Regolamenti dwar Apparat ta' Pressjoni

APPARAT TA’ PRESSJONI

LE{ISLAZZJONI SUSSIDJARJA 427.29

REGOLAMENTI DWAR APPARAT TA’ PRESSJONI*

18 ta’ Lulju, 2016

L-AVVI| LEGALI 240 tal-2016.

*Dawn ir-Regolamenti [ew pubblikati bl-ilsien Ingli\ biss.

(1) The title of these regulations is the Pressure Equipment

Regulations.

(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.

(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

Regulations, 2002, 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, 2002, shall be valid under these

regulations.

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

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

PRESSURE EQUIPMENT

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

"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;

" th e D i r e c t i v e " m e a n s E u r o p e a n P a r l i a m e n t a n d C ou n c i l

Directive 2014/68/EU on the approximation 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 that

the pressure equipment and assemblies covered by these

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

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

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, table 5);

(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

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

(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.

8. (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

eq uipm ent or assem bly does not allow it, that th e required

information is provided on the packaging or in a document

accompanying the equipment.

(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

a n d s a f e t y i n f o r m a t i o n s h a l l b e c l e a r, u n d e r s t a n d a b l e a n d

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.

9. (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.

10. (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

a c c o r d a n c e w i t h r e g u la t i o n 1 6 h a s be e n c a r r i e d ou t b y t he

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

a s s e m bl y r e f e r r e d t o i n r e g u la t i o n 4 ( 3 ) i s a c c o m p a ni e d 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.

11. (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

langu age, and that th e manufacturer an d the imp orter 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

t he ir re s po n s ib il i ty, s to ra ge o r t ra ns p o rt c on di t io ns d o no t

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,

i f ap p r o p r i a t e , a r e t a ke n . F u rth e r m o r e, w h er e th e pr e ss ur e

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.

12. 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

a ss e m b l y a l r e a d y p l a c e d o n t h e m a r k e t i n su c h a w a y t h a t

compliance with the requirements of these regulations may be

affected.

13. (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.

14. (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.

15. (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 to

F;

(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.

16. (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.

17. (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.

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

tasks carried out by the notified bodies, the Technical Regulations

Division may authorise on the Maltese market the placing on the

market and the putting into service by users, 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

M e m b e r St a t e s a n d t h e E u r o p e a n C o m m i s s i o n w h i c h u s e r

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

fulfilment of essential safety requirements set out in Schedule I has

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

European Commission and the other Member States of the notified

bodies and the user inspectorates authorised to carry out conformity

assessment tasks in accordance with regulation 16, regulation 17 or

regulation 18 and 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 26.

(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.

(1) For the purposes of notification under these

regulations, a conformity assessment body shall meet the

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

Method for Designating Conformity Assessment Bodies

Regulations.

(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.

(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

a s s e s s m e n t t a s k s sh al l n o t b e t h e d e s i g n e r,

manufacturer, supplier, installer, purchaser, owner,

u ser or m ain tai ner o f th e p ressure equ ipm en t o r

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.

Where a conformity assessment body demonstrates its

conformity with the criteria laid down in the relevant harmonised

standards or parts thereof the references of which have been

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.

(1) Where a notified body, a user inspectorate or a

recognised third-party organisation subcontracts specific tasks

connected with conformity assessment or has recourse to a

subsidiary, it shall ensure that the subcontractor or the subsidiary

meets the 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

shall submit an application for notification under these regulations

to 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

Conformity Assessment Bodies Regulations,.

( 3 ) T h e Te c h n i c a l R e g u la t io n s D iv i s i o n m a y o n l y n o ti f y

conformity assessment bodies which have satisfied the

requirements laid down in regulation 23 or regulation 24 and the

Method for 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

bo d y o nl y w he r e no ob j e c t i on s ar e r a i s e d by t h e E u ro p e a n

Commission or the other Member States within two weeks 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 Co mmission and the ot her Mem ber Stat es 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

n o t i f i e d b o d y, r e c o g n i s e d t h i r d - p a r t y o rg a n i s a t i o n o r u s e r

inspectorate, or kept available to the Technical Regulations

Division, at their request.

(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

third-party organisations shall carry out conformity assessments in

accordance with the conformity assessment tasks provided for in

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

3.1.3 of Schedule I.

