Pressure Equipment Regulations, 2016

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 19,599, 28 ta’ Ġunju, 2016

L.N. 240 of 2016

PRODUCT SAFETY ACT

(CAP. 427)

Pressure Equipment Regulations, 2016

IN exercise of the powers conferred by articles 38 and 39 of the

Product Safety Act, the Minister for Social Dialogue, Consumer

Affairs and Civil Liberties, on the advice of the Malta Competition

and Consumer Affairs Authority, has made the following

regulations:-

(1) The title of these regulations is Pressure Equipment Title and scope.

Regulations, 2016.

(2) These regulations transpose Directive 2014/68/EU of the

European Parliament and of the Council of 15 May 2014 on the

harmonisation of the laws of the Member States relating to the

making available of pressure equipment (recast).

(1)

These regulations shall apply as from 18 July 2016.

Applicability.

(2) The putting into service of pressure equipment and

assemblies or the making available on the market of pressure

equipment and assemblies covered by the Pressure Equipment S.L. 427.29

Regulations which are in conformity with those regulations and

which were placed on the market before 18 July 2016 shall not be

impeded.

(3) Certificates and decisions by notified bodies under

Pressure Equipment Regulations shall be valid under these

regulations.

(1) These regulations shall also apply to the design, Objective.

manufacture and conformity assessment of pressure equipment and

assemblies with a maximum pressure allowable pressure PS greater

than 0,5 bar.

(2) These regulations shall not apply to

(a) pipelines comprising piping or a system of piping

designed for the conveyance of any fluid or substance to or from

an installation (onshore or offshore) starting from and including

the last isolation device located within the confines of 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

of 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 of the European Parliament and of the Council;

(d) aerosol dispensers covered by Council Directive 75/

324/EEC;

(e)

equipment intended for the functioning of vehicles

defined by the following legal acts

(i) Directive of the European Parliament and of

the Council;

(ii) Regulation (EU) No 167/2013

of

the

European Parliament and of the Council;

(iii) Regulation (EU) No 168/2013

of

the

European Parliament and of the Council;

(f)

equipment classified as no higher than category I

under regulation 15 and covered by one of the following

Directives

(i) Directive 2006/42/EC

of

the

European

Parliament and of the Council;

(ii) Directive 2014/33/EU

of

the

European

Parliament and of the Council;

(iii) Directive 2014/35/EU

of

the

European

Parliament and of the Council;

(iv) Council Directive 93/42/EEC;

(v) Directive 2009/142/EC of the European

Parliament and of the Council;

(vi) Directive 2014/34/EU

of

the

European

Parliament and of the Council;

(g)

equipment covered by point (b) of Article 346(1)

TFEU;

(h) items specifically designed for nuclear use, failure

of which may cause an emission of radioactivity;

(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;

(j)

equipment comprising casings or machinery where

the dimensioning, choice of 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

(i) engines including turbines and internal

combustion engines;

(ii) steam engines, gas/steam turbines, turbo-

generators, compressors, pumps and actuating devices;

(k) blast furnaces including the furnace cooling system,

hot-blast recuperators, dust extractors and blast-furnace

exhaust-gas scrubbers and direct reducing cupolas, including

the furnace cooling, gas converters and pans for melting, re-

melting, de-gassing and casting of steel, iron and non-ferrous

metals;

(l)

enclosures for high-voltage electrical equipment

such as switchgear, control gear, transformers, and rotating

machines;

(m) pressurised pipes for the containment of

transmission systems, e.g. for electrical power and telephone

cables;

(n) ships, rockets, aircraft and mobile off-shore units, as

well as equipment specifically intended for installation on board

or the propulsion thereof;

(o) pressure equipment consisting of a flexible casing,

e.g. tyres, air cushions, balls used for play, inflatable craft, and

other similar pressure equipment;

(p)

exhaust and inlet silencers;

(q) bottles or cans for carbonated drinks for final

consumption;

(r)

vessels designed for the transport and distribution of

drinks having a PS·V of not more than 500 bar·L and a

maximum allowable pressure not exceeding 7 bar;

(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;

(t)

radiators and pipes in warm water heating systems;

(u) vessels designed to contain liquids with a gas

pressure above the liquid of not more than 0,5 bar.

For the purpose of these regulations, the following

definitions shall apply

"accreditation" means accreditation as defined in point 10 of

Article 2 of Regulation (EC) No 765/2008;

"assemblies" means several pieces of 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 of these regulations 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;

"the Directive" means European Parliament and Council

Directive 2014/68/EU on the approximation of the laws of the

Member States relating to the making available on the market of

Pressure Equipment;

"European approval for materials" means a technical document

defining the characteristics of materials intended for repeated use in

the manufacture of 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 of solids;

"harmonised standard" means harmonised standard as defined in

point (c) of Article 2(1) of 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 of pressure

equipment or assemblies for distribution or use on the Union market

in the course of a commercial activity, whether in return for payment

or free of 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 of protective and, or limiting devices, or the top of

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 of Article 2 of Regulation (EC) No 765/2008;

"nominal size (DN)" means a numerical designation of 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;

"piping" means piping components intended for the transport of

fluids, when connected together for integration into a pressure

system; piping includes in particular a pipe or system of pipes, tubing,

fittings, expansion joints, hoses, or other pressure-bearing

components as appropriate; heat exchangers consisting of pipes for

the purpose of cooling or heating air shall be considered as piping;

"placing on the market" means the first making available of

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 of pressure equipment

or an assembly by its user;

"recall" means any measure aimed at achieving the return of

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 of products.

"volume (V)" means the internal volume of a chamber,

including the volume of nozzles to the first connection or weld and

excluding the volume of 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 of

more than one chamber

(1) All appropriate measures must be taken to ensure Making

that the pressure equipment and assemblies covered by these available

market and

regulations may be placed on the market and put into service only if putting

service.

they comply with these regulations, when properly installed and

maintained and used for their intended purpose.

(2) The provisions of these regulations shall not prevent from

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.

(3) At trade fairs, exhibitions or demonstrations, the showing

of 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 of persons.

(1) The following pressure equipment shall satisfy the Technical

requirements.

essential safety requirements set out in Schedule I

(a)

vessels, except those referred to in paragraph (b),

for

(i) gases, liquefied gases, gases dissolved under

pressure, vapours and also 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 volume greater

than 1 L and a product of 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 of 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 of 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 of 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 of 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 of overheating intended for generation of steam or

super-heated water at temperatures higher than 110 °C having a

volume greater than 2 L, and all pressure cookers (Schedule II,

(c)

piping intended for

(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 of PS and DN greater than 1

000 bar (Schedule II, table 7);

(ii) liquids having a vapour pressure at the

maximum allowable temperature of 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 of 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 of PS

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

(d) safety and pressure accessories intended for

equipment covered by paragraphs (a), (b), and (c) including

where such equipment is incorporated into an assembly.

(2) The following assemblies which include at least one item

of pressure equipment covered by sub-regulation (1) shall satisfy the

essential safety requirements set out in Schedule I

(a)

assemblies intended for generating steam or

superheated water at a temperature higher than 110 °C

comprising at least one item of fired or otherwise heated

pressure equipment presenting a risk of 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 of derogation from sub-regulation (1), assemblies

intended for generating warm water at temperatures not greater than

110 °C which are manually fed with solid fuels and have a PS·V

greater than 50 bar·L shall comply with the essential safety

requirements referred to in points 2.10, 2.11, 3.4, 5 (a) and 5 (d) of

Schedule I.

(3) Pressure equipment and assemblies below or equal to the

limits set out in sub-regulation (1)(a), (b) and (c) and in sub-

regulation (2) respectively shall be designed and manufactured in

accordance with the sound engineering practice of 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.

(1) The making available on the market or putting into Free movement.

service of 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.

(2) Pressure equipment or assemblies complying with

regulation 6(3) shall not on the ground of the risks due to pressure, be

prohibited, restricted or impeded from being made available on the

market or put into service.

(3) The placing on the market or putting into service of

pressure equipment or assemblies the conformity of 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 of the risks due to pressure, be prohibited, restricted or

impeded provided that these comply with regulation 18.

(4) For the safe and correct use of pressure equipment and

assemblies made available on the Maltese market, the information

referred to in points 3.3 and 3.4 of Schedule I, may be required to be

provided in at least the Maltese or English language.

(1) When placing their pressure equipment or

assemblies referred to in regulations 6(1) and 6(2) on the market or

using them for their own purposes, manufacturers shall ensure that

they have been designed and manufactured in accordance with the

essential safety requirements set out in Schedule 1.

(2) When placing their pressure equipment or assemblies

referred to in regulation 6(3) on the market or using them for their

own purposes, manufacturers shall ensure that they have been

designed and manufactured in accordance with the sound engineering

practice of a Member State.

(3) For the pressure equipment or assemblies referred to in

regulation 6(1) and regulation 6(2), manufacturers shall draw up the

technical documentation referred to in Schedule III and carry out the

relevant conformity assessment procedure referred to in regulation 16

or have it carried out.

(4) Where compliance of the pressure equipment or

assemblies referred to in regulation 6(1) and 6(2) with the

requirements have been demonstrated by that procedure referred to in

sub-regulation (3), manufacturers shall draw up an EU declaration of

conformity and affix the CE marking.

(5) Manufacturers shall keep the technical documentation and

the EU declaration of conformity for 10 years after the pressure

equipment or assemblies has been placed on the market.

(6) Manufacturers shall ensure that procedures are in place for

series production to remain in conformity with these regulations.

Changes in design or characteristics of pressure equipment or

assemblies and changes in the harmonised standards or in other

technical specifications by reference to which conformity of pressure

equipment or assemblies is declared shall be adequately taken into

account.

(7) When deemed appropriate with regard to the risks

presented by pressure equipment or assemblies, manufacturers shall,

to protect the health and safety of consumers and other users, carry

out sample testing of pressure equipment or assemblies made

available on the market, investigate, and, if necessary, keep a register

of complaints, of non-conforming pressure equipment and recalls of

such equipment and assemblies and recalls of such equipment, and

shall keep distributors informed of any such monitoring.

(8) Manufacturers shall ensure that pressure equipment or

assemblies bear a type, batch or serial number or other element

allowing their identification, or, where the size or nature of the

equipment or assembly does not allow it, that the required

information is provided on the packaging or in a document

accompanying the equipment.

(9) Manufacturers shall indicate on the pressure equipment or

assembly their name, registered trade name or registered trade mark

and the postal address at which they can be contacted or, where that is

not possible, on the packaging or in a document accompanying the

equipment or assembly. The address shall indicate a single point at

which the manufacturer can be contacted. The contact details shall be

either in Maltese or English language.

(10) Manufacturers shall ensure that the pressure equipment or

assemblies referred to in regulations 6(1) and 6(2) is accompanied by

instructions and safety information in accordance with points 3.3 and

3.4 of Schedule I, in at least the Maltese or English language. Such

instructions and safety information shall be clear, understandable and

intelligible.

(11) Manufacturers shall ensure that the pressure equipment or

assemblies referred to in regulation 6(3) are accompanied by

instructions and safety information in accordance with regulation

6(3), in at least the Maltese or English language. Such instructions

and safety information shall be clear, understandable and intelligible.

(12) Manufacturers who consider or have reason to believe that

pressure equipment or assemblies which they have placed on the

market is not in conformity with these regulations shall immediately

take the corrective measures necessary to bring that pressure

equipment or those assemblies into conformity, to withdraw it or

recall it, if appropriate. Furthermore, where pressure equipment or

assemblies presents a risk, manufacturers shall immediately inform

the Technical Regulations Division to that effect, giving details, in

particular, of the non-conformity and of any corrective measures

taken.

(13) Manufacturers shall, further to a reasoned request from the

Technical Regulations Division, provide it with all the information

and documentation necessary to demonstrate the conformity of 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.

(1) A manufacturer may, by a written mandate, appoint an

authorised representative. The obligations laid down in regulations

8(1) and 8(2), and the obligation to draw up technical documentation

referred to in regulations 8(3) and 8(4) shall not form part of the

authorised representative’s mandate.

(2) An authorised representative shall perform the tasks

specified in the mandate received from the manufacturer. The

mandate shall allow the authorised representative to do at least the

following

(a)

keep the EU declaration of conformity and the

technical documentation at the disposal of 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 of 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.

(1) Importers shall place only compliant pressure

equipment or assemblies on the market.

(2) Before placing on the market the pressure equipment or

assemblies referred to in regulations 6(1) and 6(2), importers shall

ensure that the appropriate conformity assessment procedure in

accordance with regulation 16 has been carried out by the

manufacturer. They shall ensure that the manufacturer has drawn up

the technical documentation, that pressure equipment or assemblies

bear the CE marking and are accompanied by instructions and safety

information in accordance with points 3.3 and 3.4 of Schedule I, and

that the manufacturer has complied with the requirements set out in

regulations 8(8) and 8(9).

(3) Before placing on the market the pressure equipment or

assemblies referred to in regulation 6(3), importers shall ensure that

the manufacturer has drawn up the technical documentation and that

pressure equipment or assemblies are accompanied by adequate

instructions for use and that the manufacturer has complied with the

requirements set out in regulations 8(8) and 8(9).

(4) Where an importer considers or has reason to believe that

the pressure equipment or assembly is not in conformity with the

essential safety requirements set out in Schedule I, he shall not place

the pressure equipment or assembly on the market until it has been

brought into conformity. Furthermore, where the pressure equipment

or assembly presents a risk, the importer shall inform the

manufacturer and the market surveillance authorities to that effect.

(5) Importers shall indicate their name, registered trade name

or registered trade mark and the postal address at which they can be

contacted on the pressure equipment or assembly, or, where that is not

possible, on its packaging or in a document accompanying the

equipment or assembly. The contact details shall be in a language

easily understood by consumers, other users and market surveillance

authorities.

(6) Importers shall ensure that the pressure equipment or

assemblies referred to in regulations 6(1) and 6(2) are accompanied

by instructions and safety information in accordance with points 3.3

and 3.4 of Schedule I, in at least the Maltese and English language.

(7) Importers shall ensure that the pressure equipment or

assembly referred to in regulation 4(3) is accompanied by instructions

and safety information in at least the Maltese and English language.

(8) Importers shall ensure that, while pressure equipment or

assemblies referred to in regulations 6(1) and 6(2) are under their

responsibility, storage or transport conditions do not jeopardise their

compliance with the essential safety requirements set out in Schedule

I.

(9) When deemed appropriate with regard to the risks

presented by pressure equipment or assemblies, importers shall, to

protect the health and safety of consumers and other users, carry out

sample testing of pressure equipment and assemblies made available

on the market, investigate, and, if necessary, keep a register of

complaints, of non-conforming pressure equipment or assemblies and

recalls of such equipment, and shall keep distributors informed of any

such monitoring.

(10) Importers who consider or have reason to believe that

pressure equipment or assemblies which they have placed on the

market are not in conformity with these regulations shall immediately

take the corrective measures necessary to bring that pressure

equipment or assembly into conformity, to withdraw it or recall it, if

appropriate. Furthermore, where the pressure equipment or assembly

presents a risk, importers shall immediately inform the Technical

Regulations Division to that effect, giving details, in particular, of the

non-compliance and of any corrective measures taken.

(11) Importers shall, for 10 years after the pressure equipment

or assembly has been placed on the market, keep a copy of the EU

declaration of conformity at the disposal of the market surveillance

authorities and ensure that the technical documentation can be made

available to those authorities, upon request.

(12) Importers shall, further to a reasoned request from the

Technical Regulations, provide it with all the information and

documentation necessary to demonstrate the conformity of 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.

(1) When making pressure equipment or assemblies

available on the market distributors shall act with due care in relation

to the requirements of these regulations.

(2) Before making the pressure equipment or assemblies

referred to in regulations 6(1) and 6(2) available on the market

distributors shall verify that the pressure equipment or assembly bears

the CE marking, that it is accompanied by the required documents

and by instructions and safety information in accordance with points

3.3 and 3.4 of 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(8) and 8(9) and

regulation 10(5) respectively.

