S.I. No. 233/2017 - European Union (Pressure Equipment) Regulations 2017

• (i) any product or partly completed product which is in the possession or under the control of such person, and

• (ii) any records, and in the case of such information in a non-legible form, to reproduce it in a legible form, and to give to the inspector such information as the inspector may reasonably require in relation to any entries in those records;

• (e) inspect and take copies of or extracts from any such records or any electronic information system at that place, including in the case of information in a non-legible form, copies of or extracts from such information in a permanent legible form or require that such copies be provided;

• (f) require a person at or in that place by whom or on whose behalf a computer is or has been used to produce or store records or any person having control of, or otherwise concerned with the operation of the computer, to afford the inspector access thereto and all reasonable assistance as the inspector may require;

• (g) remove from that place and retain the records (including documents stored in a non-legible form) and copies taken and detain the records for such period as the inspector reasonably considers to be necessary for further examination or until the conclusion of any legal proceedings;

• (h) require that records at or in that place be maintained for such period as may be reasonable;

• (i) require the person in charge to give the inspector such information as the inspector may reasonably require for the purposes of any search, examination, investigation, inspection or inquiry under these Regulations;

• (j) require the person in charge to give the inspector such assistance and facilities within the person’s power or control as are reasonably necessary to enable the inspector to exercise any of his or her powers under these Regulations;

• (k) require by notice, at a time and place specified in the notice, any person (including the person in charge) to give the inspector any information that the inspector may reasonably require in relation to the place, any product, equipment, item, activity, installation or procedure at or in the place, and to produce to the inspector any records that are under that person’s power or control;

• (l) examine any person whom the inspector reasonably believes to be able to give to the inspector information relevant to any search, examination, investigation, inspection or inquiry under these Regulations and require the person to answer such questions as the inspector may ask relative to the search, examination, investigation, inspection or inquiry and to sign a declaration of the truth of the answers;

• (m) require that any procedure be followed for the purposes of any search, examination, investigation, inspection or inquiry under these Regulations;

• (n) take any measurements or photographs or make any tape, electrical or other recordings that the inspector considers necessary for the purposes of any search, examination, investigation, inspection or inquiry under the Directive or these Regulations;

• (o) take samples of air, soil, water or waste at or near that place;

• (p) where appropriate, install, use and maintain at that place monitoring instruments, systems and seals for the purposes of the Directive or these Regulations;

• (q) at that place, or at any other location, carry out, or have carried out, such testing, examination or analysis of any item or product found at that place, as he or she reasonably considers to be necessary, and for that purpose—

• (i) require the person in charge to supply to the inspector without charge any product, equipment or item, or samples thereof, or

• (ii) remove, or have removed, to another location, any product, equipment or item, or samples thereof;

• (r) cause any pressure equipment or assembly found at that place in respect of which there has been or there appears to the inspector to have been a contravention of the Directive or these Regulations, to be subjected to any testing, examination or analysis in accordance with subparagraph (q) (but not so as to damage or destroy it unless necessary for the purposes of the Directive or these Regulations) and where an inspector proposes to exercise the power conferred by this subparagraph in the case of any such product found at any place, he or she shall, if so requested by the person in charge, cause anything that is to be done by virtue of that power to be done in the presence of that person, save that the person in charge is responsible for his or her own costs in attending at the exercise of the inspector’s powers and cannot unreasonably delay the inspector in the exercise of those powers;

• (s) remove and retain for such period as is necessary any product, equipment or item found at that place for all or any of the following purposes:

• (i) to examine or arrange for the examination, testing or analysis of the product, equipment or item;

• (ii) to ensure that it is not tampered with before the examination of it under subparagraph (i) is completed;

• (iii) to ensure that it is available for use as evidence in any proceedings;

• (t) where necessary—

• (i) require the disposal of any product presenting a serious risk in respect of which there has been or there appears to the inspector to have been a contravention of the Directive or these Regulations at the expense of the person in charge, or remove that product and arrange for it to be disposed of at the expense of the person in charge, and

• (ii) require that such disposal shall be—

• (I) such as will prevent the product from being used or placed or made available on the market, and

• (II) in compliance with requirements under the Waste Management Acts 1996 to 2003;

• (u) require the recall or removal from the market of a product by the person who has placed or made available that product on the market, where it appears to the inspector that, in relation to that product, the Directive or these Regulations have been contravened.

