very toxic          PS > 0,5 bar and                                       G or H 1
                                                               PS · DN > 2 000 bar or
                          •
                                  «
                                                               PS < - 0,5 bar and DN > 1 000
DN > 32                             lb     other fluids        PS > 0,5 bar and                                       G or H 1
                                        «
                                                               PS * DN > 3 500 bar
                        i                                      PS > 0,5 bar and                                       A 1
                                                               2 000 < PS · DN < 3 500 bar or
                                                               PS < -0,5 bar and DN > 1 000
Fluids in Group II   I
                                    IIa                        PS > 0,5 bar and                                       B + E or
                                                               PS ■ DN > 3 500 bar                                    B + F 4
DN > 32                             IIb                        PS > 0,5 bar and                                       A 1
                                                               2 000 < PS · DN < 3 500 bar or
                       ,*
                                                               PS < - 0,5 bar and DN > 1 000
Fluids in Group III                                            PS · DN > 5 000 bar                                    A
DN > 100                                                       PS < - 0,5 bar and DN > 1 000
 ---pagebreak--- No C 246/22                                 Official Journal of the European Communities                                         9. 9. 93
                                                                     TABLE 6
                                                                                                                   s
                                                Accessories according to Article 3 ( 1 ), point 4
                                                                                                    r
                                                                                                                       Module
                                                                  I
Protective devices and limiting devices                  safety valves                                G
                                                         'MCR' devices                                B + D
                                                                                                      B + F 4
                                   I
                                                                                                                               y
      /
                                                         bursting disc safety devices, buckling rod   B + DorB + F4
                                                         etc.                                         B + E for fluids in Group III
                                       s
                                                         pressure, level and temperature switches     B + D or B + F 4
                                                         etc.                                         B + E for fluids in Group III
                                                       /
Regulating devices for the control of operating parameters                                            B + E
                                                                                                      B + C 1
                                                                                                  v
                                                                                                      B + C 2
                                                     1
Monitoring devices and indicators such as for water level, pressure, temperature                      B + E
        I
                                                                                                      B + C 1
               I
                                                                                                      B + C 2
                                                 ( f
Manually operated isolating valves for very toxic and toxic fluids in Group I                         B + D
                                                                                                      B + F 4
                                                                                                      G
                                                                                                                     \
Manually operated isolating valves for fluids in Groups I and II other than for very toxic and        B + E
toxic                                                                                                 B + C 1
                                                                                                      B + C 2
                                                                                                                             I
Manually operated isolating valves for fluids in Group III                                            A
                                                                    ANNEX III
               Module A: Internal control of production
                  i
               1 . This module describes the procedure whereby the manufacturer or his authorized representative
                    established within the Community, who carries out the obligations laid down in point 2, ensures and
                    declares that the pressure equipment satisfies the relevant requirements of the Directive. The
                    manufacturer shall affix the CE mark to all pressure equipment and draw up a written declaration of
                    conformity .
               2 . The manufacturer shall establish the technical documentation described in paragraph 3 and he or his
                    authorized representative established within the Community shall keep it, for a period ending not less
                    than 10 years after the last of the pressure equipment has been manufactured, at the disposal of the
                    relevant national authorities for inspection purposes.
                    Where neither the manufacturer nor his authorized representative is established within the Community,
                    the obligation to keep the technical documentation available shall be the responsibility of the person
                    who places the pressure equipment on the Community market.
               3. Technical documentation shall enable an assessment to be made of the conformity of the pressure
                    equipment with the relevant requirements of the Directive. It shall cover the design, manufacture and
                    operation of the pressure equipment and shall contain as far as is relevant for assessment:
                    *— a general type description,
                    —. conceptual design and manufacturing drawings and diagrams of components, sub-assemblies,
                        circuits, etc.,
                    — descriptions and explanations necessary for an understanding of the said drawings and diagrams and
                        the operation of the product,
 ---pagebreak--- 9 . 9 . 93                                 Official Journal of the European Communities                                    No C 246/23
               — a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the
                     solutions adopted to meet the essential requirements of the Directive where the standards referred to
                     in Article 5 have not been applied,
               — results of design calculations made, examinations carried out, etc.,
               — test reports .
           4. The manufacturer or his authorized representative shall keep a copy of the declaration of conformity
               with the technical documentation .
           5. The manufacturer shall take all measures necessary in order that the manufacturing process shall ensure
               that the manufactured pressure equipment complies with the technical documentation referred to in
               point 2 and with the relevant requirements of the Directive.
           6. Before affixing the CE marking the manufacturer shall carry out a final test as referred to in Article 9
               ( 1 ), point 1 which may be applied to the individual item of pressure equipment or by applying a
               sampling inspection of his own choice.
           Module A 1
           In addition to the requirements of Module A, points 1 to 5, the following shall apply:
           The final test as referred to in Article 9(1 ), point 1 shall be applied to each item of pressure equipment and
           be carried out under the responsibility of a notified body chosen by the manufacturer.
           On the responsibility of the notified body, the manufacturer shall affix the former's identification number
           during the manufacturing process.
           Module A 2
           In addition to the requirements of Module A, points 1 to 5 , the following shall apply:
           A notified body chosen by the manufacturer shall carry out or have carried out a final test as referred to in
           Article 9 ( 1 ), point 1 at random intervals. An adequate sample of the pressure equipment, taken on site by
           the notified body, shall be examined and the final test as set out in the relevant standard(s) referred to in
           Article 5, or equivalent tests, shall be carried out to check the conformity of the pressure equipment with
           the relevant requirements of the Directive.
