Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (recast) Text with EEA relevance

That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 44(2).

Article 34

Operational obligations of notified bodies, user inspectorates and recognised third party organisations

Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the pressure equipment or assembly technology in question and the mass or serial nature of the production process.

In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the pressure equipment with the requirements of this Directive.

Article 35

Appeal against decisions of notified bodies, recognised third party organisations and user inspectorates

Member States shall ensure that appeal procedures against decisions of notified bodies, recognised third-party organisations and user inspectorates are available.

Article 36

Information obligation on notified bodies, recognised third party organisations and user inspectorates

• (a) any refusal, restriction, suspension or withdrawal of a certificate;

• (b) any circumstances affecting the scope of or conditions for notification;

• (c) any request for information which they have received from market surveillance authorities regarding conformity assessment activities;

• (d) on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.

Article 37

Exchange of experience

The Commission shall provide for the organisation of exchange of experience between the Member States’ national authorities responsible for notification policy.

Article 38

Coordination of notified bodies, recognised third-party organisations and user inspectorates

The Commission shall ensure that appropriate coordination and cooperation between the conformity assessment bodies notified under this Directive are put in place and properly operated in the form of a sectoral group or groups of conformity assessment bodies.

Member States shall ensure that the conformity assessment bodies notified by them participate in the work of that or those group or groups, directly or by means of designated representatives.

CHAPTER 5 UNION MARKET SURVEILLANCE, CONTROL OF PRESSURE EQUIPMENT AND ASSEMBLIES ENTERING THE UNION MARKET, AND UNION SAFEGUARD PROCEDURE

Article 39

Union market surveillance and control of pressure equipment and assemblies entering the Union market

Article 15 (3) and Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to pressure equipment and assemblies covered by Article 1 of this Directive.

Article 40

Procedure for dealing with pressure equipment or assemblies presenting a risk at national level

Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the equipment or assembly does not comply with the requirements laid down in this Directive, they shall without delay require the relevant economic operator to take all appropriate corrective actions to bring the pressure equipment or assembly into compliance with those requirements, to withdraw the equipment or assembly from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe.

The market surveillance authorities shall inform the relevant notified body accordingly.

Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph.

The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.

• (a) failure of the equipment or assembly to meet requirements relating to the health or safety of persons or to the protection of domestic animals or property; or

• (b) shortcomings in the harmonised standards referred to in Article 12 conferring a presumption of conformity.

Article 41

Union safeguard procedure

The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.

Article 42

Compliant pressure equipment or assemblies which present a risk

The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 44(3).

On duly justified imperative grounds of urgency relating to the protection of health and safety of persons, or of domestic animals or of property, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 44(4).

Article 43

Formal non-compliance

• (a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 19 of this Directive;

• (b) the CE marking has not been affixed;

• (c) the identification number of the notified body involved in the production control phase, has been affixed in violation of Article 19 or has not been affixed;

• (d) the marking and labelling referred to in point 3.3. of Annex I have not been affixed or have been affixed in violation of Article 19 or point 3.3 of Annex I;

• (e) the EU declaration of conformity has not been drawn up;

• (f) the EU declaration of conformity has not been drawn up correctly;

• (g) the technical documentation is either not available or not complete;

• (h) the information referred to in Article 6(6) or Article 8(3) is absent, false or incomplete;

• (i) any other administrative requirement provided for in Article 6 or Article 8 is not fulfilled.

CHAPTER 5a EMERGENCY PROCEDURES

Article 43a

Application of emergency procedures

However, Article 43c(7) of this Directive shall apply during the internal market emergency mode and after its expiry or deactivation.