(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

t a k e a p pr op r i a t e c o r r e c t i v e m e a s u r e s an d s ha l l n ot i s s u e 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 m eans of designated representatives, in t he 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

t a k e n b y Te c h n i c a l R e g u l a t i o n s D i v i s i o n ; t h e E u r o p e a n

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

E u r o p e a n C o m m i s s i o n a n d t h e o t h e r M e m b e r St a t e s . T h a t

information shall include all available details, in particular the data

necessary for the identification 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.

(1) Any references to the Pressure Equipment

Regulations, 2002, revoked by these 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.

PRESSURE EQUIPMENT

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

com pul so ry. Th e obl igat ions f oll owi ng fro m those essenti al safet y

requirements apply only if the corresponding hazard exists for the pressure

equipment in question when it is used under conditions which are reasonably

foreseeable by the manufacturer.

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

order to identify those which apply to his equipment on account of pressure;

he shall then design and construct it taking account of his analysis.

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

way as to take account of the state of the art and current practice at the time

of design and manufacture as well as of technical and economic

considerations which are consistent with a high degree of health and safety

protection.

1. GENERAL

1.1. Pressure equipment shall be designed, manufactured and checked, and if

applicable equipped and installed, in such a way as to ensure its safety when

put into service in accordance with the manufacturer’s instructions, or in

reasonably foreseeable conditions.

1.2. In choosing the most appropriate solutions, the manufacturer shall apply the

principles set out below in the following order

-

eliminate or reduce hazards as far as is reasonably practicable;

-

apply appropriate protection measures against hazards which cannot be

eliminated;

-

where appropriate, inform users of residual hazards and indicate

whether it is necessary to take appropriate special measures to reduce

the risks at the time of installation and, or use.

1.3. Where the potential for misuse is known or can be clearly foreseen, the

pressure equipment shall be designed to prevent risks from such misuse or, if

that is not possible, adequate warning given that the pressure equipment

shall not be used in that way.

2. DESIGN

2.1. General

The pressure equipment shall be properly designed taking all relevant

factors into account in order to ensure that the equipment will be safe

throughout its intended life.

The design shall incorporate appropriate safety coefficients using

comprehensive methods which are known to incorporate adequate safety

margins against all relevant failure modes in a consistent manner.

2.2. Design for adequate strength

2.2.1. The pressure equipment shall be designed for loadings appropriate to its

intended use and other reasonably foreseeable operating conditions. In

particular, the following factors shall be taken into account

internal/external pressure,

ambient and operational temperatures,

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

traffic, wind, earthquake loading,

reaction forces and moments which result from the supports,

attachments, piping, etc.,

corrosion and erosion, fatigue, etc.,

decomposition of unstable fluids.

Various loadings which can occur at the same time shall be considered,

taking into account the probability of their simultaneous occurrence.

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

as a general rule, a calculation method, as described in point 2.2.3, and

supplemented if necessary by an experimental design method as

described in point 2.2.4,

an experimental design method without calculation, as described in

point 2.2.4, when the product of the maximum allowable pressure PS

and the volume V is less than 6 000 bar·L or the product PS·DN less

than 3 000 bar.

2.2.3. Calculation method

(a) Pressure containment and other loading aspects

The allowable stresses for pressure equipment shall be limited having

regard to reasonably foreseeable failure modes under operating

conditions. To this end, safety factors shall be applied to eliminate fully

any uncertainty arising out of manufacture, actual operational

conditions, stresses, calculation models and the properties and

behaviour of the material.

These calculation methods shall provide sufficient safety margins

consistent, where applicable, with the requirements of point 7.

The requirements set out above may be met by applying one of the

following methods, as appropriate, if necessary as a supplement to or in

combination with another method

-

design by formula,

-

design by analysis,

-

design by fracture mechanics.

(b) Resistance

Appropriate design calculations shall be used to establish the resistance

of the pressure equipment concerned.