           In those cases where one or more of the items of pressure equipment checked does not conform, the notified
           body shall take appropriate measures.
           On the responsibility of the notified body, the manufacturer shall affix the former's identification number
           during the manufacturing process.
           Module B : EC type-examination
           1.    This module describes that part of the procedure by which a notified body ascertains and attests that a
                  specimen, representative of the production envisaged, meets the relevant provisions of the Directive.
           2.    The application for the EC type-examination shall be lodged by the manufacturer or his authorized
                  representative established within the Community with a notified body of his choice.
                 The application shall include:
                 — the name and address of the manufacturer and, if the application is lodged by the authorized
                       representative, his name and address as well,
                 — a written declaration that the same application has not been lodged with any other notified
                       body,
                 — the technical documentation, as described in point 3 .
                 The applicant shall place at the disposal of the notified body a specimen representative of the.
                 production envisaged and hereinafter called 'type'. The notified body may request further specimens if
                  needed for carrying out the test programme.                                                            r
                  A type may cover several versions of pressure equipment provided that the differences between the
                 versions do not affect the level of safety.
 ---pagebreak--- /
    I                                                                                «
  No C 246/24                             Official Journal of the European Communities                                      9 . 9 . 93
             3.  The technical documentation shall enable the conformity of the pressure equipment with the
                 requirements of the Directive to be assessed. It shall cover the design, manufacture and operation of
                 the pressure equipment and shall contain as far as is relevant for assessment:
                 — a general type description,
                 — conceptual design and manufacturing drawings and diagrams of components, sub-assemblies,
                      circuits, etc.,
                 — descriptions and explanations necessary for an understanding of the said drawings and diagrams
                      and the operation of the product,
                 — a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the
                      solutions adopted to meet the essential requirements of the Directive where the standards referred
                      to in Article 5 have not been applied,
                 — results of design calculations made, examinations carried out, etc.,
                 — test reports .                                                        (
                                                                                           1
                                                                                                                          I
             4.  The notified body shall :
             4.1 examine the technical documentation, verify that the type has been manufactured in conformity with
                 the technical documentation and identify the elements which have been designed in accordance with
                 the relevant provisions of the standards referred to in Article 5, as well as the components which have
                 been designed without applying the relevant provisions of those standards;
             4.2 perform or have performed the appropriate examinations and necessary tests to check whether, where
                 the standards referred to in Article 5 have not been applied, the solutions adopted by the manufacturer
                 meet the essential requirements of the Directive;
             4.3 perform or have performed the appropriate examinations and necessary tests to check whether, where
                 the manufacturer has chosen to apply the relevant standards, these have actually been applied;
             4.4 agree with the applicant the location where the examinations and necessary tests shall be carried
                 out .
             5.  Where the type meets the relevant provisions of the Directive, the notified body shall issue an EC
                 type-examination certificate to the applicant. The certificate shall contain the name and address of the
                 manufacturer, conclusions of the examination 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.
                 If the manufacturer or his authorized representative established in the Community is denied type
                 certification, the notified body shall provide detailed reasons for such denial.
             6.  The applicant shall inform the notified body that holds the technical documentation concerning the EC
                 type-examination certificate of all modifications to the approved pressure equipment which must
                 receive additional approval where such changes may affect the conformity with the essential
                 requirements or the prescribed conditions for use of the product. This additional approval is given in
                 the form of an addition to the original EC type-examination certificate .
                                                    •*V
                                                                                                      *
             7.  Each notified body shall communicate to the other notified bodies the relevant information concerning
                 the EC type-examination certificates and additions issued and withdrawn.
             8.  The other notified bodies may receive copies of the EC type-examination certificates and/or their
                 additions. The Annexes to the certificates shall be kept at the disposal of the other notified bodies.
             9.  The manufacturer or his authorized representative established within the Community shall keep with
                 the technical documentation copies of the EC type-examination certificates and their additions for a
                 period ending not less than 10 years after the last of the pressure equipment or protective systems has
                 been manufactured .
                    ,                            -
                                                                                                         i       *
                 Where neither the manufacturer nor his authorized representative is established within the Community,
                 the obligation to keep the technical documentation available shall be the responsibility of the person
                 who places the product on the Community market.
 ---pagebreak--- 9 . 9 . 93                                Official Journal of the European Communities                                  No C 246/25
           Module C 1 : Conformity to type
           1 . This module describes that part of the procedure whereby the manufacturer or his authorized
               representative established within the Community ensures and declares that pressure equipment is in
               conformity with the type as described in the EC type-examination certificate and satisfies the relevant
               requirements of the Directive. The manufacturer shall affix the CE marking to all pressure equipment
               and draw up a written declaration of conformity.
           2. The manufacturer shall take all measures necessary to ensure that the manufacturing process ensures
               compliance of the manufactured pressure equipment with the type as described in the EC
               type-examination certificate and with the relevant requirements of the Directive.
           3. The manufacturer or his authorized representative shall keep a copy of the declaration of conformity for
               a period ending not less than 10 years after the last of the pressure equipment has been
               manufactured .
               Where neither the manufacturer nor his authorized representative is established within the Community,
               the obligation to keep the technical documentation available shall be the responsibility of the person
               who places the pressure equipment on the Community market.
