[ S.L.427.29 PRESSURE EQUIPMENT 1 SUBSIDIARY LEGISLATION 427.29 PRESSURE EQUIPMENT REGULATIONS 18th July, 2016 LEGAL NOTICE 240

2016. 1.

these regulations is the Pressure Equipment Regulations. Citation and scope.

the European Parliament and

the Council

15 May 2014 on the harmonisation

the laws

the Member States relating to the making available

pressure equipment (recast). 2.

pressure equipment and assemblies or the making available on the market

pressure equipment and assemblies covered by the Pressure Equipment Regulations, 2002, which are in conformity with those regulations and which were placed on the market before 18 July 2016 shall not be impeded.

pressure equipment and assemblies with a maximum pressure allowable pressure PS greater than 0,5 bar.

piping designed for the conveyance

any fluid or substance to or from an installation (onshore or

fshore) starting from and including the last isolation device located within the confines

the installation, including all the annexed equipment designed specifically for pipelines; this exclusion shall not apply to standard pressure equipment such as may be found in pressure reduction stations or compression stations; (b) networks for the supply, distribution and discharge

water and associated equipment and headraces such as penstocks, pressure tunnels, pressure shafts for hydroelectric installations and their related specific accessories; (c) simple pressure vessels covered by Directive 2014/29/ EU

the European Parliament and

the Council; (

1. d)aerosol dispensers covered by Council Directive 75/ 324/EEC; (
2. e)equipment intended for the functioning

vehicles Objective. 2 [ S.L.427.29 PRESSURE EQUIPMENT defined by the following legal acts: (i) Directive

the European Parliament and

the Council; (ii) Regulation (EU) No 167/2013

the European Parliament and

the Council; (iii) Regulation (EU) No 168/2013

the European Parliament and

the Council; (f) equipment classified as no higher than category I under regulation 15 and covered by one

the following Directives: (i) Directive 2006/42/EC

Parliament and

the Council; (ii) Directive 2014/33/EU

Parliament and

the Council; (iii) Directive 2014/35/EU

Parliament and

the Council; (

1. iv)Council Directive 93/42/EEC; (
2. v)Directive 2009/142/EC

Parliament and

the Council; (vi) Directive 2014/34/EU

Parliament and

the Council; the European the European the European the European the European (g) equipment covered by point (b)

Article 346

which may cause an emission

radioactivity; (

1. i)well-control equipment used in the petroleum, gas or geothermal exploration and extraction industry and in underground storage which is intended to contain and, or control well pressure; this shall comprise the wellhead (Christmas tree), the blow out preventers (BOP), the piping manifolds and all their equipment upstream; (
2. j)equipment comprising casings or machinery where the dimensioning, choice

material and manufacturing rules are based primarily on requirements for sufficient strength, rigidity and stability to meet the static and dynamic operational effects or other operational characteristics and for which pressure is not a significant design factor; such equipment may include: (

1. i)engines including turbines and internal combustion engines; (
2. ii)steam engines, gas/steam turbines, turbogenerators, compressors, pumps and actuating devices; (
3. k)blast furnaces including the furnace cooling system, hot-blast recuperators, dust extractors and blastfurnace exhaust-gas scrubbers and direct reducing cupolas, including the furnace cooling, gas converters PRESSURE EQUIPMENT [ S.L.427.29 and pans for melting, re-melting, de-gassing and casting

steel, iron and non-ferrous metals; (

1. l)enclosures for high-voltage electrical equipment such as switchgear, control gear, transformers, and rotating machines; (
2. m)pressurised pipes for the containment

transmission systems, e.g. for electrical power and telephone cables; (n) ships, rockets, aircraft and mobile

f-shore units, as well as equipment specifically intended for installation on board or the propulsion thereof; (o) pressure equipment consisting

a flexible casing, e.g. tyres, air cushions, balls used for play, inflatable craft, and other similar pressure equipment; (

1. p)exhaust and inlet silencers; (
2. q)bottles or cans for carbonated drinks for final consumption; (
3. r)vessels designed for the transport and distribution

drinks having a PS·V

not more than 500 bar·L and a maximum allowable pressure not exceeding 7 bar; (

1. s)equipment covered by Directive 2008/68/EC and Directive 2010/35/EU and equipment covered by the International Maritime Dangerous Goods Code and the Convention on International Civil Aviation; (
2. t)radiators and pipes in warm water heating systems; (
3. u)vessels designed to contain liquids with a gas pressure above the liquid

not more than 0,5 bar. 4. For the purpose

these regulations, the following definitions shall apply: "accreditation" means accreditation as defined in point 10

Article 2

Regulation (EC) No 765/2008; "assemblies" means several pieces

pressure equipment assembled by a manufacturer to constitute an integrated and functional whole; "authorised representative" means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks; "CE marking" means a marking by which the manufacturer indicates that the pressure equipment or assembly is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing; "conformity assessment body" means a body that performs conformity assessment activities including calibration, testing, certification and inspection; "conformity assessment" means the process demonstrating whether the essential safety requirements

these regulations Definitions. 3 4 [ S.L.427.29 PRESSURE EQUIPMENT relating to pressure equipment or assemblies have been fulfilled; "distributor" means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes pressure equipment or assemblies available on the market; "economic operators" means the manufacturer, the authorised representative, the importer and the distributor; " th e D i r e c t i v e " m e a n s E u r o p e a n P a r l i a m e n t a n d C ou n c i l Directive 2014/68/EU on the approximation

the laws

the Member States relating to the making available on the market

Pressure Equipment; "European approval for materials" means a technical document defining the characteristics

materials intended for repeated use in the manufacture

pressure equipment which are not covered by any harmonised standard; "fluids" means gases, liquids and vapours in pure phase as well as mixtures thereof; fluids may contain a suspension

solids; "harmonised standard" means harmonised standard as defined in point (c)

Article 2

Regulation (EU) No 1025/2012; "importer" means any natural or legal person established within the Union who places pressure equipment or assemblies from a third country on the Union market; "making available on the market" means any supply

pressure equipment or assemblies for distribution or use on the Union market in the course

a commercial activity, whether in return for payment or free

charge; "manufacturer" means any natural or legal person who manufactures pressure equipment or an assembly or has such equipment or assembly designed or manufactured, and markets that pressure equipment or assembly under his name or trademark or uses it for his own purposes; "maximum allowable pressure PS" means the maximum pressure for which the equipment is designed, as specified by the manufacturer, and defined at a location specified by him, being either the connection

protective and, or limiting devices, or the top

equipment or, if not appropriate, any point specified; "maximum/minimum allowable temperature TS" means the maximum/minimum temperatures for which the equipment is designed, as specified by the manufacturer; "national accreditation body" means national accreditation body as defined in point 11