In particular

-

the calculation pressures shall not be less than the maximum

allowable pressures and take into account static head and dynamic

fluid pressures and the decomposition of unstable fluids. Where a

vessel is separated into individual pressure-containing chambers,

the partition wall shall be designed on the basis of the highest

possible chamber pressure relative to the lowest pressure possible

PRESSURE EQUIPMENT

in the adjoining chamber,

the calculation temperatures shall allow for appropriate safety

margins,

the design shall take appropriate account of all possible

combinations of temperature and pressure which might arise

under reasonably foreseeable operating conditions for the

equipment,

the maximum stresses and peak stress concentrations shall be kept

within safe limits,

the calculation for pressure containment shall utilise the values

appropriate to the properties of the material, based on

documented data, having regard to the provisions set out in point

4 together with appropriate safety factors. Material characteristics

to be considered, where applicable, include

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

calculation temperature,

tensile strength,

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

fatigue data,

Young’s modulus (modulus of elasticity),

appropriate amount of plastic strain,

bending rupture energy,

fracture toughness.

appropriate joint factors shall be applied to the material properties

depending, for example, on the type of non-destructive testing,

the materials joined and the operating conditions envisaged,

the design shall take appropriate account of all reasonably

foreseeable degradation mechanisms (e.g. corrosion, creep,

fatigue) commensurate with the intended use of the equipment.

Attention shall be drawn, in the instructions referred to in point

3.4, to particular features of the design which are relevant to the

life of the equipment, for example

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

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

- for corrosion: design corrosion allowance.

(c) Stability aspects

Where the calculated thickness does not allow for adequate structural

stability, the necessary measures shall be taken to remedy the situation

taking into account the risks from transport and handling.

2.2.4. Experimental design method

The design of the equipment may be validated, in all or in part, by an

appropriate test programme carried out on a sample representative of the

equipment or the category of equipment.

The test programme shall be clearly defined prior to testing and accepted by

the notified body responsible for the design conformity assessment module,

where it exists.

This programme shall define test conditions and criteria for acceptance or

refusal. The actual values of the essential dimensions and characteristics of

the materials which constitute the equipment tested shall be measured before

the test.

Where appropriate, during tests, it shall be possible to observe the critical

zones of the pressure equipment with adequate instrumentation capable of

registering strains and stresses with sufficient precision.

The test programme shall include

(a) A pressure strength test, the purpose of which is to check that, at a

pressure with a defined safety margin in relation to the maximum

allowable pressure, the equipment does not exhibit significant leaks or

deformation exceeding a determined threshold. The test pressure shall

be determined on the basis of the differences between the values of the

geometrical and material characteristics measures under test conditions

and the values used for design purposes; it shall take into account the

differences between the test and design temperatures;

(b) where the risk of creep or fatigue exists, appropriate tests determined on

the basis of the service conditions laid down for the equipment, for

instance hold time at specified temperatures, number of cycles at

specified stress-levels;

(c) where necessary, additional tests concerning other factors referred to in

point 2.2.1 such as corrosion, external damage.

2.3. Provisions to ensure safe handling and operation

The method of operation specified for pressure equipment shall be such as to

preclude any reasonably foreseeable risk in operation of the equipment.

Particular attention shall be paid, where appropriate, to

closures and openings,

dangerous discharge of pressure relief blow-off,

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

surface temperature taking into consideration the intended use,

decomposition of unstable fluids.

In particular, pressure equipment fitted with an access door shall be

equipped with an automatic or manual device enabling the user easily to

ascertain that the opening will not present any risk. Furthermore, where the

opening can be operated quickly, the pressure equipment shall be fitted with

a device to prevent it being opened whenever the pressure or temperature of

the fluid presents a risk.

2.4. Means of examination

(a) Pressure equipment shall be designed and constructed so that all

necessary examinations to ensure safety can be carried out;

(b) Means of determining the internal condition of the equipment shall be

available, where it is necessary to ensure the continued safety of the

equipment, such as access openings allowing physical access to the

inside of the pressure equipment so that appropriate examinations can

be carried out safely and ergonomically;

(c) Other means of ensuring the safe condition of the pressure equipment

may be applied in any of the following situations

-

where it is too small for physical internal access,

-

where opening the pressure equipment would adversely affect the

PRESSURE EQUIPMENT

inside,

-

where the substance contained has been shown not to be harmful

to the material from which the pressure equipment is made and no

other internal degradation mechanisms are reasonably

foreseeable.

2.5. Means of draining and venting

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

equipment where necessary

-

to avoid harmful effects such as water hammer, vacuum collapse,

corrosion and uncontrolled chemical reactions. All stages of operation

and testing, particularly pressure testing, shall be considered,

-

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

2.6. Corrosion or other chemical attack

Where necessary, adequate allowance or protection against corrosion or

other chemical attack shall be provided, taking due account of the intended

and reasonably foreseeable use.