(3) Where a distributor considers or has reason to believe that

pressure equipment or assemblies are not in conformity with the

essential safety requirements set out in Schedule I, he shall not make

the pressure equipment or assembly available on the market until it

has been brought into conformity. Furthermore, where the pressure

equipment or assembly presents a risk, the distributor shall inform the

manufacturer or the importer to that effect as well as the market

surveillance authorities.

(4) Before making the pressure equipment or assembly

referred to in regulation 6(3) available on the market, distributors

shall verify that that pressure equipment or assembly is accompanied

by adequate instructions for use, 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(8) and 8(9) and

regulation 10(5) respectively.

(5) Distributors shall ensure that, while the pressure

equipment or assemblies referred to in regulations 6(1) and 6(2) are

under their responsibility, storage or transport conditions do not

jeopardise their compliance with the essential safety requirements set

out in Schedule I.

(6) Distributors who consider or have reason to believe that

pressure equipment or assemblies which they have made available on

the market are not in conformity with these regulations shall make

sure that the corrective measures necessary to bring that equipment or

assembly into conformity, to withdraw it or recall it, if appropriate,

are taken. Furthermore, where the pressure equipment or assembly

presents a risk, distributors shall immediately inform the Technical

Regulations Division to that effect, giving details, in particular, of the

non-compliance and of any corrective measures taken.

(7) Distributors shall, further to a reasoned request from the

Technical Regulations Division, provide it with all the information

and documentation necessary to demonstrate the conformity of

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.

An importer or distributor shall be considered a

manufacturer for the purposes of these regulations and he shall be

subject to the obligations of 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

assembly already placed on the market in such a way that compliance

with the requirements of these regulations may be affected.

(1) Economic operators shall, on request, identify the

following to the Technical Regulations Division

(a)

any economic operator who has supplied them with

pressure equipment or an assembly;

(b) any economic operator to whom they have supplied

pressure equipment or an assembly;

(2) Economic operators shall be able to present the

information referred to in sub-regulation (1) for 10 years after they

have been supplied with the pressure equipment or assembly and for

10 years after they have supplied the pressure equipment or assembly.

(1) Pressure equipment or assemblies referred to in

regulations 6(1) and 6(2) which are in conformity with harmonised

standards or parts thereof the references of which have been

published in the Official Journal of 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.

(2) The materials used for the manufacture of pressure

equipment or assemblies which are in conformity with European

approvals for materials, the references of which have been published

in the Official Journal of the European Union in accordance with

regulation 17(4), shall be presumed to be in conformity with the

applicable essential safety requirements set out in Schedule I.

(1) Pressure equipment referred to in regulation 6(1) shall

be classified by category in accordance with Schedule II, according to

an ascending level of hazard. For the purposes of such classification

fluids shall be divided into the following two groups

(a)

group 1 consisting of substances and mixtures, as

defined in points (7) and (8) of Article 2 of Regulation (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 of Schedule I to that Regulation

(i)

unstable

explosives

or

explosives

of

Divisions 1.1, 1.2, 1.3, 1.4 and 1.5;

(ii) flammable gases, category 1 and 2;

(iii) oxidising gases, category 1;

(iv) flammable liquids, category 1 and 2;

(v) flammable liquids, category 3 where the

maximum allowable temperature is above the flashpoint;

(vi) flammable solids, category 1 and 2;

(vii) self-reactive substances and mixtures, type A

(viii) pyrophoric liquids, category 1;

(ix) pyrophoric solids, category 1;

(x) substances and mixtures which in contact

with water emit flammable gases, category 1, 2 and 3;

(xi) oxidising liquids, category 1, 2 and 3;

(xii) oxidising solids, category 1, 2 and 3;

(xiii) organic peroxides types A to F;

(xiv) acute oral toxicity, category 1 and 2;

(xv) acute dermal toxicity, category 1 and 2;

(xvi) acute inhalation toxicity, category 1, 2 and 3;

(xvii) 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 of the fluid;

(b) group 2 consisting of substances and mixtures not

referred to in paragraph (a).

(2) Where a vessel is composed of a number of 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 of the fluid which requires the highest category.

(1) The conformity assessment procedures to be applied to

an item of pressure equipment shall be determined by the category, as

set out in regulation 15, in which the equipment is classified.

(2) The conformity assessment procedures to be applied for

the various categories are the following

(a)

category I

-

Module A

(b)

category II

-

Module A2

-

Module D1

-

Module E1

(c)

category III

-

Modules B (design type) + D

-

Modules B (design type) + F

-

Modules B (production type) + E

-

Modules B (production type) + C2

-

Module H

(d)

category IV

-

Modules B (production type) + D

-

Modules B (production type) + F

-

Module G

-

Module H1

The conformity assessment procedures are set out in Schedule

III.

(3) Pressure equipment shall be subject to one of 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 of the

procedures which apply to a higher category, if available.

(4) In the framework of quality assurance procedures for

pressure equipment in categories III and IV referred to in sub-

paragraph (i) of paragraph (a) of regulation 6(1), first indent of sub-

paragraph (ii) of paragraph (a) of regulation 6(1) and paragraph (b) of

regulation 6(1), the notified body shall, when performing unexpected

visits, take a sample of 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 of the intended schedule of production.

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

year of manufacturing. The frequency of subsequent visits shall be

determined by the notified body on the basis of the criteria set out in

point 4.4 of modules D, E and H and point 5.4 of module H1.

(5) In the case of one-off production of vessels and pressure

equipment in category III referred to in paragraph (b) of regulation

6(1) under the module H procedure, the notified body shall perform

or have performed the final assessment, as referred to in point 3.2 of

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

communicate the intended schedule of production to the notified

body.

(6) Assemblies referred to in regulation 6(2) shall be subject to

a global conformity assessment procedure comprising the following

assessments

(a)

the assessment of each item of pressure equipment

making up the assembly and referred to in regulation 6(1) which

has not been previously subjected to a conformity assessment

procedure and to a separate CE marking; the assessment

procedure shall be determined by the category of each item of

equipment;

(b) the assessment of the integration of the various

components of the assembly as referred to in points 2.3, 2.8 and

2.9 of 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 of the protection of an assembly

against exceeding the permissible operating limits as referred to

in points 2.10 and 3.2.3 of Schedule I shall be conducted in the

light of the highest category applicable to the items of

equipment to be protected.

(7) By way of derogation from regulations (1) and (2), the

Technical Regulations Division may, where justified, allow the

making available on the market and putting into service in the

Maltese market, in respect of which the procedures referred to in sub-

regulations (1) and (2) have not been applied and the use of which is

in the interests of experimentation.

(8) The records and correspondence relating to conformity

assessment procedures shall be drafted in an official language of the

Member State where the body responsible for carrying out these

conformity assessment procedures is established, or in a language

accepted by that body.

(1) European approval for materials shall be issued at the

request of one or more manufacturers of materials or equipment, by

one of 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 of, the appropriate

inspections and tests to certify the conformity of the types of material

with the corresponding requirements of these regulations. In the case

of materials recognised as being safe to use before 29 November

1999, the notified body shall take account of the existing data when

certifying such conformity.

(2) Before issuing a European approval for materials, the

notified body shall notify the Member States and the European

Commission by sending them the appropriate information. Within

three months, a Member State or the European Commission may

provide comments giving its reasons. The notified body may issue the

European approval for materials taking into account the comments

submitted.

(3) A copy of the European approval for materials shall be

sent to the Member States, the notified bodies and the European

Commission.

(4) When the European approval for materials satisfies the

requirements which it covers and which are set out in Schedule I, the

European Commission shall publish the references of that approval.

The Commission shall keep up to date a list of such approvals in the

Official Journal of the European Union.

(5) The notified body which issued the European approval for

materials shall withdraw that approval if it finds that it should not

have been issued or if the type of materials is covered by a

harmonised standard. It shall immediately inform the other Member

States, the notified bodies and the European Commission of any

withdrawal of an approval.

(1) By way of derogation from the provisions relating to User

the tasks carried out by the notified bodies, the Technical Regulations inspectorates.

Division may authorise on the Maltese market the placing on the

market and the putting into service by users, of pressure equipment or

assemblies of which conformity with the essential safety

requirements has been assessed by a user inspectorate designated in

accordance with sub-regulation (7).

(2) Pressure equipment and assemblies the conformity of

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

marking.

(3) The pressure equipment or assemblies referred to in sub-

regulation (1) may be used only in establishments operated by the

group of 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 of pressure

equipment and assemblies.

(4) The user inspectorates shall act exclusively for the group

of which they are part.

(5) The conformity assessment procedures applicable by user

inspectorates shall be modules A2, C2, F and G, set out in Schedule

III.

(6) The Technical Regulations Division shall notify the other

Member States and the European Commission which user

inspectorates they have authorised, the tasks for which they have been

designated and, for each inspectorate, a list of the establishments

satisfying the provisions of sub-regulation (3).

(7) In designating the user inspectorates, the Technical

Regulations Division shall apply the requirements set out in

regulation 24 and ensure that the group of which the inspectorate is

part applies the criteria referred to in the second sentence of sub-

regulation (3).

(1) The EU declaration of conformity shall state that the EU declaration

fulfilment of essential safety requirements set out in Schedule I has of conformity.

been demonstrated.

(2) The EU declaration of 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.

(3) Where pressure equipment or an assembly is subject to

more than one Union act requiring an EU declaration of conformity, a

single EU declaration of conformity shall be drawn up in respect of

all such Union acts. That declaration shall contain the identification

of the Union acts concerned including their publication references.

(4) By drawing up the EU declaration of conformity, the

manufacturer shall assume responsibility for the compliance of the

pressure equipment or assembly with the requirements laid down in

these regulations.

The CE marking shall be subject to the general principles

set out in Article 30 of Regulation (EC) No 765/2008.

(1) The CE marking shall be affixed visibly, legibly and

indelibly to any of the following

(a)

each item of pressure equipment referred to in

regulation 6(1) or its dataplate;

(b) each assembly referred to in regulation 6(2) or its

dataplate.

(2) Where the affixing of the CE marking is not possible or not

warranted on account of the nature of 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) of the sub-

regulation (1) shall be complete or shall be in a state permitting final

assessment as described in point 3.2 of Schedule I.

(3) It is not necessary for the CE marking to be affixed to each

individual item of pressure equipment making up an assembly.

Individual items of pressure equipment already bearing the CE

marking when incorporated into the assembly shall continue to bear

that marking.

(4) The CE marking shall be affixed before the item of

pressure equipment or the assembly is placed on the market.

(5) The CE marking shall be followed by the identification

number of the notified body, where that body is involved in the

production control phase. The identification number of the notified

body shall be affixed by the body itself or, under its instructions, by

the manufacturer or his authorised representative.

(6) The CE marking and, where applicable, the identification

number referred to in sub-regulation (5) may be followed by any

other mark indicating a special risk or use.

(7) Member States shall build upon existing mechanisms to

ensure correct application of the regime governing the CE marking

and shall take appropriate action in the event of improper use of that

marking.

(1) The Technical Regulations Division shall notify the Notification of

European Commission and the other Member States of the notified conformity

assessment

bodies and the user inspectorates authorised to carry out conformity bodies.

assessment tasks in accordance with regulation 16, regulation 17 or

regulation 18 and of the third-party organisations they have

recognised, for the purposes of the tasks referred to in points 3.1.2

and 3.1.3 of Schedule I.

(2) The Technical Regulations Division shall be responsible

for setting up and carrying out the necessary procedures for the

assessment and notification of conformity assessment bodies and the

monitoring of notified bodies, including compliance with regulation

(3) The assessment and monitoring referred to in sub-

regulation (2) shall be carried out by the National Accreditation

Board (Malta).

(4) The Technical Regulations Division shall take full

responsibility for the tasks performed by National Accreditation

Board (Malta) referred to in sub-regulation (4).

(5) The Technical Regulations Division shall inform the

European Commission of their procedures for the assessment and

notification of conformity assessment bodies and the monitoring of

notified bodies, recognised third-party organisations and user

inspectorates, and of any changes thereto.

23. (1) For the purposes of notification under these Requirements

regulations, a conformity assessment body shall meet the relating

notified bodies

requirements laid down in sub-regulations (2) to (11) and in the and

third-party

Method for Designating Conformity Assessment Bodies Regulations. organisations.

(2) A conformity assessment body shall be established under

Maltese law and have legal personality.

(3) A conformity assessment body shall be a third-party body

independent of 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 of

pressure equipment or assemblies which it assesses, may, on

condition that its independence and the absence of any conflict of

interest are demonstrated, be considered such a body.

(4) (a)

A conformity assessment body, its top level

management and the personnel responsible for carrying out the

conformity assessment tasks shall not be the designer, manufacturer,

supplier, installer, purchaser, owner, user or maintainer of the

pressure equipment or assembly which they assess, nor the

representative of any of those parties. This shall not preclude the use

of assessed pressure equipment or assemblies that are necessary for

the operations of the conformity assessment body or the use of 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 of 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 of judgement or

integrity in 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 of their subsidiaries or subcontractors do not affect the

confidentiality, objectivity or impartiality of their conformity

assessment activities.

(5) Conformity assessment bodies and their personnel shall

carry out the conformity assessment activities with the highest degree

of 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 of their conformity assessment activities, especially as regards

persons or groups of persons with an interest in the results of those

activities.

(6) (a)

A conformity assessment body shall be capable of

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 of 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 of pressure equipment in relation

to which it has been notified, a conformity assessment body shall

have at its disposal the necessary

(i) personnel with technical knowledge and

sufficient and appropriate experience to perform the

conformity assessment tasks;

(ii) descriptions of procedures in accordance with

which conformity assessment is carried out, ensuring the

transparency and the ability of reproduction of 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 of activities

which take due account of the size of an undertaking, the

sector in which it operates, its structure, the degree of

complexity of the product technology in question and the

mass or serial nature of 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.

(7) The personnel responsible for carrying out conformity

assessment tasks shall have the following

(a)

sound technical and vocational training covering all

the conformity assessment activities in relation to which the

conformity assessment body has been notified;

(b) satisfactory knowledge of the requirements of the

assessments they carry out and adequate authority to carry out

those assessments;

(c)

appropriate knowledge and understanding of the

essential safety requirements set out in Schedule I, of the

applicable harmonised standards and of the relevant provisions

of Union harmonisation legislation and of national legislation;

(d) the ability to draw up certificates, records and

reports demonstrating that assessments have been carried out.

(8) The impartiality of the conformity assessment bodies, their

top level management and of the personnel responsible for carrying

out the conformity assessment tasks shall be guaranteed. The

remuneration of the top level management and personnel responsible

for carrying out the conformity assessment tasks of a conformity

assessment body shall not depend on the number of assessments

carried out or on the results of those assessments.

(9) Conformity assessment bodies shall take out liability

insurance unless liability is assumed by the State in accordance with

national law, or the Member State itself is directly responsible for the

conformity assessment.

(10) The personnel of 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 of Schedule I or any provision of national law

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

of the Member State in which its activities are carried out. Proprietary

rights shall be protected.

(11) Conformity assessment bodies shall participate in, or

ensure that their personnel responsible for carrying out conformity

assessment tasks are informed of, the relevant standardisation

activities and the activities of 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 of the work of that group.

24. (1) For the purposes of notification, a user inspectorate

shall meet the requirements laid down in sub-regulations (2) to (11).

(2) A user inspectorate shall be established under the Maltese

law and have legal personality.

(3) A user inspectorate shall be organisationally identifiable

and have reporting methods within the group of which it is part which

ensure and demonstrate its impartiality.

(4) (a)

A user inspectorate, its top level management and

the personnel responsible for carrying out the conformity assessment

tasks shall not be the designer, manufacturer, supplier, installer,

purchaser, owner, user or maintainer of the pressure equipment or

assembly which they assess, nor the authorised representative of any

of those parties. This shall not preclude the use of assessed pressure

equipment or assemblies that are necessary for the operations of the

user inspectorate or the use of 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 of 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 of judgement or integrity in relation

to conformity assessment activities for which they are notified. This

shall in particular apply to consultancy services.