Article 2

Regulation (EC) No 765/2008; "nominal size (DN)" means a numerical designation

size which is common to all components in a piping system other than components indicated by outside diameters or by thread size; it is a convenient round number for reference purposes and is only loosely related to manufacturing dimensions; the nominal size is designated by DN followed by a number; "permanent joints" means joints which cannot be disconnected except by destructive methods; PRESSURE EQUIPMENT [ S.L.427.29 5 "piping" means piping components intended for the transport

fluids, when connected together for integration into a pressure system; piping includes in particular a pipe or system

pipes, tubing, fittings, expansion joints, hoses, or other pressure-bearing components as appropriate; heat exchangers consisting

pipes for the purpose

cooling or heating air shall be considered as piping; "placing on the market" means the first making available

pressure equipment or assemblies on the Union market; "pressure accessories" means devices with an operational function and having pressure-bearing housings; "pressure" means pressure relative to atmospheric pressure, i.e. gauge pressure. As a consequence, vacuum is designated by a negative value; "putting into service" means the first use

pressure equipment or an assembly by its user; "recall" means any measure aimed at achieving the return

pressure equipment or assemblies that have already been made available to consumers or other users; "safety accessories" means devices designed to protect pressure equipment against the allowable limits being exceeded, including devices for direct pressure limitation, such as safety valves, bursting disc safety devices, buckling rods, controlled safety pressure relief systems (CSPRS), and limiting devices, which either activate the means for correction or provide for shutdown or shutdown and lockout, such as pressure switches or temperature switches or fluid level switches and safety related measurement control and regulation (SRMCR) devices; "technical specification" means a document that prescribes technical requirements to be fulfilled by pressure equipment or assemblies; "Union harmonisation legislation" means any Union legislation harmonising the conditions for the marketing

products; "volume (V)" means the internal volume

a chamber, including the volume

nozzles to the first connection or weld and excluding the volume

permanent internal parts; "withdrawal" means any measure aimed at preventing pressure equipment or assemblies in the supply chain from being made available on the market; ‘vessel" means a housing designed and built to contain fluids under pressure including its direct attachments up to the coupling point connecting it to other equipment; a vessel may be composed

more than one chamber. 5.

these regulations shall not prevent from Making available on the market and putting into service. 6 [ S.L.427.29 PRESSURE EQUIPMENT adopting provisions in conformity with the European Union law that are deemed necessary to ensure that persons and in particular, workers are protected when the pressure equipment or assembly in question are put into service or used, provided that this does not mean that such equipment or assembly are modified in a way not specified in these regulations.

pressure equipment or assemblies which are not in conformity with these regulations, provided that a visible sign clearly indicates that they are not in conformity and will not be placed or made available on the market until they have been brought into conformity. During demonstrations, adequate safety measures shall be taken to ensure the protection

persons. Technical requirements. 6.

PS and V greater than 25 bar·L, or with a pressure PS greater than 200 bar (Schedule II, table 1), for fluids in Group 2, with a volume greater than 1 L and a product

PS and V is greater than 50 bar·L, or with a pressure PS greater than 1 000 bar, and all portable extinguishers and bottles for breathing apparatus (Schedule II, table 2); (ii) liquids having a vapour pressure at the maximum allowable temperature

not more than 0,5 bar above normal atmospheric pressure (1 013 mbar) within the following limits: for fluids in Group 1 with a volume greater than 1 L and a product

PS and V greater than 200 bar·L, or with a pressure PS greater than 500 bar (Schedule II, table 3), for fluids in Group 2 with a pressure PS greater than 10 bar and a product

PS and V greater than 10 000 bar·L, or with a pressure PS greater than 1 000 bar (Schedule II, table 4); (b) fired or otherwise heated pressure equipment with the risk

overheating intended for generation

steam or super-heated water at temperatures higher than 110 °C having a volume greater than 2 L, and all pressure cookers (Schedule II, table 5); PRESSURE EQUIPMENT [ S.L.427.29 (

1. c)piping intended for: (
2. i)gases, liquefied gases, gases dissolved under pressure, vapours and those liquids whose vapour pressure at the maximum allowable temperature is greater than 0,5 bar above normal atmospheric pressure (1 013 mbar) within the following limits: for fluids in Group 1 with a DN greater than 25 (Schedule II, table 6), for fluids in Group 2 with a DN greater than 32 and a product

PS and DN greater than 1 000 bar (Schedule II, table 7); (ii) liquids having a vapour pressure at the maximum allowable temperature

not more than 0,5 bar above normal atmospheric pressure (1 013 mbar) within the following limits: for fluids in Group 1 with a DN greater than 25 and a product

PS and DN greater than 2 000 bar (Schedule II, table 8), for fluids in Group 2 with a PS greater than 10 bar, a DN greater than 200 and a product

PS and DN greater than 5 000 bar (Schedule II, table 9). (

1. d)safety and pressure accessories intended for equipment covered by paragraphs (a), (b), and (
2. c)including where such equipment is incorporated into an assembly.

pressure equipment covered by sub-regulation

fired or otherwise heated pressure equipment presenting a risk

overheating; (b) assemblies other than those referred to in paragraph (a), if the manufacturer intends them to be made available on the market and put into service as assemblies. By way

derogation from sub-regulation

Schedule I.

a Member State in order to ensure safe use. Pressure equipment and assemblies shall be accompanied by adequate instructions for use. Without prejudice to other applicable Union harmonisation legislation providing for its affixing, such equipment or assemblies shall not bear the CE marking referred to in regulation 20. Free movement. 7.

pressure equipment or assemblies under the conditions specified by the manufacturer shall not be prohibited, restricted or impeded provided that these comply with these regulations.

the risks due to pressure, be prohibited, restricted or impeded from being made available on the market or put into service.

pressure equipment or assemblies the conformity

which has been assessed by a user inspectorate designated by another Member State in accordance with the requirements set out in regulation 24, may not, on the grounds

the risks due to pressure, be prohibited, restricted or impeded provided that these comply with regulation 18.

pressure equipment and assemblies made available on the Maltese market, the information referred to in points 3.3 and 3.4

Schedule I, may be required to be provided in at least the Maltese or English language. Obligations

the manufacturer. 8.

a Member State.

the pressure equipment or assemblies referred to in regulation 6

conformity and affix the CE marking.

conformity for 10 years after the pressure equipment or assemblies has been placed on the market.

pressure equipment or assemblies and changes in the harmonised standards or in other technical specifications by reference to which conformity

pressure equipment or assemblies is declared shall be adequately taken into account.

consumers and other users, carry out sample testing

pressure equipment or assemblies made available on the market, investigate, and, if necessary, keep a register

complaints,

non-conforming pressure equipment and recalls

such equipment and assemblies and recalls

such equipment, and shall keep distributors informed

any such monitoring.

the eq uipm ent or assem bly does not allow it, that th e required information is provided on the packaging or in a document accompanying the equipment.