2.7. Wear

Where severe conditions of erosion or abrasion may arise, adequate

measures shall be taken to

-

minimise that effect by appropriate design, e.g. additional material

thickness, or by the use of liners or cladding materials,

-

permit replacement of parts which are most affected,

-

draw attention, in the instructions referred to in point 3.4, to measures

necessary for continued safe use.

2.8. Assemblies

Assemblies shall be so designed that

-

the components to be assembled together are suitable and reliable for

their duty,

-

all the components are properly integrated and assembled in an

appropriate manner.

2.9. Provisions for filling and discharge

Where appropriate, the pressure equipment shall be so designed and

provided with accessories, or provision made for their fitting, as to ensure

safe filling and discharge in particular with respect to risks such as

(a) on filling

-

overfilling or overpressurisation having regard in particular to the

filling ratio and to vapour pressure at the reference temperature,

-

instability of the pressure equipment;

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

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

2.10. Protection against exceeding the allowable limits of pressure equipment

Where, under reasonably foreseeable conditions, the allowable limits could

be exceeded, the pressure equipment shall be fitted with, or provision made

for the fitting of, suitable protective devices, unless the equipment is

intended to be protected by other protective devices within an assembly.

The suitable device or combination of such devices shall be determined on

the basis of the particular characteristics of the equipment or assembly.

Suitable protective devices and combinations thereof comprise

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

(b) where appropriate, adequate monitoring devices such as indicators and,

or alarms which enable adequate action to be taken either automatically

or manually to keep the pressure equipment within the allowable limits.

2.11. Safety accessories

2.11.1. Safety accessories shall

-

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

intended duty and take into account the maintenance and testing

requirements of the devices, where applicable,

-

be independent of other functions, unless their safety function cannot be

affected by such other functions,

-

comply with appropriate design principles in order to obtain suitable

and reliable protection. These principles include, in particular, fail-safe

modes, redundancy, diversity and self-diagnosis.

2.11.2. Pressure limiting devices

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

exceed the maximum allowable pressure PS; however a short duration

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

allowable, where appropriate.

2.11.3. Temperature monitoring devices

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

consistent with the measurement function.

2.12. External fire

Where necessary, pressure equipment shall be so designed and, where

appropriate, fitted with suitable accessories, or provision made for their

fitting, to meet damage-limitation requirements in the event of external fire,

having particular regard to its intended use.

3. MANUFACTURING

3.1. Manufacturing procedures

The manufacturer shall ensure the competent execution of the provisions set

out at the design stage by applying the appropriate techniques and relevant

procedures, especially with a view to the aspects set out below.

3.1.1. Preparation of the component parts

Preparation of the component parts (e.g. forming and chamfering) shall not

give rise to defects or cracks or changes in the mechanical characteristics

likely to be detrimental to the safety of the pressure equipment.

3.1.2. Permanent joining

Permanent joints and adjacent zones shall be free of any surface or internal

defects detrimental to the safety of the equipment.

The properties of permanent joints shall meet the minimum properties

PRESSURE EQUIPMENT

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.

3.2. Final assessment

Pressure equipment shall be subjected to final assessment as described

below.

3.2.1. Final inspection

Pressure equipment shall undergo a final inspection to assess visually and by

examination of the accompanying documents compliance with the

requirements of 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.

3.3. 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

PRESSURE EQUIPMENT

and the warnings referred to in point (c), provided it remains legible for

the appropriate period of time.

3.4. Operating instructions

(a) When pressure equipment is made available on the market, it shall be

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

containing all the necessary safety information relating to

-

mounting including assembling of different pieces of pressure

equipment,

-

putting into service,

-

use,

-

maintenance including checks by the user.

(b) Instructions shall cover information affixed to the pressure equipment in

accordance with point 3.3, with the exception of serial identification,

and shall be accompanied, where appropriate, by the technical

documents, drawings and diagrams necessary for a full understanding of

these instructions.

(c) If appropriate, these instructions shall also refer to risks arising from

misuse in accordance with point 1.3 and particular features of the design

in accordance with point 2.2.3.

4. MATERIALS

Materials used for the manufacture of pressure equipment shall be suitable

for such application during the scheduled lifetime unless replacement is

foreseen.

Welding consumables and other joining materials need to fulfil only the

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

4.3, in an appropriate way, both individually and in a joined structure.