(5) User inspectorates and their personnel shall carry out the

conformity assessment activities with the highest degree of

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 of their conformity assessment activities, especially as regards

persons or groups of persons with an interest in the results of those

activities.

(6) (a)

A user inspectorate shall be capable of 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 of pressure equipment in relation

to which it has been notified, the user inspectorate shall have at its

disposal the necessary

(i) personnel with technical knowledge and

sufficient and appropriate experience to perform the

conformity assessment tasks;

(ii) descriptions of procedures in accordance with

which conformity assessment is carried out, ensuring the

transparency and the ability of reproduction of 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 of activities

which take due account of the size of an undertaking, the

sector in which it operates, its structure, the degree of

complexity of the product technology in question and the

mass or serial nature of 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.

(7) The personnel responsible for carrying out conformity

assessment tasks shall have the following

(a)

sound technical and vocational training covering all

the conformity assessment activities in relation to which the

conformity assessment body has been notified;

(b) satisfactory knowledge of the requirements of the

assessments they carry out and adequate authority to carry out

those assessments;

(c)

appropriate knowledge and understanding of the

essential safety requirements set out in Schedule I, of the

applicable harmonised standards and of the relevant provisions

of Union harmonisation legislation and of national legislation;

(d) the ability to draw up certificates, records and

reports demonstrating that assessments have been carried out.

(8) (a)

The impartiality of the user inspectorates, their top

level management and of 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 of judgement and integrity in relation to its inspection

activities.

(b) The remuneration of the top level management and

personnel responsible for carrying out conformity assessment tasks of

a user inspectorate shall not depend on the number of assessments

carried out or on the results of those assessments.

(9) User inspectorates shall take out liability insurance unless

liability is assumed by the group of which they are part.

(10) The personnel of user inspectorates shall observe

professional secrecy with regard to all information obtained in

carrying out their tasks under regulation 18 or any provision of

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

authorities of the Member State in which its activities are carried out.

Proprietary rights shall be protected.

(11) User inspectorates shall participate in, or ensure that their

personnel responsible for carrying out conformity assessment tasks

are informed of, the relevant standardisation activities and the

activities of 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 of the work of that group.

25. Where a conformity assessment body demonstrates its Presumption of

conformity with the criteria laid down in the relevant harmonised conformity

assessment

standards or parts thereof the references of which have been bodies.

published in the Official Journal of 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.

26. (1) Where a notified body, a user inspectorate or a Subsidiaries of

recognised third-party organisation subcontracts specific tasks and

subcontracting

connected with conformity assessment or has recourse to a subsidiary, by

assessment

it shall ensure that the subcontractor or the subsidiary meets the bodies.

requirements set out in regulation 23 or regulation 24 and shall

inform the Technical Regulations Division accordingly.

(2) Notified bodies, user inspectorates and recognised third-

party organisations shall take full responsibility for the tasks

performed by subcontractors or subsidiaries wherever these are

established.

(3) Activities may be subcontracted or carried out by a

subsidiary only with the agreement of the client.

(4) Notified bodies, user inspectorates and recognised third-

party organisations shall keep at the disposal of the Technical

Regulations Division the relevant documents concerning the

assessment of the qualifications of 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 of Schedule I.

(1) A conformity assessment body established in Malta Notification

shall submit an application for notification under these regulations to procedures.

the Technical Regulations Division.

(2) The application referred to in the preceding sub-regulation

shall be accompanied by a description of 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 S.L. 427.45

Conformity Assessment Bodies Regulations,.

(3) The Technical Regulations Division may only notify

conformity assessment bodies which have satisfied the requirements

laid down in regulation 23 or regulation 24 and the Method for S.L. 427.45

Designating Conformity Assessment Bodies Regulations.

(4) The Technical Regulations Division shall notify

conformity assessment bodies to the European Commission and the

other Member States using the electronic notification tool developed

and managed by the European Commission.

(5) The notification shall include full details of the conformity

assessment activities, the conformity assessment module or modules

and the pressure equipment concerned and the relevant attestation of

competence.

(6) The body concerned may perform the activities of a

notified body only where no objections are raised by the European

Commission or the other Member States within two weeks of a

notification. Only such a body shall be considered a notified body, a

recognised third-party organisation or a user inspectorate for the

purposes of these regulations.

(7) The Technical Regulations Division shall notify the

European Commission and the other Member States of any

subsequent relevant changes to the notification.

(8) (a)

Where the Technical Regulations Division has

ascertained or has been informed that a notified body or a recognised

third-party organisation no longer meets the requirements laid down

in regulation 23 or the Method for Designating Conformity

Assessment Bodies Regulations, or that it is failing to fulfil its

obligations, the Technical Regulations Division shall restrict, suspend

or withdraw notification as appropriate, depending on the seriousness

of the failure to meet those requirements or fulfil those obligations. It

shall immediately inform the European Commission and the other

Member States accordingly.

(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 of the failure to meet those requirements or fulfil

those obligations. It shall immediately inform the European

Commission and the other Member States accordingly.

(9) In the event of restriction, suspension or withdrawal of

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 of that body are either processed by another notified

body, recognised third-party organisation or user inspectorate, or kept

available to the Technical Regulations Division, at their request.

(10) The Technical Regulations Division shall provide the

Commission, on request, with all information relating to the basis for

the notification or the maintenance of the competence of the body

concerned.

(1) Notified bodies, user inspectorates and recognised Operational

third-party organisations shall carry out conformity assessments in obligations

notified bodies,

accordance with the conformity assessment tasks provided for in user

inspectorates

regulation 16, regulation 17, regulation 18, or in points 3.1.2 and and recognised

third party

3.1.3 of Schedule I.

organisations.

(2) Conformity assessments shall be carried out in a

proportionate manner, avoiding unnecessary burdens for economic

operators. Conformity assessment bodies shall perform their activities

taking due account of the size of an undertaking, the sector in which it

operates, its structure, the degree of complexity of the pressure

equipment or assembly technology in question and the mass or serial

nature of the production process. In so doing they shall nevertheless

respect the degree of rigour and the level of protection required for

the compliance of the pressure equipment with the requirements of

these regulations.

(3) Where a conformity assessment body finds that essential

safety requirements set out in Schedule I or corresponding

harmonised standards or other technical specifications have not been

met by a manufacturer, it shall require that manufacturer to take

appropriate corrective measures and shall not issue a certificate of

conformity.

(4) Where, in the course of the monitoring of conformity

following the issue of 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.

(5) Where corrective measures are not taken or do not have the

required effect, the conformity assessment body shall restrict,

suspend or withdraw any certificates, as appropriate.

(6) Notified bodies, recognised third-party organisations and

user inspectorates shall inform the Technical Regulations Division of

the following

(a)

any refusal, restriction, suspension or withdrawal of

a certificate;

(b) any circumstances affecting the scope of or

conditions for notification;

(c)

any request for information which they have

received from market surveillance authorities regarding

conformity assessment activities;

(d) on request, conformity assessment activities

performed within the scope of their notification and any other

activity performed, including cross-border activities and

subcontracting.

(7) Notified bodies, recognised third-party organisations and

user inspectorates shall provide the other bodies notified these

regulations carrying out similar conformity assessment activities

covering the same pressure equipment with relevant information on

issues relating to negative and, on request, positive conformity

assessment results.

(8) Conformity assessment bodies shall participate, directly or

by means of designated representatives, in the appropriate

coordination and cooperation groups for conformity assessment

bodies organised by the European Commission.

(1) Article 15(3) and articles 16 to 29 of Regulation (EC)

No 765/2008 shall apply to pressure equipment and assemblies

covered by regulation 3 of these regulations.

(2) (a)

Where the Technical Regulations Division have

sufficient reasons to believe that pressure equipment or assemblies

covered by these regulations present a risk to the health or safety of

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 of the evaluation referred to in

sub-regulation (2), the market Technical Regulations Division find

that the equipment or assembly does not comply with the

requirements laid down in these regulations, they shall without delay

require the relevant economic operator to take all appropriate

corrective actions to bring the pressure equipment or assembly into

compliance with those requirements, to withdraw the equipment or

assembly from the market, or to recall it within a reasonable period,

commensurate with the nature of the risk, as they may prescribe.

(c)

They shall also inform the relevant notified body

accordingly.

(d) Article 21 of Regulation (EC) No 765/2008 shall

apply to the measures referred to in sub-regulation (4).

(3) Where the Technical Regulations Division consider that

non-compliance is not restricted to the Maltese territory, it shall

inform the European Commission and the other Member States of the

results of the evaluation and of the actions which they have required

the economic operator to take.

(4) The economic operator shall ensure that all appropriate

corrective action is taken in respect of all the pressure equipment

concerned that it has made available on the market throughout the

European Union.

(5) Where the relevant economic operator does not take

adequate corrective action within the period referred to in sub-

regulation (2)(b), the Technical Regulations Division shall take all

appropriate provisional measures to prohibit or restrict the placing on

the Maltese market or the use of the pressure equipment or assembly

concerned, or recall it.

(6) The Technical Regulations Division shall inform the

European Commission and the other Member States, without delay, of

those measures.

(7) The information referred to in the sub-regulation (6) shall

include all available details, in particular the data necessary for the

identification of the non-compliant equipment or assembly, the origin

of the equipment or assembly, the nature of the non-compliance

alleged and the risk involved, the nature and duration of 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 of the

following

(a)

failure of the equipment or assembly to meet the

requirements relating to the health and safety of persons or to

the protection of domestic animals or property; or

(b) shortcomings in the harmonised standards referred

to in regulation 14 conferring a presumption of conformity.

(8) When the procedure under these regulations is initiated by

another Member State, the Technical Regulations Division, shall

without delay inform the European Commission and the other

Member States of any measures adopted and of any additional

information at their disposal relating to the non-compliance of the

equipment or assembly concerned, and, in the event of disagreement

with the adopted national measure, of their objections.

(9) Where, within three months of receipt of the information

referred to in sub-regulation (6), no objection has been raised by

either a Member State or the European Commission in respect of a

provisional measure taken by a Member State, that measure shall be

deemed justified.

(10) In such cases, the Technical Regulations Division shall

ensure that appropriate restrictive measures, such as withdrawal of

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

respect of the equipment or assembly concerned without delay.

(11) Where on completion of the procedure set out in sub-

regulations (4) and (5), objections are raised against the measures

taken by Technical Regulations Division; the European Commission

shall conduct an evaluation including appropriate consultations with

these entities and the relevant economic operator or operators.

(12) If, on the basis of 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 of

the non-compliant equipment or assembly is withdrawn from the

Maltese market and shall inform the European Commission

accordingly. If, on the basis of this evaluation, the national measure is

considered unjustified, the national measure shall be withdrawn.

(13) Where, having carried out an evaluation under sub-

regulation (2), the Technical Regulations Division, finds that

although pressure equipment or an assembly is in compliance with

these regulations, it presents a risk to the health or safety of persons

or to other aspects of 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 of the risk, as it may prescribe.

(14) The economic operator shall ensure that corrective action

is taken in respect of all the equipment or assemblies concerned that

he has made available on the market throughout the European Union.

(15) The Technical Regulations Division, upon consultation

with the Commissioner of Police, shall immediately inform the

European Commission and the other Member States. That

information shall include all available details, in particular the data

necessary for the identification of the equipment or assembly

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

assembly, the nature of the risk involved and the nature and duration

of the national measures taken.

(16) Without prejudice to sub-regulations (2) to (10), where the

Technical Regulations Division and, or the Commissioner of Police

make one of 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 of

Article 30 of Regulation (EC) No 765/2008 or of 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 regulation 21 or has not been affixed;

(d) the marking and labelling referred to in point 3.3. of

Schedule I have not been affixed or have been affixed in

violation of regulation 21 or point 3.3 of Schedule I;

(e)

the EU declaration of conformity has not been

drawn up

(f)

the EU declaration of conformity has not been

drawn up correctly;

(g) technical documentation is either not available or

not complete;

(h) the information referred to in regulation 8(9) or

regulation 10(5) is absent, false or incomplete;

(i)

any other administrative requirement provided for in

regulation 8 or regulation 10 is not fulfilled.

(17) Where the non-compliance referred to in sub-regulation

(16) persists, the Technical Regulations Division shall take all

appropriate measures to restrict or prohibit the equipment or

assembly being made available on the Maltese market or ensure that it

is recalled or withdrawn from the Maltese market.

(18) The powers of the Commissioner of Police under this

regulation may be exercised by any officer or other entity as he may

direct.

The penalties applicable for the infringement of any of the

provisions of these regulations shall be those provided for in Part IV

of the Product Safety Act.

The Pressure Equipment Regulations are hereby revoked.

(1) Any references to the revoked regulations shall be

construed as references to these regulations.

(2) Any references in existing laws, regulations and

administrative provisions to Directive 2007/23/EC shall be construed

as references to Directive 2013/29/EU.

Schedule I

ESSENTIAL SAFETY REQUIREMENTS

PRELIMINARY OBSERVATIONS

1. The obligations arising from the essential safety requirements listed in

this Schedule for pressure equipment also apply to assemblies where the

corresponding hazard exists.

2. The essential safety requirements laid down in these regulations are

compulsory. The obligations following from those essential safety

requirements apply only if the corresponding hazard exists for the

pressure equipment in question when it is used under conditions which

are reasonably foreseeable by the manufacturer.

3. The manufacturer is under an obligation to analyse the hazards and risks

in order to identify those which apply to his equipment on account of

pressure; he shall then design and construct it taking account of his

analysis.

4. The essential safety requirements are to be interpreted and applied in

such a way as to take account of the state of the art and current practice

at the time of design and manufacture as well as of technical and

economic considerations which are consistent with a high degree of

health and safety protection.

1. GENERAL

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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

(a)

on filling

overfilling or overpressurisation having regard in particular to the

filling ratio and to vapour pressure at the reference temperature,

instability of the pressure equipment;

(b)

on discharge: the uncontrolled release of the pressurised fluid;

(c)

on filling or discharge: unsafe connection and disconnection.

2.10. Protection against exceeding the allowable limits of pressure equipment

Where, under reasonably foreseeable conditions, the allowable limits

could be exceeded, the pressure equipment shall be fitted with, or

provision made for the fitting of, suitable protective devices, unless the

equipment is intended to be protected by other protective devices within

an assembly.

The suitable device or combination of such devices shall be determined

on the basis of the particular characteristics of the equipment or

assembly.

Suitable protective devices and combinations thereof comprise

(a)

safety accessories as defined in point 4 of 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.

Safety accessories

2.11.1. Safety accessories shall

-

be so designed and constructed as to be reliable and suitable for

their intended duty and take into account the maintenance and

testing requirements of the devices, where applicable,

-

be independent of other functions, unless their safety function

cannot be affected by such other functions,

-

comply with appropriate design principles in order to obtain

suitable and reliable protection. These principles include, in

particular, fail-safe modes, redundancy, diversity and self-diagnosis.

2.11.2. Pressure limiting devices

These devices shall be so designed that the pressure will not permanently

exceed the maximum allowable pressure PS; however a short duration

pressure surge in keeping with the specifications laid down in point 7.3

is allowable, where appropriate.

2.11.3. Temperature monitoring devices

These devices shall have an adequate response time on safety grounds,

consistent with the measurement function.

2.12. External fire

Where necessary, pressure equipment shall be so designed and,

where appropriate, fitted with suitable accessories, or provision

made for their fitting, to meet damage-limitation requirements in the

event of external fire, having particular regard to its intended use.

3. MANUFACTURING

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 regulation 22(1).

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 regulation 22(1).

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.

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 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 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.

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(9)

and regulation 10(5), 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.

Operating instructions

(a)

When pressure equipment is made available on the market, it shall

be accompanied, as far as relevant, with instructions for the user,

containing all the necessary safety information relating to

mounting including assembling of different pieces of pressure

equipment,

putting into service,

use,

maintenance including checks by the user.

(b)

Instructions shall cover information affixed to the pressure

equipment in accordance with point 3.3, with the exception of serial

identification, and shall be accompanied, where appropriate, by the

technical documents, drawings and diagrams necessary for a full

understanding of these instructions.

