Annexes to COM(2013)471 - Harmonisation of the laws of the Member States relating to making available on the market of pressure equipment (Recast)

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dossier COM(2013)471 - Harmonisation of the laws of the Member States relating to making available on the market of pressure equipment (Recast).
document COM(2013)471 EN
date May 15, 2014
Annex V, Part A.

(5) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).

(6) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).

(7) Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p. 13).

(8) Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165, 30.6.2010, p. 1).

(9) Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ 196, 16.8.1967, p. 1).

(10) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

(11) Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).

(12) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

(13) Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels (OJ L 96, 29.3.2014, p. 45).

(14) Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers (OJ L 147, 9.6.1975, p. 40).

(15) Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework Directive) (OJ L 263, 9.10.2007, p. 1).

(16) Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1).

(17) Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52).

(18) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).

(19) Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251).

(20) Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357).

(21) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).

(22) Directive 2009/142/EC of the European Parliament and of the Council of 30 November 2009 relating to appliances burning gaseous fuels (OJ L 330, 16.12.2009, p. 10).

(23) Directive 2014/34/EU of the European Parliament and the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (OJ L 96, 29.3.2014, p. 309).


ANNEX I

ESSENTIAL SAFETY REQUIREMENTS

PRELIMINARY OBSERVATIONS

1.The obligations arising from the essential safety requirements listed in this Annex for pressure equipment also apply to assemblies where the corresponding hazard exists.

2.The essential safety requirements laid down in this Directive are compulsory. The obligations following from those essential safety requirements apply only if the corresponding hazard exists for the pressure equipment in question when it is used under conditions which are reasonably foreseeable by the manufacturer.

3.The manufacturer is under an obligation to analyse the hazards and risks in order to identify those which apply to his equipment on account of pressure; he shall then design and construct it taking account of his analysis.

4.The essential safety requirements are to be interpreted and applied in such a way as to take account of the state of the art and current practice at the time of design and manufacture as well as of technical and economic considerations which are consistent with a high degree of health and safety protection.

1. GENERAL

1.1.Pressure equipment shall be designed, manufactured and checked, and if applicable equipped and installed, in such a way as to ensure its safety when put into service in accordance with the manufacturer’s instructions, or in reasonably foreseeable conditions.

1.2.In choosing the most appropriate solutions, the manufacturer shall apply the principles set out below in the following order:

—eliminate or reduce hazards as far as is reasonably practicable;

—apply appropriate protection measures against hazards which cannot be eliminated;

—where appropriate, inform users of residual hazards and indicate whether it is necessary to take appropriate special measures to reduce the risks at the time of installation and/or use.

1.3.Where the potential for misuse is known or can be clearly foreseen, the pressure equipment shall be designed to prevent risks from such misuse or, if that is not possible, adequate warning given that the pressure equipment shall not be used in that way.

2. DESIGN

2.1.   General

The pressure equipment shall be properly designed taking all relevant factors into account in order to ensure that the equipment will be safe throughout its intended life.

The design shall incorporate appropriate safety coefficients using comprehensive methods which are known to incorporate adequate safety margins against all relevant failure modes in a consistent manner.

2.2.   Design for adequate strength

2.2.1.   The pressure equipment shall be designed for loadings appropriate to its intended use and other reasonably foreseeable operating conditions. In particular, the following factors shall be taken into account:

—internal/external pressure,

—ambient and operational temperatures,

—static pressure and mass of contents in operating and test conditions,

—traffic, wind, earthquake loading,

—reaction forces and moments which result from the supports, attachments, piping, etc.,

—corrosion and erosion, fatigue, etc.,

—decomposition of unstable fluids.

Various loadings which can occur at the same time shall be considered, taking into account the probability of their simultaneous occurrence.

2.2.2.   Design for adequate strength shall be based on either of the following:

—as a general rule, a calculation method, as described in point 2.2.3, and supplemented if necessary by an experimental design method as described in point 2.2.4,

—an experimental design method without calculation, as described in point 2.2.4, when the product of the maximum allowable pressure PS and the volume V is less than 6 000 bar·L or the product PS·DN less than 3 000 bar.

2.2.3.   Calculation method

(a)   Pressure containment and other loading aspects

The allowable stresses for pressure equipment shall be limited having regard to reasonably foreseeable failure modes under operating conditions. To this end, safety factors shall be applied to eliminate fully any uncertainty arising out of manufacture, actual operational conditions, stresses, calculation models and the properties and behaviour of the material.

These calculation methods shall provide sufficient safety margins consistent, where applicable, with the requirements of point 7.

The requirements set out above may be met by applying one of the following methods, as appropriate, if necessary as a supplement to or in combination with another method:

—design by formula,

—design by analysis,

—design by fracture mechanics.

(b)   Resistance

Appropriate design calculations shall be used to establish the resistance of the pressure equipment concerned.

In particular:

—the calculation pressures shall not be less than the maximum allowable pressures and take into account static head and dynamic fluid pressures and the decomposition of unstable fluids. Where a vessel is separated into individual pressure-containing chambers, the partition wall shall be designed on the basis of the highest possible chamber pressure relative to the lowest pressure possible in the adjoining chamber,

—the calculation temperatures shall allow for appropriate safety margins,

—the design shall take appropriate account of all possible combinations of temperature and pressure which might arise under reasonably foreseeable operating conditions for the equipment,

—the maximum stresses and peak stress concentrations shall be kept within safe limits,

—the calculation for pressure containment shall utilise the values appropriate to the properties of the material, based on documented data, having regard to the provisions set out in point 4 together with appropriate safety factors. Material characteristics to be considered, where applicable, include:

—yield strength, 0,2 % or 1,0 % proof strength as appropriate at calculation temperature,

—tensile strength,

—time-dependent strength, i.e. creep strength,

—fatigue data,

—Young’s modulus (modulus of elasticity),

—appropriate amount of plastic strain,

—bending rupture energy,

—fracture toughness.

—appropriate joint factors shall be applied to the material properties depending, for example, on the type of non-destructive testing, the materials joined and the operating conditions envisaged,

—the design shall take appropriate account of all reasonably foreseeable degradation mechanisms (e.g. corrosion, creep, fatigue) commensurate with the intended use of the equipment. Attention shall be drawn, in the instructions referred to in point 3.4, to particular features of the design which are relevant to the life of the equipment, for example:

—for creep: design hours of operation at specified temperatures,

—for fatigue: design number of cycles at specified stress levels,

—for corrosion: design corrosion allowance.

(c)   Stability aspects

Where the calculated thickness does not allow for adequate structural stability, the necessary measures shall be taken to remedy the situation taking into account the risks from transport and handling.

2.2.4.   Experimental design method

The design of the equipment may be validated, in all or in part, by an appropriate test programme carried out on a sample representative of the equipment or the category of equipment.

The test programme shall be clearly defined prior to testing and accepted by the notified body responsible for the design conformity assessment module, where it exists.

This programme shall define test conditions and criteria for acceptance or refusal. The actual values of the essential dimensions and characteristics of the materials which constitute the equipment tested shall be measured before the test.

Where appropriate, during tests, it shall be possible to observe the critical zones of the pressure equipment with adequate instrumentation capable of registering strains and stresses with sufficient precision.

The test programme shall include:

(a)A pressure strength test, the purpose of which is to check that, at a pressure with a defined safety margin in relation to the maximum allowable pressure, the equipment does not exhibit significant leaks or deformation exceeding a determined threshold.

The test pressure shall be determined on the basis of the differences between the values of the geometrical and material characteristics measures under test conditions and the values used for design purposes; it shall take into account the differences between the test and design temperatures;

(b)where the risk of creep or fatigue exists, appropriate tests determined on the basis of the service conditions laid down for the equipment, for instance hold time at specified temperatures, number of cycles at specified stress-levels;

(c)where necessary, additional tests concerning other factors referred to in point 2.2.1 such as corrosion, external damage.

2.3.   Provisions to ensure safe handling and operation

The method of operation specified for pressure equipment shall be such as to preclude any reasonably foreseeable risk in operation of the equipment. Particular attention shall be paid, where appropriate, to:

—closures and openings,

—dangerous discharge of pressure relief blow-off,

—devices to prevent physical access whilst pressure or a vacuum exists,

—surface temperature taking into consideration the intended use,

—decomposition of unstable fluids.

In particular, pressure equipment fitted with an access door shall be equipped with an automatic or manual device enabling the user easily to ascertain that the opening will not present any risk. Furthermore, where the opening can be operated quickly, the pressure equipment shall be fitted with a device to prevent it being opened whenever the pressure or temperature of the fluid presents a risk.