4.1. Materials for pressurised parts shall

(a) have appropriate properties for all operating conditions which are

reasonably foreseeable and for all test conditions, and in particular they

should be sufficiently ductile and tough. Where appropriate, the

characteristics of the materials shall comply with the requirements of

point 7.5. Moreover, due care should be exercised in particular in

selecting materials in order to prevent brittle-type fracture where

necessary; where for specific reasons brittle material has to be used

appropriate measures shall be taken;

(b) be sufficiently chemically resistant to the fluid contained in the pressure

equipment; the chemical and physical properties necessary for

operational safety shall not be significantly affected within the

scheduled lifetime of the equipment;

(c) not be significantly affected by ageing;

(d) be suitable for the intended processing procedures;

(e) be selected in order to avoid significant undesirable effects when the

various materials are put together.

4.2. The pressure equipment manufacturer shall

(a) define in an appropriate manner the values necessary for the design

calculations referred to in point 2.2.3 and the essential characteristics of

the materials and their treatment referred to in point 4.1;

(b) provide in his technical documentation elements relating to compliance

with the materials specifications of 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.

4.3. The equipment manufacturer shall take appropriate measures to ensure that

the material used conforms with the required specification. In particular,

documentation prepared by the material manufacturer affirming compliance

with a specification shall be obtained for all materials.

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

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

control.

Where a material manufacturer has an appropriate quality-assurance

system, certified by a competent body established within the Union and

having undergone a specific assessment for materials, certificates issued

by the manufacturer are presumed to certify conformity with the

relevant requirements of this point.

SPECIFIC PRESSURE EQUIPMENT REQUIREMENTS

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

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

5. FIRED OR OTHERWISE HEATED PRESSURE EQUIPMENT WITH A

RISK OF OVERHEATING AS REFERRED TO IN 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

PRESSURE EQUIPMENT

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.

7.1. Allowable stresses

7.1.1. Symbols

R e/t , yield limit, indicates the value at the calculation temperature of

the upper flow limit for a material presenting upper and lower flow

limits,

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

the 0,2% proof strength in other cases.

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

R m/t designates the ultimate tensile strength at the calculation temperature.

7.1.2. The permissible general membrane stress for predominantly static loads and

for temperatures outside the range in which creep is significant shall not

exceed the smaller of the following values, according to the material used

in the case of ferritic steel including normalised (normalised rolled)

steel and excluding fine-grained steel and specially heat-treated steel, 2/

3 of 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.

7.2. Joint coefficients

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

for equipment subject to destructive and non-destructive tests which

confirm that the whole series of joints show no significant defects: 1,

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

for equipment not subject to non-destructive testing other than visual

inspection: 0,7.

If necessary, the type of stress and the mechanical and technological

properties of the joint shall also be taken into account.

7.3. Pressure limiting devices, particularly for pressure vessels

The momentary pressure surge referred to in point 2.11.2 shall be kept to

10% of the maximum allowable pressure.

7.4. Hydrostatic test pressure

For pressure vessels, the hydrostatic test pressure referred to in point 3.2.2

shall be no less than either of the following

that corresponding to the maximum loading to which the pressure

equipment may be subject in service taking into account its maximum

allowable pressure and its maximum allowable temperature, multiplied

by the coefficient 1,25,

the maximum allowable pressure multiplied by the coefficient 1,43,

whichever is the greater.

7.5. Material characteristics

Unless other values are required in accordance with other criteria that

shall be taken into account, a steel is considered as sufficiently ductile

to satisfy point 4.1(a) if, in a tensile test carried out by a standard

procedure, its elongation after rupture is no less than 14% and its

bending rupture energy measured on an ISO V test-piece is no less than

27 J, at a temperature not greater than 20 °C but not higher than the

PRESSURE EQUIPMENT

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.

PRESSURE EQUIPMENT

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).

PRESSURE EQUIPMENT

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

PRESSURE EQUIPMENT

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

PRESSURE EQUIPMENT

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

4.1. The manufacturer shall affix the CE marking to each individual pressure

equipment that satisfies the applicable requirements of these regulations.

4.2. The manufacturer shall draw up a written EU declaration of conformity for

the pressure equipment model and keep it together with the technical

documentation at the disposal of the national authorities for 10 years after

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

of conformity shall identify the pressure equipment for which it has been

drawn up.

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

relevant authorities upon request.