• (2) Where a product is found at a place, and an inquiry is made by an inspector in the course of a search, examination, investigation or inspection as to the identity of the person who supplied that product, the person in charge shall give the inspector the name and address of the supplier from whom the product was purchased or otherwise obtained.

• (3) Before exercising any of the powers conferred by subparagraphs (q) to (t) of paragraph (1), an inspector shall, in so far as it is practicable, consult such persons as appear to him or her to be appropriate for the purpose of ascertaining what dangers, if any, there may be in doing what he or she proposes to do under those subparagraphs.

• (4) An inspector shall not enter a dwelling other than—

• (a) with the consent of the occupier, or

• (b) in accordance with a warrant of the District Court issued under paragraph (7) authorising such entry.

• (5) The market surveillance authority may authorise such and so many other persons as it considers appropriate to accompany an inspector in the performance of his or her functions.

• (6) Where an inspector in the exercise of his or her powers under this Regulation is prevented from entering any of the places or premises specified in Regulation 36(1)(a), an application may be made to the District Court for a warrant under paragraph (7) authorising such entry.

• (7) Without prejudice to the powers conferred on an inspector by or under any other provision of this Regulation, if a judge of the District Court is satisfied by information on oath of an inspector that there are reasonable grounds for believing that—

• (a) there is any product, equipment or item at any place or premises any records (including documents stored in a non-legible form) or information, relating to a place, premises or to any pressure equipment or assembly, that the authorised officer requires to inspect for the purposes of these Regulations, held at any place or premises, or

• (b) there is, or such an inspection is likely to disclose, evidence of a contravention of the Directive or these Regulations,

the judge may issue a warrant authorising an inspector, accompanied by such other inspectors or such other competent persons as may be appropriate or members of the Garda Síochána as may be necessary, at any time or times, within one month from the date of issue of the warrant, on production of the warrant if requested, to enter that place or premises, if necessary by the use of reasonable force, and perform the functions conferred on an inspector by or under these Regulations.

• (8) Where an inspector has reasonable grounds for apprehending any serious obstruction in the performance of his or her functions or otherwise considers it necessary, he or she may be accompanied by a member or members of the Garda Síochána and by any other person or persons authorised by the market surveillance authority, when performing any functions conferred on him or her by or under these Regulations.

• (9) Where an inspector, upon reasonable grounds, believes that a person has committed an offence under these Regulations he or she may require that person to provide him or her with the person’s name and the address at which the person ordinarily resides.

• (10) A statement or admission made by a person pursuant to a requirement under paragraph (1)(i), (k) or (l) shall not be admissible in proceedings brought against that person for an offence (other than an offence under Regulation 46(4)) relating to a breach of, or failure to comply with, an obligation in the said paragraph (1) (i), (k) or (l).

Measures entailing refusal or restriction

• (a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No. 765/2008, Article 19 of the Directive, or Regulation 21 of these Regulations,

• (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 of the Directive or Regulation 21(5) or has not been affixed,

• (d) the marking and labelling referred to in point 3.3 of Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations, have not been affixed or have been affixed in violation of Regulation 21 or point 3.3 of Annex I to the Directive,

• (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 Regulation 7(i) or Regulation 9(2)(d) is absent, false or incomplete,

• (i) any other administrative requirement provided for in Article 6 or 8 of the Directive or Regulation 7 or Regulation 9 is not fulfilled,

may issue a direction in writing to the relevant economic operator to put an end to the non-compliance observed within a specified timeframe.

Contravention notice

• (a) is contravening or has contravened any of the provisions of the Directive or these Regulations, or

• (b) has failed to comply with a direction under Regulation 37,

may serve a notice on the person who has or may reasonably be presumed to have control of the activity concerned.