(c)

If appropriate, these instructions shall also refer to risks arising

from misuse in accordance with point 1.3 and particular features of

the design in accordance with point 2.2.3.

4. MATERIALS

Materials used for the manufacture of pressure equipment shall be

suitable for such application during the scheduled lifetime unless

replacement is foreseen.

Welding consumables and other joining materials need to fulfil only the

relevant requirements of points 4.1, 4.2(a) and the first paragraph of

point 4.3, in an appropriate way, both individually and in a joined

structure.

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.

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 these regulations 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 regulation 17,

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.

The equipment manufacturer shall take appropriate measures to ensure

that the material used conforms with the required specification. In

particular, documentation prepared by the material manufacturer

affirming compliance with a specification shall be obtained for all

materials.

For the main pressure-bearing parts of equipment in categories II,

III and IV, this shall take the form of a certificate of specific product

control.

Where a material manufacturer has an appropriate quality-assurance

system, certified by a competent body established within the Union

and having undergone a specific assessment for materials,

certificates issued by the manufacturer are presumed to certify

conformity with the relevant requirements of this point.

SPECIFIC PRESSURE EQUIPMENT REQUIREMENTS

In addition to the applicable requirements of points 1 to 4, the following

requirements apply to the pressure equipment covered by points 5 and 6.

5. FIRED OR OTHERWISE HEATED PRESSURE EQUIPMENT WITH

A RISK OF OVERHEATING AS REFERRED TO IN REGULATION

6(1)

This pressure equipment includes

steam and hot-water generators as referred to in regulation 6(1)(b),

such as fired steam and hot-water boilers, superheaters and

reheaters, waste-heat boilers, waste incineration boilers, electrode

or immersion-type electrically heated boilers, pressure cookers,

together with their accessories and where applicable their systems

for treatment of feedwater and for fuel supply,

process-heating equipment for other than steam and hot water

generation falling under regulation 6(1)(a), such as heaters for

chemical and other similar processes and pressurised food-

processing equipment.

This pressure equipment shall be calculated, designed and constructed so

as to avoid or minimise risks of a significant loss of containment from

overheating. In particular it shall be ensured, where applicable, that

(a)

appropriate means of protection are provided to restrict operating

parameters such as heat input, heat take-off and, where applicable,

fluid level so as to avoid any risk of local and general overheating;

(b)

sampling points are provided where required to allow evaluation of

the properties of the fluid so as to avoid risks related to deposits

and, or corrosion;

(c)

adequate provisions are made to eliminate risks of damage from

deposits;

(d)

means of safe removal of residual heat after shutdown are provided;

(e)

steps are taken to avoid a dangerous accumulation of ignitable

mixtures of combustible substances and air, or flame blowback.

6. PIPING AS REFERRED TO IN REGULATION 6(1)(c)

Design and construction shall ensure

(a)

that the risk of overstressing from inadmissible free movement or

excessive forces being produced, e.g. on flanges, connections,

bellows or hoses, is adequately controlled by means such as

support, constraint, anchoring, alignment and pre-tension;

(b)

that where there is a possibility of condensation occurring inside

pipes for gaseous fluids, means are provided for drainage and

removal of deposits from low areas to avoid damage from water

hammer or corrosion;

(c)

that due consideration is given to the potential damage from

turbulence and formation of vortices; the relevant parts of point 2.7

are applicable;

(d)

that due consideration is given to the risk of fatigue due to

vibrations in pipes;

(e)

that, where fluids of Group 1 are contained in the piping,

appropriate means are provided to isolate ‘take-off’ pipes the size of

which represents a significant risk;

(f)

that the risk of inadvertent discharge is minimised; the take-off

points shall be clearly marked on the permanent side, indicating the

fluid contained;

(g)

that the position and route of underground piping is at least recorded

in the technical documentation to facilitate safe maintenance,

inspection or repair.

7. SPECIFIC QUANTITATIVE REQUIREMENTS FOR

CERTAIN

PRESSURE EQUIPMENT

The following provisions apply as a general rule. However, where they

are not applied, including in cases where materials are not specifically

referred to and no harmonised standards are applied, the manufacturer

shall demonstrate that appropriate measures have been taken to achieve

an equivalent overall level of safety.

The provisions laid down in this section supplement the essential safety

requirements of points 1 to 6 for the pressure equipment to which they

apply.

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 Re/t and 5/12 of Rm/20,

-

in the case of austenitic steel

-

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

-

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

of Re/t and 1/3 of R m/t,

in the case of non-alloy or low-alloy cast steel, 10/19 of Re/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.

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.

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.

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.

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.

Schedule II

CONFORMITY ASSESSMENT TABLES

=

Module A

=

Modules A2, D1, E1

=

Modules B (design type) + D, B (design type) + F, B (production type) +

E, B (production type) + C2, H

=

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(1)(d), are classified in category IV. However, by way of

exception, safety accessories manufactured for specific equipment may

be classified in the same category as the equipment they protect.

3. The pressure accessories defined in regulation 4, and referred to in

regulation 6(1)(d), are classified on the basis of

their maximum allowable pressure PS,

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

the group of fluids for which they are intended.

The appropriate table for vessels or piping is to be used to determine the

conformity assessment category.

Where both the volume and the nominal size are considered appropriate

in the second indent of the first 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.

Table 1

Vessels referred to in regulation 6(1)(a)(i), 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 regulation 6(1)(a)(i), second indent

Exceptionally, portable extinguishers and bottles for breathing

equipment shall be classified at least in category III.

Table 3

Vessels referred to in regulation 6(1)(a)(ii), first indent

Table 4

Vessels referred to in regulation 6(1)(a)(ii), second indent

Exceptionally, assemblies intended for generating warm water as

referred to in paragraph (b) of regulation 6(2), shall be subject either to

an EU-type examination (Module B-design type) with respect to their

conformity with the essential requirements referred to in points 2.10,

2.11, 3.4, 5(a) and 5(d) of Schedule I, or to full quality assurance

(Module H).

Table 5

Pressure equipment referred to in regulation 6(1)(b)

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 regulation 6(1)(c)(i), 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 regulation 6(1)(c)(i), 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 regulation 6(1)(c)(ii), first indent

Table 9

Piping referred to in regulation 6(1)(c)(ii), second indent

Schedule III

CONFORMITY ASSESSMENT PROCEDURES

The obligations arising from the provisions on pressure equipment in this

Schedule also apply to assemblies.

1. MODULE A: (INTERNAL PRODUCTION CONTROL)

1. Internal production control is the conformity assessment procedure

whereby the manufacturer fulfils the obligations laid down in points 2, 3

and 4, and ensures and declares on his sole responsibility that the

pressure equipment concerned satisfy the requirements of these

regulations.

2. Technical documentation

The manufacturer shall establish the technical documentation.

The technical documentation shall make it possible to assess the

conformity of the pressure equipment to the relevant requirements, and

shall include an adequate analysis and assessment of the risk(s). The

technical documentation shall specify the applicable requirements and

cover, as far as relevant for the assessment, the design, manufacture and

operation of the pressure equipment. The technical documentation shall,

wherever applicable, contain at least the following elements

-

a general description of the pressure equipment,

-

conceptual design and manufacturing drawings and diagrams of

components, sub-assemblies, circuits, etc.,

-

descriptions and explanations necessary for an understanding of

those drawings and diagrams and the operation of the pressure

equipment,

-

a list of the harmonised standards the references of which have been

published in the Official Journal of the European Union, applied in

full or in part, and a description of the solutions adopted to meet the

essential safety requirements of these regulations where those

harmonised standards have not been applied. In the event of partly

applied harmonised standards, the technical documentation shall

specify the parts which have been applied,

-

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

-

test reports.

3. Manufacturing

The manufacturer shall take all measures necessary so that the

manufacturing process and its monitoring ensure compliance of the

manufactured pressure equipment with the technical documentation

referred to in point 2 and with the requirements of these regulations.

4. CE marking and EU declaration of conformity

The manufacturer shall affix the CE marking to each individual pressure

equipment that satisfies the applicable requirements of these regulations.

The manufacturer shall draw up a written EU declaration of conformity

for the pressure equipment model and keep it together with the technical

documentation at the disposal of the national authorities for 10 years

after the pressure equipment has been placed on the market. The EU

declaration of conformity shall identify the pressure equipment for

which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to

the relevant authorities upon request.

5. Authorised representative

The manufacturer’s obligations set out in point 4 may be fulfilled by his

authorised representative, on his behalf and under his responsibility,

provided that they are specified in the mandate.

2. MODULE A2: INTERNAL PRODUCTION CONTROL PLUS

SUPERVISED PRESSURE EQUIPMENT CHECKS AT RANDOM

INTERVALS

1. Internal production control plus supervised pressure equipment checks at

random intervals is the conformity assessment procedure whereby the

manufacturer fulfils the obligations laid down in points 2, 3, 4 and 5, and

ensures and declares on his sole responsibility that the pressure

equipment concerned satisfy the requirements of these regulations.

2. Technical documentation

The manufacturer shall establish the technical documentation. The

documentation shall make it possible to assess the conformity of the

pressure equipment with the relevant requirements, and shall include an

adequate analysis and assessment of the risk(s). The technical

documentation shall specify the applicable requirements and cover, as

far as relevant for the assessment, the design, manufacture and operation

of the pressure equipment. The technical documentation shall contain,

wherever applicable, at least the following elements

-

a general description of the pressure equipment,

-

conceptual design and manufacturing drawings and diagrams of

components, sub-assemblies, circuits, etc.,

-

descriptions and explanations necessary for the understanding of

those drawings and diagrams and the operation of the pressure

equipment,

-

a list of the harmonised standards the references of which have been

published in the Official Journal of the European Union, applied in

full or in part, and descriptions of the solutions adopted to meet the

essential safety requirements of these regulations where those

harmonised standards have not been applied. In the event of partly

applied harmonised standards, the technical documentation shall

specify the parts which have been applied,

-

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

and

-

test reports.

3. Manufacturing

The manufacturer shall take all measures necessary so that the

manufacturing process and its monitoring ensure compliance of the

manufactured pressure equipment with the technical documentation

referred to in point 2 and with the requirements of these regulations that

apply to it.

4. Final assessment and pressure equipment checks

The manufacturer shall perform a final assessment of the pressure

equipment, monitored by means of unexpected visits by a notified body

chosen by the manufacturer.

The notified body shall carry out product checks or have them carried

out at random intervals determined by the body, in order to verify the

quality of the internal checks of the pressure equipment, taking into

account, inter alia, the technological complexity of the pressure

equipment and the quantity of production.

During its unexpected visits, the notified body shall

-

establish that the manufacturer actually performs final assessment

in accordance with point 3.2 of Schedule I.

-

take samples of pressure equipment at the manufacturing or storage

premises in order to conduct checks. The notified body assesses the

number of items of equipment to sample and whether it is necessary

to perform, or have performed, all or part of the final assessment of

the pressure equipment samples.

The acceptance sampling procedure to be applied is intended to

determine whether the manufacturing process of the pressure equipment

performs within acceptable limits, with a view to ensuring conformity of

the pressure equipment.

Should one or more of the items of pressure equipment or assembly not

conform, the notified body shall take appropriate measures.

The manufacturer shall, under the responsibility of the notified body,

affix the notified body’s identification number during the manufacturing

process.

5. CE marking and EU declaration of conformity

The manufacturer shall affix the CE marking to each individual pressure

equipment that satisfies the applicable requirements of these regulations.

The manufacturer shall draw up a written EU declaration of conformity

for the pressure equipment model and keep it together with the technical

documentation at the disposal of the national authorities for 10 years

after the pressure equipment has been placed on the market. The EU

declaration of conformity shall identify the pressure equipment for

which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to

the relevant authorities upon request.

6. Authorised representative

The manufacturer’s obligations set out in point 5 may be fulfilled by his

authorised representative, on his behalf and under his responsibility,

provided that they are specified in the mandate.

3. MODULE B: EU-TYPE EXAMINATION

EU-Type examination - production type

1. EU-type examination - production type is the part of a conformity

assessment procedure in which a notified body examines the technical

design of the pressure equipment and verifies and attests that the

technical design of the pressure equipment meets the requirements of

these regulations.

2. EU-type examination - production type shall consist of an assessment of

the adequacy of the technical design of the pressure equipment through

examination of the technical documentation and supporting evidence

referred to in point 3, plus examination of a specimen, representative of

the production envisaged, of the complete pressure equipment.

3. The manufacturer shall lodge an application for EU-type examination

with a single notified body of his choice.

The application shall include

-

the name and address of the manufacturer and, if the application is

lodged by the authorised representative, his name and address as

well,

-

a written declaration that the same application has not been lodged

with any other notified body,

-

the technical documentation. The technical documentation shall

make it possible to assess the conformity of the pressure equipment

with the applicable requirements of these regulations and shall

include an adequate analysis and assessment of the risk(s). The

technical documentation shall specify the applicable requirements

and cover, as far as relevant for the assessment, the design,

manufacture and operation of the pressure equipment. The technical

documentation shall contain, wherever applicable, at least the

following elements

a general description of the pressure equipment,

conceptual design and manufacturing drawings and diagrams of

components, sub-assemblies, circuits, etc.,

descriptions and explanations necessary for the understanding of

those drawings and diagrams and the operation of the pressure

equipment,

a list of the harmonised standards the references of which have been

published in the Official Journal of the European Union, applied in

full or in part, and descriptions of the solutions adopted to meet the

essential safety requirements of these regulations where those

harmonised standards have not been applied. In the event of partly

applied harmonised standards, the technical documentation shall

specify the parts which have been applied,

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

test reports,

information concerning the tests provided for in manufacture,

information concerning the qualifications or approvals required

under points 3.1.2 and 3.1.3 of Schedule I,

the specimens representative of the production envisaged.

The specimen may cover several versions of the pressure equipment

provided that the differences between the versions do not affect the level

of safety.

The notified body may request further specimens if needed for carrying

out the test programme;

the supporting evidence for the adequacy of the technical design

solution. This supporting evidence shall mention any documents

that have been used, in particular where the relevant harmonised

standards have not been applied in full. The supporting evidence

shall include, where necessary, the results of tests carried out by the

appropriate laboratory of the manufacturer applying other relevant

technical specifications, or by another testing laboratory on his

behalf and under his responsibility.

4. The notified body shall

examine the technical documentation and supporting evidence to assess

the adequacy of the technical design of the pressure equipment and the

manufacturing procedures.

In particular, the notified body shall

-

assess the materials where these are not in conformity with the

relevant harmonised standards or with a European approval for

pressure equipment materials, and check the certificate issued by

the material manufacturer in accordance with point 4.3 of Schedule

I,

-

approve the procedures for the permanent joining of pressure

equipment parts, or check that they have been previously approved

in accordance with point 3.1.2 of Schedule I,

-

verify that the personnel undertaking the permanent joining of

pressure equipment parts and the non-destructive tests are qualified

or approved in accordance with points 3.1.2 or 3.1.3 of Schedule I.

verify that the specimen(s) have been manufactured in conformity with

the technical documentation and identify the elements which have been

designed in accordance with the applicable provisions of the relevant

harmonised standards as well as the elements which have been designed

using other relevant technical specifications without applying the

relevant provisions of those standards.

carry out appropriate examinations and necessary tests to check whether

when the manufacturer has chosen to apply the solutions in the relevant

harmonised standards, these have been applied correctly.

carry out appropriate examinations and necessary tests to check whether,

where the solutions in the relevant harmonised standards have not been

applied, the solutions adopted by the manufacturer applying other

relevant technical specifications meet the corresponding essential safety

requirements of these regulations.

agree with the manufacturer on a location where the examinations and

tests will be carried out.

5. The notified body shall draw up an evaluation report that records the

activities undertaken in accordance with point 4 and their outcomes.

Without prejudice to its obligations vis-à-vis the notifying authority, the

notified body shall release the content of that report, in full or in part,

only with the agreement of the manufacturer.