5. Authorised representative

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

authorised representative, on his behalf and under his responsibility,

provided that they are specified in the mandate.

2. MODULE A2: INTERNAL PRODUCTION CONTROL PLUS

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

PRESSURE EQUIPMENT

5.1. The manufacturer shall affix the CE marking to each individual pressure

equipment that satisfies the applicable requirements of these regulations.

5.2. The manufacturer shall draw up a written EU declaration of conformity for

the pressure equipment model and keep it together with the technical

documentation at the disposal of the national authorities for 10 years after

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

of conformity shall identify the pressure equipment for which it has been

drawn up.

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

relevant authorities upon request.

6. Authorised representative

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

authorised representative, on his behalf and under his responsibility,

provided that they are specified in the mandate.

3. MODULE B: EU-TYPE EXAMINATION

3.1. EU-Type examination - production type

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

assessment procedure in which a notified body examines the technical

design of the pressure equipment and verifies and attests that the technical

design of the pressure equipment meets the requirements of 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

4.1. examine the technical documentation and supporting evidence to assess the

adequacy of the technical design of the pressure equipment and the

manufacturing procedures.

In particular, the notified body shall

assess the materials where these are not in conformity with the relevant

harmonised standards or with a European approval for pressure

equipment materials, and check the certificate issued by the material

manufacturer in accordance with point 4.3 of 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.

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

technical documentation and identify the elements which have been

designed in accordance with the applicable provisions of the relevant

harmonised standards as well as the elements which have been designed

using other relevant technical specifications without applying the relevant

provisions of those standards.

carry out appropriate examinations and necessary tests to check whether

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

PRESSURE EQUIPMENT

harmonised standards, these have been applied correctly.

4.4. carry out appropriate examinations and necessary tests to check whether,

where the solutions in the relevant harmonised standards have not been

applied, the solutions adopted by the manufacturer applying other relevant

technical specifications meet the corresponding essential safety

requirements of these regulations.

4.5. agree with the manufacturer on a location where the examinations and tests

will be carried out.

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

activities undertaken in accordance with point 4 and their outcomes. Without

prejudice to its obligations vis-à-vis the notifying authority, the notified

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

agreement of the manufacturer.

6. Where the type meets the requirements of 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.

3.2. EU-Type examination - design type

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

procedure in which a notified body examines the technical design of the

pressure equipment and verifies and attests that the technical design of the

pressure equipment meets the requirements of 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

PRESSURE EQUIPMENT

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

4.1. examine the technical documentation and supporting evidence to assess the

adequacy of the technical design of the product.

In particular, the notified body shall

assess the materials where these are not in conformity with the relevant

harmonised standards or with a European approval for pressure

equipment materials,

approve the procedures for the permanent joining of pressure equipment

parts, or check that they have been previously approved in accordance

with point 3.1.2 of Schedule I.

4.2. carry out appropriate examinations to check whether where the manufacturer

has chosen to apply the solutions in the relevant harmonised standards these

have been applied correctly.

4.3. carry out appropriate examinations to check whether, where the solutions in

the relevant harmonised standards have not been applied, the solutions

adopted by the manufacturer meet the corresponding essential safety

requirements of 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-

d e s i g n t y p e , i t s a n n e x e s a n d a d di t i o n s t o g e t h e r w i t h t h e t e c h n i ca l

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

PRESSURE EQUIPMENT

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

4.1. The manufacturer shall affix the CE marking to each individual pressure

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

EU-type examination certificate and satisfies the applicable requirements of

these regulations.

4.2. The manufacturer shall draw up a written EU declaration of conformity for a

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

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

market. The EU declaration of conformity shall identify the pressure

equipment model for which it has been drawn up.

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

relevant authorities upon request.

5. Authorised representative

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

authorised representative, on his behalf and under his responsibility,

provided that they are specified in the mandate.

5. MODULE D: CONFORMITY TO TYPE BASED

ON

QUALITY

ASSURANCE OF THE PRODUCTION PROCESS

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

that part of a conformity assessment procedure whereby the manufacturer

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

on his sole responsibility that the pressure equipment or assembly concerned

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

certificate and satisfies the requirements of 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

3.1. The manufacturer shall lodge an application for assessment of his quality

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

concerned.