• (2) A contravention notice shall—

• (a) state that the inspector is of the opinion referred to in paragraph (1),

• (b) specify the grounds for the inspector being of the opinion referred to in paragraph (1) and specify the Regulation or Regulations concerned,

• (c) identify the relevant provision in respect of which that opinion is held,

• (d) direct the person, where required, to—

• (i) remedy, by a date specified in the notice, the contravention or the matters occasioning that notice, or

• (ii) cease placing or making available the product on the market or putting it into use,

• (iii) remove the product from the market,

• (iv) recall the product,

• (v) dispose of the product,

• (vi) destroy the product where it presents a serious risk,

by a date specified in the notice that shall not be earlier than the end of the period within which an appeal may be made under Regulation 39(1),

• (e) include information regarding the making of an appeal under Regulation 39(1) and (2),

• (f) include any other requirement that the inspector considers appropriate, and

• (g) state that if the person to whom the notice is addressed fails to take such measures as are specified in the notice within the time period specified in that notice, that person commits an offence, and

• (h) be signed and dated by the inspector.

• (3) A contravention notice may include directions—

• (a) as to the measures to be taken to remedy any contravention or matter to which the notice relates, or to otherwise comply with the notice, and

• (b) to bring the notice to the attention of any person who may be affected by it, or the public generally.

• (4) A person on whom a contravention notice has been served who is of the opinion that the contravention notice has been complied with shall confirm in writing to the inspector that the matters referred to in the notice have been so remedied.

• (5) Where a person on whom a contravention notice has been served so confirms in writing to the inspector in accordance with paragraph (4) that the matters referred to in the contravention notice have been remedied, the inspector shall, on being satisfied that the matters have been so remedied, within one month of receipt of such confirmation, give notice to the person concerned of compliance with the contravention notice.

• (6) An inspector may—

• (a) withdraw or amend a contravention notice at any time, or

• (b) where no appeal is made or pending under Regulation 39(1), extend the period specified under paragraph 2(d) of this Regulation.

• (7) Where there is no appeal under Regulation 39(1), the contravention notice shall take effect on the later of—

• (a) the end of the period for making an appeal, or

• (b) the day specified in the notice.

• (8) A person shall comply with a contravention notice under this Regulation.

Appeal against contravention notice

• (2) A person who appeals under paragraph (1) shall at the same time notify the market surveillance authority of the appeal and the grounds for the appeal and the authority shall be entitled to appear, be heard and adduce evidence on the hearing of the appeal.

• (3) Where an appeal under paragraph (1) is taken, and the contravention notice is not cancelled, the notice shall take effect on the later of—

• (a) the day next following the day on which the notice is confirmed on appeal or the appeal is withdrawn, or

• (b) the day specified in the notice.

• (4) Subject to paragraph (5), in the case of a product which the inspector does not consider to present a serious risk requiring rapid intervention under Article 20 of EU Regulation 765/2008, the intended recipient of a measure referred to in Regulation 38(1) shall have the opportunity to make representations within 10 working days of first being advised of the inspector’s intention, to the market surveillance authority in advance of the measure being taken.

• (5) Where, due to the urgency of the measure referred to in Regulation 38(1), as justified in particular by public health, security or safety requirements, it is not possible to give the person concerned the opportunity to make representations in advance of the measure being taken, the market surveillance authority shall give such opportunity, as soon as may be, thereafter.

Prohibition notice

• (a) on the person who is or who may reasonably be presumed to be in control of the activity concerned, where that inspector is of the opinion that at any place there is occurring or is likely to occur any activity relating to a product that gives rise to or is likely to give rise to a serious risk requiring rapid intervention, including a serious risk the effects of which are not immediate, or

• (b) on any person in relation to a product in respect of which a direction under Regulation 37 or a contravention notice has been issued but not complied with.

• (2) A prohibition notice shall—

• (a) state that the inspector is of the opinion referred to in paragraph (1),

• (b) state the reason for that opinion,

• (c) specify the activity in respect of which that opinion is held,

• (d) where in the opinion of the inspector the activity involves a contravention, or likely contravention of any provision of the Directive or these Regulations, specify the provision,

• (e) prohibit the carrying on of the activity concerned until the matters that give rise or are likely to give rise to the risk are remedied,

• (f) inform the person concerned that he or she may appeal the prohibition notice to the District Court in accordance with Regulation 41(1),

• (g) state that if the person to whom the prohibition notice is addressed fails to comply with the notice within the time period specified in the notice, the person commits an offence, and

• (h) be signed and dated by the inspector.

• (3) A prohibition notice may include directions—

• (a) as to the measures to be taken to remedy any contravention or matter to which the notice relates, or to otherwise comply with the notice, and

• (b) to bring the notice to the attention of any person who may be affected by it, or to the attention of the public generally.