6. Where the type meets the requirements of these regulations, the notified

body shall issue an EU-type examination certificate - production type to

the manufacturer. Without prejudice to point 7, the certificate shall be

valid for 10 years and be renewable and shall contain the name and

address of the manufacturer, the conclusions of the examination, the

conditions (if any) for its validity and the necessary data for

identification of the approved type.

A list of the relevant parts of the technical documentation shall be

annexed to the certificate and a copy kept by the notified body.

The certificate and its annexes shall contain all relevant information to

allow the conformity of manufactured pressure equipment with the

examined type to be evaluated and to allow for in-service control.

Where the type does not satisfy the applicable requirements of these

regulations, the notified body shall refuse to issue an EU-type

examination certificate - production type and shall inform the applicant

accordingly, giving detailed reasons for its refusal. Provision shall be

made for an appeals procedure.

7. The notified body shall keep itself apprised of any changes in the

generally acknowledged state of the art which indicate that the approved

type may no longer comply with the applicable requirements of these

regulations, and shall determine whether such changes require further

investigation. If so, the notified body shall inform the manufacturer

accordingly.

The manufacturer shall inform the notified body that holds the technical

documentation relating to the EU-type examination certificate -

production type of all modifications to the approved type that may affect

the conformity of the pressure equipment with the essential safety

requirements of these regulations or the conditions for validity of the

certificate. Such modifications shall require additional approval in the

form of an addition to the original EU-type examination certificate -

production type.

8. Each notified body shall inform its notifying authority concerning the

EU-type examination certificates - production type and, or any additions

thereto which it has issued or withdrawn, and shall, periodically or upon

request, make available to its notifying authorities the list of certificates

and, or any additions thereto refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies concerning the

EU-type examination certificates - production type and, or any additions

thereto which it has refused, withdrawn, suspended or otherwise

restricted, and, upon request, concerning the certificates and, or

additions thereto which it has issued.

The Commission, the Member States and the other notified bodies may,

on request, obtain a copy of the EU-type examination certificates -

production type and, or additions thereto. On request, the Commission

and the Member States may obtain a copy of the technical

documentation and the results of the examinations carried out by the

notified body. The notified body shall keep a copy of the EU-type

examination certificate - production type, its annexes and additions, as

well as the technical file including the documentation submitted by the

manufacturer, until the expiry of the validity of the certificate.

9. The manufacturer shall keep a copy of the EU-type examination

certificate - production type, its annexes and additions together with the

technical documentation at the disposal of the national authorities for 10

years after the pressure equipment has been placed on the market.

10. The manufacturer’s authorised representative may lodge the application

referred to in point 3 and fulfil the obligations set out in points 7 and 9,

provided that they are specified in the mandate.

EU-Type examination - design type

1. EU-type examination - design type is the part of a conformity

assessment procedure in which a notified body examines the technical

design of the pressure equipment and verifies and attests that the

technical design of the pressure equipment meets the requirements of

these regulations.

2. The EU-type examination - design type shall consist of an assessment of

the adequacy of the technical design of the pressure equipment through

examination of the technical documentation and supporting evidence

referred to in point 3, without examination of a specimen.

The experimental design method provided for in point 2.2.4 of Schedule

I shall not be used in the context of this module.

3. The manufacturer shall lodge an application for EU-type examination -

design type with a single notified body of his choice.

The application shall include

-

the name and address of the manufacturer and, if the application is

lodged by the authorised representative, his name and address as

well,

-

a written declaration that the same application has not been lodged

with any other notified body,

the technical documentation. The technical documentation shall

make it possible to assess the conformity of the pressure equipment

with the applicable requirements of the Directive and shall include

an adequate analysis and assessment of the risk(s). The technical

documentation shall specify the applicable requirements and cover,

as far as relevant for the assessment, the design, manufacture and

operation of the pressure equipment. The technical documentation

shall contain, wherever applicable, at least the following elements

a general description of the pressure equipment,

conceptual design and manufacturing drawings and diagrams of

components, sub-assemblies, circuits, etc.,

descriptions and explanations necessary for the understanding of

those drawings and diagrams and the operation of the pressure

equipment,

a list of the harmonised standards the references of which have been

published in the Official Journal of the European Union, applied in

full or in part, and descriptions of the solutions adopted to meet the

essential safety requirements of these regulations where those

harmonised standards have not been applied. In the event of partly

applied harmonised standards, the technical documentation shall

specify the parts which have been applied,

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

information regarding the qualifications or approvals required under

points 3.1.2 and 3.1.3 of Schedule I,

the supporting evidence for the adequacy of the technical design

solution. This supporting evidence shall mention any documents

that have been used, in particular where the relevant harmonised

standards have not been applied in full. This supporting evidence

shall include, where necessary, the results of tests carried out by the

appropriate laboratory of the manufacturer or by another testing

laboratory on his behalf and under his responsibility.

The application may cover several versions of the pressure equipment

provided that the differences between the versions do not affect the level

of safety.

4. The notified body shall

examine the technical documentation and supporting evidence to assess

the adequacy of the technical design of the product.

In particular, the notified body shall

-

assess the materials where these are not in conformity with the

relevant harmonised standards or with a European approval for

pressure equipment materials,

-

approve the procedures for the permanent joining of pressure

equipment parts, or check that they have been previously approved

in accordance with point 3.1.2 of Schedule I.

carry out appropriate examinations to check whether where the

manufacturer has chosen to apply the solutions in the relevant

harmonised standards these have been applied correctly.

carry out appropriate examinations to check whether, where the

solutions in the relevant harmonised standards have not been applied, the

solutions adopted by the manufacturer meet the corresponding essential

safety requirements of these regulations.

5. The notified body shall draw up an evaluation report that records the

activities undertaken in accordance with point 4 and their outcomes.

Without prejudice to its obligations vis-à-vis the notifying authorities,

the notified body shall release the content of that report, in full or in part,

only with the agreement of the manufacturer.

6. Where the design meets the requirements of these regulations, the

notified body shall issue an EU-type examination certificate-design type

to the manufacturer. Without prejudice to point 7, the certificate shall be

valid for 10 years and be renewable and shall contain the name and

address of the manufacturer, the conclusions of the examination, the

conditions (if any) for its validity and the necessary data for

identification of the approved design.

A list of the relevant parts of the technical documentation shall be

annexed to the certificate and a copy kept by the notified body.

The certificate and its annexes shall contain all relevant information to

allow the conformity of manufactured pressure equipment with the

examined design to be evaluated and to allow for in-service control.

Where the design does not satisfy the applicable requirements of these

regulations, the notified body shall refuse to issue an EU-type

examination certificate-design type and shall inform the applicant

accordingly, giving detailed reasons for its refusal.

7. The notified body shall keep itself apprised of any changes in the

generally acknowledged state of the art which indicate that the approved

design may no longer comply with the applicable requirements of these

regulations, and shall determine whether such changes require further

investigation. If so, the notified body shall inform the manufacturer

accordingly.

The manufacturer shall inform the notified body that holds the technical

documentation relating to the EU-type examination certificate-design

type of all modifications to the approved design that may affect the

conformity of the pressure equipment with the essential safety

requirements of these regulations or the conditions for validity of the

certificate. Such modifications shall require additional approval in the

form of an addition to the original EU-type examination certificate-

design type.

8. Each notified body shall inform its notifying authorities concerning the

EU-type examination certificates-design type and, or any additions

thereto which it has issued or withdrawn, and shall, periodically or upon

request, make available to its notifying authorities the list of certificates

and, or any additions thereto refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies concerning the

EU-type examination certificates-design type and, or any additions

thereto which it has refused, withdrawn, suspended or otherwise

restricted, and, upon request, concerning the certificates and, or

additions thereto which it has issued.

The Commission, the Member States and the other notified bodies may,

on request, obtain a copy of the EU-type examination certificates -

design type and, or additions thereto. On request, the Commission and

the Member States may obtain a copy of the technical documentation

and the results of the examinations carried out by the notified body. The

notified body shall keep a copy of the EU-type examination certificate -

design type, its annexes and additions, as well as the technical file

including the documentation submitted by the manufacturer, until the

expiry of the validity of the certificate.

9. The manufacturer shall keep a copy of the EU-type examination

certificate-design type, its annexes and additions together with the

technical documentation at the disposal of the national authorities for 10

years after the pressure equipment has been placed on the market.

10. The manufacturer’s authorised representative may lodge the application

referred to in point 3 and fulfil the obligations set out in points 7 and 9,

provided that they are specified in the mandate.

4. MODULE C2: CONFORMITY TO TYPE BASED ON INTERNAL

PRODUCTION CONTROL PLUS SUPERVISED PRESSURE

EQUIPMENT CHECKS AT RANDOM INTERVALS

1. Conformity to type based on internal production control plus supervised

pressure equipment checks at random intervals is the part of a

conformity assessment procedure whereby the manufacturer fulfils the

obligations laid down in points 2, 3 and 4, and ensures and declares on

his sole responsibility that the pressure equipment concerned is in

conformity with the type described in the EU-type examination

certificate and satisfy the requirements of these regulations that apply to

it.

2. Manufacturing

The manufacturer shall take all measures necessary so that the

manufacturing process and its monitoring ensure conformity of the

manufactured pressure equipment with the type described in the EU-type

examination certificate and with the requirements of these regulations

that apply to them.

3. Final assessment and pressure equipment checks

A notified body, chosen by the manufacturer, shall carry out checks or

have them carried out at random intervals determined by the body, in

order to verify the quality of the final assessment and of the internal

checks on the pressure equipment, taking into account, inter alia, the

technological complexity of the pressure equipment and the quantity of

production.

The notified body shall establish that the manufacturer actually performs

final assessment in accordance with point 3.2 of Schedule I.

An adequate sample of the final pressure equipment, taken on site by the

notified body before the placing on the market, shall be examined and

appropriate tests as identified by the relevant parts of the harmonised

standards, and, or equivalent tests applying other technical

specifications, shall be carried out to check the conformity of the

pressure equipment with the relevant requirements of these regulations.

The notified body shall assess the number of items of equipment to

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

part of final assessment on the pressure equipment samples.

Where a sample does not conform to the acceptable quality level, the

body shall take appropriate measures.

The acceptance sampling procedure to be applied is intended to

determine whether the manufacturing process of the pressure equipment

performs within acceptable limits, with a view to ensuring conformity of

the pressure equipment.

Where the tests are carried out by a notified body, the manufacturer

shall, under the responsibility of the notified body, affix the notified

body’s identification number during the manufacturing process.

4. CE marking and EU declaration of conformity

The manufacturer shall affix the CE marking to each individual pressure

equipment or assembly that is in conformity with the type described in

the EU-type examination certificate and satisfies the applicable

requirements of these regulations.

The manufacturer shall draw up a written EU declaration of conformity

for a pressure equipment model and keep it at the disposal of the national

authorities for 10 years after the pressure equipment has been placed on

the market. The EU declaration of conformity shall identify the pressure

equipment model for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to

the relevant authorities upon request.

5. Authorised representative

The manufacturer’s obligations set out in point 4 may be fulfilled by his

authorised representative, on his behalf and under his responsibility,

provided that they are specified in the mandate.

5. MODULE D: CONFORMITY TO TYPE BASED ON QUALITY

ASSURANCE OF THE PRODUCTION PROCESS

1. Conformity to type based on quality assurance of the production process

is that part of a conformity assessment procedure whereby the

manufacturer fulfils the obligations laid down in points 2 and 5, and

ensures and declares on his sole responsibility that the pressure

equipment or assembly concerned is in conformity with the type

described in the EU-type examination certificate and satisfies the

requirements of these regulations that apply to it.

2. Manufacturing

The manufacturer shall operate an approved quality system for

production, final product inspection and testing of the pressure

equipment concerned as specified in point 3 and shall be subject to

surveillance as specified in point 4.

3. Quality system

The manufacturer shall lodge an application for assessment of his quality

system with the notified body of his choice for the pressure equipment

concerned.

The application shall include

the name and address of the manufacturer and, if the application is

lodged by the authorised representative, his name and address as

well,

a written declaration that the same application has not been lodged

with any other notified body,

all relevant information on the pressure equipment type envisaged,

the documentation concerning the quality system,

the technical documentation of the approved type and a copy of the

EU-type examination certificate.

The quality system shall ensure that the pressure equipment is in

conformity with the type described in the EU-type examination

certificate and comply with the requirements of these regulations that

apply to it.

All the elements, requirements and provisions adopted by the

manufacturer shall be documented in a systematic and orderly manner in

the form of written policies, procedures and instructions. This quality

system documentation shall permit a consistent interpretation of the

quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of

the quality objectives and the organisational structure,

responsibilities and powers of the management with regard to the

quality of the pressure equipment,

the corresponding manufacturing, quality control and quality

assurance techniques, processes and systematic actions that will be

used, particularly the procedures used for the permanent joining of

parts as approved in accordance with point 3.1.2 of Schedule I,

the examinations and tests that will be carried out before, during

and after manufacture, and the frequency with which they will be

carried out,

the quality records, such as inspection reports and test data,

calibration data, reports concerning the qualifications or approvals

of the personnel concerned, particularly those of the personnel

undertaking the permanent joining of parts and the non-destructive

tests in accordance with points 3.1.2 and 3.1.3 of Schedule I, etc.,

and

-

the means of monitoring the achievement of the required quality and

the effective operation of the quality system.

3.3. The notified body shall assess the quality system to determine whether it

satisfies the requirements referred to in point 3.2.

It shall presume conformity with those requirements in respect of the

elements of the quality system that comply with the corresponding

specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the auditing

team shall have at least one member with experience of evaluation in the

relevant pressure equipment field and pressure equipment technology

concerned, and knowledge of the applicable requirements of these

regulations. The audit shall include an inspection visit to the

manufacturer’s premises.

The auditing team shall review the technical documentation referred to

in point 3.1, fifth indent, to verify the manufacturer’s ability to identify

the relevant requirements of these regulations and to carry out the

necessary examinations with a view to ensuring compliance of the

product with those requirements.

The decision shall be notified to the manufacturer. The notification shall

contain the conclusions of the audit and the reasoned assessment

decision.

The manufacturer shall undertake to fulfil the obligations arising out of

the quality system as approved and to maintain it so that it remains

adequate and efficient.

The manufacturer shall keep the notified body that has approved the

quality system informed of any intended change to the quality system.

The notified body shall evaluate the proposed changes and decide

whether the modified quality system will continue to satisfy the

requirements referred to in point 3.2 or whether a reassessment is

necessary.

It shall notify the manufacturer of its decision. The notification shall

contain the conclusions of the examination and the reasoned assessment

decision.

4. Surveillance under the responsibility of the notified body

The purpose of surveillance is to make sure that the manufacturer duly

fulfils the obligations arising out of the approved quality system.

The manufacturer shall, for assessment purposes, allow the notified body

access to the manufacture, inspection, testing and storage sites and shall

provide it with all necessary information, in particular

-

the quality system documentation,

-

the quality records, such as inspection reports and test data,

calibration data, qualification reports of the personnel concerned,

etc.

The notified body shall carry out periodic audits to make sure that the

manufacturer maintains and applies the quality system and provide the

manufacturer with an audit report. The frequency of periodic audits shall

be such that a full reassessment is carried out every three years.

In addition the notified body may pay unexpected visits to the

manufacturer. The need for such additional visits, and the frequency

thereof, will be determined on the basis of a visit control system

operated by the notified body. In particular, the following factors shall be

considered in the visit control system

-

the category of the pressure equipment,

-

the results of previous surveillance visits,

-

the need to follow up corrective actions,

-

special conditions linked to the approval of the system, where

applicable,

-

significant changes in manufacturing organisation, policy or

techniques.

During such visits the notified body may, if necessary, carry out product

tests or have them carried out in order to verify that the quality system is

functioning correctly. The notified body shall provide the manufacturer

with a visit report and, if tests have been carried out, with a test report.