The application shall include

-

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

lodged by the authorised representative, his name and address as well,

-

a written declaration that the same application has not been lodged with

any other notified body,

-

all relevant information on the pressure equipment type envisaged,

-

the documentation concerning the quality system,

-

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

type examination certificate.

3.2. The quality system shall ensure that the pressure equipment is in conformity

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

with the requirements of 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

w r i t t e n p o l i c i e s , p r o c e d u r e s an d i n s t r u c t i o n s . T h i s q u a l i t y s y s t e m

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

PRESSURE EQUIPMENT

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.

3.4. The manufacturer shall undertake to fulfil the obligations arising out of the

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

efficient.

3.5. The manufacturer shall keep the notified body that has approved the quality

system informed of any intended change to the quality system.

The notified body shall evaluate the proposed changes and decide whether

the modified quality system will continue to satisfy the requirements

referred to in point 3.2 or whether a reassessment is necessary.

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

the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

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

fulfils the obligations arising out of the approved quality system.

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

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

provide it with all necessary information, in particular

-

the quality system documentation,

-

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

data, qualification reports of the personnel concerned, etc.

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

manufacturer maintains and applies the quality system and provide the

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

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

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

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

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

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

control system

-

the category of the pressure equipment,

-

the results of previous surveillance visits,

-

the need to follow up corrective actions,

-

special conditions linked to the approval of the system, where

applicable,

-

significant changes in manufacturing organisation, policy or techniques.

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

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

functioning correctly. The notified body shall provide the manufacturer with

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

5. CE marking and EU declaration of conformity

5.1. The manufacturer shall affix the CE marking and, under the responsibility of

the notified body referred to in point 3.1, the latter’s identification number

to each individual pressure equipment that is in conformity with the type

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

requirements of these regulations.

5.2. The manufacturer shall draw up a written EU declaration of conformity for

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

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

market. The EU declaration of conformity shall identify the pressure

equipment model for which it has been drawn up.

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

relevant authorities upon request.

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

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

national authorities

-

the documentation referred to point 3.1,

-

the change referred to in point 3.5, as approved,

-

the decisions and reports of the notified body referred to in points 3.3,

3.5, 4.3 and 4.4.

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

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

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

PRESSURE EQUIPMENT

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

5.1. The manufacturer shall lodge an application for assessment of his quality

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

concerned.

The application shall include

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

lodged by the authorised representative, his name and address as well,

a written declaration that the same application has not been lodged with

any other notified body,

all relevant information on the pressure equipment type envisaged,

the documentation concerning the quality system,

the technical documentation referred to in point 2.

5.2. The quality system shall ensure compliance of the pressure equipment with

the requirements of 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

w r i t t e n p o l i c i e s , p r o c e d u r e s an d i n s t r u c t i o n s . T h i s q u a l i t y s y s t e m

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.

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

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

quality system which conform to the relevant harmonised standard are

presumed to comply with the corresponding requirements referred to in

point 5.2.

In addition to experience in quality management systems, the auditing team

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

equipment technology concerned, and the knowledge of the applicable

requirements of these regulations. The audit shall include an assessment

visit to the manufacturer’s premises.

PRESSURE EQUIPMENT

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.

5.4. The manufacturer shall undertake to fulfil the obligations arising out of the

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

efficient.

5.5. The manufacturer shall keep the notified body that has approved the quality

system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether

the modified quality system will continue to satisfy the requirements

referred to in point 5.2 or whether a reassessment is necessary.

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

the conclusions of the examination and the reasoned assessment decision.

6. Surveillance under the responsibility of the notified body

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

fulfils the obligations arising out of the approved quality system.

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

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

provide it with all necessary information, in particular

-

the quality system documentation,

-

the technical documentation referred to in point 2,

-

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

data, qualification reports of the personnel concerned, etc.

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

manufacturer maintains and applies the quality system and provide the

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

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

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

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

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

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

control system

-

the category of the pressure equipment,

-

the results of previous surveillance visits,

-

the need to follow up corrective action(s),

-

special conditions linked to the approval of the system, where

applicable,

-

significant changes in manufacturing organisation, policy or techniques.

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

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

functioning correctly. The notified body shall provide the manufacturer with

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

7. CE marking and EU declaration of conformity

7.1. The manufacturer shall affix the CE marking and, under the responsibility of

the notified body referred to in point 5.1, the latter’s identification number

to each in dividual p ressure equi pment th at satisfies the appli cable

requirements of these regulations.