2.4.   Means of examination

(a)Pressure equipment shall be designed and constructed so that all necessary examinations to ensure safety can be carried out;

(b)Means of determining the internal condition of the equipment shall be available, where it is necessary to ensure the continued safety of the equipment, such as access openings allowing physical access to the inside of the pressure equipment so that appropriate examinations can be carried out safely and ergonomically;

(c)Other means of ensuring the safe condition of the pressure equipment may be applied in any of the following situations:

—where it is too small for physical internal access,

—where opening the pressure equipment would adversely affect the inside,

—where the substance contained has been shown not to be harmful to the material from which the pressure equipment is made and no other internal degradation mechanisms are reasonably foreseeable.

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, corrosion and uncontrolled chemical reactions. All stages of operation and testing, particularly pressure testing, shall be considered,

—to permit cleaning, inspection and maintenance in a safe manner.

2.6.   Corrosion or other chemical attack

Where necessary, adequate allowance or protection against corrosion or other chemical attack shall be provided, taking due account of the intended and reasonably foreseeable use.

2.7.   Wear

Where severe conditions of erosion or abrasion may arise, adequate measures shall be taken to:

—minimise that effect by appropriate design, e.g. additional material thickness, or by the use of liners or cladding materials,

—permit replacement of parts which are most affected,

—draw attention, in the instructions referred to in point 3.4, to measures necessary for continued safe use.

2.8.   Assemblies

Assemblies shall be so designed that:

—the components to be assembled together are suitable and reliable for their duty,

—all the components are properly integrated and assembled in an appropriate manner.

2.9.   Provisions for filling and discharge

Where appropriate, the pressure equipment shall be so designed and provided with accessories, or provision made for their fitting, as to ensure safe filling and discharge in particular with respect to risks such as:

(a)on filling:

—overfilling or overpressurisation having regard in particular to the filling ratio and to vapour pressure at the reference temperature,

—instability of the pressure equipment;

(b)on discharge: the uncontrolled release of the pressurised fluid;

(c)on filling or discharge: unsafe connection and disconnection.

2.10.   Protection against exceeding the allowable limits of pressure equipment

Where, under reasonably foreseeable conditions, the allowable limits could be exceeded, the pressure equipment shall be fitted with, or provision made for the fitting of, suitable protective devices, unless the equipment is intended to be protected by other protective devices within an assembly.

The suitable device or combination of such devices shall be determined on the basis of the particular characteristics of the equipment or assembly.

Suitable protective devices and combinations thereof comprise:

(a)safety accessories as defined in point 4 of Article 2,

(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 limits.

2.11.   Safety accessories

2.11.1.   Safety accessories shall:

—be so designed and constructed as to be reliable and suitable for their intended duty and take into account the maintenance and testing requirements of the devices, where applicable,

—be independent of other functions, unless their safety function cannot be affected by such other functions,

—comply with appropriate design principles in order to obtain suitable and reliable protection. These principles include, in particular, fail-safe modes, redundancy, diversity and self-diagnosis.

2.11.2.   Pressure limiting devices

These devices shall be so designed that the pressure will not permanently exceed the maximum allowable pressure PS; however a short duration pressure surge in keeping with the specifications laid down in point 7.3 is allowable, where appropriate.

2.11.3.   Temperature monitoring devices

These devices shall have an adequate response time on safety grounds, consistent with the measurement function.

2.12.   External fire

Where necessary, pressure equipment shall be so designed and, where appropriate, fitted with suitable accessories, or provision made for their fitting, to meet damage-limitation requirements in the event of external fire, having particular regard to its intended use.

3. MANUFACTURING

3.1.   Manufacturing procedures

The manufacturer shall ensure the competent execution of the provisions set out at the design stage by applying the appropriate techniques and relevant procedures, especially with a view to the aspects set out below.

3.1.1.   Preparation of the component parts

Preparation of the component parts (e.g. forming and chamfering) shall not give rise to defects or cracks or changes in the mechanical characteristics likely to be detrimental to the safety of the pressure equipment.

3.1.2.   Permanent joining

Permanent joints and adjacent zones shall be free of any surface or internal defects detrimental to the safety of the equipment.

The properties of permanent joints shall meet the minimum properties specified for the materials to be joined unless other relevant property values are specifically taken into account in the design calculations.

For pressure equipment, permanent joining of components which contribute to the pressure resistance of equipment and components which are directly attached to them shall be carried out by suitably qualified personnel according to suitable operating procedures.

For pressure equipment in categories II, III and IV, operating procedures and personnel shall be approved by a competent third party which, at the manufacturer’s discretion, may be:

—a notified body,

—a third-party organisation recognised by a Member State as provided for in Article 20.

To carry out these approvals the third party must perform examinations and tests as set out in the appropriate harmonised standards or equivalent examinations and tests or shall have them performed.

3.1.3.   Non-destructive tests

For pressure equipment, non-destructive tests of permanent joints shall be carried out by suitable qualified personnel. For pressure equipment in categories III and IV, the personnel shall be approved by a third-party organisation recognised by a Member State pursuant to Article 20.

3.1.4.   Heat treatment

Where there is a risk that the manufacturing process will change the material properties to an extent which would impair the safety of the pressure equipment, suitable heat treatment shall be applied at the appropriate stage of manufacture.

3.1.5.   Traceability

Suitable procedures shall be established and maintained for identifying the material making up the components of the equipment which contribute to pressure resistance by suitable means from receipt, through production, up to the final test of the manufactured pressure equipment.

3.2.   Final assessment

Pressure equipment shall be subjected to final assessment as described below.

3.2.1.   Final inspection

Pressure equipment shall undergo a final inspection to assess visually and by examination of the accompanying documents compliance with the requirements of this Directive. Test carried out during manufacture may be taken into account. As far as is necessary on safety grounds, the final inspection shall be carried out internally and externally on every part of the equipment, where appropriate in the course of manufacture (e.g. where examination during the final inspection is no longer possible).

3.2.2.   Proof test

Final assessment of pressure equipment shall include a test for the pressure containment aspect, which will normally take the form of a hydrostatic pressure test at a pressure at least equal, where appropriate, to the value laid down in point 7.4.

For category I series-produced pressure equipment, this test may be performed on a statistical basis.

Where the hydrostatic pressure test is harmful or impractical, other tests of a recognised value may be carried out. For tests other than the hydrostatic pressure test, additional measures, such as non-destructive tests or other methods of equivalent validity, shall be applied before those tests are carried out.

3.2.3.   Inspection of safety devices

For assemblies, the final assessment shall also include a check of the safety devices intended to check full compliance with the requirements referred to in point 2.10.

3.3.   Marking and labelling

In addition to the CE marking referred to in Articles 18 and 19 and the information to be provided in accordance with Article 6(6) and Article 8(3), the following information shall be provided:

(a)for all pressure equipment:

—the year of manufacture,

—identification of the pressure equipment according to its nature, such as type, series or batch identification and serial number,

—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 volume V of the pressure equipment in L,

—the nominal size for piping DN,

—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 V (volts),

—intended use,

—filling ratio kg/L,

—maximum filling mass in kg,

—tare mass in kg,

—the fluid group.

(c)where necessary, warnings fixed to the pressure equipment drawing attention to misuse which experience has shown might occur.

The information referred to in points (a), (b) and (c) shall be given on the pressure equipment or on a dataplate firmly attached to it, with the following exceptions:

—where applicable, appropriate documentation may be used to avoid repetitive marking of individual parts such as piping components, intended for the same assembly,

—where the pressure equipment is too small, e.g. accessories, this information may be given on a label attached to that pressure equipment,

—labelling or other adequate means may be used for the mass to be filled and the warnings referred to in point (c), provided it remains legible for the appropriate period of time.

3.4.   Operating instructions

(a)When pressure equipment is made available on the market, it shall be accompanied, as far as relevant, with instructions for the user, containing all the necessary safety information relating to:

—mounting including assembling of different pieces of pressure equipment,

—putting into service,

—use,

—maintenance including checks by the user.

(b)Instructions shall cover information affixed to the pressure equipment in accordance with point 3.3, with the exception of serial identification, and shall be accompanied, where appropriate, by the technical documents, drawings and diagrams necessary for a full understanding of these instructions.

(c)If appropriate, these instructions shall also refer to risks arising from misuse in accordance with point 1.3 and particular features of the design in accordance with point 2.2.3.