5. CE marking and EU declaration of conformity

The manufacturer shall affix the CE marking and, under the

responsibility of the notified body referred to in point 3.1, the latter’s

identification number to each individual pressure equipment that is in

conformity with the type described in the EU-type examination

certificate and satisfies the applicable requirements of these regulations.

The manufacturer shall draw up a written EU declaration of conformity

for each pressure equipment model and keep it at the disposal of the

national authorities for 10 years after the pressure equipment has been

placed on the market. The EU declaration of conformity shall identify

the pressure equipment model for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to

the relevant authorities upon request.

6. The manufacturer shall, for a period ending 10 years after the pressure

equipment has been placed on the market, keep at the disposal of the

national authorities

-

the documentation referred to point 3.1,

-

the change referred to in point 3.5, as approved,

-

the decisions and reports of the notified body referred to in points

3.3, 3.5, 4.3 and 4.4.

7. Each notified body shall inform its notifying authorities of the quality

system approvals issued or withdrawn, and shall, periodically or upon

request, make available to its notifying authorities the list of quality

system approvals refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of the quality

system approvals which it has refused, suspended, withdrawn or

otherwise restricted, and, upon request, of quality system approvals

which it has issued.

8. Authorised representative

The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be

fulfilled by his authorised representative, on his behalf and under his

responsibility, provided that they are specified in the mandate.

6. MODULE D1: QUALITY ASSURANCE OF THE PRODUCTION

PROCESS

1. Quality assurance of the production process is the conformity

assessment procedure whereby the manufacturer fulfils the obligations

laid down in points 2, 4 and 7, and ensures and declares on his sole

responsibility that the pressure equipment concerned satisfy the

requirements of these regulations that apply to it.

2. Technical documentation

The manufacturer shall establish the technical documentation. The

documentation shall make it possible to assess the conformity of the

pressure equipment with the relevant requirements and shall include an

adequate analysis and assessment of the risk(s). The technical

documentation shall specify the applicable requirements and cover, as

far as relevant for the assessment, the design, manufacture and operation

of the product. The technical documentation shall, wherever applicable,

contain at least the following elements

-

a general description of the pressure equipment,

-

conceptual design and manufacturing drawings and diagrams of

components, sub-assemblies, circuits, etc.,

-

descriptions and explanations necessary for an understanding of

those drawings and diagrams and the operation of the pressure

equipment,

-

a list of the harmonised standards the references of which have been

published in the Official Journal of the European Union, applied in

full or in part, and descriptions of the solutions adopted to meet the

essential safety requirements of these regulations where those

harmonised standards have not been applied. In the event of partly

applied harmonised standards, the technical documentation shall

specify the parts which have been applied,

-

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

and

-

test reports.

3. The manufacturer shall keep the technical documentation at the disposal

of the relevant national authorities for 10 years after the pressure

equipment has been placed on the market.

4. Manufacturing

The manufacturer shall operate an approved quality system for

production, final product inspection and testing of the pressure

equipment concerned as specified in point 5, and shall be subject to

surveillance as specified in point 6.

5. Quality system

The manufacturer shall lodge an application for assessment of his quality

system with the notified body of his choice for the pressure equipment

concerned.

The application shall include

the name and address of the manufacturer and, if the application is

lodged by the authorised representative, his name and address as

well,

a written declaration that the same application has not been lodged

with any other notified body,

all relevant information on the pressure equipment type envisaged,

the documentation concerning the quality system,

the technical documentation referred to in point 2.

The quality system shall ensure compliance of the pressure equipment

with the requirements of these regulations that apply to it.

All the elements, requirements and provisions adopted by the

manufacturer shall be documented in a systematic and orderly manner in

the form of written policies, procedures and instructions. This quality

system documentation shall permit a consistent interpretation of the

quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of

the quality objectives and the organisational structure,

responsibilities and powers of the management with regard to the

quality of the pressure equipment,

the corresponding manufacturing, quality control and quality

assurance techniques, processes and systematic measures that will

be used, particularly the procedures used for the permanent joining

of parts as approved in accordance with point 3.1.2 of Schedule I,

the examinations and tests that will be carried out before, during

and after manufacture, and the frequency with which they will be

carried out,

the quality records, such as inspection reports and test data,

calibration data, reports concerning the qualifications or approvals

of the personnel concerned, particularly those of the personnel

undertaking the permanent joining of parts in accordance with point

3.1.2 of Schedule I, etc.,

the means of monitoring the achievement of the required product

quality and the effective operation of the quality system.

The notified body shall assess the quality system to determine whether it

satisfies the requirements referred to in point 5.2. The elements of the

quality system which conform to the relevant harmonised standard are

presumed to comply with the corresponding requirements referred to in

point 5.2.

In addition to experience in quality management systems, the auditing

team shall have at least one member with experience of evaluation in the

pressure equipment technology concerned, and the knowledge of the

applicable requirements of these regulations. The audit shall include an

assessment visit to the manufacturer’s premises.

The auditing team shall review the technical documentation referred to

in point 2 in order to verify the manufacturer’s ability to identify the

relevant requirements of these regulations and to carry out the necessary

examinations with a view to ensuring compliance of the pressure

equipment with those requirements.

The decision shall be notified to the manufacturer. The notification shall

contain the conclusions of the audit and the reasoned assessment

decision.

The manufacturer shall undertake to fulfil the obligations arising out of

the quality system as approved and to maintain it so that it remains

adequate and efficient.

The manufacturer shall keep the notified body that has approved the

quality system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide

whether the modified quality system will continue to satisfy the

requirements referred to in point 5.2 or whether a reassessment is

necessary.

It shall notify the manufacturer of its decision. The notification shall

contain the conclusions of the examination and the reasoned assessment

decision.

6. Surveillance under the responsibility of the notified body

The purpose of surveillance is to make sure that the manufacturer duly

fulfils the obligations arising out of the approved quality system.

The manufacturer shall, for assessment purposes, allow the notified body

access to the manufacture, inspection, testing and storage sites and shall

provide it with all necessary information, in particular

-

the quality system documentation,

-

the technical documentation referred to in point 2,

-

the quality records, such as inspection reports and test data,

calibration data, qualification reports of the personnel concerned,

etc.

The notified body shall carry out periodic audits to make sure that the

manufacturer maintains and applies the quality system and provide the

manufacturer with an audit report. The frequency of periodic audits shall

be such that a full reassessment is carried out every three years.

In addition the notified body may pay unexpected visits to the

manufacturer. The need for such additional visits, and the frequency

thereof, will be determined on the basis of a visit control system

operated by the notified body. In particular, the following factors shall be

considered in the visit control system

-

the category of the pressure equipment,

-

the results of previous surveillance visits,

-

the need to follow up corrective action(s),

-

special conditions linked to the approval of the system, where

applicable,

-

significant changes in manufacturing organisation, policy or

techniques.

During such visits the notified body may, if necessary, carry out product

tests, or have them carried out, in order to verify that the quality system

is functioning correctly. The notified body shall provide the

manufacturer with a visit report and, if tests have been carried out, with a

test report.

7. CE marking and EU declaration of conformity

The manufacturer shall affix the CE marking and, under the

responsibility of the notified body referred to in point 5.1, the latter’s

identification number to each individual pressure equipment that

satisfies the applicable requirements of these regulations.

The manufacturer shall draw up a written EU declaration of conformity

for each pressure equipment model and keep it at the disposal of the

national authorities for 10 years after the pressure equipment has been

placed on the market. The EU declaration of conformity shall identify

the product model for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to

the relevant authorities upon request.

8. The manufacturer shall, for a period ending 10 years after the pressure

equipment has been placed on the market, keep at the disposal of the

national authorities

-

the documentation referred to in point 5.1,

-

the change referred to in point 5.5,

-

the decisions and reports of the notified body referred to in points

5.5, 6.3 and 6.4.

9. Each notified body shall inform its notifying authorities of the quality

system approvals issued or withdrawn, and shall periodically, or upon

request, make available to its notifying authorities the list of quality

system approvals refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality

system approvals which it has refused, suspended, or withdrawn, and

upon request, of quality system approvals which it has issued.

10. Authorised representative

The manufacturer’s obligations set out in points 3, 5.1, 5.5, 7 and 8 may

be fulfilled by his authorised representative, on his behalf and under his

responsibility, provided that they are specified in the mandate.

7. MODULE E: CONFORMITY TO TYPE BASED ON PRESSURE

EQUIPMENT QUALITY ASSURANCE

1. Conformity to type based on pressure equipment quality assurance is

that part of a conformity assessment procedure whereby the

manufacturer fulfils the obligations laid down in points 2 and 5, and

ensures and declares on his sole responsibility that the pressure

equipment concerned is in conformity with the type described in the EU-

type examination certificate and satisfies the requirements of these

regulations that apply to it.

2. Manufacturing

The manufacturer shall operate an approved quality system for the final

product inspection and testing of the pressure equipment concerned as

specified in point 3 and shall be subject to surveillance as specified in

point 4.

3. Quality system

The manufacturer shall lodge an application for assessment of his quality

system with the notified body of his choice, for the pressure equipment

concerned.

The application shall include

the name and address of the manufacturer and, if the application is

lodged by the authorised representative, his name and address as

well,

a written declaration that the same application has not been lodged

with any other notified body,

all relevant information on the pressure equipment type envisaged,

the documentation concerning the quality system,

the technical documentation of the approved type and a copy of the

EU-type examination certificate.

The quality system shall ensure compliance of the products with the type

described in the EU-type examination certificate and with the applicable

requirements of these regulations.

All the elements, requirements and provisions adopted by the

manufacturer shall be documented in a systematic and orderly manner in

the form of written policies, procedures and instructions. This quality

system documentation shall permit a consistent interpretation of the

quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of

the quality objectives and the organisational structure,

responsibilities and powers of the management with regard to

product quality,

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

the quality records, such as inspection reports and test data,

calibration data, reports concerning the qualifications or approvals

of the personnel concerned, particularly those of the personnel

undertaking the permanent joining of parts and the non-destructive

tests in accordance with points 3.1.2 and 3.1.3 of Schedule I,

the means of monitoring the effective operation of the quality

system.

The notified body shall assess the quality system to determine whether it

satisfies the requirements referred to in point 3.2. It shall presume

conformity with those requirements in respect of the elements of the

quality system that comply with the corresponding specifications of the

relevant harmonised standard.

In addition to experience in quality management systems, the auditing

team shall have at least one member with experience of evaluation in the

relevant pressure equipment field and pressure equipment technology

concerned and knowledge of the applicable requirements of these

regulations. The audit shall include an assessment visit to the

manufacturer’s premises.

The auditing team shall review the technical documentation referred to

in point 3.1, fifth indent, in order to verify the manufacturer’s ability to

identify the relevant requirements of these regulations and to carry out

the necessary examinations with a view to ensuring compliance of the

pressure equipment with those requirements.

The decision shall be notified to the manufacturer. The notification shall

contain the conclusions of the audit and the reasoned assessment

decision.

The manufacturer shall undertake to fulfil the obligations arising out of

the quality system as approved and to maintain it so that it remains

adequate and efficient.

The manufacturer shall keep the notified body that has approved the

quality system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide

whether the modified quality system will continue to satisfy the

requirements referred to in point 3.2 or whether a reassessment is

necessary.

It shall notify the manufacturer of its decision. The notification shall

contain the conclusions of the examination and the reasoned assessment

decision.

4. Surveillance under the responsibility of the notified body

The purpose of surveillance is to make sure that the manufacturer duly

fulfils the obligations arising out of the approved quality system.

The manufacturer shall, for assessment purposes, allow the notified body

access to the manufacture, inspection, testing and storage sites and shall

provide it with all necessary information, in particular

-

the quality system documentation,

-

the technical documentation,

-

the quality records, such as inspection reports and test data,

calibration data, reports concerning the qualifications of the

personnel concerned, etc.

The notified body shall carry out periodic audits to make sure that the

manufacturer maintains and applies the quality system and provide the

manufacturer with an audit report. The frequency of periodic audits must

be such that a full reassessment is carried out every three years.

In addition the notified body may pay unexpected visits to the

manufacturer.

The need for such additional visits, and the frequency thereof, will be

determined on the basis of a visit control system operated by the notified

body. In particular, the following factors shall be considered in the visit

control system

-

the category of the pressure equipment,

-

the results of previous surveillance visits,

-

the need to follow up corrective actions,

-

special conditions linked to the approval of the system, where

applicable,

-

significant changes in manufacturing organisation, policy or

techniques.

During such visits, the notified body may, if necessary, carry out product

tests, or have them carried out, in order to verify that the quality system

is functioning correctly. The notified body shall provide the

manufacturer with a visit report and, if tests have been carried out, with a

test report.

5. CE marking and EU declaration of conformity

The manufacturer shall affix the CE marking and, under the

responsibility of the notified body referred to in point 3.1, the latter’s

identification number to each individual pressure equipment that is in

conformity with the type described in the EU-type examination

certificate and satisfies the applicable requirements of these regulations.

The manufacturer shall draw up a written EU declaration of conformity

for each pressure equipment model and keep it at the disposal of the

national authorities for 10 years after the pressure equipment has been

placed on the market. The EU declaration of conformity shall identify

the product model for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to

the relevant authorities upon request.

6. The manufacturer shall, for a period ending 10 years after the pressure

equipment has been placed on the market, keep at the disposal of the

national authorities

-

the documentation referred to in point 3.1,

-

the change referred to in point 3.5, as approved,

-

the decisions and reports from the notified body which are referred

to in points 3.3, 3.5, 4.3 and 4.4.

7. Each notified body shall inform its notifying authorities of quality

system approvals issued or withdrawn and shall, periodically or upon

request, make available to its notifying authorities the list of quality

system approvals refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality

system approvals which it has refused, suspended or withdrawn, and,

upon request, of quality system approvals which it has issued.

8. Authorised representative

The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be

fulfilled by his authorised representative, on his behalf and under his

responsibility, provided that they are specified in the mandate.

8. MODULE E1: QUALITY ASSURANCE OF FINAL PRESSURE

EQUIPMENT INSPECTION AND TESTING

1. Quality assurance of final pressure equipment inspection and testing is

the conformity assessment procedure whereby the manufacturer fulfils

the obligations laid down in points 2, 4 and 7, and ensures and declares

on his sole responsibility that the pressure equipment concerned satisfy

the requirements of these regulations that apply to it.

2. Technical documentation

The manufacturer shall establish the technical documentation. The

technical documentation shall make it possible to assess the conformity

of the pressure equipment with the relevant requirements, and shall

include an adequate analysis and assessment of the risk(s) The technical

documentation shall specify the applicable requirements and cover, as

far as relevant for the assessment, the design, manufacture and operation

of the pressure equipment. The technical documentation shall, wherever

applicable, contain at least the following elements

a general description of the pressure equipment,

conceptual design and manufacturing drawings and diagrams of

components, sub-assemblies, circuits, etc.,

descriptions and explanations necessary for the understanding of

those drawings and diagrams and the operation of the pressure

equipment,

a list of the harmonised standards, the references of which have

been published in the Official Journal of the European Union,

applied in full or in part, and descriptions of the solutions adopted to

meet the essential safety requirements of these regulations where

those harmonised standards have not been applied. In the event of

partly applied harmonised standards, the technical documentation

shall specify the parts which have been applied,

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

and

test reports.

3. The manufacturer shall keep the technical documentation at the disposal

of the relevant national authorities for 10 years after the pressure

equipment has been placed on the market.

4. Manufacturing

The manufacturer shall operate an approved quality system for the final

product inspection and testing of the pressure equipment as specified in

point 5 and shall be subject to surveillance as specified in point 6.

5. Quality system

The manufacturer shall lodge an application for assessment of his quality

system with the notified body of his choice, for the pressure equipment

concerned.

The application shall include

the name and address of the manufacturer and, if the application is

lodged by the authorised representative, his name and address as

well,

a written declaration that the same application has not been lodged

with any other notified body,

all relevant information on the pressure equipment type envisaged,

-

the documentation concerning the quality system, and

-

the technical documentation referred to in point 2.

The quality system shall ensure compliance of the pressure equipment

with the requirements of these regulations that apply to it.