Schedule I, in at least the Maltese or English language. Such instructions and safety information shall be clear, understandable and intelligible.

the non-conformity and

any corrective measures taken.

the pressure equipment or assembly with these regulations, in at least the Maltese or English language. That information and documentation may be provided in paper or electronic form. They shall cooperate with the Technical Regulations Division, at its request, on any action taken to eliminate the risks posed by the pressure equipment or assembly which they have placed on the market. Authorised representatives. 9.

the authorised representative’s mandate.

conformity and the technical documentation at the disposal

the Technical Regulations Division for 10 years after pressure equipment has been placed on the market; (b) further to a reasoned request from the Technical Regulations Division, provide that authority with all the information and documentation necessary to demonstrate the conformity

the pressure equipment or assembly; (c) cooperate with the Technical Regulations Division, at their request, on any action taken to eliminate the risks posed by pressure equipment covered by the authorised representative’s mandate. Obligations

importers. 10.

Schedule I, and that the manufacturer has complied with the requirements set out in regulations 8

Schedule I, in at least the Maltese and English language.

consumers and other users, carry out sample testing

pressure equipment and assemblies made available on the market, investigate, and, if necessary, keep a register

complaints,

non-conforming pressure equipment or assemblies and recalls

such equipment, and shall keep distributors informed

any such monitoring.

the non-compliance and

any corrective measures taken.

the EU declaration

conformity at the disposal

the market surveillance authorities and ensure that the technical documentation can be 11 12 [ S.L.427.29 PRESSURE EQUIPMENT made available to those authorities, upon request.

pressure equipment or an assembly in at least the Maltese and English language. That information and documentation may be provided in paper or electronic form. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by pressure equipment or an assembly which they have placed on the market. Obligations

distributors. 11.

these regulations.

Schedule I, in at least the Maltese and English language, and that the manufacturer and the importer have complied with the requirements set out in regulations 8

the non-compliance and

PRESSURE EQUIPMENT [ S.L.427.29 13 any corrective measures taken.

pressure equipment or assemblies. That information and documentation may be provided in paper or electronic form. They shall cooperate with the Technical Regulations Division, at its request, on any action taken to eliminate the risks posed by the pressure equipment or assemblies which they have made available on the market. 12. An importer or distributor shall be considered a manufacturer for the purposes

these regulations and he shall be subject to the obligations

the manufacturer under regulation 8, where he places pressure equipment or an assembly on the market under his name or trademark or modifies pressure equipment or an a ss e m b l y a l r e a d y p l a c e d o n t h e m a r k e t i n su c h a w a y t h a t compliance with the requirements

these regulations may be affected. Cases in which obligations

manufacturers apply to importers and distributors. 13.

economic operators. (

1. a)any economic operator who has supplied them with pressure equipment or an assembly; (
2. b)any economic operator to whom they have supplied pressure equipment or an assembly;

which have been published in the

ficial Journal

the European Union shall be presumed to be in conformity with the essential safety requirements covered by those standards or parts thereof, referred to in Schedule I. Presumption

conformity.

pressure equipment or assemblies which are in conformity with European approvals for materials, the references

which have been published in the

ficial Journal

the European Union in accordance with regulation 17

hazard. For the purposes

such classification fluids shall be divided into the following two groups: (a) group 1 consisting

substances and mixtures, as defined in points

Article 2

Regulation Classification

pressure equipment. 14 [ S.L.427.29 PRESSURE EQUIPMENT (EC) No 1272/2008, that are classified as hazardous in accordance with the following physical or health hazard classes laid down in Parts 2 and 3

Schedule I to that Regulation: (i) unstable explosives or explosives

Divisions 1.1, 1.2, 1.3, 1.4 and 1.5; (

1. ii)flammable gases, category 1 and 2; (iii) oxidising gases, category 1; (
2. iv)flammable liquids, category 1 and 2; (
3. v)flammable liquids, category 3 where the maximum allowable temperature is above the flashpoint; (
4. vi)flammable solids, category 1 and 2; (vii) self-reactive substances and mixtures, type A to F; (viii) pyrophoric liquids, category 1; (
5. ix)pyrophoric solids, category 1; (
6. x)substances and mixtures which in contact with water emit flammable gases, category 1, 2 and 3; (
7. xi)oxidising liquids, category 1, 2 and 3; (xii) (xiii) (xiv) (
8. xv)(xvi) (xvii) oxidising solids, category 1, 2 and 3; organic peroxides types A to F; acute oral toxicity, category 1 and 2; acute dermal toxicity, category 1 and 2; acute inhalation toxicity, category 1, 2 and 3; specific target organ toxicity - single exposure, category 1. Group 1 comprises also substances and mixtures contained in pressure equipment with a maximum allowable temperature TS which exceeds the flashpoint

the fluid; (b) group 2 consisting

substances and mixtures not referred to in paragraph (a).

a number

chambers, it shall be classified in the highest category applicable to the individual chambers. Where a chamber contains several fluids, classification shall be on the basis

the fluid which requires the highest category. Conformity assessment procedures. 16.

pressure equipment shall be determined by the category, as set out in regulation 15, in which the equipment is classified.

the conformity assessment procedures which may be chosen by the manufacturer among those laid down for the category in which it is classified. The manufacturer may also choose to apply one

the procedures which apply to a higher category, if available.

quality assurance procedures for pressure equipment in categories III and IV referred to in subparagraph (i)

paragraph (a)

regulation 6

subparagraph (ii)

paragraph (a)

regulation 6

regulation 6

equipment from the manufacturing or storage premises in order to perform, or have performed, the final assessment as referred to in Schedule I, point 3.2. To this end, the manufacturer shall inform the notified body

the intended schedule

production. The notified body shall carry out at least two visits during the first year

manufacturing. The frequency

subsequent visits shall be determined by the notified body on the basis

the criteria set out in point 4.4

modules D, E and H and point 5.4

module H1.