           4. For each item of pressure equipment manufactured a final test as referred to in Article 9 ( 1 ), point 1
               shall be carried out by the manufacturer or on his behalf. The tests shall be carried out on the
               responsibility of a notified body, chosen by the manufacturer.
               On the responsibility of the notified body, the manufacturer shall affix the former's identification
               number during the manufacturing process.
           Module C 2:
           In addition to the requirements of Module C 1 , points 1 to 3, the following shall apply:
           A notified body chosen by the manufacturer shall carry out or have carried out a final test as referred to in
           Article 9 ( 1 ), point 1 at random intervals. An adequate sample of the pressure equipment, taken on site by
           the notified body, shall be examined and the final test as set out in the relevant standard(s) referred to in
           Article 5 , or equivalent shall be carried ^out to check the conformity of the pressure equipment with the
           relevant requirements of the Directive.
           In those cases where one or more of the items of pressure equipment checked does not conform, the notified
           body shall take appropriate measures.
           On the responsability of the notified body, the manufacturer shall affix the former's identification number
           during the manufacturing process.
                                                               i
           Module D: Production quality assurance
                                                                                                                  i
                             i
           1.   This module describes the procedure whereby the manufacturer who satisfies the obligations of point 2
                ensures and declares that the pressure equipment concerned is in conformity with the type as described
                in the EC type-examination certificate and satisfies the requirements of the Directive that apply to it.
                The manufacturer shall affix the CE marking to all pressure equipment and draw up a written
                declaration of conformity. The CE marking shall be accompanied by the identification number of the
                notified body responsible for EC monitoring as specified in point 4.                                 %
           2.   The manufacturer shall operate an approved quality system for production, final inspection and testing
                 as specified in point 3 and shall be subject to monitoring as specified in point 4.
           3.    Quality system
           3.1 The manufacturer shall lodge an application for assessment of his quality system with a notified body
                 of his choice, for the pressure equipment concerned.
                 The application shall include:
                — all relevant information for the pressure equipment envisaged,
                — the documentation concerning the quality system,
                — the technical documentation of the approved type and a copy of the EC type-examination
                    certificate.
                                                                                                     >
                      <                                                                            '
           3.2 The quality system shall ensure compliance of the pressure equipment with the type as described in the
                 EC type-examination certificate and with the requirements of the Directive that apply to it.
                                                                                   V
 ---pagebreak---                                                                                                                           /
No C 246/26                               Official Journal of the European Communities                                       9.9 . 93
                  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. The quality
                  system documentation must permit a consistent interpretation of the quality programmes, plans,
                  manuals and records.
                                                                                                                       r
                  It shall contain in particular an adequate description of:
                  — the quality objectives , and the organizational structure, responsibilities and powers of the
                      management with regard to the quality of the pressure equipment,
                                                                                                          <
                  — the manufacturing, quality control and quality assurance techniques, processes and systematic
                      measures that will be used,
                  — 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 of the personnel concerned, etc.,
                  — 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 these requirements in respect of quality
                  systems that implement the relevant harmonized standard.
                  The auditing te&m shall have at least one member with experience of evaluation in the pressure
                  equipment technology concerned. The evaluation procedure shall include an inspection visit to the
                  manufacturer's premises.
                t                                                                        s
                  The decision shall be notified to the manufacturer . The notification shall contain the conclusions of the
                  examination 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 uphold it so that it remains adequate and efficient.
                  The manufacturer or his authorized representative shall keep the notified body that has approved the
                  quality system informed of any intended updating of the quality system.
                  The notified body shall evaluate the modifications proposed and decide whether the amended quality
                  system will still satisfy the requirements referred to in point 3.2 . or whether a reassessment is
                  required.
                  It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the
                  examination and the reasoned assessment decision .
                                                                             *                                   i
           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.
              i
           4.2 The manufacturer shall allow the notified body entrance for inspection purposes to the locations of
                  manufacture, inspection and testing, and storage 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, reports concerning
                      the qualifications of the personnel concerned, etc.
           4.3 The notified body shall normally carry out audits twice a year to make sure that the manufacturer
                  maintains and applies the quality system and shall provide an audit report to the manufacturer.
           4.4 Additionally, the notified body may pay unexpected visits to the manufacturer. During such visits the
                  notified body may carry out, or cause to be carried out, tests to verify that the quality system is
                  functioning correctly, if necessary. The notified body shall provide the manufacturer with a visit report
                  and, if a test has taken place, with a test report.
           5.     The manufacturar shall, for a period ending not less than 10 years after the last pressure equipment
                  has been manufactured, keep at the disposal of the national authorities:
                  — the documentation referred to in the second indent of point 3.1 .
                  — the updating referred to in the second paragraph of point 3.4,
 ---pagebreak--- 9 . 9 . 93                             Official Journal of the European Communities                                   No C 246/27
               — the decisions and reports from the notified body which are referred to in the final paragraph of
                   point 3.4, point 4.3 and point 4.4,
           6.  Each notified body shall give the other notified bodies the relevant information concerning the quality
               system approvals issued and withdrawn.