4. MATERIALS

Materials used for the manufacture of pressure equipment shall be suitable for such application during the scheduled lifetime unless replacement is foreseen.

Welding consumables and other joining materials need to fulfil only the relevant requirements of points 4.1, 4.2(a) and the first paragraph of point 4.3, in an appropriate way, both individually and in a joined structure.

4.1.Materials for pressurised parts shall:

(a)have appropriate properties for all operating conditions which are reasonably foreseeable and for all test conditions, and in particular they should be sufficiently ductile and tough. Where appropriate, the characteristics of the materials shall comply with the requirements of point 7.5. Moreover, due care should be exercised in particular in selecting materials in order to prevent brittle-type fracture where necessary; where for specific reasons brittle material has to be used appropriate measures shall be taken;

(b)be sufficiently chemically resistant to the fluid contained in the pressure equipment; the chemical and physical properties necessary for operational safety shall not be significantly affected within the scheduled lifetime of the equipment;

(c)not be significantly affected by ageing;

(d)be suitable for the intended processing procedures;

(e)be selected in order to avoid significant undesirable effects when the various materials are put together.

4.2.The pressure equipment manufacturer shall:

(a)define in an appropriate manner the values necessary for the design calculations referred to in point 2.2.3 and the essential characteristics of the materials and their treatment referred to in point 4.1;

(b)provide in his technical documentation elements relating to compliance with the materials specifications of this Directive in one of the following forms:

—by using materials which comply with harmonised standards,

—by using materials covered by a European approval of pressure equipment materials in accordance with Article 15,

—by a particular material appraisal;

(c)for pressure equipment in categories III and IV, a specific assessment of the particular material appraisal shall be performed by the notified body in charge of conformity assessment procedures for the pressure equipment.

4.3.The equipment manufacturer shall take appropriate measures to ensure that the material used conforms with the required specification. In particular, documentation prepared by the material manufacturer affirming compliance with a specification shall be obtained for all materials.

For the main pressure-bearing parts of equipment in categories II, III and IV, this shall take the form of a certificate of specific product control.

Where a material manufacturer has an appropriate quality-assurance system, certified by a competent body established within the Union and having undergone a specific assessment for materials, certificates issued by the manufacturer are presumed to certify conformity with the relevant requirements of this point.

SPECIFIC PRESSURE EQUIPMENT REQUIREMENTS

In addition to the applicable requirements of points 1 to 4, the following requirements apply to the pressure equipment covered by points 5 and 6.

5. FIRED OR OTHERWISE HEATED PRESSURE EQUIPMENT WITH A RISK OF OVERHEATING AS REFERRED TO IN ARTICLE 4(1)

This pressure equipment includes:

—steam and hot-water generators as referred to in Article 4(1)(b), such as fired steam and hot-water boilers, superheaters and reheaters, waste-heat boilers, waste incineration boilers, electrode or immersion-type electrically heated boilers, pressure cookers, together with their accessories and where applicable their systems for treatment of feedwater and for fuel supply,

—process-heating equipment for other than steam and hot water generation falling under Article 4(1)(a), such as heaters for chemical and other similar processes and pressurised food-processing equipment.

This pressure equipment shall be calculated, designed and constructed so as to avoid or minimise risks of a significant loss of containment from overheating. In particular it shall be ensured, where applicable, that:

(a)appropriate means of protection are provided to restrict operating parameters such as heat input, heat take-off and, where applicable, fluid level so as to avoid any risk of local and general overheating;

(b)sampling points are provided where required to allow evaluation of the properties of the fluid so as to avoid risks related to deposits and/or corrosion;

(c)adequate provisions are made to eliminate risks of damage from deposits;

(d)means of safe removal of residual heat after shutdown are provided;

(e)steps are taken to avoid a dangerous accumulation of ignitable mixtures of combustible substances and air, or flame blowback.

6. PIPING AS REFERRED TO IN ARTICLE 4(1)(c)

Design and construction shall ensure:

(a)that the risk of overstressing from inadmissible free movement or excessive forces being produced, e.g. on flanges, connections, bellows or hoses, is adequately controlled by means such as support, constraint, anchoring, alignment and pre-tension;

(b)that where there is a possibility of condensation occurring inside pipes for gaseous fluids, means are provided for drainage and removal of deposits from low areas to avoid damage from water hammer or corrosion;

(c)that due consideration is given to the potential damage from turbulence and formation of vortices; the relevant parts of point 2.7 are applicable;

(d)that due consideration is given to the risk of fatigue due to vibrations in pipes;

(e)that, where fluids of Group 1 are contained in the piping, appropriate means are provided to isolate ‘take-off’ pipes the size of which represents a significant risk;

(f)that the risk of inadvertent discharge is minimised; the take-off points shall be clearly marked on the permanent side, indicating the fluid contained;

(g)that the position and route of underground piping is at least recorded in the technical documentation to facilitate safe maintenance, inspection or repair.

7. SPECIFIC QUANTITATIVE REQUIREMENTS FOR CERTAIN PRESSURE EQUIPMENT

The following provisions apply as a general rule. However, where they are not applied, including in cases where materials are not specifically referred to and no harmonised standards are applied, the manufacturer shall demonstrate that appropriate measures have been taken to achieve an equivalent overall level of safety.

The provisions laid down in this section supplement the essential safety requirements of points 1 to 6 for the pressure equipment to which they apply.

7.1.   Allowable stresses

7.1.1.   Symbols

Re/t, yield limit, indicates the value at the calculation temperature of:

—the upper flow limit for a material presenting upper and lower flow limits,

—the 1,0 % proof strength of austenitic steel and non-alloyed aluminium,

—the 0,2 % proof strength in other cases.

Rm/20 indicates the minimum value of the ultimate tensile strength at 20 °C.

Rm/t designates the ultimate tensile strength at the calculation temperature.

7.1.2.   The permissible general membrane stress for predominantly static loads and for temperatures outside the range in which creep is significant shall not exceed the smaller of the following values, according to the material used:

—in the case of ferritic steel including normalised (normalised rolled) steel and excluding fine-grained steel and specially heat-treated steel, 2/3 of Re/t and 5/12 of Rm/20,

—in the case of austenitic steel:

—if its elongation after rupture exceeds 30 %, 2/3 of Re/t

—or, alternatively, and if its elongation after rupture exceeds 35 %, 5/6 of Re/t and 1/3 of Rm/t,

—in the case of non-alloy or low-alloy cast steel, 10/19 of Re/t and 1/3 of Rm/20,

—in the case of aluminium, 2/3 of Re/t,

—in the case of aluminium alloys excluding precipitation hardening alloys 2/3 of Re/t and 5/12 of Rm/20.

7.2.   Joint coefficients

For welded joints, the joint coefficient shall not exceed the following values:

—for equipment subject to destructive and non-destructive tests which confirm that the whole series of joints show no significant defects: 1,

—for equipment subject to random non-destructive testing: 0,85,

—for equipment not subject to non-destructive testing other than visual inspection: 0,7.

If necessary, the type of stress and the mechanical and technological properties of the joint shall also be taken into account.

7.3.   Pressure limiting devices, particularly for pressure vessels

The momentary pressure surge referred to in point 2.11.2 shall be kept to 10 % of the maximum allowable pressure.

7.4.   Hydrostatic test pressure

For pressure vessels, the hydrostatic test pressure referred to in point 3.2.2 shall be no less than either of the following:

—that corresponding to the maximum loading to which the pressure equipment may be subject in service taking into account its maximum allowable pressure and its maximum allowable temperature, multiplied by the coefficient 1,25,

—the maximum allowable pressure multiplied by the coefficient 1,43, whichever is the greater.

7.5.   Material characteristics

Unless other values are required in accordance with other criteria that shall be taken into account, a steel is considered as sufficiently ductile to satisfy point 4.1(a) if, in a tensile test carried out by a standard procedure, its elongation after rupture is no less than 14 % and its bending rupture energy measured on an ISO V test-piece is no less than 27 J, at a temperature not greater than 20 °C but not higher than the lowest scheduled operating temperature.


ANNEX II

CONFORMITY ASSESSMENT TABLES

1.The references in the tables to categories of modules are the following:

I=Module A
II=Modules A2, D1, E1
III=Modules B (design type) + D, B (design type) + F, B (production type) + E, B (production type) + C2, H
IV=Modules B (production type) + D, B (production type) + F, G, H1

2.The safety accessories defined in point 4 of Article 2, and referred to in Article 4(1)(d), are classified in category IV. However, by way of exception, safety accessories manufactured for specific equipment may be classified in the same category as the equipment they protect.