Under the quality system, each item of pressure equipment shall be

examined and appropriate tests as set out in the relevant standard(s)

referred to in regulation 14, or equivalent tests, and particularly final

assessment as referred to in point 3.2 of Schedule I, shall be carried out

in order to ensure its conformity with the requirements of these

regulations which apply to it.

All the elements, requirements and provisions adopted by the

manufacturer shall be documented in a systematic and orderly manner in

the form of written policies, procedures and instructions. This quality

system documentation shall permit a consistent interpretation of the

quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of

-

the quality objectives and the organisational structure,

responsibilities and powers of the management with regard to the

quality of the pressure equipment,

-

the procedures used for the permanent joining of parts as approved

in accordance with point 3.1.2 of Schedule I,

-

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

-

the quality records, such as inspection reports and test data,

calibration data, reports concerning the qualifications or approvals

of the personnel concerned, particularly those of the personnel

undertaking the permanent joining of parts in accordance with point

3.1.2 of Schedule I,

-

the means of monitoring the effective operation of the quality

system.

The notified body shall assess the quality system to determine whether it

satisfies the requirements referred to in point 5.2.

It shall presume conformity with those requirements in respect of the

elements of the quality system that comply with the corresponding

specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the auditing

team shall have at least one member with experience of evaluation in the

relevant pressure equipment field and pressure equipment technology

concerned, and knowledge of the applicable requirements of these

regulations. The audit shall include an assessment visit to the

manufacturer’s premises.

The auditing team shall review the technical documentation referred to

in point 2 in order to verify the manufacturer’s ability to identify the

relevant requirements of these regulations and to carry out the necessary

examinations with a view to ensuring compliance of the pressure

equipment with those requirements.

The decision shall be notified to the manufacturer. The notification shall

contain the conclusions of the audit and the reasoned assessment

decision.

The manufacturer shall undertake to fulfil the obligations arising out of

the quality system as approved and to maintain it so that it remains

adequate and efficient.

The manufacturer shall keep the notified body that has approved the

quality system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide

whether the modified quality system will continue to satisfy the

requirements referred to in point 5.2 or whether a reassessment is

required.

It shall notify the manufacturer of its decision. The notification shall

contain the conclusions of the examination and the reasoned assessment

decision.

6. Surveillance under the responsibility of the notified body

The purpose of surveillance is to make sure that the manufacturer duly

fulfils the obligations arising out of the approved quality system.

The manufacturer shall, for assessment purposes, allow the notified body

access to the manufacture, inspection, testing and storage sites and shall

provide it with all necessary information, in particular

-

the quality system documentation,

-

the technical documentation referred to in point 2,

-

the quality records, such as inspection reports and test data,

calibration data, qualification reports on the personnel concerned,

etc.

The notified body shall carry out periodic audits to make sure that the

manufacturer maintains and applies the quality system and provide the

manufacturer with an audit report. The frequency of periodic audits shall

be such that a full reassessment is carried out every three years.

In addition the notified body may pay unexpected visits to the

manufacturer. The need for such additional visits, and the frequency

thereof, will be determined on the basis of a visit control system

operated by the notified body. In particular, the following factors shall be

considered in the visit control system

-

the category of the equipment,

-

the results of previous surveillance visits,

-

the need to follow up corrective action(s),

-

special conditions linked to the approval of the system, where

applicable,

-

significant changes in manufacturing organisation, policy or

techniques.

During such visits the notified body may, if necessary, carry out product

tests, or have them carried out, in order to verify that the quality system

is functioning correctly. The notified body shall provide the

manufacturer with a visit report and, if tests have been carried out, with a

test report.

7. CE marking and EU declaration of conformity

The manufacturer shall affix the CE marking and, under the

responsibility of the notified body referred to in point 5.1, the latter’s

identification number to each individual item of pressure equipment that

satisfies the applicable requirements of these regulations.

The manufacturer shall draw up a written EU declaration of conformity

for each pressure equipment model and keep it at the disposal of the

national authorities for 10 years after the pressure equipment has been

placed on the market. The EU declaration of conformity shall identify

the pressure equipment model for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to

the relevant authorities upon request.

8. The manufacturer shall, for a period ending 10 years after the pressure

equipment has been placed on the market, keep at the disposal of the

national authorities

-

the documentation referred to in point 5.1,

-

the change referred to in point 5.5, as approved,

-

the decisions and reports of the notified body referred to in points

5.3, 5.5, 6.3 and 6.4.

9. Each notified body shall inform its notifying authorities of quality

system approvals issued or withdrawn and shall periodically or upon

request, make available to its notifying authorities the list of quality

system approvals refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality

system approvals which it has refused, suspended or withdrawn, and,

upon request, of quality system approvals which it has issued.

10. Authorised representative

The manufacturer’s obligations set out in points 3, 5.1, 5.5, 7 and 8 may

be fulfilled by his authorised representative, on his behalf and under his

responsibility, provided that they are specified in the mandate.

9. MODULE F: CONFORMITY TO TYPE BASED ON PRESSURE

EQUIPMENT VERIFICATION

1. Conformity to type based on pressure equipment verification is the part

of a conformity assessment procedure whereby the manufacturer fulfils

the obligations laid down in points 2 and 5, and ensures and declares on

his sole responsibility that the pressure equipment concerned, which has

been subject to the provisions of point 3, is in conformity with the type

described in the EU-type examination certificate and satisfies the

requirements of these regulations which apply to it.

2. Manufacturing

The manufacturer shall take all measures necessary so that the

manufacturing process and its monitoring ensure conformity of the

manufactured products with the approved type described in the EU-type

examination certificate and with the requirements of these regulations

which apply to them.

3. Verification

A notified body chosen by the manufacturer shall carry out the

appropriate examinations and tests in order to check the conformity of

the pressure equipment with the approved type described in the EU-type

examination certificate and with the appropriate requirements of these

regulations.

The examinations and tests to check the conformity of the pressure

equipment with the appropriate requirements shall be carried out by

examination and testing of every product as specified in point 4.

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

pressure equipment

All pressure equipment shall be individually examined and appropriate

tests set out in the relevant harmonised standard(s) or equivalent tests

shall be carried out in order to verify conformity with the approved type

and described in the EU-type examination certificate and with the

appropriate requirements of these regulations. In the absence of such a

harmonised standard, the notified body concerned shall decide on the

appropriate tests to be carried out.

In particular, the notified body shall

-

verify that the personnel undertaking the permanent joining of parts

and the non-destructive tests are qualified or approved in

accordance with points 3.1.2 and 3.1.3 of Schedule I,

-

verify the certificate issued by the materials manufacturer in

accordance with point 4.3 of Schedule I,

-

carry out or have carried out the final inspection and proof test

referred to in point 3.2 of Schedule I and examine the safety

devices, if applicable.

The notified body shall issue a certificate of conformity in respect of the

examinations and tests carried out, and shall affix its identification

number or have it affixed under its responsibility to each approved item

of pressure equipment.

The manufacturer shall keep the certificates of conformity available for

inspection by the national authorities for 10 years after the pressure

equipment has been placed on the market.

5. CE marking and EU declaration of conformity

The manufacturer shall affix the CE marking and, under the

responsibility of the notified body referred to in point 3, the latter’s

identification number to each individual item of pressure equipment that

is in conformity with the approved type described in the EU-type

examination certificate and satisfies the applicable requirements of these

regulations.

The manufacturer shall draw up a written EU declaration of conformity

for each pressure equipment model and keep it at the disposal of the

national authorities, for 10 years after the pressure equipment has been

placed on the market. The EU declaration of conformity shall identify

the pressure equipment model for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to

the relevant authorities upon request.

If the notified body referred to in point 3 agrees and under its

responsibility, the manufacturer may also affix the notified body’s

identification number to the pressure equipment.

6. If the notified body agrees and under its responsibility, the manufacturer

may affix the notified body’s identification number to the pressure

equipment during the manufacturing process.

7. Authorised representative

The manufacturer’s obligations may be fulfilled by his authorised

representative, on his behalf and under his responsibility, provided that

they are specified in the mandate. An authorised representative may not

fulfil the manufacturer’s obligations set out in point 2.

10. MODULE G: CONFORMITY BASED ON UNIT VERIFICATION

1. Conformity based on unit verification is the conformity assessment

procedure whereby the manufacturer fulfils the obligations laid down in

points 2, 3 and 5, and ensures and declares on his sole responsibility that

the pressure equipment concerned, which has been subject to the

provisions of point 4, is in conformity with the requirements of these

regulations that apply to it.

2. Technical documentation

The manufacturer shall establish the technical documentation and make

it available to the notified body referred to in point 4.

The documentation shall make it possible to assess the conformity of the

pressure equipment with the relevant requirements and shall include an

adequate analysis and assessment of the risk(s). The technical

documentation shall specify the applicable requirements and cover, as

far as relevant for the assessment, the design, manufacture and operation

of the pressure equipment.

The technical documentation shall, wherever applicable, contain at least

the following elements

-

a general description of the pressure equipment,

conceptual design and manufacturing drawings and diagrams of

components, sub-assemblies, circuits, etc.,

descriptions and explanations necessary for an understanding of

those drawings and diagrams and the operation of the pressure

equipment,

a list of the harmonised standards the references of which have been

published in the Official Journal of the European Union, applied in

full or in part, and descriptions of the solutions adopted to meet the

essential safety requirements of these regulations where those

harmonised standards, have not been applied. In the event of partly

applied harmonised standards, the technical documentation shall

specify the parts which have been applied,

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

test reports,

appropriate details relating to the approval of the manufacturing and

test procedures and of the qualifications or approvals of the

personnel concerned in accordance with points 3.1.2 and 3.1.3 of

Schedule I.

The manufacturer shall keep the technical documentation at the disposal

of the relevant national authorities for 10 years after the pressure

equipment has been placed on the market.

3. Manufacturing

The manufacturer shall take all measures necessary so that the

manufacturing process and its monitoring ensure conformity of the

manufactured pressure equipment with the applicable requirements of

these regulations.

4. Verification

A notified body chosen by the manufacturer shall carry out appropriate

examinations and tests, set out in the relevant harmonised standard(s)

and, or equivalent tests, to check the conformity of the pressure

equipment with the applicable requirements of these regulations, or have

them carried out. In the absence of such a harmonised standard the

notified body concerned shall decide on the appropriate tests to be

carried out applying other technical specifications.

In particular the notified body shall

examine the technical documentation with respect to the design and

the manufacturing procedures,

-

assess the materials used where these are not in conformity with the

relevant harmonised standards or with a European approval for

pressure equipment materials, and check the certificate issued by

the material manufacturer in accordance with point 4.3 of Schedule

I,

-

approve the procedures for the permanent joining of parts or check

that they have been previously approved in accordance with point

3.1.2 of Schedule I,

-

verify the qualifications or approvals required under points 3.1.2

and 3.1.3 of Schedule I,

-

carry out the final inspection referred to in point 3.2.1 of Schedule I,

perform or have performed the proof test referred to in point 3.2.2

of Schedule I, and examine the safety devices, if applicable.

The notified body shall issue a certificate of conformity in respect of the

examinations and tests carried out and shall affix its identification

number to the approved pressure equipment, or have it affixed under its

responsibility. The manufacturer shall keep the certificates of conformity

at the disposal of the national authorities for 10 years after the pressure

equipment has been placed on the market.

5. CE marking and EU declaration of conformity

The manufacturer shall affix the CE marking and, under the

responsibility of the notified body referred to in point 4, the latter’s

identification number to each item of pressure equipment that satisfies

the applicable requirements of these regulations.

The manufacturer shall draw up a written EU declaration of conformity

and keep it at the disposal of the national authorities for 10 years after

the pressure equipment has been placed on the market. The EU

declaration of conformity shall identify the pressure equipment for

which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to

the relevant authorities upon request.

6. Authorised representative

The manufacturer’s obligations set out in points 2 and 5 may be fulfilled

by his authorised representative, on his behalf and under his

responsibility, provided that they are specified in the mandate.

11. MODULE H: CONFORMITY BASED ON FULL QUALITY

ASSURANCE

1. Conformity based on full quality assurance is the conformity assessment

procedure whereby the manufacturer fulfils the obligations laid down in

points 2 and 5, and ensures and declares on his sole responsibility that

the pressure equipment concerned satisfies the requirements of these

regulations that apply to it.

2. Manufacturing

The manufacturer shall operate an approved quality system for design,

manufacture, final product inspection and testing of the pressure

equipment as specified in point 3 and shall be subject to surveillance as

specified in point 4.

3. Quality system

The manufacturer shall lodge an application for assessment of his quality

system with the notified body of his choice, for the pressure equipment

concerned.

The application shall include

the name and address of the manufacturer and, if the application is

lodged by the authorised representative, his name and address as

well,

the technical documentation for one model of each type of pressure

equipment intended to be manufactured. The technical

documentation shall, wherever applicable, contain at least the

following elements

a general description of the pressure equipment,

conceptual design and manufacturing drawings and diagrams of

components, sub-assemblies, circuits, etc.,

descriptions and explanations necessary for the understanding of

those drawings and diagrams and the operation of the pressure

equipment,

a list of the harmonised standards the references of which have been

published in the Official Journal of the European Union, applied in

full or in part, and descriptions of the solutions adopted to meet the

essential safety requirements of these regulations where those

harmonised standards have not been applied. In the event of partly

applied harmonised standards, the technical documentation shall

specify the parts which have been applied,

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

test reports,

the documentation concerning the quality system, and

a written declaration that the same application has not been lodged

with any other notified body.

The quality system shall ensure compliance of the pressure equipment

with the requirements of these regulations that apply to it.

All the elements, requirements and provisions adopted by the

manufacturer shall be documented in a systematic and orderly manner in

the form of written policies, procedures and instructions. That quality

system documentation shall permit a consistent interpretation of the

quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of

the quality objectives and the organisational structure,

responsibilities and powers of the management with regard to

design and product quality,

the technical design specifications, including standards, that will be

applied and, where the relevant harmonised standards will not be

applied in full, the means that will be used to ensure that the

essential requirements of these regulations that apply to the pressure

equipment will be met,

the design control and design verification techniques, processes and

systematic actions that will be used when designing the pressure

equipment, pertaining to the product type covered, particularly with

regard to materials in accordance with point 4 of Schedule I,

the corresponding manufacturing, quality control and quality

assurance techniques, processes and systematic actions that will be

used, particularly the procedures for the permanent joining of parts

as approved in accordance with point 3.1.2 of Schedule I,

the examinations and tests to be carried out before, during, and after

manufacture, and the frequency with which they will be carried out,

the quality records, such as inspection reports and test data,

calibration data, reports concerning the qualifications or approvals

of the personnel concerned, particularly those of the personnel

undertaking the permanent joining of parts and the non-destructive

tests in accordance with points 3.1.2 and 3.1.3 of Schedule I, etc.,

-

the means of monitoring the achievement of the required design and

pressure equipment quality and the effective operation of the quality

system.

The notified body shall assess the quality system to determine whether it

satisfies the requirements referred to in point 3.2. It shall presume

conformity with those requirements in respect of the elements of the

quality system that comply with the corresponding specifications of the

relevant harmonised standard.

In addition to experience in quality management systems, the auditing

team shall have at least one member experienced as assessor in the

pressure equipment technology concerned, and knowledge of the

applicable requirements of these regulations. The audit shall include an

assessment visit to the manufacturer’s premises.

The auditing team shall review the technical documentation referred to

in point 3.1, second indent, to verify the manufacturer’s ability to

identify the applicable requirements of these regulations and to carry out

the necessary examinations with a view to ensuring compliance of the

pressure equipment with those requirements.

The manufacturer or his authorised representative shall be notified of the

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

the reasoned assessment decision.

The manufacturer shall undertake to fulfil the obligations arising out of

the quality system as approved and to maintain it so that it remains

adequate and efficient.

The manufacturer shall keep the notified body that has approved the

quality system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide

whether the modified quality system will continue to satisfy the

requirements referred to in point 3.2 or whether a reassessment is

necessary.