           Module D a: For assembling of CE-marked equipment carrying the CE marking
           1.  This module describes the procedure whereby the manufacturer who satisfies the obligations of point 4
               ensures and declares that the assemblies referred to in Article 9 (2) (b) concerned satisfy the
               requirements of the Directive that apply to them. The manufacturer shall affix the CE marking to each
               product and draw up a written declaration of conformity. The CE marking shall be accompanied by
               the identification number of the notified body responsible for EC monitoring as specified in point 6 .
           2.  The manufacturer shall establish the technical documentation described in point 3 and he or his
               authorized representative established within the Community shall keep it, for a period ending not less
               than 10 years after the last product has been manufactured, at the disposal of the relevant national
               authorities for inspection purposes.
               Where neither the manufacturer nor his authorized representative is established within the Community,
               the obligation to keep the technical documentation available shall be the responsibility of the person
               who places the product on the Community market.
           3.  Technical documentation shall enable the conformity of the assembly with the requirements of the
               Directive to be assessed. It shall, as far as relevant for such assessment, cover the design, assembling
               and operation of the assembly and include the instructions for the assembled equipment.
                                                                                          i
           4.  The manufacturer shall operate an approved quality system for assembling, final inspection and testing
               as specified in point 5 and shall be subject to monitoring as specified in point 6.
           5.  Quality system
                                                                                                           i
           5.1 The manufacturer shall lodge an application for assessment of his quality system with a notified body
               of his choice, for the assembly concerned.
               The application shall include:
               — all relevant information for the assembly envisaged,
               — the documentation concerning the quality system,
               — the technical documentation.
           5.2 The quality system shall ensure compliance of the assembly with the requirements of the 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. The quality
               system documentation must permit a consistent interpretation of the quality programmes, plans,
               manuals and records.
               It shall contain in particular an adequate description of:
               — the quality objectives and the organizational structure, responsibilities and powers of the
                   management with regard to product quality,
               — the manufacturing, quality control and quality assurance techniques, processes and systematic
                   measures that will be used,
               — 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 of the personnel concerned, 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. It shall presume conformity with these requirements in respect of quality
               systems that implement the relevant harmonized standard.
 ---pagebreak--- No C 246/28                              Official Journal of the European Communities                                     9 . 9 . 93
                The auditing team shall have at least one member with experience of evaluation in the product
                technology concerned. The evaluation procedure shall include an inspection visit to the manufacturer's
                premises .
                The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the
                examination and the reasoned assessment decision .
                                                                                t
           5.4 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved
                and to uphold it so that it remains adequate and efficient.
                The manufacturer or his authorized representative shall keep the notified body that has approved the
                quality system informed of any intended updating of the quality system.
                The notified body shall evaluate the modifications proposed and decide whether the amended quality
                system will still satisfy the requirements referred to in point 5.2 or whether a re-assessment is
                required.
                                                                                           s
                It shall notify its decision to the manufacturer. 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 allow the notified body entrance for inspection purposes to the locations of
                manufacture, inspection and testing, and storage and shall provide it with all necessary information, in
                particular:
                                                                 V
                — the quality system documentation,
                   i
                — the quality records, such as inspection reports and test data, calibration data, reports concerning
                     the qualifications of the personnel concerned, etc.
           6.3 The notified body shall periodically carry out audits to make sure that the manufacturer maintains and
                applies the quality system and shall provide an audit report to the manufacturer.
           6.4 Additionally, the notified body may pay unexpected visits to the manufacturer. During such visits the
                notified body may carry out, or cause to be carried out, tests to verify that the quality system is
                functioning correctly, if necessary. The notified body shall provide the manufacturer with a visit report
                and, if a test has taken place, with a test report.
                                                   i
           7.   The manufacturer shall, for a period ending not less than 10 years after the last product has been
                manufactured, keep at the disposal of the national authorities:
                — the documentation referred to in the second indent of point 5.1 ,
                — the updating referred to in the second paragraph of point 5.4,
                — the decisions and reports from the notified body which are referred to in the final paragraph of
                     point 5.4, and in points 6.3 and 6.4.
           8.   Each notified body shall give the other notified bodies the relevant information concerning the quality
                system approvals issued and withdrawn.
           Module E: Product quality assurance
            1.  This module describes the procedure whereby the manufacturer who satisfies the obligations of point 2
                ensures and declares that the pressure equipment is in conformity with the type as described in the EC
                type-examination certificate. The manufacturer shall affix the CE marking to each product and draw
                up a written declaration of conformity. The CE marking shall be accompanied by the identification
                number of the notified body responsible for surveillance as specified in point 4.
           2.   The manufacturer shall operate an approved quality system for the final pressure equipment inspection
                and testing 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 for the pressure
                equipment with a notified body of his choice.
 ---pagebreak--- 9 . 9 . 93                              Official Journal of the European Communities                                      No C 246/29
               The application shall include:
                         V
               — all relevant information for the pressure equipment category envisaged,
               — the quality system documentation,
               — the technical documentation of the approved type and a copy of the EC type-examination
                   certificate .
                                                                  %                                           ,
           3,2 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 5 or equivalent tests and in particular a final
               test as referred to in Article 9 ( 1 ), point 1 shall be carried out in order to ensure its conformity with
               the relevant requirements of the 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 ensure a common
               understanding of the quality programmes, plans, manuals and records.
                                                                              \
               It shall contain in particular an adequate description of:
                                                                                ^                          «
               — the quality objectives and the organizational structure, responsibilities and powers of the
                   management with regard to product quality,
               — the examinations and tests that will be carried out after manufacture,
                                      4
               — the means to monitor the effective operation of the quality system,
               — quality records, such as inspection reports and test data, calibration data, reports concerning the
                   qualifications of the personnel concerned, etc.