3.The pressure accessories defined in point 5 of Article 2, and referred to in Article 4(1)(d), are classified on the basis of:

—their maximum allowable pressure PS,

—their volume V or their nominal size DN, as appropriate,

—the group of fluids for which they are intended.

The appropriate table for vessels or piping is to be used to determine the conformity assessment category.

Where both the volume and the nominal size are considered appropriate in the second indent of the first subparagraph, the pressure accessory shall be classified in the highest category.

4.The demarcation lines in the following conformity assessment tables indicate the upper limit for each category.


Exceptionally, vessels intended to contain an unstable gas and falling within categories I or II on the basis of table 1 shall be classified in category III.



Exceptionally, portable extinguishers and bottles for breathing equipment shall be classified at least in category III.





Exceptionally, assemblies intended for generating warm water as referred to in the second subparagraph of Article 4(2), shall be subject either to an EU-type examination (Module B — design type) with respect to their conformity with the essential requirements referred to in points 2.10, 2.11, 3.4, 5(a) and 5(d) of Annex I, or to full quality assurance (Module H).



Exceptionally, the design of pressure-cookers shall be subject to a conformity assessment procedure equivalent to at least one of the category III modules.



Exceptionally, piping intended for unstable gases and falling within categories I or II on the basis of Table 6 shall be classified in category III.



Exceptionally, all piping containing fluids at a temperature greater than 350 °C and falling within category II on the basis of Table 7 shall be classified in category III.






ANNEX III

CONFORMITY ASSESSMENT PROCEDURES

The obligations arising from the provisions on pressure equipment in this Annex also apply to assemblies.

1. MODULE A: (INTERNAL PRODUCTION CONTROL)

1. Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfy the requirements of this Directive.

2. Technical documentation

The manufacturer shall establish the technical documentation.

The technical documentation shall make it possible to assess the conformity of the pressure equipment to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the pressure equipment. The technical documentation shall, wherever applicable, contain at least the following elements:

—a general description of the pressure equipment,

—conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

—descriptions and explanations necessary for an understanding of those drawings and diagrams and the operation of the pressure equipment,

—a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and a description of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

—results of design calculations made, examinations carried out, etc.,

—test reports.

3. Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured pressure equipment with the technical documentation referred to in point 2 and with the requirements of this Directive.

4. CE marking and EU declaration of conformity

4.1.The manufacturer shall affix the CE marking to each individual pressure equipment that satisfies the applicable requirements of this Directive.

4.2.The manufacturer shall draw up a written EU declaration of conformity for the pressure equipment model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

5. Authorised representative

The manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

2. MODULE A2: INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRESSURE EQUIPMENT CHECKS AT RANDOM INTERVALS

1. Internal production control plus supervised pressure equipment checks at random intervals is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 4 and 5, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfy the requirements of this Directive.

2. Technical documentation

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the conformity of the pressure equipment with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the pressure equipment. The technical documentation shall contain, wherever applicable, at least the following elements:

—a general description of the pressure equipment,

—conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

—descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment,

—a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

—results of design calculations made, examinations carried out, etc., and

—test reports.

3. Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured pressure equipment with the technical documentation referred to in point 2 and with the requirements of this Directive that apply to it.

4. Final assessment and pressure equipment checks

The manufacturer shall perform a final assessment of the pressure equipment, monitored by means of unexpected visits by a notified body chosen by the manufacturer.

The notified body shall carry out product checks or have them carried out at random intervals determined by the body, in order to verify the quality of the internal checks of the pressure equipment, taking into account, inter alia, the technological complexity of the pressure equipment and the quantity of production.

During its unexpected visits, the notified body shall:

—establish that the manufacturer actually performs final assessment in accordance with point 3.2 of Annex I.

—take samples of pressure equipment at the manufacturing or storage premises in order to conduct checks. The notified body assesses the number of items of equipment to sample and whether it is necessary to perform, or have performed, all or part of the final assessment of the pressure equipment samples.

The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the pressure equipment performs within acceptable limits, with a view to ensuring conformity of the pressure equipment.

Should one or more of the items of pressure equipment or assembly not conform, the notified body shall take appropriate measures.

The manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.

5. CE marking and EU declaration of conformity

5.1.The manufacturer shall affix the CE marking to each individual pressure equipment that satisfies the applicable requirements of this Directive.

5.2.The manufacturer shall draw up a written EU declaration of conformity for the pressure equipment model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

6. Authorised representative

The manufacturer’s obligations set out in point 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

3. MODULE B: EU-TYPE EXAMINATION

3.1.    EU-Type examination – production type

1.EU-type examination — production type is the part of a conformity assessment procedure in which a notified body examines the technical design of the pressure equipment and verifies and attests that the technical design of the pressure equipment meets the requirements of this Directive.

2.EU-type examination — production type shall consist of an assessment of the adequacy of the technical design of the pressure equipment through examination of the technical documentation and supporting evidence referred to in point 3, plus examination of a specimen, representative of the production envisaged, of the complete pressure equipment.

3.The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice.

The application shall include:

—the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

—a written declaration that the same application has not been lodged with any other notified body,

—the technical documentation. The technical documentation shall make it possible to assess the conformity of the pressure equipment with the applicable requirements of this Directive and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the pressure equipment. The technical documentation shall contain, wherever applicable, at least the following elements:

—a general description of the pressure equipment,

—conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

—descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment,

—a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

—results of design calculations made, examinations carried out, etc.,

—test reports,

—information concerning the tests provided for in manufacture,

—information concerning the qualifications or approvals required under points 3.1.2 and 3.1.3 of Annex I,

—the specimens representative of the production envisaged.

The specimen may cover several versions of the pressure equipment provided that the differences between the versions do not affect the level of safety.

The notified body may request further specimens if needed for carrying out the test programme;

—the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer applying other relevant technical specifications, or by another testing laboratory on his behalf and under his responsibility.

4.The notified body shall:

4.1.examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the pressure equipment and the manufacturing procedures.

In particular, the notified body shall:

—assess the materials where these are not in conformity with the relevant harmonised standards or with a European approval for pressure equipment materials, and check the certificate issued by the material manufacturer in accordance with point 4.3 of Annex I,

—approve the procedures for the permanent joining of pressure equipment parts, or check that they have been previously approved in accordance with point 3.1.2 of Annex I,

—verify that the personnel undertaking the permanent joining of pressure equipment parts and the non-destructive tests are qualified or approved in accordance with points 3.1.2 or 3.1.3 of Annex I.

4.2.verify that the specimen(s) have been manufactured in conformity with the technical documentation and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards as well as the elements which have been designed using other relevant technical specifications without applying the relevant provisions of those standards.

4.3.carry out appropriate examinations and necessary tests to check whether when the manufacturer has chosen to apply the solutions in the relevant harmonised standards, these have been applied correctly.

4.4.carry out appropriate examinations and necessary tests to check whether, where the solutions in the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential safety requirements of this Directive.

4.5.agree with the manufacturer on a location where the examinations and tests will be carried out.

5.The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis the notifying authority, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

6.Where the type meets the requirements of this Directive, the notified body shall issue an EU-type examination certificate – production type to the manufacturer. Without prejudice to point 7, the certificate shall be valid for 10 years and be renewable and shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type.

A list of the relevant parts of the technical documentation shall be annexed to the certificate and a copy kept by the notified body.

The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured pressure equipment with the examined type to be evaluated and to allow for in-service control.

Where the type does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue an EU-type examination certificate – production type and shall inform the applicant accordingly, giving detailed reasons for its refusal. Provision shall be made for an appeals procedure.

7.The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of this Directive, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate – production type of all modifications to the approved type that may affect the conformity of the pressure equipment with the essential safety requirements of this Directive or the conditions for validity of the certificate. Such modifications shall require additional approval in the form of an addition to the original EU- type examination certificate – production type.

8.Each notified body shall inform its notifying authority concerning the EU-type examination certificates – production type and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies concerning the EU-type examination certificates – production type and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued.

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates – production type and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate – production type, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.

9.The manufacturer shall keep a copy of the EU-type examination certificate – production type, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market.

10.The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.

3.2.    EU-Type examination – design type

1.EU-type examination – design type is the part of a conformity assessment procedure in which a notified body examines the technical design of the pressure equipment and verifies and attests that the technical design of the pressure equipment meets the requirements of this Directive.