• (4) A prohibition notice shall take effect—

• (a) when the notice is received by the person on whom it is served, or

• (b) where an appeal is brought against the prohibition notice, on the day immediately following—

• (i) the day on which the notice is confirmed on appeal or the appeal is withdrawn, or

• (ii) the day specified in the notice,

whichever occurs later.

• (5) A person on whom a prohibition notice has been served who is of the opinion that the matters referred to in the prohibition notice have been remedied by the date specified in the notice shall confirm in writing to the inspector that those matters have been so remedied.

• (6) Where a person on whom a prohibition notice has been served confirms in writing to the inspector in accordance with paragraph (5) that the matters referred to in the prohibition notice have been remedied, the inspector shall, on being satisfied that the matters have been so remedied, within one month of receipt of such confirmation, give notice to the person concerned of such compliance with the prohibition notice.

• (7) An inspector may at any time withdraw a prohibition notice if—

• (a) the inspector is satisfied that the activity to which the notice relates no longer gives rise to a serious risk to safety or health, or

• (b) the inspector is satisfied that the notice was issued in error or is incorrect in some material respect.

• (8) A person shall comply with a prohibition notice under this Regulation.

Appeal against prohibition notice

• (2) Where, on the hearing of an appeal under this Regulation, a prohibition notice is confirmed, notwithstanding Regulation 40(4), the judge by whom the appeal is heard may, on the application of the appellant, suspend the operation of the prohibition notice for such period as in the circumstances of the case the judge considers appropriate.

• (3) A person who—

• (a) brings an appeal under paragraph (1), or

• (b) applies for the suspension of the operation of a prohibition notice under this Regulation,

shall at the same time notify the market surveillance authority of the appeal or the application, and the grounds for the appeal or application.

• (4) In the case of an appeal or any application to suspend the operation of the prohibition notice under this Regulation, the market surveillance authority shall be entitled to appear, be heard and adduce evidence on the hearing of the appeal or application.

• (5) The bringing of an appeal against a prohibition notice shall not have the effect of suspending the operation of the notice but the appellant may apply to the court to have the operation of the notice suspended until the appeal is disposed of and, on such application, the court may, if it thinks proper to do so, direct that the operation of the notice be suspended until the appeal is disposed of.

Order of the High Court

• (2) The High Court may, upon an application under this Regulation, order the person on whom the prohibition notice concerned was served to cease doing such acts as the High Court directs.

Information notice

• (2) Upon the written application of the person on whom the notice is served, the period specified in the information notice may be extended by and at the discretion of—

• (i) the market surveillance authority, or

• (ii) an inspector.

• (3) A person on whom an information notice is served may, within 7 days beginning on the day on which the notice is served on him or her, appeal against the notice to a judge of the District Court in the district court district in which the notice was served and in determining the appeal the judge may, if he or she is satisfied that it is reasonable to do so, confirm, vary or cancel the notice.

• (4) A person who appeals under paragraph (3) shall at the same time notify the market surveillance authority of the appeal and the grounds for the appeal and the authority shall be entitled to appear, be heard and adduce evidence on the hearing of the appeal.

• (5) Where, on the hearing of an appeal under paragraph (3), an information notice is confirmed or varied, the judge of the District Court by whom the appeal is heard may, on the application of the appellant, suspend the operation of the notice for such period as in the circumstances of the case the judge considers appropriate.

• (6) Subject to paragraph (7), a person on whom an information notice is served shall comply with the notice before the later of—

• (a) the end of the period specified in the notice, or

• (b) where the period referred to in subparagraph (a) is extended under paragraph (2), the end of that extended period.

• (7) Where an appeal is brought under this Regulation, and the information notice to which the appeal relates is confirmed or varied or the appeal is withdrawn, the person on whom the notice is served shall comply with the notice before—

• (a) the day immediately following the day on which the notice is confirmed or varied or the appeal is withdrawn,

• (b) the end of the period specified in the notice, or

• (c) where the operation of the notice has been suspended under paragraph (5), the end of the period of suspension,

whichever occurs latest.