                         \
           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 these requirements in respect of quality
               systems that implement the relevant harmonized standard.
                                                                    i                                                   •
                                 «
               The auditing team shall have at least one member experienced as an assessor in the product technology
               concerned. The assessment procedure shall include an assessment visit to the manufacturer's
               premises.
               The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the
               examination and the reasoned assessment decision.
           3.4 The manufacturer shall undertake to discharge the obligations arising from the quality system as
               approved and to maintain it in an appropriate and efficient manner.
               The manufacturer or his authorized representative ^hall keep the notified body which has approved the
               quality system informed of any intended updating of the quality system.
               The notified body shall evaluate the modifications proposed and decide whether the modified quality
               system will still satisfy the requirements referred to in point 3.2 or whether a reassessment is
               required.
                                                                      i
               It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the
               examination and the reasoned assessment decision .
                                                                                  i
           4.  Surveillance under the responsibility of the notified body
                                                                                                                i
           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 allow the notified body entrance for inspection purposes to the locations of
               inspection, testing and storage 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 normally carry out audits twice a year to ensure that the manufacturer
               maintains and applies the quality system and shall provide an audit report to the manufacturer.
                      /
           4.4 Additionally, the notified body may pay unexpected visits to the manufacturer. At the time of such
               visits, the notified body may carry out tests or have them carried out in order to check the proper
               functioning of the quality system where necessary; it shall provide the manufacturer with a visit report
               and, if a test has been carried out, with a test report.
                            \
                /
 ---pagebreak--- No C 246/30                              Official Journal of the European Communities                                        9 . 9 . 93
           5.  The manufacturer shall, for a period ending at least 10 years after the final pressure equipment has
               been manufactured, keep at the disposal the national authorities:
               — the documentation referred to in the third indent of point 3.1 ,
               — the updating referred to in the second paragraph of point 3.4,
               — the decisions and reports from the notified body which are referred to in the final paragraph of
                   point 3.4, and in point 4.3 and point 4.4.
           6.  Each notified body shall forward to the other notified bodies the relevant information concerning the
               quality system approvals issued and withdrawn.
                                                            f
           Module F 4: Product verification
           1.  This module describes the procedure whereby a manufacturer or his authorized representative
               established within the Community checks and attests that the pressure equipment subject to the
               provisions of point 3 is in conformity vsith the type as described:
               — in the EC type-examination certificate, or
               — in the technical documentation, as referred to in point 1.1 ,
               and satisfy the relevant requirements of the Directive.
           1.1 Where module F 4 can be used without module B the manufacturer shall establish the technical
               documentation described below and he or his authorized representative established within the
               Community shall keep it, for a period ending not less than 10 years after the last product has been
               manufactured, at the disposal of the relevant national authorities for inspection purposes.
               Where neither the manufacturer nor his authorized representative is established within the Community,
               the obligation to keep the technical documentation available shall be the responsibility of the person
               who places the product on the Community market.
               The technical documentation shall enable the conformity of the product with the requirements of the
               Directive to be assessed. It shall, as far as relevant for such assessment, cover the design, manufacture
               and operation of the product and contain in particular:
               — a general type description,
               — conceptual design, and manufacturing drawings and diagrams of components, sub-assemblies,
                   circuits, etc.,
               — descriptions and explanations necessary for the understanding of the said drawings and diagrams
                   and the operation of the product,
               — a list of the standards referred to in Article 5, applied in full or in part, and descriptions of "the
                   solutions adopted to meet the essential requirements of the Directive where the standards referred
                   to in Article 5 have not been applied .
               — results of design calculations made, examinations carried out, etc.,
                        j
               — test reports .
           2.  The manufacturer shall take all measures necessary in order that the manufacturing process ensures
               conformity of the pressure equipment with the type as described
                                 i*
               — in the EC type-examination certificate, or
                                                                                                                     /
               — in the technical documentation, as referred to in point 1.1 ,
               and with the requirements of the Directive that apply to it. He shall affix the CE marking to all
               pressure equipment and shall draw up a declaration of conformity.
           3.  The notified body shall carry out the appropriate examinations and tests in order to check the
               conformity of the pressure equipment with the relevant requirements of the Directive by examination
               and testing of every procjuct as specified in point 4.
               The manufacturer or his authorized representative shall keep a copy of the declaration of conformity
               for a period ending not less than 10 years after the final pressure equipment has been manufactured.
                                                                                                              <
                                                          •                              «
           4.  Verification by examination and testing of all pressure equipment
           4.1 All pressure equipment shall be individually examined and appropriate tests as set out in the relevant
               standard(s) referred to in Article 5 or equivalent tests and in particular a final test as referred to in
               Article 9 ( 1 ), point 1 shall be carried out in order to verify conformity with the type as described in the
               EC type-examination certificate and the relevant requirements of the Directive.
 ---pagebreak---                                                                                                                                           »
9 . 9 . 93                               Official Journal of the European Communities                                         No C 246/31
           4.2 The notified body shall affix, or cause to be affixed, its identification number to all pressure equipment
                and draw up a written certificate of conformity relating to the tests carried out.
                                                »
           4.3 The manufacturer or his authorized representative shall ensure that he is able to supply the notified
                body's certificates of conformity on request.