2.The EU-type examination – design type shall consist of an assessment of the adequacy of the technical design of the pressure equipment through examination of the technical documentation and supporting evidence referred to in point 3, without examination of a specimen.

The experimental design method provided for in point 2.2.4 of Annex I shall not be used in the context of this module.

3.The manufacturer shall lodge an application for EU-type examination — design type with a single notified body of his choice.

The application shall include:

—the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

—a written declaration that the same application has not been lodged with any other notified body,

—the technical documentation. The technical documentation shall make it possible to assess the conformity of the pressure equipment with the applicable requirements of the Directive and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the pressure equipment. The technical documentation shall contain, wherever applicable, at least the following elements:

—a general description of the pressure equipment,

—conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

—descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment,

—a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

—results of design calculations made, examinations carried out, etc.,

—information regarding the qualifications or approvals required under points 3.1.2 and 3.1.3 of Annex I,

—the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards have not been applied in full. This supporting evidence shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer or by another testing laboratory on his behalf and under his responsibility.

The application may cover several versions of the pressure equipment provided that the differences between the versions do not affect the level of safety.

4.The notified body shall:

4.1.examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the product.

In particular, the notified body shall:

—assess the materials where these are not in conformity with the relevant harmonised standards or with a European approval for pressure equipment materials,

—approve the procedures for the permanent joining of pressure equipment parts, or check that they have been previously approved in accordance with point 3.1.2 of Annex I.

4.2.carry out appropriate examinations to check whether where the manufacturer has chosen to apply the solutions in the relevant harmonised standards these have been applied correctly.

4.3.carry out appropriate examinations to check whether, where the solutions in the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer meet the corresponding essential safety requirements of this Directive.

5.The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

6.Where the design meets the requirements of this Directive, the notified body shall issue an EU-type examination certificate — design type to the manufacturer. Without prejudice to point 7, the certificate shall be valid for 10 years and be renewable and shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved design.

A list of the relevant parts of the technical documentation shall be annexed to the certificate and a copy kept by the notified body.

The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured pressure equipment with the examined design to be evaluated and to allow for in-service control.

Where the design does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue an EU-type examination certificate — design type and shall inform the applicant accordingly, giving detailed reasons for its refusal.

7.The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of this Directive, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate — design type of all modifications to the approved design that may affect the conformity of the pressure equipment with the essential safety requirements of this Directive or the conditions for validity of the certificate. Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate — design type.

8.Each notified body shall inform its notifying authorities concerning the EU-type examination certificates — design type and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies concerning the EU-type examination certificates — design type and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued.

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates — design type and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate — design type, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.

9.The manufacturer shall keep a copy of the EU-type examination certificate — design type, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market.

10.The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.

4. MODULE C2: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRESSURE EQUIPMENT CHECKS AT RANDOM INTERVALS

1. Conformity to type based on internal production control plus supervised pressure equipment checks at random intervals is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the pressure equipment concerned is in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to it.

2. Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured pressure equipment with the type described in the EU-type examination certificate and with the requirements of this Directive that apply to them.

3. Final assessment and pressure equipment checks

A notified body, chosen by the manufacturer, shall carry out checks or have them carried out at random intervals determined by the body, in order to verify the quality of the final assessment and of the internal checks on the pressure equipment, taking into account, inter alia, the technological complexity of the pressure equipment and the quantity of production.

The notified body shall establish that the manufacturer actually performs final assessment in accordance with point 3.2 of Annex I.

An adequate sample of the final pressure equipment, taken on site by the notified body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the harmonised standards, and/or equivalent tests applying other technical specifications, shall be carried out to check the conformity of the pressure equipment with the relevant requirements of this Directive.

The notified body shall assess the number of items of equipment to sample and whether it is necessary to perform, or have performed, all or part of final assessment on the pressure equipment samples.

Where a sample does not conform to the acceptable quality level, the body shall take appropriate measures.

The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the pressure equipment performs within acceptable limits, with a view to ensuring conformity of the pressure equipment.

Where the tests are carried out by a notified body, the manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.

4. CE marking and EU declaration of conformity

4.1.The manufacturer shall affix the CE marking to each individual pressure equipment or assembly that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.

4.2.The manufacturer shall draw up a written EU declaration of conformity for a pressure equipment model and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment model for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

5. Authorised representative

The manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

5. MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS

1. Conformity to type based on quality assurance of the production process is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the pressure equipment or assembly concerned is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of this Directive that apply to it.

2. Manufacturing

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the pressure equipment concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.

3. Quality system

3.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice for the pressure equipment concerned.

The application shall include:

—the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

—a written declaration that the same application has not been lodged with any other notified body,

—all relevant information on the pressure equipment type envisaged,

—the documentation concerning the quality system,

—the technical documentation of the approved type and a copy of the EU-type examination certificate.

3.2.The quality system shall ensure that the pressure equipment is in conformity with the type described in the EU-type examination certificate and comply with the requirements of this Directive that apply to it.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

—the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment,

—the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used, particularly the procedures used for the permanent joining of parts as approved in accordance with point 3.1.2 of Annex I,

—the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

—the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the non-destructive tests in accordance with points 3.1.2 and 3.1.3 of Annex I, etc., and

—the means of monitoring the achievement of the required quality and the effective operation of the quality system.

3.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.

It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant pressure equipment field and pressure equipment technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an inspection visit to the manufacturer’s premises.

The auditing team shall review the technical documentation referred to in point 3.1, fifth indent, to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

3.4.The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

3.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

The notified body shall evaluate the proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

4.1.The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2.The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:

—the quality system documentation,

—the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

4.3.The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits shall be such that a full reassessment is carried out every three years.

4.4.In addition the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors shall be considered in the visit control system:

—the category of the pressure equipment,

—the results of previous surveillance visits,

—the need to follow up corrective actions,

—special conditions linked to the approval of the system, where applicable,

—significant changes in manufacturing organisation, policy or techniques.

During such visits the notified body may, if necessary, carry out product tests or have them carried out in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

5. CE marking and EU declaration of conformity

5.1.The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual pressure equipment that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.

5.2.The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment model for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

6. The manufacturer shall, for a period ending 10 years after the pressure equipment has been placed on the market, keep at the disposal of the national authorities:

—the documentation referred to point 3.1,

—the change referred to in point 3.5, as approved,

—the decisions and reports of the notified body referred to in points 3.3, 3.5, 4.3 and 4.4.

7. Each notified body shall inform its notifying authorities of the quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of the quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.

8. Authorised representative

The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

6. MODULE D1: QUALITY ASSURANCE OF THE PRODUCTION PROCESS

1. Quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 4 and 7, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfy the requirements of this Directive that apply to it.

2. Technical documentation

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the conformity of the pressure equipment with the relevant requirements and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall, wherever applicable, contain at least the following elements:

—a general description of the pressure equipment,

—conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

—descriptions and explanations necessary for an understanding of those drawings and diagrams and the operation of the pressure equipment,

—a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

—results of design calculations made, examinations carried out, etc., and

—test reports.

3. The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the pressure equipment has been placed on the market.

4. Manufacturing

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the pressure equipment concerned as specified in point 5, and shall be subject to surveillance as specified in point 6.

5. Quality system

5.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice for the pressure equipment concerned.

The application shall include:

—the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

—a written declaration that the same application has not been lodged with any other notified body,

—all relevant information on the pressure equipment type envisaged,

—the documentation concerning the quality system,

—the technical documentation referred to in point 2.

5.2.The quality system shall ensure compliance of the pressure equipment with the requirements of this Directive that apply to it.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

—the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment,

—the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic measures that will be used, particularly the procedures used for the permanent joining of parts as approved in accordance with point 3.1.2 of Annex I,

—the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

—the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts in accordance with point 3.1.2 of Annex I, etc.,

—the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

5.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 5.2. The elements of the quality system which conform to the relevant harmonised standard are presumed to comply with the corresponding requirements referred to in point 5.2.

In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the pressure equipment technology concerned, and the knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises.

The auditing team shall review the technical documentation referred to in point 2 in order to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the pressure equipment with those requirements.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

5.4.The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

5.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 5.2 or whether a reassessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

6. Surveillance under the responsibility of the notified body

6.1.The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

6.2.The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:

—the quality system documentation,

—the technical documentation referred to in point 2,

—the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

6.3.The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits shall be such that a full reassessment is carried out every three years.