Service of notifications

• (a) by delivering it to the person,

• (b) by leaving it at the address at which the person carries on business or ordinarily resides or, in the case in which an address for service has been furnished, at that address,

• (c) by sending it by post in a prepaid registered letter to the address at which the person carries on business or ordinarily resides or, in a case in which an address for service has been furnished, to that address,

• (d) if the person concerned has agreed to service of notices by means of an electronic communication (within the meaning assigned by section 2 of the Electronic Commerce Act 2000 ), service by such means, provided that there is a facility for confirming receipt of electronic communication and that such receipt has been confirmed, or

• (e) if the address at which the person ordinarily resides cannot be ascertained by reasonable enquiry and the compliance notice relates to a premises, by delivering it to the premises or by affixing it in a conspicuous position on or near the premises,

• (f) by any other means that may be prescribed.

• (2) Where a notice or other document required or authorised to be served on, sent or given to a person is to be given to a person who is the owner or occupier of land or property and the name of the person cannot be ascertained by reasonable inquiry, it may be addressed to the person by using the words “the owner” or, as the case may require, “the occupier”.

• (3) For the purposes of this Regulation, a company within the meaning of the Companies Acts shall be deemed to be ordinarily resident at its registered office, and every other body corporate and every unincorporated body shall be deemed to be ordinarily resident at its principal office or place of business.

Sharing information on the application of the Directive

• (2) The market surveillance authority may, in the interest of the protection of safety, take such measures as it considers appropriate to bring to the attention of the public, any matter of concern arising from the requirements of these Regulations.

PART 7 OFFENCES AND PENALTIES

Offences

• (2) A person who contravenes a requirement of Regulation 36, 37, 38, 40 or 43 or a notice issued or measure taken thereunder commits an offence.

• (3) A person who, in relation to the CE marking or any document required for the purposes of these Regulations—

• (a) forges or counterfeits any such document,

• (b) gives or signs a document or makes a marking knowing it to be false in any material particular,

• (c) knowingly uses a marking or document so forged or counterfeited, or which is false as aforesaid,

• (d) knowingly uses as applying to any person or product a marking or document which does not so apply,

• (e) knowingly connives at any such forging, counterfeiting, giving, signing, or using,

• (f) knowingly makes a false entry in any such document which is so required to be kept, served or sent,

• (g) knowingly uses any such false entry, or

• (h) knowingly has, without lawful authority, a forged marking or document or an altered marking or document in his or her possession,

commits an offence.

• (4) Any person who obstructs or interferes with an inspector or a member of the Garda Síochána in the course of exercising a power conferred on him or her by these Regulations or a warrant under Regulation 36(7) or impedes the exercise by the inspector or member, as the case may be, of such power, or fails or refuses to comply with a request or requirement of, or to answer a question asked by, an inspector or such a member pursuant to a power conferred by these Regulations, or in purported compliance with such request or requirement, or who in answer to such question gives information to the inspector or member that he or she knows to be false or misleading in any material respect, commits an offence.

• (5) A person who falsely represents himself or herself to be an inspector commits an offence.

• (6) A person who, at any time during the period of 3 months immediately following the affixing of a notice in accordance with Regulation 44(1)(e) removes, alters, damages or defaces the notice without lawful authority commits an offence.

• (7) A person who, prevents or attempts to prevent any person from answering any question to which an inspector may require an answer under Regulation 36, commits an offence.

• (8) A person who, fails to comply with a bona fide request, instruction or directions from an inspector in the exercise of his or her functions under these Regulations, commits an offence.

• (9) Where an offence under any of these Regulations is committed by reason of a failure to do something at or within a time fixed by or under any of those provisions, the offence shall be deemed to continue until that thing is done.

• (10) A person who states to the market surveillance authority that another person has committed an offence under this Regulation or has failed to comply with a provision of these Regulations, knowing the statement to be false, commits an offence.

• (11) A person who, in purported compliance with a requirement in an information notice, furnishes information to the market surveillance authority that he or she knows to be false or misleading in a material respect commits an offence.

Penalties

• (a) on summary conviction, to a class A fine or imprisonment for a term not exceeding 6 months or both, or

• (b) on conviction on indictment, to a fine not exceeding €500,000 or imprisonment for a term not exceeding 2 years or both.