           Module Fa: For assembling of pressure equipment carrying the CE marking
           1.     This module describes the procedure whereby a manufacturer or his authorized representative
                  established within the Community checks and attests that the assemblies referred to in
                  Article 9 (2) (b) subject to the provisions of point 5 satisfy the requirements of the Directive that
                  apply to them.
           2.     The manufacturer shall establish the technical documentation described in point 3 and he or his
                  authorized representative established within the Community shall keep it, for a period ending not less
                  than 10 years after the last product has been manufactured, at the disposal of the relevant national
                  authorities for inspection purposes.
                  Where neither the manufacturer nor his authorized representative is established within the
                  Community, the obligation to keep the technical documentation available shall be the responsibility
                  of the person who places the product on the Community market.
           3.     Technical documentation shall enable the conformity of the assembly with the relevant requirements
                  of the Directive to be assessed. It shall, as far as relevant for such assessment, cover the design,
                  assembling and operation of the assembly and include the instructions of the assembled equipment.
                                                        >                                  .                         <
           4.     The manufacturer shall take all measures necessary to ensure that the assemblies are in conformity
                  with the requirements of the Directive that apply to them. He shall affix the CE marking to each
                  assembly and shall draw up a declaration of conformity.
           5.     The notified body shall carry out or have carried out the appropriate examinations and tests in order
                  to check the conformity of the assembly with the requirements of the Directive by examination and
                  testing
                  — of every assembly, as specified in point 6, for assemblies for fluids in Groups I and II,
                  — on a statistical basis, as specified in point 7, for assemblies for fluids in Group III.
           5a     The manufacturer or his authorized representative shall keep a copy of the declaration of conformity
                  for a period ending at least 10 years after the last product has been manufactured.
           6.     Verification by examination and testing of every assembly
                                                              *     -
           6.1    Each assembly shall be individually examined and appropriate tests as set out in the relevant
                  standard(s) referred to in Article 5 or equivalent tests shall be carried out in order to verify their
                  conformity with the requirements of the Directive that apply to them.
                                                          i                                  '
           6.2    The notified body shall affix, or cause to be affixed, its identification number to each approved
                  product and draw up a written certificate of conformity relating to the tests carried out.
           6.3    The manufacturer or his authorized representative shall ensure that he is able to supply the notified
                  body's certificates of conformity on request.
                                                            i
           7.      Verification by statistical means or at random intervals
                  The manufacturer shall apply verification by statistical means as referred to in point 7.1 . Where that
                  method is not appropriate, verification at random intervals as referred to in point 7.2 shall be
                  applied.
           7.1    The manufacturer shall present the assemblies in the form of homogeneous lots and shall take all
                  measures necessary in order that the process of assembling ensures the homogeneity of each lot
                  produced.
           7.1.1 All assemblies shall be available for verification in the form of homogeneous lots. A random sample
                  shall be drawn from each lot. Assemblies in a sample shall be individually examined and appropriate
                  tests as set out in the relevant standard(s) referred to in Article 5, or equivalent tests, shall be carried
                  out to verify their conformity with the requirements of the Directive which apply to them and to
                  determine whether the lot is accepted or rejected.
 ---pagebreak--- No C 246/32                                Official Journal of the European Communities                                        9 . 9 . 93
           7.1.2 The statistical procedure shall use the following elements:
                                         «
                                                                                                                      i
                   A sampling plan with the following operating characteristics shall be applied:
                  — a standard quality level corresponding to a 95 % probability of acceptance with a percentage of
                        non-conformity between 0,5 and 1,5% ,
                  — a limit quality corresponding to a 5 % probability of acceptance with a percentage of
                        non-conformity between 5 and 10% .
           7.1.3 In the case of accepted lots, the notified body shall affix, or cause to be affixed, its identification
                   number to each assembly and shall draw up a written certificate of conformity relating to the tests
                   carried out. All assemblies in the lot may be put on the market except those from the sample which
                   were found not to be in conformity.
                   If a lot is rejected, the notified body or the competent authority shall take appropriate measures to
                   prevent the placing on the market of that lot. In the event of frequent rejection of lots the notified
                   body may suspend statistical verification.
           7.2    Where verification by statistical means as referred to in point 7.1 is not appropriate, a notified body
                   chosen by the manufacturer shall carry out or have carried out checks at random intervals. An
                   adequate sample of the final assemblies, taken on site by the notified body, shall be examined and
                   appropriate tests as set out in the relevant standard(s) referred to in Article 5, or equivalent tests,
                   shall be carried out to check the conformity of the assemblies with the relevant requirements of the
                   Directive .
                   In those cases where one or more of the assemblies checked do not conform the notified body shall
                   take appropriate measures.
                   On the responsibility of the notified body, the manufacturer shall affix the former's identification
                   number during the manufacturing process.
           7.3    The manufacturer or his authorized representative shall ensure that he is able to supply the notified
                   bodies certificates of conformity on request.
           Module G: EC-unit verification
           1 . This module describes the procedure whereby the manufacturer ensures and declares that pressure
               equipment which has been issued with the certificate referred to in point 2 conforms to the relevant
               requirements of the Directive. The manufacturer shall affix the CE marking to the pressure equipment
               and draw up a declaration of conformity.