6.4.In addition the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors shall be considered in the visit control system:

—the category of the pressure equipment,

—the results of previous surveillance visits,

—the need to follow up corrective action(s),

—special conditions linked to the approval of the system, where applicable,

—significant changes in manufacturing organisation, policy or techniques.

During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

7. CE marking and EU declaration of conformity

7.1.The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 5.1, the latter’s identification number to each individual pressure equipment that satisfies the applicable requirements of this Directive.

7.2.The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the product model for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

8. The manufacturer shall, for a period ending 10 years after the pressure equipment has been placed on the market, keep at the disposal of the national authorities:

—the documentation referred to in point 5.1,

—the change referred to in point 5.5,

—the decisions and reports of the notified body referred to in points 5.5, 6.3 and 6.4.

9. Each notified body shall inform its notifying authorities of the quality system approvals issued or withdrawn, and shall periodically, or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended, or withdrawn, and upon request, of quality system approvals which it has issued.

10. Authorised representative

The manufacturer’s obligations set out in points 3, 5.1, 5.5, 7 and 8 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

7. MODULE E: CONFORMITY TO TYPE BASED ON PRESSURE EQUIPMENT QUALITY ASSURANCE

1. Conformity to type based on pressure equipment quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the pressure equipment concerned is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of this Directive that apply to it.

2. Manufacturing

The manufacturer shall operate an approved quality system for the final product inspection and testing of the pressure equipment concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.

3. Quality system

3.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the pressure equipment concerned.

The application shall include:

—the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

—a written declaration that the same application has not been lodged with any other notified body,

—all relevant information on the pressure equipment type envisaged,

—the documentation concerning the quality system,

—the technical documentation of the approved type and a copy of the EU-type examination certificate.

3.2.The quality system shall ensure compliance of the products with the type described in the EU-type examination certificate and with the applicable requirements of this Directive.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

—the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,

—the examinations and tests that will be carried out after manufacture,

—the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the non-destructive tests in accordance with points 3.1.2 and 3.1.3 of Annex I,

—the means of monitoring the effective operation of the quality system.

3.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant pressure equipment field and pressure equipment technology concerned and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises.

The auditing team shall review the technical documentation referred to in point 3.1, fifth indent, in order to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the pressure equipment with those requirements.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

3.4.The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

3.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

4.1.The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2.The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:

—the quality system documentation,

—the technical documentation,

—the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel concerned, etc.

4.3.The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years.

4.4.In addition the notified body may pay unexpected visits to the manufacturer.

The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors shall be considered in the visit control system:

—the category of the pressure equipment,

—the results of previous surveillance visits,

—the need to follow up corrective actions,

—special conditions linked to the approval of the system, where applicable,

—significant changes in manufacturing organisation, policy or techniques.

During such visits, the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

5. CE marking and EU declaration of conformity

5.1.The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual pressure equipment that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.

5.2.The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the product model for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

6. The manufacturer shall, for a period ending 10 years after the pressure equipment has been placed on the market, keep at the disposal of the national authorities:

—the documentation referred to in point 3.1,

—the change referred to in point 3.5, as approved,

—the decisions and reports from the notified body which are referred to in points 3.3, 3.5, 4.3 and 4.4.

7. Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued.

8. Authorised representative

The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

8. MODULE E1: QUALITY ASSURANCE OF FINAL PRESSURE EQUIPMENT INSPECTION AND TESTING

1. Quality assurance of final pressure equipment inspection and testing is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 4 and 7, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfy the requirements of this Directive that apply to it.

2. Technical documentation

The manufacturer shall establish the technical documentation. The technical documentation shall make it possible to assess the conformity of the pressure equipment with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s) The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the pressure equipment. The technical documentation shall, wherever applicable, contain at least the following elements:

—a general description of the pressure equipment,

—conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

—descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment,

—a list of the harmonised standards, the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

—results of design calculations made, examinations carried out, etc., and

—test reports.

3. The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the pressure equipment has been placed on the market.

4. Manufacturing

The manufacturer shall operate an approved quality system for the final product inspection and testing of the pressure equipment as specified in point 5 and shall be subject to surveillance as specified in point 6.

5. Quality system

5.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the pressure equipment concerned.

The application shall include:

—the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

—a written declaration that the same application has not been lodged with any other notified body,

—all relevant information on the pressure equipment type envisaged,

—the documentation concerning the quality system, and

—the technical documentation referred to in point 2.

5.2.The quality system shall ensure compliance of the pressure equipment with the requirements of this Directive that apply to it.

Under the quality system, each item of pressure equipment shall be examined and appropriate tests as set out in the relevant standard(s) referred to in Article 12, or equivalent tests, and particularly final assessment as referred to in point 3.2 of Annex I, shall be carried out in order to ensure its conformity with the requirements of this Directive which apply to it.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

—the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment,

—the procedures used for the permanent joining of parts as approved in accordance with point 3.1.2 of Annex I,

—the examinations and tests that will be carried out after manufacture,

—the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts in accordance with point 3.1.2 of Annex I,

—the means of monitoring the effective operation of the quality system.

5.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 5.2.

It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant pressure equipment field and pressure equipment technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises.

The auditing team shall review the technical documentation referred to in point 2 in order to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the pressure equipment with those requirements.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

5.4.The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

5.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 5.2 or whether a reassessment is required.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

6. Surveillance under the responsibility of the notified body

6.1.The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

6.2.The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:

—the quality system documentation,

—the technical documentation referred to in point 2,

—the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

6.3.The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits shall be such that a full reassessment is carried out every three years.

6.4.In addition the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors shall be considered in the visit control system:

—the category of the equipment,

—the results of previous surveillance visits,

—the need to follow up corrective action(s),

—special conditions linked to the approval of the system, where applicable,

—significant changes in manufacturing organisation, policy or techniques.

During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

7. CE marking and EU declaration of conformity

7.1.The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 5.1, the latter’s identification number to each individual item of pressure equipment that satisfies the applicable requirements of this Directive.

7.2.The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment model for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

8. The manufacturer shall, for a period ending 10 years after the pressure equipment has been placed on the market, keep at the disposal of the national authorities:

—the documentation referred to in point 5.1,

—the change referred to in point 5.5, as approved,

—the decisions and reports of the notified body referred to in points 5.3, 5.5, 6.3 and 6.4.

9. Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn and shall periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued.

10. Authorised representative

The manufacturer’s obligations set out in points 3, 5.1, 5.5, 7 and 8 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

9. MODULE F: CONFORMITY TO TYPE BASED ON PRESSURE EQUIPMENT VERIFICATION

1. Conformity to type based on pressure equipment verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the pressure equipment concerned, which has been subject to the provisions of point 3, is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of this Directive which apply to it.

2. Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the approved type described in the EU-type examination certificate and with the requirements of this Directive which apply to them.

3. Verification

A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests in order to check the conformity of the pressure equipment with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Directive.

The examinations and tests to check the conformity of the pressure equipment with the appropriate requirements shall be carried out by examination and testing of every product as specified in point 4.

4. Verification of conformity by examination and testing of every item of pressure equipment

4.1.All pressure equipment shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) or equivalent tests shall be carried out in order to verify conformity with the approved type and described in the EU-type examination certificate and with the appropriate requirements of this Directive. In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out.

In particular, the notified body shall:

—verify that the personnel undertaking the permanent joining of parts and the non-destructive tests are qualified or approved in accordance with points 3.1.2 and 3.1.3 of Annex I,

—verify the certificate issued by the materials manufacturer in accordance with point 4.3 of Annex I,

—carry out or have carried out the final inspection and proof test referred to in point 3.2 of Annex I and examine the safety devices, if applicable.

4.2.The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number or have it affixed under its responsibility to each approved item of pressure equipment.

The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the pressure equipment has been placed on the market.

5. CE marking and EU declaration of conformity

5.1.The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3, the latter’s identification number to each individual item of pressure equipment that is in conformity with the approved type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.

5.2.The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities, for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment model for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

If the notified body referred to in point 3 agrees and under its responsibility, the manufacturer may also affix the notified body’s identification number to the pressure equipment.

6. If the notified body agrees and under its responsibility, the manufacturer may affix the notified body’s identification number to the pressure equipment during the manufacturing process.

7. Authorised representative

The manufacturer’s obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer’s obligations set out in point 2.