Article 43b

Prioritisation of the conformity assessment of pressure equipment and assemblies designated as crisis-relevant goods

Article 43c

Derogation from the conformity assessment procedures requiring the mandatory involvement of a notified body

The pressure equipment or assemblies subject to the extension of validity referred to in the first subparagraph shall bear the information that they are placed on the market or used for the manufacturer’s own purposes as a ‘crisis-relevant good’. The implementing act referred to in the first subparagraph shall specify the content and presentation of that information. That information, as well as any labelling, shall be clear, understandable and intelligible and, where relevant, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

• (a) a description of the procedures by means of which compliance with the applicable essential safety requirements set out in Annex I to this Directive was successfully demonstrated;

• (b) any specific requirements regarding the traceability of the pressure equipment or assembly concerned;

• (c) an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the internal market emergency mode has been activated in accordance with Article 18 of Regulation (EU) 2024/2747;

• (d) any specific requirements regarding the need to ensure a continuous conformity assessment with respect to the pressure equipment or assembly concerned;

• (e) measures to be taken upon expiry or deactivation of the internal market emergency mode with respect to the pressure equipment or assembly concerned that has been placed on the market or used for the manufacturer’s own purposes.

Article 43d

Presumption of conformity based on standards and common specifications

• (a) where a reference to harmonised standards covering the applicable essential safety requirements set out in Annex I to this Directive has not been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period; or

• (b) where severe disruptions to the functioning of the internal market, which led to the activation of the internal market emergency mode in accordance with Article 18 of Regulation (EU) 2024/2747, significantly restrict the possibilities of manufacturers to make use of the harmonised standards that cover the applicable essential safety requirements set out in Annex I to this Directive and the references of which have already been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Article 43e

Prioritisation of market surveillance activities and mutual assistance among authorities

CHAPTER 6 COMMITTEE PROCEDURE AND DELEGATED ACTS

Article 44

Committee procedure

The committee may furthermore examine any other matter concerning the application of this Directive raised either by its chair or by a representative of a Member State in accordance with its rules of procedure.

Article 45

Delegated power

• (a) make an item or family of pressure equipment referred to in Article 4(3) subject to the requirements of Article 4(1);

• (b) make an assembly or family of assemblies referred to in Article 4(3) subject to the requirements of Article 4(2);

• (c) classify an item or family of pressure equipment, by way of derogation from the requirements of Annex II, in another category.

Article 46

Exercise of the delegation

CHAPTER 7 TRANSITIONAL AND FINAL PROVISIONS

Article 47

Penalties

Member States shall lay down rules on penalties applicable to infringements by economic operators of the provisions of national law adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. Such rules may include criminal penalties for serious infringements.

The penalties referred to in the first paragraph shall be effective, proportionate and dissuasive.

Article 48

Transitional provisions

Article 49

Transposition

They shall apply those measures from 1 June 2015.

When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to Article 9 of Directive 97/23/EC shall be construed as references to Article 13 of this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated.

They shall apply those measures from 19 July 2016.

When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to the Directive repealed by this Directive shall be construed as references to this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated.

Article 50

Repeal

Article 9 of Directive 97/23/EC is deleted with effect from 1 June 2015, without prejudice to the obligations of the Member States relating to the time-limit for transposition into national law and the date of application of that Article, set out in Annex V, Part B.

Directive 97/23/EC, as amended by the acts listed in Annex V, Part A, is repealed with effect from 19 July 2016, without prejudice to the obligations of the Member States relating to the time-limit for transposition into national law and the date of application of the Directive set out in Annex V, Part B.

References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex VI.

Article 51

Entry into force and application

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 1 , points 1 to 14 of Article 2, Articles 3, 4, 5, 14, 15 and 16, Article 19(1) and (2), and Articles 44, 45 and 46 shall apply from 19 July 2016.

Article 52

Addressees

This Directive is addressed to the Member States.

ANNEX I

ESSENTIAL SAFETY REQUIREMENTS

PRELIMINARY OBSERVATIONS

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

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

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

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

1. GENERAL

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

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

• — 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.

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Article 4 , paragraph 3

Table 1

Vessels referred to in Article 4(1)(a)(i), first indent