• (2) Where a person is convicted of an offence under these Regulations in proceedings brought by the market surveillance authority, or instituted following an investigation by the authority, the court shall, unless it is satisfied that there are special and substantial reasons for not so doing, order the person to pay to the authority the costs and expenses, measured by the court, incurred by the authority in relation to the investigation, detection and prosecution of the offence, including the costs and expenses incurred in the taking of samples, the carrying out of tests, examinations and analyses and in respect of the remuneration and other expenses of employees, consultants and advisers engaged by the authority.

Offences by bodies corporate

Prosecution of offences

• (2) Notwithstanding section 10(4) of the Petty Sessions (Ireland) Act 1851 , summary proceedings for an offence under Regulation 46 may be instituted at any time within 12 months from the date on which the offence was committed or alleged to have been committed.

PART 8 MISCELLANEOUS

Appeal to Circuit Court from certain orders of District Court

Notice or direction to be in writing

Immunity

Indemnification

Restrictions on the disclosure of information

• (a) for the purpose of the discharge of functions under these Regulations,

• (b) made with the consent of the person to whom the information applies, or

• (c) for the purposes of—

• (i) any legal proceedings (including by means of a report to a coroner holding an inquest under the Coroners Acts 1962 and 2005 on the body of a person whose death may have been caused through personal injury), or

• (ii) any investigation or special report under section 70 of the Act of 2005,

• (d) necessary in order to protect the health and safety of persons,

• (e) required by the provisions of these Regulations or the Directive, or

• (f) ordered by a court of law.

Transitional

• (2) Certificates and decisions issued by conformity assessment bodies under Directive 97/23/EC shall be valid under these Regulations.

Revocation

• (a) the European Communities (Pressure Equipment) Regulations 1999 ( S.I. No. 400 of 1999 ), and

• (b) the European Communities (Pressure Equipment) (Amendment) Regulations 2015 ( S.I. No. 81 of 2015 ).

Regulations 2, 6, 7, 9, 10, 13,

18, 19, 21, 22, 27,

34 and 37

SCHEDULE 1 TEXT OF ANNEX I TO THE DIRECTIVE

ESSENTIAL SAFETY REQUIREMENTS

PRELIMINARY OBSERVATIONS

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.

2.1. 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.

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 of the Directive,

• (b) where appropriate, adequate monitoring devices such as indicators and/or alarms which enable adequateaction 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.

3.1. 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 of the Directive.

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 of the Directive.

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 the 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 of the Directive and the information to be provided in accordance with Article 6(6) and Article 8(3) of the Directive, 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.

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 the 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 of the Directive,

— 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.

This pressure equipment includes:

— steam and hot-water generators as referred to in Article 4(1)(b) of the Directive, 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) of the Directive, 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.

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.

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

R e/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.

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

R m/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 R e/t and 5/12 of R m/20,

— in the case of austenitic steel:

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

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

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

— in the case of aluminium, 2/3 of R e/t,

— in the case of aluminium alloys excluding precipitation hardening alloys 2/3 of R e/t and 5/12 of R m/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.

Regulation 14

SCHEDULE 2 TEXT OF ANNEX II TO THE DIRECTIVE

CONFORMITY ASSESSMENT TABLES

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

— 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.

Table 1

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

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

Table 2

Vessels referred to in Article 4(1)(a)(i) of the Directive, second indent

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

Table 3

Vessels referred to in Article 4(1)(a)(ii) of the Directive, first indent

Table 4

Vessels referred to in Article 4(1)(a)(ii) of the Directive, second indent

Exceptionally, assemblies intended for generating warm water as referred to in the second subparagraph of Article 4(2) of the Directive, 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 Schedule 1, or to full quality assurance (Module H).

Table 5

Pressure equipment referred to in Article 4(1)(b) of the Directive

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

Table 6

Piping referred to in Article 4(1)(c)(i) of the Directive, first indent

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

Table 7

Piping referred to in Article 4(1)(c)(i) of the Directive, second indent

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

Table 8

Piping referred to in Article 4(1)(c)(ii) of the Directive, first indent

Table 9

Piping referred to in Article 4(1)(c)(ii) of the Directive, second indent

Regulations 7, 17 and 19

SCHEDULE 3 TEXT OF ANNEX III to Directive 2014/68/EU

CONFORMITY ASSESSMENT PROCEDURES