10. MODULE G: CONFORMITY BASED ON UNIT VERIFICATION

1. Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 5, and ensures and declares on his sole responsibility that the pressure equipment concerned, which has been subject to the provisions of point 4, is in conformity with the requirements of this Directive that apply to it.

2. Technical documentation

The manufacturer shall establish the technical documentation and make it available to the notified body referred to in point 4.

The documentation shall make it possible to assess the conformity of the pressure equipment with the relevant requirements and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the pressure equipment.

The technical documentation shall, wherever applicable, contain at least the following elements:

—a general description of the pressure equipment,

—conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

—descriptions and explanations necessary for an understanding of those drawings and diagrams and the operation of the pressure equipment,

—a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards, have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

—results of design calculations made, examinations carried out, etc.,

—test reports,

—appropriate details relating to the approval of the manufacturing and test procedures and of the qualifications or approvals of the personnel concerned in accordance with points 3.1.2 and 3.1.3 of Annex I.

The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the pressure equipment has been placed on the market.

3. Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured pressure equipment with the applicable requirements of this Directive.

4. Verification

A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant harmonised standard(s) and/or equivalent tests, to check the conformity of the pressure equipment with the applicable requirements of this Directive, or have them carried out. In the absence of such a harmonised standard the notified body concerned shall decide on the appropriate tests to be carried out applying other technical specifications.

In particular the notified body shall:

—examine the technical documentation with respect to the design and the manufacturing procedures,

—assess the materials used where these are not in conformity with the relevant harmonised standards or with a European approval for pressure equipment materials, and check the certificate issued by the material manufacturer in accordance with point 4.3 of Annex I,

—approve the procedures for the permanent joining of parts or check that they have been previously approved in accordance with point 3.1.2 of Annex I,

—verify the qualifications or approvals required under points 3.1.2 and 3.1.3 of Annex I,

—carry out the final inspection referred to in point 3.2.1 of Annex I, perform or have performed the proof test referred to in point 3.2.2 of Annex I, and examine the safety devices, if applicable.

The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved pressure equipment, or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market.

5. CE marking and EU declaration of conformity

5.1.The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 4, the latter’s identification number to each item of pressure equipment that satisfies the applicable requirements of this Directive.

5.2.The manufacturer shall draw up a written EU declaration of conformity and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

6. Authorised representative

The manufacturer’s obligations set out in points 2 and 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

11. MODULE H: CONFORMITY BASED ON FULL QUALITY ASSURANCE

1. Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfies the requirements of this Directive that apply to it.

2. Manufacturing

The manufacturer shall operate an approved quality system for design, manufacture, final product inspection and testing of the pressure equipment as specified in point 3 and shall be subject to surveillance as specified in point 4.

3. Quality system

3.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the pressure equipment concerned.

The application shall include:

—the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

—the technical documentation for one model of each type of pressure equipment intended to be manufactured. The technical documentation shall, wherever applicable, contain at least the following elements:

—a general description of the pressure equipment,

—conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

—descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment,

—a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

—results of design calculations made, examinations carried out, etc.,

—test reports,

—the documentation concerning the quality system, and

—a written declaration that the same application has not been lodged with any other notified body.

3.2.The quality system shall ensure compliance of the pressure equipment with the requirements of this Directive that apply to it.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. That quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

—the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality,

—the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards will not be applied in full, the means that will be used to ensure that the essential requirements of this Directive that apply to the pressure equipment will be met,

—the design control and design verification techniques, processes and systematic actions that will be used when designing the pressure equipment, pertaining to the product type covered, particularly with regard to materials in accordance with point 4 of Annex I,

—the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used, particularly the procedures for the permanent joining of parts as approved in accordance with point 3.1.2 of Annex I,

—the examinations and tests to be carried out before, during, and after manufacture, and the frequency with which they will be carried out,

—the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the non-destructive tests in accordance with points 3.1.2 and 3.1.3 of Annex I, etc.,

—the means of monitoring the achievement of the required design and pressure equipment quality and the effective operation of the quality system.

3.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the auditing team shall have at least one member experienced as assessor in the pressure equipment technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises.

The auditing team shall review the technical documentation referred to in point 3.1, second indent, to verify the manufacturer’s ability to identify the applicable requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the pressure equipment with those requirements.

The manufacturer or his authorised representative shall be notified of the decision. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

3.4.The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

3.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

4.1.The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2.The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:

—the quality system documentation,

—the quality records provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.,

—the quality records provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

4.3.The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. The frequency of periodic audits shall be such that a full reassessment is carried out every three years.

4.4.In addition, the notified body may pay unexpected visits to the manufacturer.

The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors shall be considered in the visit control system:

—the category of the equipment,

—the results of previous surveillance visits,

—the need to follow up corrective action(s),

—special conditions linked to the approval of the system, where applicable,

—significant changes in manufacturing organisation, policy or techniques.

During such visits, the notified body may, if necessary, carry out product tests, or have them carried out, in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

5. CE marking and EU declaration of conformity

5.1.The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual item of pressure equipment that satisfies the applicable requirements of this Directive.

5.2.The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment model for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

6. The manufacturer shall, for a period ending 10 years after the pressure equipment has been placed on the market, keep at the disposal of the national authorities:

—the technical documentation referred to in point 3.1,

—the documentation concerning the quality system referred to in point 3.1,

—the change referred to point 3.4, as approved,

—the decisions and reports of the notified body referred to in points 3.3, 3.4, 4.3 and 4.4.

7. Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued.

8. Authorised representative

The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

12. MODULE H1: CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION

1. Conformity based on full quality assurance plus design examination and special surveillance of the final assessment is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 6, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfy the requirements of the Directive that apply to it.

2. Manufacturing

The manufacturer shall operate an approved quality system for design, manufacture and final product inspection and testing of the products concerned as specified in point 3 and shall be subject to surveillance as specified in point 5. The adequacy of the technical design of the pressure equipment shall have been examined in accordance with point 4.

3. Quality system

3.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the pressure equipment concerned.

The application shall include:

—the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

—the technical documentation for one model of each type of pressure equipment intended to be manufactured. The technical documentation shall, wherever applicable, contain at least the following elements:

—a general description of the pressure equipment,

—conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

—descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment,

—a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

—results of design calculations made, examinations carried out, etc.,

—test reports,

—the documentation concerning the quality system,

—a written declaration that the same application has not been lodged with any other notified body.

3.2.The quality system shall ensure compliance of the pressure equipment with the requirements of this Directive that apply to it.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

—the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality,

—the technical design specifications, including standards, that will be applied and, where relevant harmonised standards will not be applied in full, the means that will be used to ensure that the essential safety requirements of the Directive that apply to the pressure equipment will be met,

—the design control and design verification techniques, processes and systematic actions that will be used when designing the pressure equipment pertaining to the pressure equipment type covered, particularly with regard to materials in accordance with point 4 of Annex I,

—the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used, particularly the procedures for the permanent joining of parts as approved in accordance with point 3.1.2 of Annex I,

—the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

—the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the non-destructive tests in accordance with points 3.1.2 and 3.1.3 of Annex I, etc.,

—the means of monitoring the achievement of the required design and pressure equipment quality and the effective operation of the quality system.

3.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.

It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant pressure equipment field and pressure equipment technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises.

The auditing team shall review the technical documentation referred to in point 3.1, second indent, to verify the manufacturer’s ability to identify the applicable requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the pressure equipment with those requirements.

The manufacturer or his authorised representative shall be notified of the decision.

The notification shall contain the conclusions of the audit and the reasoned assessment decision.

3.4.The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

3.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a re-assessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

3.6.Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued.

4. Design examination

4.1.The manufacturer shall lodge an application for examination of the design of each item of pressure equipment not covered by a previous design examination with the notified body referred to in point 3.1.

4.2.The application shall make it possible to understand the design, manufacture and operation of the pressure equipment, and to assess the conformity with the requirements of this Directive that apply to it. It shall include:

—the name and address of the manufacturer,

—a written declaration that the same application has not been lodged with any other notified body,

—the technical documentation. The documentation shall make it possible to assess the conformity of the pressure equipment with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design and operation of the pressure equipment. The technical documentation shall, wherever applicable, contain at least the following elements:

—a general description of the pressure equipment,

—conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

—descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment,

—a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive, where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

—results of design calculations made, examinations carried out, etc., and

—test reports,

—the supporting evidence for the adequacy of the technical design. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards have not been applied in full, and shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer or by another testing laboratory on his behalf and under his responsibility.