one-

f production

vessels and pressure equipment in category III referred to in paragraph (b)

regulation 6

Schedule I, for each unit. To this end, the manufacturer shall communicate the intended schedule

production to the notified body.

each item

pressure equipment making up the assembly and referred to in regulation 6

each item

equipment; (b) the assessment

the integration

the various components

the assembly as referred to in points 2.3, 2.8 and 2.9

Schedule I which shall be determined by the highest category applicable to the equipment concerned other than that applicable to any safety accessories; (c) the assessment

the protection

an assembly against exceeding the permissible operating limits as referred to in points 2.10 and 3.2.3

Schedule I shall be conducted in the light

the highest category applicable to the items

equipment to be protected.

derogation from regulations

which the procedures referred to in sub-regulations

which is in the interests

experimentation.

ficial language

the Member State where the body responsible for carrying out these conformity assessment procedures is established, or in a language accepted by that body. European approval for materials. 17.

one or more manufacturers

materials or equipment, by one

the notified bodies referred to in regulation 22 specifically designated for that task. The notified body shall determine and perform, or arrange for the performance

, the appropriate inspections and tests to certify the conformity

the types

material with the corresponding requirements

these regulations. In the case

materials recognised as being safe to use before 29 November 1999, the notified body shall take account

the existing data when certifying such conformity.

the European approval for materials shall be sent to the Member States, the notified bodies and the European Commission.

that approval. The Commission shall keep up to date a list

such approvals in the

ficial Journal

the European Union. PRESSURE EQUIPMENT [ S.L.427.29 17

materials is covered by a harmonised standard. It shall immediately inform the other Member States, the notified bodies and the European Commission

any withdrawal

an approval. 18.

derogation from the provisions relating to the tasks carried out by the notified bodies, the Technical Regulations Division may authorise on the Maltese market the placing on the market and the putting into service by users,

pressure equipment or assemblies

which conformity with the essential safety requirements has been assessed by a user inspectorate designated in accordance with sub-regulation

which has been assessed by a user inspectorate shall not bear the CE marking.

which the inspectorate is part. The group shall apply a common safety policy as regards the technical specifications for the design, manufacture, inspection, maintenance and use

pressure equipment and assemblies.

which they are part.

the establishments satisfying the provisions

sub-regulation

which the inspectorate is part applies the criteria referred to in the second sentence

subregulation

conformity shall state that the fulfilment

essential safety requirements set out in Schedule I has been demonstrated.

conformity shall have the model structure set out in Schedule IV and shall contain the elements specified in the relevant conformity assessment procedures set out in Schedule III and shall be continuously updated. It shall be translated into at least the Maltese and English language.

conformity, a single EU declaration

conformity shall be drawn up in respect

all such Union acts. That declaration shall contain EU declaration

conformity. 18 [ S.L.427.29 PRESSURE EQUIPMENT the identification

the Union acts concerned including their publication references.

conformity, the manufacturer shall assume responsibility for the compliance

the pressure equipment or assembly with the requirements laid down in these regulations. General principles

the CE marking. 20. The CE marking shall be subject to the general principles set out in Article 30

Regulation (EC) No 765/2008. Rules and conditions for affixing the CE marking. 21.

the following: (a) each item

pressure equipment referred to in regulation 6

the CE marking is not possible or not warranted on account

the nature

the equipment or assembly, it shall be affixed to the packaging and to the accompanying documents. The item or assembly referred to in paragraphs (a) and (b)

the sub-regulation

Schedule I.

pressure equipment making up an assembly. Individual items

pressure equipment already bearing the CE marking when incorporated into the assembly shall continue to bear that marking.

pressure equipment or the assembly is placed on the market.

the notified body, where that body is involved in the production control phase. The identification number

the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative.

the regime governing the CE marking and shall take appropriate action in the event

improper use

that marking. Notification

conformity assessment bodies. 22.

the notified bodies and the user inspectorates authorised to carry out conformity assessment tasks in accordance with regulation 16, regulation 17 or regulation 18 and

the third-party organisations they have recognised, for the purposes

the tasks referred to in points 3.1.2 and 3.1.3

Schedule I.

conformity assessment bodies and the monitoring

notified bodies, including compliance with regulation 26.

their procedures for the assessment and notification

conformity assessment bodies and the monitoring

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

any changes thereto. 23.

notification under these regulations, a conformity assessment body shall meet the requirements laid down in sub-regulations

the organisation or the pressure equipment or assembly it assesses. A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance

pressure equipment or assemblies which it assesses, may, on condition that its independence and the absence

any conflict

interest are demonstrated, be considered such a body.

the pressure equipment or assembly which they assess, nor the representative

any

those parties. This shall not preclude the use

assessed pressure equipment or assemblies that are necessary for the operations

the conformity assessment body or the use

such equipment for personal purposes. (b) A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance

that pressure equipment or assembly, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence

judgement or integrity in Requirements relating to notified bodies and recognised thirdparty organisations. S.L. 427.45 20 [ S.L.427.29 PRESSURE EQUIPMENT relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services. (c) Conformity assessment bodies shall ensure that the activities

their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality

their conformity assessment activities.

professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results

their conformity assessment activities, especially as regards persons or groups

persons with an interest in the results

those activities.

carrying out all the conformity assessment tasks assigned to it by regulation 16 or regulation 17, or points 3.1.2 and 3.1.3

Schedule I and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility. (b) At all times and for each conformity assessment procedure and each kind or category

pressure equipment in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary: (

1. i)personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks; (
2. ii)descriptions

procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability

reproduction

those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a conformity assessment body and other activities; (iii) procedures for the performance

activities which take due account

the size

an undertaking, the sector in which it operates, its structure, the degree

complexity

the product technology in question and the mass or serial nature

the production process. (c) A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.

the requirements

the assessments they carry out and adequate authority to carry out those assessments; (c) appropriate knowledge and understanding

the essential safety requirements set out in Schedule I,

the applicable harmonised standards and

the relevant provisions

Union harmonisation legislation and

national legislation; (d) the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

the conformity assessment bodies, their top level management and

the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed. The remuneration

the top level management and personnel responsible for carrying out the conformity assessment tasks

a conformity assessment body shall not depend on the number

assessments carried out or on the results

those assessments.

a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under regulation 16, regulation 17, or under points 3.1.2 and 3.1.3

Schedule I or any provision

national law giving effect to them, except in relation to the competent authorities

the Member State in which its activities are carried out. Proprietary rights shall be protected.