It shall notify the manufacturer of its decision. The notification shall

contain the conclusions of the examination and the reasoned assessment

decision.

4. Surveillance under the responsibility of the notified body

The purpose of surveillance is to make sure that the manufacturer duly

fulfils the obligations arising out of the approved quality system.

The manufacturer shall, for assessment purposes, allow the notified body

access to the design, manufacture, inspection, testing and storage sites

and shall provide it with all necessary information, in particular

-

the quality system documentation,

-

the quality records provided for by the design part of the quality

system, such as results of analyses, calculations, tests, etc.,

-

the quality records provided for by the manufacturing part of the

quality system, such as inspection reports and test data, calibration

data, qualification reports on the personnel concerned, etc.

The notified body shall carry out periodic audits to make sure that the

manufacturer maintains and applies the quality system and shall provide

the manufacturer with an audit report. The frequency of periodic audits

shall be such that a full reassessment is carried out every three years.

In addition, the notified body may pay unexpected visits to the

manufacturer.

The need for such additional visits, and the frequency thereof, will be

determined on the basis of a visit control system operated by the notified

body. In particular, the following factors shall be considered in the visit

control system

-

the category of the equipment,

-

the results of previous surveillance visits,

-

the need to follow up corrective action(s),

-

special conditions linked to the approval of the system, where

applicable,

-

significant changes in manufacturing organisation, policy or

techniques.

During such visits, the notified body may, if necessary, carry out product

tests, or have them carried out, in order to check the proper functioning

of the quality system. It shall provide the manufacturer with a visit report

and, if tests have been carried out, with a test report.

5. CE marking and EU declaration of conformity

The manufacturer shall affix the CE marking and, under the

responsibility of the notified body referred to in point 3.1, the latter’s

identification number to each individual item of pressure equipment that

satisfies the applicable requirements of these regulations.

The manufacturer shall draw up a written EU declaration of conformity

for each pressure equipment model and keep it at the disposal of the

national authorities for 10 years after the pressure equipment has been

placed on the market. The EU declaration of conformity shall identify

the pressure equipment model for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to

the relevant authorities upon request.

6. The manufacturer shall, for a period ending 10 years after the pressure

equipment has been placed on the market, keep at the disposal of the

national authorities

-

the technical documentation referred to in point 3.1,

-

the documentation concerning the quality system referred to in

point 3.1,

-

the change referred to point 3.4, as approved,

-

the decisions and reports of the notified body referred to in points

3.3, 3.4, 4.3 and 4.4.

7. Each notified body shall inform its notifying authorities of quality

system approvals issued or withdrawn, and shall, periodically or upon

request, make available to its notifying authorities the list of quality

system approvals refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality

system approvals which it has refused, suspended or withdrawn, and,

upon request, of quality system approvals which it has issued.

8. Authorised representative

The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be

fulfilled by his authorised representative, on his behalf and under his

responsibility, provided that they are specified in the mandate.

12. MODULE H1: CONFORMITY BASED ON FULL QUALITY

ASSURANCE PLUS DESIGN EXAMINATION

1. Conformity based on full quality assurance plus design examination and

special surveillance of the final assessment is the conformity assessment

procedure whereby the manufacturer fulfils the obligations laid down in

points 2 and 6, and ensures and declares on his sole responsibility that

the pressure equipment concerned satisfy the requirements of the

Directive that apply to it.

2. Manufacturing

The manufacturer shall operate an approved quality system for design,

manufacture and final product inspection and testing of the products

concerned as specified in point 3 and shall be subject to surveillance as

specified in point 5. The adequacy of the technical design of the pressure

equipment shall have been examined in accordance with point 4.

3. Quality system

The manufacturer shall lodge an application for assessment of his quality

system with the notified body of his choice, for the pressure equipment

concerned.

The application shall include

the name and address of the manufacturer and, if the application is

lodged by the authorised representative, his name and address as

well,

the technical documentation for one model of each type of pressure

equipment intended to be manufactured. The technical

documentation shall, wherever applicable, contain at least the

following elements

a general description of the pressure equipment,

conceptual design and manufacturing drawings and diagrams of

components, sub-assemblies, circuits, etc.,

descriptions and explanations necessary for the understanding of

those drawings and diagrams and the operation of the pressure

equipment,

a list of the harmonised standards the references of which have been

published in the Official Journal of the European Union, applied in

full or in part, and descriptions of the solutions adopted to meet the

essential safety requirements of these regulations where those

harmonised standards have not been applied. In the event of partly

applied harmonised standards, the technical documentation shall

specify the parts which have been applied,

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

test reports,

the documentation concerning the quality system,

a written declaration that the same application has not been lodged

with any other notified body.

The quality system shall ensure compliance of the pressure equipment

with the requirements of these regulations that apply to it.

All the elements, requirements and provisions adopted by the

manufacturer shall be documented in a systematic and orderly manner in

the form of written policies, procedures and instructions. This quality

system documentation shall permit a consistent interpretation of the

quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of

the quality objectives and the organisational structure,

responsibilities and powers of the management with regard to

design and product quality,

the technical design specifications, including standards, that will be

applied and, where relevant harmonised standards will not be

applied in full, the means that will be used to ensure that the

essential safety requirements of the Directive that apply to the

pressure equipment will be met,

the design control and design verification techniques, processes and

systematic actions that will be used when designing the pressure

equipment pertaining to the pressure equipment type covered,

particularly with regard to materials in accordance with point 4 of

Schedule I,

the corresponding manufacturing, quality control and quality

assurance techniques, processes and systematic actions that will be

used, particularly the procedures for the permanent joining of parts

as approved in accordance with point 3.1.2 of Schedule I,

the examinations and tests that will be carried out before, during

and after manufacture, and the frequency with which they will be

carried out,

the quality records, such as inspection reports and test data,

calibration data, reports concerning the qualifications or approvals

of the personnel concerned, particularly those of the personnel

undertaking the permanent joining of parts and the non-destructive

tests in accordance with points 3.1.2 and 3.1.3 of Schedule I, etc.,

-

the means of monitoring the achievement of the required design and

pressure equipment quality and the effective operation of the quality

system.

The notified body shall assess the quality system to determine whether it

satisfies the requirements referred to in point 3.2.

It shall presume conformity with those requirements in respect of the

elements of the quality system that comply with the corresponding

specifications of the relevant harmonised standard. In addition to

experience in quality management systems, the auditing team shall have

at least one member experienced as an assessor in the relevant pressure

equipment field and pressure equipment technology concerned, and

knowledge of the applicable requirements of these regulations. The audit

shall include an assessment visit to the manufacturer’s premises.

The auditing team shall review the technical documentation referred to

in point 3.1, second indent, to verify the manufacturer’s ability to

identify the applicable requirements of these regulations and to carry out

the necessary examinations with a view to ensuring compliance of the

pressure equipment with those requirements.

The manufacturer or his authorised representative shall be notified of the

decision.

The notification shall contain the conclusions of the audit and the

reasoned assessment decision.

The manufacturer shall undertake to fulfil the obligations arising out of

the quality system as approved and to maintain it so that it remains

adequate and efficient.

The manufacturer shall keep the notified body that has approved the

quality system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide

whether the modified quality system will continue to satisfy the

requirements referred to in point 3.2 or whether a re-assessment is

necessary.

It shall notify the manufacturer of its decision. The notification shall

contain the conclusions of the examination and the reasoned assessment

decision.

Each notified body shall inform its notifying authorities of quality

system approvals issued or withdrawn, and shall, periodically or upon

request, make available to its notifying authorities the list of quality

system approvals refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality

system approvals which it has refused, suspended or withdrawn, and,

upon request, of quality system approvals which it has issued.

4. Design examination

The manufacturer shall lodge an application for examination of the

design of each item of pressure equipment not covered by a previous

design examination with the notified body referred to in point 3.1.

The application shall make it possible to understand the design,

manufacture and operation of the pressure equipment, and to assess the

conformity with the requirements of these regulations that apply to it. It

shall include

the name and address of the manufacturer,

a written declaration that the same application has not been lodged

with any other notified body,

the technical documentation. The documentation shall make it

possible to assess the conformity of the pressure equipment with the

relevant requirements, and shall include an adequate analysis and

assessment of the risk(s). The technical documentation shall specify

the applicable requirements and cover, as far as relevant for the

assessment, the design and operation of the pressure equipment. The

technical documentation shall, wherever applicable, contain at least

the following elements

a general description of the pressure equipment,

conceptual design and manufacturing drawings and diagrams of

components, sub-assemblies, circuits, etc.,

descriptions and explanations necessary for the understanding of

those drawings and diagrams and the operation of the pressure

equipment,

a list of the harmonised standards the references of which have been

published in the Official Journal of the European Union, applied in

full or in part, and descriptions of the solutions adopted to meet the

essential safety requirements of these regulations, where those

harmonised standards have not been applied. In the event of partly

applied harmonised standards, the technical documentation shall

specify the parts which have been applied,

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

and

-

test reports,

-

the supporting evidence for the adequacy of the technical design.

This supporting evidence shall mention any documents that have

been used, in particular where the relevant harmonised standards

have not been applied in full, and shall include, where necessary, the

results of tests carried out by the appropriate laboratory of the

manufacturer or by another testing laboratory on his behalf and

under his responsibility.

The notified body shall examine the application, and where the design

meets the requirements of these regulations that apply to the pressure

equipment it shall issue an EU design examination certificate to the

manufacturer. The certificate shall give the name and address of the

manufacturer, the conclusions of the examination, the conditions (if any)

for its validity and the data necessary for identification of the approved

design. The certificate may have one or more annexes attached.

The certificate and its annexes shall contain all relevant information to

allow the conformity of manufactured products with the examined

design to be evaluated, and to allow for in-service control, where

applicable.

Where the design does not satisfy the applicable requirements of these

regulations, the notified body shall refuse to issue a design examination

certificate and shall inform the applicant accordingly, giving detailed

reasons for its refusal.

The notified body shall keep itself apprised of any changes in the

generally acknowledged state of the art which indicate that the approved

design may no longer comply with the applicable requirements of these

regulations, and shall determine whether such changes require further

investigation. If so, the notified body shall inform the manufacturer

accordingly.

The manufacturer shall keep the notified body that has issued the EU

design examination certificate informed of any modification to the

approved design that may affect the conformity with the essential safety

requirements of these regulations or the conditions for validity of the

certificate. Such modifications shall require additional approval-from

the notified body that issued the EU design examination certificate-in the

form of an addition to the original EU design examination certificate.

Each notified body shall inform its notifying authorities of the EU design

examination certificates and, or any additions thereto which it has issued

or withdrawn, and shall, periodically or upon request, make available to

its notifying authorities the list of certificates and, or any additions

thereto refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of the EU

design examination certificates and, or any additions thereto which it has

refused, withdrawn, suspended or otherwise restricted, and, upon

request, of the certificates and, or additions thereto which it has issued.

The Commission, the Member States and the other notified bodies may,

on request, obtain a copy of the EU design examination certificates and,

or additions thereto. On request, the Commission and the Member States

may obtain a copy of the technical documentation and of the results of

the examinations carried out by the notified body.

The notified body shall keep a copy of the EU design examination

certificate, its annexes and additions, as well as the technical file

including the documentation submitted by the manufacturer until the

expiry of the validity of the certificate.

The manufacturer shall keep a copy of the EU design examination

certificate, its annexes and additions together with the technical

documentation at the disposal of the national authorities for 10 years

after the pressure equipment has been placed on the market.

5. Surveillance under the responsibility of the notified body

The purpose of surveillance is to make sure that the manufacturer duly

fulfils the obligations arising out of the approved quality system.

The manufacturer shall, for assessment purposes, allow the notified body

access to the design, manufacture, inspection, testing and storage sites,

and shall provide it with all necessary information, in particular

-

the quality system documentation,

-

the quality records as provided for by the design part of the quality

system, such as results of analyses, calculations, tests, etc.,

-

the quality records as provided for by the manufacturing part of the

quality system, such as inspection reports and test data, calibration

data, qualification reports on the personnel concerned, etc.

The notified body shall carry out periodic audits to make sure that the

manufacturer maintains and applies the quality system and shall provide

the manufacturer with an audit report. The frequency of periodic audits

shall be such that a full reassessment is carried out every three years.

In addition, the notified body may pay unexpected visits to the

manufacturer.

The need for such additional visits, and the frequency thereof, will be

determined on the basis of a visit control system operated by the notified

body. In particular, the following factors must be considered in the visit

control system

-

the category of the equipment,

-

the results of previous surveillance visits,

-

the need to follow up corrective action(s),

-

special conditions linked to the approval of the system, where

applicable,

-

significant changes in manufacturing organisation, policy or

techniques.

During such visits, the notified body may, if necessary, carry out product

tests, or have them carried out, in order to check the proper functioning

of the quality system. It shall provide the manufacturer with a visit report

and, if tests have been carried out, with a test report.

Special surveillance of the final assessment

Final assessment as referred to in section 3.2 of Schedule I is subject to

increased surveillance in the form of unexpected visits by the notified

body. In the course of such visits, the notified body shall conduct

examinations on the pressure equipment.

It shall provide the manufacturer with a visit report and, if tests have

been carried out, with a test report.

6. CE marking and EU declaration of conformity

The manufacturer shall affix the CE marking and, under the

responsibility of the notified body referred to in point 3.1, the latter’s

identification number to each individual item of pressure equipment that

satisfies the applicable requirements of these regulations.

The manufacturer shall draw up a written EU declaration of conformity

for each pressure equipment model and keep it at the disposal of the

national authorities for 10 years after the pressure equipment has been

placed on the market. The EU declaration of conformity shall identify

the pressure equipment model for which it has been drawn up and shall

mention the number of the design examination certificate.

A copy of the EU declaration of conformity shall be made available to

the relevant authorities upon request.

7. The manufacturer shall, for a period ending 10 years after the pressure

equipment has been placed on the market, keep at the disposal of the

national authorities

-

the documentation concerning the quality system referred to in

point 3.1,

-

the change referred to in point 3.5, as approved,

-

the decisions and reports of the notified body referred to in points

3.5, 5.3 and 5.4.

8. Authorised representative

The manufacturer’s authorised representative may lodge the application

referred to in points 4.1 and 4.2 and fulfil the obligations set out in points

3.1, 3.5, 4.4, 4.6, 6 and 7, on his behalf and under his responsibility,

provided that they are specified in the mandate.

Schedule IV

EU DECLARATION OF CONFORMITY (No XXXX) ( * )

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

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

authorised representative

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

the manufacturer.

4. Object of the declaration (identification of pressure equipment or

assembly allowing traceability; it may, where necessary for the

identification of the pressure equipment or assembly, include an image)

-

description of the pressure equipment or assembly,

-

conformity assessment procedure followed,

-

in the case of assemblies, description of the pressure equipment

constituting the assembly, and the conformity assessment

procedures followed,

* It is optional for the manufacturer to assign a number to the declaration of conformity.

5. The object of the declaration described above is in conformity with the

relevant Union harmonisation legislation

6. References to the relevant harmonised standards used or references to

the other technical specifications in relation to which conformity is

declared

7. Where appropriate, the name, address and number of the notified body

which carried out the conformity assessment and the number of the

certificate issued, and a reference to the EU-type examination certificate

- production type, EU-type examination certificate - design type, EU

design examination certificate or certificate of conformity.

8. Additional information

Signed for and on behalf of

(place and date of issue)

(name, function) (signature)

(where appropriate, particulars of the signatory authorised to sign the

legally binding declaration for the manufacturer or his authorised

representative)

STATEMENT OF THE EUROPEAN PARLIAMENT

The European Parliament considers that only when and insofar as implementing

acts in the sense of Regulation (EU) No 182/2011 are discussed in meetings of

committees, can the latter be considered as ‘comitology committees’ within the

meaning of Schedule I to the Framework Agreement on the relations between the

European Parliament and the European Commission. Meetings of committees

thus fall within the scope of point 15 of the Framework Agreement when and

insofar as other issues are discussed.

€4.86