4.3.The notified body shall examine the application, and where the design meets the requirements of this Directive that apply to the pressure equipment it shall issue an EU design examination certificate to the manufacturer. The certificate shall give the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for identification of the approved design. The certificate may have one or more annexes attached.

The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured products with the examined design to be evaluated, and to allow for in-service control, where applicable.

Where the design does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue a design examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

4.4.The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of this Directive, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

The manufacturer shall keep the notified body that has issued the EU design examination certificate informed of any modification to the approved design that may affect the conformity with the essential safety requirements of this Directive or the conditions for validity of the certificate. Such modifications shall require additional approval — from the notified body that issued the EU design examination certificate — in the form of an addition to the original EU design examination certificate.

4.5.Each notified body shall inform its notifying authorities of the EU design examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of the EU design examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or additions thereto which it has issued.

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU design examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and of the results of the examinations carried out by the notified body.

The notified body shall keep a copy of the EU design examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer until the expiry of the validity of the certificate.

4.6.The manufacturer shall keep a copy of the EU design examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market.

5. Surveillance under the responsibility of the notified body

5.1.   The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

5.2.   The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:

—the quality system documentation,

—the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.,

—the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

5.3.   The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. The frequency of periodic audits shall be such that a full reassessment is carried out every three years.

5.4.   In addition, the notified body may pay unexpected visits to the manufacturer.

The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system:

—the category of the equipment,

—the results of previous surveillance visits,

—the need to follow up corrective action(s),

—special conditions linked to the approval of the system, where applicable,

—significant changes in manufacturing organisation, policy or techniques.

During such visits, the notified body may, if necessary, carry out product tests, or have them carried out, in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

5.5.   Special surveillance of the final assessment

Final assessment as referred to in section 3.2 of Annex I is subject to increased surveillance in the form of unexpected visits by the notified body. In the course of such visits, the notified body shall conduct examinations on the pressure equipment.

It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

6. CE marking and EU declaration of conformity

6.1.The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual item of pressure equipment that satisfies the applicable requirements of this Directive.

6.2.The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment model for which it has been drawn up and shall mention the number of the design examination certificate.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

7. The manufacturer shall, for a period ending 10 years after the pressure equipment has been placed on the market, keep at the disposal of the national authorities:

—the documentation concerning the quality system referred to in point 3.1,

—the change referred to in point 3.5, as approved,

—the decisions and reports of the notified body referred to in points 3.5, 5.3 and 5.4.

8. Authorised representative

The manufacturer’s authorised representative may lodge the application referred to in points 4.1 and 4.2 and fulfil the obligations set out in points 3.1, 3.5, 4.4, 4.6, 6 and 7, on his behalf and under his responsibility, provided that they are specified in the mandate.


ANNEX IV

EU DECLARATION OF CONFORMITY (No XXXX)  (1)

1.Pressure equipment or assembly (product, type, batch or serial number):

2.Name and address of the manufacturer and, where applicable, his authorised representative:

3.This declaration of conformity is issued under the sole responsibility of the manufacturer.

4.Object of the declaration (identification of pressure equipment or assembly allowing traceability; it may, where necessary for the identification of the pressure equipment or assembly, include an image):

—description of the pressure equipment or assembly,

—conformity assessment procedure followed,

—in the case of assemblies, description of the pressure equipment constituting the assembly, and the conformity assessment procedures followed,

5.The object of the declaration described above is in conformity with the relevant Union harmonisation legislation:

6.References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared:

7.Where appropriate, the name, address and number of the notified body which carried out the conformity assessment and the number of the certificate issued, and a reference to the EU-type examination certificate – production type, EU-type examination certificate – design type, EU design examination certificate or certificate of conformity.

8.Additional information:

Signed for and on behalf of:

(place and date of issue):

(name, function) (signature):

(where appropriate, particulars of the signatory authorised to sign the legally binding declaration for the manufacturer or his authorised representative)


(1) It is optional for the manufacturer to assign a number to the declaration of conformity.


ANNEX V

PART A

Repealed Directive with list of the successive amendments thereto

(referred to in Article 50)

Directive 97/23/EC of the European Parliament and of the Council

(OJ L 181, 9.7.1997, p. 1).
Regulation (EC) No 1882/2003 of the European Parliament and of the Council

(OJ L 284, 31.10.2003, p. 1).
Only point 13 of Annex I
Regulation (EU) No 1025/2012 of the European Parliament and of the Council

(OJ L 316, 14.11.2012, p. 12).
Only point (f) of Article 26(1)


PART B

Time-limit for transposition into national law and date of application

(referred to in Article 49)

DirectiveTime-limit for transpositionDate of application
97/23/EC29 May 199929 November 1999 (1)


(1) In accordance with Article 20(3) of Directive 97/23/EC, Member States shall permit the putting into service of pressure equipment and assemblies which comply with the regulations in force in their territory at the date of application of the Directive beyond that date.


ANNEX VI

CORRELATION TABLE

Directive 97/23/ECThis Directive
Article 1(1)Article 1(1)
Article 1(2)Article 2(1) to (14)
Article 1(3)Article 1(2)
—Article 2(15) to (32)
Article 2Article 3
Article 3Article 4
Article 4(1)Article 5(1)
Article 4(2)Article 5(3)
—Article 6
—Article 7
—Article 8
—Article 9
—Article 10
—Article 11
Article 5—
Article 6—
—Article 12(1)
Article 7(1)Article 45
Article 7(2)Article 44(1)
Article 7(3)—
Article 7(4)Article 44(5), second subparagraph
Article 8—
Article 9(1)Article 13(1), introductory sentence
Article 9(2) point 1—
—Article 13(1)(a)
Article 9(2) point 2Article 13(1)(b)
Article 9(3)Article 13(2)
Article 10Article 14
Article 11(1)Article 15(1)
Article 11(2)Article 15(2)
Article 11(3)Article 15(3)
Article 11(4)Article 12(2)
—Article 15(4)
Article 11(5)Article 15(5)
—Article 15(6)
Article 12—
Article 13—
Article 14(1)Article 16(1)
Article 14(2)Article 5(2)
Article 14(3) to (8)Article 16(2) to (7)
Article 14(9) and (10)—
—Article 17
—Article 18
Article 15(1)—
Article 15(2)Article 19(1)
Article 15(3)Article 19(2)
Article 15(4) and (5)—
—Article 19(3) to (6)
—Article 20
—Article 21
—Article 22
—Article 23
—Article 24
—Article 25
—Article 26
—Article 27
—Article 28
—Article 29
—Article 30
—Article 31
—Article 32
—Article 33
—Article 34
—Article 35
—Article 36
—Article 37
—Article 38
Article 16—
Article 17—
Article 18—
—Article 39
—Article 40
—Article 41
—Article 42
—Article 43
—Article 44(2) to (4)
—Article 44(5), first subparagraph
—Article 46
—Article 47
Article 19—
Article 20(1) to (2)—
Article 20(3)Article 48(1)
—Article 48(2) and (3)
—Article 49
—Article 50
—Article 51
Article 21Article 52
Annex IAnnex I
Annex IIAnnex II
Annex III, introductory wordingAnnex III, introductory wording
Annex III, Module AAnnex III, point 1, Module A
Annex III, Module A1Annex III, point 2, Module A2
Annex III, Module BAnnex III, point 3.1, Module B, EU-type examination – production type
Annex III, Module B1Annex III, point 3.2, Module B, EU-type examination – design type
Annex III, Module C1Annex III, point 4, Module C2
Annex III, Module DAnnex III, point 5, Module D
Annex III, Module D1Annex III, point 6, Module D1
Annex III, Module EAnnex III, point 7, Module E
Annex III, Module E1Annex III, point 8, Module E1
Annex III, Module FAnnex III, point 9, Module F
Annex III, Module GAnnex III, point 10, Module G
Annex III, Module HAnnex III, point 11, Module H
Annex III, Module H1Annex III, point 12, Module H1
Annex IV—
Annex V—
Annex VI—
Annex VIIAnnex IV
—Annex V
—Annex VI


STATEMENT OF THE EUROPEAN PARLIAMENT

The European Parliament considers that only when and insofar as implementing acts in the sense of Regulation (EU) No 182/2011 are discussed in meetings of committees, can the latter be considered as ‘comitology committees’ within the meaning of Annex I to the Framework Agreement on the relations between the European Parliament and the European Commission. Meetings of committees thus fall within the scope of point 15 of the Framework Agreement when and insofar as other issues are discussed.