, the relevant standardisation activities and the activities

the notified body coordination group established under the relevant Union harmonisation legislation and shall apply as general guidance the administrative decisions and documents produced as a result

the work

that group. 24.

notification, a user inspectorate shall meet the requirements laid down in sub-regulations

which it is part which ensure and demonstrate its impartiality.

any

those parties. This shall not preclude the use

assessed pressure equipment or assemblies that are necessary for the operations

the user inspectorate or the use

such equipment for personal purposes. (b) A user inspectorate, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance

that pressure equipment or assembly, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence

judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.

professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results

their conformity assessment activities, especially as regards persons or groups

persons with an interest in the results

those activities.

carrying out all the conformity assessment tasks assigned to it by regulation 18 and in relation to which it has been notified, whether those tasks are carried out by the user inspectorate itself or on its behalf and under its responsibility. (b) At all times and for each conformity assessment procedure and each kind or category

pressure equipment in relation to which it has been notified, the user inspectorate shall have at its disposal the necessary: (

1. i)personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks; (
2. ii)descriptions

procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability

reproduction

those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a user inspectorate and other activities; (iii) procedures for the performance

activities which take due account

the size

an undertaking, the sector in which it operates, its PRESSURE EQUIPMENT [ S.L.427.29 structure, the degree

complexity

the product technology in question and the mass or serial nature

the production process. (c) A user inspectorate shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.

the requirements

the assessments they carry out and adequate authority to carry out those assessments; (c) appropriate knowledge and understanding

the essential safety requirements set out in Schedule I,

the applicable harmonised standards and

the relevant provisions

Union harmonisation legislation and

national legislation; (d) the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

the user inspectorates, their top level management and

the personnel responsible for carrying out conformity assessment tasks shall be guaranteed. User inspectorates must not engage in any activities that might conflict with its independence

judgement and integrity in relation to its inspection activities. (b) The remuneration

the top level management and personnel responsible for carrying out conformity assessment tasks

a user inspectorate shall not depend on the number

assessments carried out or on the results

those assessments.

which they are part.

user inspectorates shall observe professional secrecy with regard to all information obtained in carrying out their tasks under regulation 18 or any provision

national law giving effect to them, except in relation to the competent authorities

the Member State in which its activities are carried out. Proprietary rights shall be protected.

, the relevant standardisation activities and the activities

the notified body coordination group established under the relevant Union harmonisation legislation and shall apply as general guidance the administrative decisions and documents 23 24 [ S.L.427.29 PRESSURE EQUIPMENT produced as a result

the work

that group. Presumption

conformity assessment bodies. 25. Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references

which have been published in the

ficial Journal

the European Union it shall be presumed to comply with the requirements set out in regulation 23 or regulation 24 in so far as the applicable harmonised standards cover those requirements. Subsidiaries

and subcontracting by conformity assessment bodies. 26.

the client.

the Technical Regulations Division the relevant documents concerning the assessment

the qualifications

the subcontractor or the subsidiary and the work carried out by them under regulation 16, regulation 17, regulation 18 or points 3.1.2 and 3.1.3

Schedule I. Notification procedures. S.L. 427.45 S.L. 427.45 27.

the conformity assessment module or modules and the pressure equipment for which that body claims to be competent, as well as by an accreditation certificate, issued by the National Accreditation Board (Malta) attesting that the conformity assessment body fulfils the requirements laid down in regulation 23 or regulation 24 and the Method for Designating Conformity Assessment Bodies Regulations,.

the conformity assessment activities, the conformity assessment module or modules and the pressure equipment concerned and the relevant [ S.L.427.29 PRESSURE EQUIPMENT 25 attestation

competence.

a notified bo d y o nl y w he r e no ob j e c t i on s ar e r a i s e d by t h e E u ro p e a n Commission or the other Member States within two weeks

a notification. Only such a body shall be considered a notified body, a recognised third-party organisation or a user inspectorate for the purposes

these regulations.

any subsequent relevant changes to the notification.

the failure to meet those requirements or fulfil those obligations. It shall immediately inform the European Commission and the other Member States accordingly. S.L. 427.45 (b) Where the Technical Regulations Division has ascertained or has been informed that a user inspectorate no longer meets the requirements laid down in regulation 24, or that it is failing to fulfil its obligations, the Technical Regulations Division shall as appropriate, restrict, suspend or withdraw the notification, depending on the seriousness

the failure to meet those requirements or fulfil those obligations. It shall immediately inform the European Commission and the other Member States accordingly.

restriction, suspension or withdrawal

notification, or where the notified body, the recognised third-party organisation or the user inspectorate has ceased its activity, the Technical Regulations Division shall take appropriate steps to ensure that the files

that body are either processed by another n o t i f i e d b o d y, r e c o g n i s e d t h i r d - p a r t y o rg a n i s a t i o n o r u s e r inspectorate, or kept available to the Technical Regulations Division, at their request.

the competence

the body concerned. 28.

Schedule I.

notified bodies, user inspectorates and recognised third party organisations. 26 [ S.L.427.29 PRESSURE EQUIPMENT proportionate manner, avoiding unnecessary burdens for economic operators. Conformity assessment bodies shall perform their activities taking due account

the size

an undertaking, the sector in which it operates, its structure, the degree

complexity

the pressure equipment or assembly technology in question and the mass or serial nature

the production process. In so doing they shall nevertheless respect the degree

rigour and the level

protection required for the compliance

the pressure equipment with the requirements

these regulations.

conformity.

the monitoring

conformity following the issue

a certificate, a conformity assessment body finds that pressure equipment no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate if necessary.

the following: (a) any refusal, restriction, suspension or withdrawal

a certificate; (b) any circumstances affecting the scope

or conditions for notification; (

1. c)any request for information which they have received from market surveillance authorities regarding conformity assessment activities; (
2. d)on request, conformity assessment activities performed within the scope

their notification and any other activity performed, including cross-border activities and subcontracting.

designated representatives, in t he appropriate coordination and cooperation groups for conformity assessment bodies organised by the European Commission. Market surveillance. 29.