           2. The notified body shall examine and approve the design of each item of pressure equipment and carry
               out the appropriate tests as set out in the relevant standard(s) referred to in Article 5, or equivalent tests,
               and in particular a final test as referred to in Article 9 ( 1 ), point 1 , to ensure its conformity with the
               relevant requirements of the Directive. The notified body shall affix, or cause to be affixed, its
               identification number on the approved pressure equipment and shall draw up a certificate of conformity
               concerning the tests carried out.
           3 . Technical documentation shall enable the conformity with the requirements of the Directive to be
               assessed and the design, manufacture and operation of the pressure equipment to be understood.
               The technical documentation shall contain :
               — a general description of the product,
                                                                                      i
               — conceptual design and manufacturing drawings and diagrams of components, sub-assemblies,
                    circuits, etc .,
               — descriptions and explanations necessary for an understanding of the said drawings and diagrams and
                    the operation of the pressure equipment,
               — a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the
                    solutions adopted to meet the essential requirements of the Directive where the standards referred to
                    in Article 5 have not been applied,
               — results of design calculations made, examinations carried out, etc.,
               — test reports .
           Module H 1 : Full quality assurance
           1.   This module describes the procedure whereby the manufacturer who satisfies the obligations of
                paragraph 2 ensures and declares that the pressure equipment concerned satisfies the relevant
 ---pagebreak--- 9 . 9 . 93                              Official Journal of the European Communities                                    No C 246/33
               requirements of the Directive. The manufacturer shall affix the CE marking to all pressure equipment
               and draw up a written declaration of conformity. The CE marking shall be accompanied by the
               identification number of the notified body responsible for the EC surveillance.
                                                                                                        j
           2.  The manufacturer shall operate an approved quality system for design, manufacture and final
               inspection and testing as specified in point 3 and shall be subject to EC surveillance as specified in
               point 4 .
           3.  Quality system
           3.1 The manufacturer shall lodge an application for assessment of his quality system with a notified
               body.
               The application shall include:
               — all relevant information for the pressure equipment category envisaged,
               — the quality system documentation.
           3.2 The quality system shall ensure compliance of the pressure equipment with the relevant requirements of
               the Directive .
                                   r'
               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 ensure a common understanding of the quality policies and procedures
               such as quality programmes, plans, manuals and records.
                                                                     '
               It shall contain in particular an adequate description of:
                                                                                         m
               — the quality objectives and the organizational 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
                   standards referred- to in Article 5 will not be applied in full, the means that will be used to ensure
                   that the essential requirements of the Directive that apply to the pressure equipment will be met,
               — the design control and design verification techniques, processes and systematic measures that will be
                   used when designing the pressure equipment,
               — the corresponding manufacturing, quality control and quality assurance techniques, processes and
                   systematic measures that will be used,
               — 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 of the personnel concerned, etc.,
                                                 /
                — the means of monitoring the achievement of the required design and pressure equipment quality
                    and the effective operation of the quality system.                                  s
           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 compliance with these requirements in respect of quality
                systems that implement the relevant harmonized standard.
                The auditing team shall have at least one member experienced as an assessor in the product
                technology concerned. The evaluation procedure shall include an assessment visit to the
                manufacturer's premises.
                The decision shall be notified to the manufacturer. The notification shall contain the conclusions of
                the examination 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 uphold it so that it remains adequate and efficient.
                The manufacturer or his authorized representative established in the Community shall keep the
                notified body that has approved the quality system informed of any intended updating of the quality
                system .
                The notified body shall evaluate the modifications proposed and decide whether the amended quality
                system will still satisfy the requirements referred to in point 3.2 or whether a reassessment is
                required.
                It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the
                examination and the reasoned assessment decision.
                                                                                                    /
 ---pagebreak--- No C 246/34                                Official Journal of the European Communities
                                                    V
                                                                                                                              9 / 9 . 93
           4.    EC surveillance
           4.1   The purpose of EC surveillance . is to make sure that the manufacturer duly fulfils the obligations
                 arising out of the approved quality system.
           4.2 The manufacturer shall allow the notified body entrance for inspection purposes to the locations of
                 design, manufacture, inspection and testing, and storage, and shall provide it with all necessary
                 information, in particular:
                 — the quality system documentation,
                 — the quality records as foreseen by the design part of the quality system, such as results of analyses,
                      calculations, tests, etc.,
                      the quality records as foreseen by the manufacturing part of the quality system, such as inspection
                      reports and test data, calibration data, reports concerning the qualifications of the personnel
                     concerned, etc.
           4.3   The notified body shall normally carry out audits twice a year to make sure that the manufacturer
               X
                 maintains and applies the quality system and shall provide an audit report to the manufacturer.
                                                                                                          '
           4.4 Additionally, the notified body may pay unexpected visits to the manufacturer. During such visits full
                 or reduced audits may be carried out by the notified body. The notified body shall provide a visit
                 report and, if applicable, an audit report to the manufacturer.
           5.    The manufacturer shall, for a ' period ending not less than 10 years after the last of the pressure
                 equipment has been manufactured, keep at the disposal of the national authorities:
                 — the documentations referred to in the second indent of the second subparagraph of point 3.1 ,
                 — the updating referred to in the second subparagraph of point 3.4,
                 — the decisions and reports from the notified body which are referred to in the final subparagraph of
                      point 3.4, and in points 4.3 and 4.4.
           6.    Each notified body shall forward to the other notified bodies the relevant information concerning the
                 quality system approvals issued and withdrawn.