Regulation (EC) No 765/2008 shall apply to pressure equipment and assemblies PRESSURE EQUIPMENT [ S.L.427.29 covered by regulation 3

these regulations.

persons or to domestic animals or property, they shall carry out an evaluation in relation to the pressure equipment or assembly concerned covering all relevant requirements laid down in these regulations. The relevant economic operators shall cooperate as necessary with the market surveillance authorities for that purpose. (b) Where, in the course

the evaluation referred to in sub-regulation

the risk, as they may prescribe. (

1. c)They shall also inform the relevant notified body accordingly. (
2. d)Article 21

Regulation (EC) No 765/2008 shall apply to the measures referred to in sub-regulation

the results

the evaluation and

the actions which they have required the economic operator to take.

all the pressure equipment concerned that it has made available on the market throughout the European Union.

the pressure equipment or assembly concerned, or recall it.

those measures.

the non-compliant equipment or assembly, the origin

the equipment or assembly, the nature

the noncompliance alleged and the risk involved, the nature and duration 27 28 [ S.L.427.29 PRESSURE EQUIPMENT

the national measures taken and the arguments put forward by the relevant economic operator. In particular, the Technical Regulations Division shall indicate whether the non-compliance is due to either

the following: (a) failure

the equipment or assembly to meet the requirements relating to the health and safety

persons or to the protection

domestic animals or property; or (b) shortcomings in the harmonised standards referred to in regulation 14 conferring a presumption

conformity.

any measures adopted and

any additional information at their disposal relating to the non-compliance

the equipment or assembly concerned, and, in the event

disagreement with the adopted national measure,

their objections.

receipt

the information referred to in sub-regulation

a provisional measure taken by a Member State, that measure shall be deemed justified.

the equipment or assembly from the Maltese market, are taken in respect

the equipment or assembly concerned without delay.

the procedure set out in subregulations

this evaluation, the national measure is considered justified, the Technical Regulations Division shall take the measures necessary to ensure that the placing on the market or use

the non-compliant equipment or assembly is withdrawn from the Maltese market and shall inform the European Commission accordingly. If, on the basis

this evaluation, the national measure is considered unjustified, the national measure shall be withdrawn.

persons or to other aspects

public interest protection, it shall require the relevant economic operator to take all appropriate measures to ensure that the equipment or assembly concerned, when placed on the Maltese market, no longer presents that risk, to withdraw the equipment from the market or to recall it within a reasonable period, commensurate with the nature

the risk, as it may PRESSURE EQUIPMENT [ S.L.427.29 prescribe.

all the equipment or assemblies concerned that he has made available on the market throughout the European Union.

Police, shall immediately inform the E u r o p e a n C o m m i s s i o n a n d t h e o t h e r M e m b e r St a t e s . T h a t information shall include all available details, in particular the data necessary for the identification

the equipment or assembly concerned, the origin and the supply chain

the equipment or assembly, the nature

the risk involved and the nature and duration

the national measures taken.

Police make one

the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned: (a) the CE marking has been affixed in violation

Article 30

Regulation (EC) No 765/2008 or

regulation 21

these regulations; (

1. b)the CE marking has not been affixed; (
2. c)the identification number

the notified body involved in the production control phase, has been affixed in violation

regulation 21 or has not been affixed; (d) the marking and labelling referred to in point 3.3.

Schedule I have not been affixed or have been affixed in violation

regulation 21 or point 3.3

Schedule I; (e) the EU declaration

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

conformity has not been drawn up correctly; (

1. g)technical documentation is either not available or not complete; (
2. h)the information referred to in regulation 8

the Commissioner

Police under this regulation may be exercised by any

ficer or other entity as he may direct. 30. The penalties applicable for the infringement

any

the provisions

these regulations shall be those provided for in Part IV

the Product Safety Act. Penalties. Cap. 427 29 30 Saving. [ S.L.427.29 PRESSURE EQUIPMENT 31.

pressure; he shall then design and construct it taking account

his analysis. 4. The essential safety requirements are to be interpreted and applied in such a way as to take account

the state

the art and current practice at the time

design and manufacture as well as

technical and economic considerations which are consistent with a high degree

health and safety protection.

1. GENERAL 1.
2. 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.
3. 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

residual hazards and indicate whether it is necessary to take appropriate special measures to reduce the risks at the time

installation and, or use. 1.

1. 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.
3. 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.
4. Design for adequate strength 2.2.
5. The pressure equipment shall be designed for loadings appropriate to its 32 [ S.L.427.29 PRESSURE EQUIPMENT 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

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

unstable fluids. Various loadings which can occur at the same time shall be considered, taking into account the probability

their simultaneous occurrence. 2.2.2. Design for adequate strength shall be based on either

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

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

manufacture, actual operational conditions, stresses, calculation models and the properties and behaviour

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

point 7. The requirements set out above may be met by applying one

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

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

unstable fluids. Where a vessel is separated into individual pressure-containing chambers, the partition wall shall be designed on the basis

the highest possible chamber pressure relative to the lowest pressure possible PRESSURE EQUIPMENT - - - [ S.L.427.29 33 in the adjoining chamber, the calculation temperatures shall allow for appropriate safety margins, the design shall take appropriate account

all possible combinations

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

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

elasticity), appropriate amount

plastic strain, bending rupture energy, fracture toughness. appropriate joint factors shall be applied to the material properties depending, for example, on the type

non-destructive testing, the materials joined and the operating conditions envisaged, the design shall take appropriate account

all reasonably foreseeable degradation mechanisms (e.g. corrosion, creep, fatigue) commensurate with the intended use

the equipment. Attention shall be drawn, in the instructions referred to in point 3.4, to particular features

the design which are relevant to the life

the equipment, for example: - for creep: design hours

operation at specified temperatures, - for fatigue: design number

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

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

the equipment or the category

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

the essential dimensions and characteristics

34 [ S.L.427.29 PRESSURE EQUIPMENT 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

the pressure equipment with adequate instrumentation capable

registering strains and stresses with sufficient precision. The test programme shall include: (a) A pressure strength test, the purpose

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

the differences between the values

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

creep or fatigue exists, appropriate tests determined on the basis

the service conditions laid down for the equipment, for instance hold time at specified temperatures, number

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

operation specified for pressure equipment shall be such as to preclude any reasonably foreseeable risk in operation

the equipment. Particular attention shall be paid, where appropriate, to: - closures and openings, - dangerous discharge

pressure relief blow-

f, - devices to prevent physical access whilst pressure or a vacuum exists, - surface temperature taking into consideration the intended use, - decomposition

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

the fluid presents a risk. 2.4. Means

examination (

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

determining the internal condition

the equipment shall be available, where it is necessary to ensure the continued safety

the equipment, such as access openings allowing physical access to the inside

the pressure equipment so that appropriate examinations can be carried out safely and ergonomically; (c) Other means

ensuring the safe condition

the pressure equipment may be applied in any

the following situations: - where it is too small for physical internal access, where opening the pressure equipment would adversely affect the PRESSURE EQUIPMENT - [ S.L.427.29 35 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

draining and venting Adequate means shall be provided for the draining and venting

pressure equipment where necessary: - to avoid harmful effects such as water hammer, vacuum collapse, corrosion and uncontrolled chemical reactions. All stages

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

the intended and reasonably foreseeable use. 2.7. Wear Where severe conditions

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

liners or cladding materials, - permit replacement

parts which are most affected, - draw attention, in the instructions referred to in point 3.4, to measures necessary for continued safe use. 2.

1. 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.
2. 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

the pressure equipment; (b) on discharge: the uncontrolled release

the pressurised fluid; (c) on filling or discharge: unsafe connection and disconnection. 2.10. Protection against exceeding the allowable limits

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

, suitable protective devices, unless the equipment is 36 [ S.L.427.29 PRESSURE EQUIPMENT intended to be protected by other protective devices within an assembly. The suitable device or combination

such devices shall be determined on the basis

the particular characteristics

the equipment or assembly. Suitable protective devices and combinations thereof comprise: (a) safety accessories as defined in point 4

regulation 4, (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.

1. Safety accessories 2.11.
2. 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

the devices, where applicable, - be independent

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.

1. 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.
2. Temperature monitoring devices These devices shall have an adequate response time on safety grounds, consistent with the measurement function. 2.
3. 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

external fire, having particular regard to its intended use.

1. MANUFACTURING 3.
2. Manufacturing procedures The manufacturer shall ensure the competent execution

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

the component parts Preparation

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

the pressure equipment. 3.1.2. Permanent joining Permanent joints and adjacent zones shall be free

any surface or internal defects detrimental to the safety

the equipment. The properties

permanent joints shall meet the minimum properties PRESSURE EQUIPMENT [ S.L.427.29 37 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

components which contribute to the pressure resistance

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 regulation 22

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 regulation 22

the pressure equipment, suitable heat treatment shall be applied at the appropriate stage

manufacture. 3.1.5. Traceability Suitable procedures shall be established and maintained for identifying the material making up the components

the equipment which contribute to pressure resistance by suitable means from receipt, through production, up to the final test

the manufactured pressure equipment. 3.

1. Final assessment Pressure equipment shall be subjected to final assessment as described below. 3.2.
2. Final inspection Pressure equipment shall undergo a final inspection to assess visually and by examination

the accompanying documents compliance with the requirements

these regulations. 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

the equipment, where appropriate in the course

manufacture (e.g. where examination during the final inspection is no longer possible). 3.2.2. Proof test Final assessment

pressure equipment shall include a test for the pressure containment aspect, which will normally take the form

a hydrostatic pressure test at a pressure at least equal, where appropriate, to the value laid down in point 7.4. 38 [ S.L.427.29 PRESSURE EQUIPMENT 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

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

equivalent validity, shall be applied before those tests are carried out. 3.2.3. Inspection

safety devices For assemblies, the final assessment shall also include a check

the safety devices intended to check full compliance with the requirements referred to in point 2.

1. 3.
2. Marking and labelling In addition to the CE marking referred to in regulation 20 and regulation 21 and the information to be provided in accordance with regulation 8

manufacture, identification

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

pressure equipment, further information necessary for safe installation, operation or use and, where applicable, maintenance and periodic inspection such as: - the volume V

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

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. (

1. 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), (
2. b)and (
3. 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

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 PRESSURE EQUIPMENT [ S.L.427.29 39 and the warnings referred to in point (c), provided it remains legible for the appropriate period

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

different pieces

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

serial identification, and shall be accompanied, where appropriate, by the technical documents, drawings and diagrams necessary for a full understanding

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

the design in accordance with point 2.2.

2. MATERIALS Materials used for the manufacture

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

points 4.1, 4.2(a) and the first paragraph

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

the materials shall comply with the requirements

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

the equipment; (

1. c)not be significantly affected by ageing; (
2. d)be suitable for the intended processing procedures; (
3. e)be selected in order to avoid significant undesirable effects when the various materials are put together. 4.2. The pressure equipment manufacturer shall: (
4. a)define in an appropriate manner the values necessary for the design calculations referred to in point 2.2.3 and the essential characteristics

the materials and their treatment referred to in point 4.1; 40 [ S.L.427.29 PRESSURE EQUIPMENT (b) provide in his technical documentation elements relating to compliance with the materials specifications

these regulations in one

the following forms: - by using materials which comply with harmonised standards, by using materials covered by a European approval

pressure equipment materials in accordance with regulation 17, by a particular material appraisal; (c) for pressure equipment in categories III and IV, a specific assessment

the particular material appraisal shall be performed by the notified body in charge

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

equipment in categories II, III and IV, this shall take the form

a certificate

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

this point. SPECIFIC PRESSURE EQUIPMENT REQUIREMENTS In addition to the applicable requirements

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

OVERHEATING AS REFERRED TO IN REGULATION 6

feedwater and for fuel supply, - process-heating equipment for other than steam and hot water generation falling under regulation 6

a significant loss

containment from overheating. In particular it shall be ensured, where applicable, that: (a) appropriate means

protection are provided to restrict operating parameters such as heat input, heat take-

f and, where applicable, fluid level so as to avoid any risk

local and general overheating; (b) sampling points are provided where required to allow evaluation

the properties

the fluid so as to avoid risks related to [ S.L.427.29 PRESSURE EQUIPMENT 41 deposits and, or corrosion; (c) adequate provisions are made to eliminate risks

damage from deposits; (d) means

safe removal

residual heat after shutdown are provided; (e) steps are taken to avoid a dangerous accumulation

ignitable mixtures

combustible substances and air, or flame blowback. 6. PIPING AS REFERRED TO IN REGULATION 6

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

condensation occurring inside pipes for gaseous fluids, means are provided for drainage and removal

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

vortices; the relevant parts

point 2.7 are applicable; (d) that due consideration is given to the risk

fatigue due to vibrations in pipes; (e) that, where fluids

Group 1 are contained in the piping, appropriate means are provided to isolate ‘take-

f’ pipes the size

which represents a significant risk; (f) that the risk

inadvertent discharge is minimised; the take-

f points shall be clearly marked on the permanent side, indicating the fluid contained; (g) that the position and route

underground piping is at least recorded in the technical documentation to facilitate safe maintenance, inspection or repair. 7. SPECIFIC QUANTITATIVE PRESSURE EQUIPMENT REQUIREMENTS FOR CERTAIN 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

safety. The provisions laid down in this section supplement the essential safety requirements

points 1 to 6 for the pressure equipment to which they apply. 7.