           7.    Design examination
                 (a) The manufacturer shall lodge an application for examination of the design with a single notified
                       body.
                 (b ) The application shall enable the design, manufacture and operation of the pressure equipment to
                       be understood, and shall enable conformity with the relevant requirements of the Directive to be
                       assessed .
                       It shall include:
                       — the technical design specifications, including standards, that have been applied,
                       — the necessary supporting evidence for their adequacy, in particular where the standards
                           referred to in Article 5 have not been applied in full. This supporting evidence shall include the
                           results of tests carried out by the appropriate laboratory of the manufacturer or on his
                           behalf.
                 (c) The notified body shall examine the application and where the design meets the provisions of the
                       Directive that apply to it shall issue an EC design-examination certificate to the applicant. The
                       certificate shall contain the conclusions of the examination, conditions for its validity, the
                       necessary data for identification of the approved design and, if relevant, a description of the
                       pressure equipment's or accessories' functioning.
                 (d ) The applicant shall keep the notified body that has issued the EC design-examination certificate
                       informed of any modification to the approved design. Modifications to the approved design must
                       receive additional approval from the notified body that issued the EC design-examination
                       certificate where such changes may affect the conformity with the essential requirements of the
                       Directive or the prescribed conditions for use of the pressure equipment. This additional approval
                       is given ih the form of an addition to the original EC design-examination certificate.
                 (e ) The notified bodies shall forward to the other certified bodies the relevant information
                       concerning:
                       — the EC design-examination certificates and additions issued,
                       — the EC design-examination certificates and additions withdrawn.
 ---pagebreak---                                                              /
9 . 9: 93                               Official Journal of the European Communities                                       No C 246/35
                                                            ANNEX IV
                          Minimum criteria to be met when designating inspection bodies to be notified
                                                                                                                                     t
          1 . The body, its director and the staff responsible for carrying out the evaluation and verification
              operations shall not be the designer, manufacturer, supplier or installer of pressure equipment which
              they control, nor the authorized representative of any of those parties. They may not become directly
              involved in the design, construction, marketing or maintenance of the pressure equipment, nor represent
              the parties engaged in these activities and the body.
          2. The body and its staff must carry out the evaluation and verifications with the highest degree of
              professional integrity and technical competence and must be free from all pressures and inducements,
              particularly financial, which might influence their judgement or the results of the inspection, especially
              from persons or groups of persons with an interest in the results of verifications.
          3. The body must be able to carry out all the tasks in Annex III assigned to such a body and for which it
              has been notified, whether those tasks are carried out by the body itself or under its responsibility. In
              particular, it must have at its disposal the necessary staff and possess the necessary facilities to enable it
              to perform properly the technical and administrative tasks connected with evaluation and verification; it
              must also have access to the pressure equipment necessary for the verifications required.
                                                                                                                                         V
          4. The staff responsible for control operations must have:
                                                                                                                i
              — sound vocational training covering all the evaluation and verification operations for which the body
                   has been designated,
              — satisfactory knowledge of the requirements of the controls they carry out and adequate experience of
                   such operations,
              — the ability required to draw up the certificates, records and reports to demonstrate that the controls
                   have been carried out.
          5 . The impartiality of inspection staff must be guaranteed. Their remuneration must not depend on the
              number of controls carried out, nor on the results of such controls.
                                                        \
                                                                                                                                       I
          6. The body must take out liability insurance unless liability is assumed by the State in accordance with
              national law, or the Member State itself is directly responsible for controls.
          7. The staff of the body are bound to observe professional secrecy with regard to all information gained in
              carrying out their tasks (except vis-a-vis the competent administrative authorities of the State in which
              their activities are carried out) under this Directive or any provision of national law giving effect to
              It .
                                                             ANNEX V
                                      Criteria to be met when authorizing user inspectorates
                                  ♦
          1 . The user inspectorate shall be organizationally identifiable and have reporting methods within the parent
              organization which ensure and demonstrate its impartiality. It shall have an adequate liability
              insurance .
          2. The user inspectorate and its personnel shall be free from any commercial, financial or other pressures
              which might affect its judgement. It shall in particular not be responsible for the design, manufacture,
              supply, installation or operation of the item which they inspect and not engage in any activities that
              might conflict with its independence of judgement and integrity in relation to its inspection activities.
          3 . The user inspectorate shall have at its disposal the technical competence, qualified personnel and the
              necessary facilities to perform with the highest degree of professional integrity the tasks referred to in
              Article 11 ( 1 ).
          4. The user inspectorate shall be organized in such a way that its capability to perform its functions
              satisfactorily is maintained.
 ---pagebreak--- No C 246/36                            Official Journal of the European Communities                                 9 . 9 . 93
                                                           ANNEX VI
                                                           CE marking
                                                                            <i
           The CE marking shall consist of the initials 'CE' taking the following form:
           If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be
           respected.
                                                                       «
           The various components of the CE marking must have substantially the same vertical dimension, which may
           not be less than 5 mm .
                                                           ANNEX VII
                                     »
               Contents of the declaration by the manufacturer or his authorized representatives established in the
                                                           Community
                                                          (Article 4 (2 )).
           The manufacturer's declaration referred to in Article 4 (2) must contain the following particulars:
           — name and address of the manufacturer or the authorized representative,
           — description of the pressure equipment parts,
           — identification of the person signing.