1. Allowable stresses 7.1.
2. Symbols R e/t , yield limit, indicates the value at the calculation temperature

: - the upper flow limit for a material presenting upper and lower flow limits, - the 1,0% proof strength

austenitic steel and non-alloyed aluminium, - the 0,2% proof strength in other cases. 42 [ S.L.427.29 PRESSURE EQUIPMENT R m/20 indicates the minimum value

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

the following values, according to the material used: - in the case

ferritic steel including normalised (normalised rolled) steel and excluding fine-grained steel and specially heat-treated steel, 2/ 3

Re/t and 5/12

Rm/20, - in the case

austenitic steel: - if its elongation after rupture exceeds 30%, 2/3

Re/t - or, alternatively, and if its elongation after rupture exceeds 35%, 5/6

Re/t and 1/3

R m/t, - in the case

non-alloy or low-alloy cast steel, 10/19

Re/t and 1/3

R m/20, - in the case

aluminium, 2/3

R e/t, - in the case

aluminium alloys excluding precipitation hardening alloys 2 / 3

R e/t and 5 / 12

R m/

1. 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

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

stress and the mechanical and technological properties

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%

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

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.

1. 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 PRESSURE EQUIPMENT [ S.L.427.29 43 lowest scheduled operating temperature. Schedule II 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
2. The safety accessories defined in regulation 4, and referred to in regulation 6

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 regulation 4, and referred to in regulation 6

: - their maximum allowable pressure PS, - their volume V or their nominal size DN, as appropriate, - the group

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

the first paragraph, 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. 44 [ S.L.427.29 PRESSURE EQUIPMENT Table 1 Vessels referred to in regulation 6

table 1 shall be classified in category III. Table 2 Vessels referred to in regulation 6

regulation 6

Schedule I, or to full quality assurance (Module H). 46 [ S.L.427.29 PRESSURE EQUIPMENT Table 5 Pressure equipment referred to in regulation 6

pressure-cookers shall be subject to a conformity assessment procedure equivalent to at least one

the category III modules. Table 6 Piping referred to in regulation 6

Table 6 shall be classified in category III. Table 7 Piping referred to in regulation 6

Table 7 shall be classified in category III. Table 8 48 [ S.L.427.29 PRESSURE EQUIPMENT Piping referred to in regulation 6

these regulations. 2. Technical documentation The manufacturer shall establish the technical documentation. The technical documentation shall make it possible to assess the conformity

the pressure equipment to the relevant requirements, and shall include an adequate analysis and assessment

the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation

the pressure equipment. The technical documentation shall, wherever applicable, contain at least the following elements: - a general description

the pressure equipment, - conceptual design and manufacturing drawings and diagrams

PRESSURE EQUIPMENT [ S.L.427.29 49 components, sub-assemblies, circuits, etc., 3. - descriptions and explanations necessary for an understanding

those drawings and diagrams and the operation

the pressure equipment, - a list

the harmonised standards the references

which have been published in the

ficial Journal

the European Union, applied in full or in part, and a description

the solutions adopted to meet the essential safety requirements

these regulations where those harmonised standards have not been applied. In the event

partly applied harmonised standards, the technical documentation shall specify the parts which have been applied, - results

design calculations made, examinations carried out, etc., - test reports. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance

the manufactured pressure equipment with the technical documentation referred to in point 2 and with the requirements

these regulations. 4. CE marking and EU declaration

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

these regulations. 4.2. The manufacturer shall draw up a written EU declaration

conformity for the pressure equipment model and keep it together with the technical documentation at the disposal

the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration

conformity shall identify the pressure equipment for which it has been drawn up. A copy

the EU declaration

conformity shall be made available to the relevant authorities upon request.

1. Authorised representative The manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
2. MODULE A2: INTERNAL PRODUCTION CONTROL PLUS S U P E RV I S E D P R E S S U R E E Q U I P M E N T C H E C K S AT R A N D O M INTERVALS
3. Internal production control plus supervised pressure equipment checks at random intervals is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 4 and 5, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfy the requirements

these regulations. 2. Technical documentation The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the conformity

the pressure equipment with the relevant requirements, and shall include an adequate analysis and assessment

the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation

the 50 [ S.L.427.29 PRESSURE EQUIPMENT pressure equipment. The technical documentation shall contain, wherever applicable, at least the following elements: 3. - a general description

the pressure equipment, - conceptual design and manufacturing drawings and diagrams

components, sub-assemblies, circuits, etc., - descriptions and explanations necessary for the understanding

those drawings and diagrams and the operation

the pressure equipment, - a list

the harmonised standards the references

which have been published in the

ficial Journal

the European Union, applied in full or in part, and descriptions

the solutions adopted to meet the essential safety requirements

these regulations where those harmonised standards have not been applied. In the event

partly applied harmonised standards, the technical documentation shall specify the parts which have been applied, - results

design calculations made, examinations carried out, etc., and - test reports. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance

the manufactured pressure equipment with the technical documentation referred to in point 2 and with the requirements

these regulations that apply to it. 4. Final assessment and pressure equipment checks The manufacturer shall perform a final assessment

the pressure equipment, monitored by means

unexpected visits by a notified body chosen by the manufacturer. The notified body shall carry out product checks or have them carried out at random intervals determined by the body, in order to verify the quality

the internal checks

the pressure equipment, taking into account, inter alia, the technological complexity

the pressure equipment and the quantity

production. During its unexpected visits, the notified body shall: - establish that the manufacturer actually performs final assessment in accordance with point 3.2

Schedule I. - take samples

pressure equipment at the manufacturing or storage premises in order to conduct checks. The notified body assesses the number

items

equipment to sample and whether it is necessary to perform, or have performed, all or part

the final assessment

the pressure equipment samples. The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process

the pressure equipment performs within acceptable limits, with a view to ensuring conformity

the pressure equipment. Should one or more

the items

pressure equipment or assembly not conform, the notified body shall take appropriate measures. The manufacturer shall, under the responsibility

the notified body, affix the notified body’s identification number during the manufacturing process. 5. CE marking and EU declaration

conformity PRESSURE EQUIPMENT [ S.L.427.29 51 5.1. The manufacturer shall affix the CE marking to each individual pressure equipment that satisfies the applicable requirements

these regulations. 5.2. The manufacturer shall draw up a written EU declaration

conformity for the pressure equipment m