7.2. The manufacturer shall draw up a written EU declaration of conformity for

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

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

market. The EU declaration of conformity shall identify the product model

for which it has been drawn up.

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

relevant authorities upon request.

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

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

national authorities

-

the documentation referred to in point 5.1,

-

the change referred to in point 5.5,

-

the decisions and reports of the notified body referred to in points 5.5,

6.3 and 6.4.

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

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

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

approvals refused, suspended or otherwise restricted.

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

approvals which it has refused, suspended, or withdrawn, and upon request,

of quality system approvals which it has issued.

10. Authorised representative

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

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

responsibility, provided that they are specified in the mandate.

7. MODULE E: CONFORMITY TO TYPE BASED ON PRESSURE

EQUIPMENT QUALITY ASSURANCE

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

part of a conformity assessment procedure whereby the manufacturer fulfils

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

sole responsibility that the pressure equipment concerned is in conformity

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

the requirements of 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

3.1. The manufacturer shall lodge an application for assessment of his quality

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

concerned.

PRESSURE EQUIPMENT

The application shall include

-

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

lodged by the authorised representative, his name and address as well,

-

a written declaration that the same application has not been lodged with

any other notified body,

-

all relevant information on the pressure equipment type envisaged,

-

the documentation concerning the quality system,

-

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

type examination certificate.

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

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

requirements of 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

w r i t t e n p o l i c i e s , p r o c e d u r e s a n d i n s t r u c t i o n s. T h i s q u a l i t y s y s te m

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.

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 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.

3.4. The manufacturer shall undertake to fulfil the obligations arising out of the

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

efficient.

3.5. The manufacturer shall keep the notified body that has approved the quality

system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether

the modified quality system will continue to satisfy the requirements

referred to in point 3.2 or whether a reassessment is necessary.

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

the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

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

fulfils the obligations arising out of the approved quality system.

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

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

provide it with all necessary information, in particular

-

the quality system documentation,

-

the technical documentation,

-

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

data, reports concerning the qualifications of the personnel concerned,

etc.

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

manufacturer maintains and applies the quality system and provide the

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

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

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

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

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

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

control system

-

the category of the pressure equipment,

-

the results of previous surveillance visits,

-

the need to follow up corrective actions,

-

special conditions linked to the approval of the system, where

applicable,

-

significant changes in manufacturing organisation, policy or techniques.

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

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

functioning correctly. The notified body shall provide the manufacturer with

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

5. CE marking and EU declaration of conformity

5.1. The manufacturer shall affix the CE marking and, under the responsibility of

the notified body referred to in point 3.1, the latter’s identification number

to each individual pressure equipment that is in conformity with the type

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

requirements of these regulations.

5.2. The manufacturer shall draw up a written EU declaration of conformity for

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

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

PRESSURE EQUIPMENT

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

assessm ent , the desig n, m anufactu re an d operatio n o f the pressu re

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

5.1. The manufacturer shall lodge an application for assessment of his quality

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

concerned.

The application shall include

-

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

lodged by the authorised representative, his name and address as well,

-

a written declaration that the same application has not been lodged with

any other notified body,

-

all relevant information on the pressure equipment type envisaged,

-

the documentation concerning the quality system, and

-

the technical documentation referred to in point 2.

5.2. The quality system shall ensure compliance of the pressure equipment with

the requirements of 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

w r i t t e n p o l i c i e s , p r o c e d u r e s an d i n s t r u c t i o n s . T h i s q u a l i t y s y s t e m

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

PRESSURE EQUIPMENT

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.

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

satisfies the requirements referred to in point 5.2.

It shall presume conformity with those requirements in respect of the

elements of the quality system that comply with the corresponding

specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the auditing team

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

pressure equipment field and pressure equipment technology concerned, and

knowledge of the applicable requirements of 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.

5.4. The manufacturer shall undertake to fulfil the obligations arising out of the

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

efficient.

5.5. The manufacturer shall keep the notified body that has approved the quality

system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether

the modified quality system will continue to satisfy the requirements

referred to in point 5.2 or whether a reassessment is required.

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

the conclusions of the examination and the reasoned assessment decision.

6. Surveillance under the responsibility of the notified body

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

fulfils the obligations arising out of the approved quality system.

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

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

provide it with all necessary information, in particular

-

the quality system documentation,

-

the technical documentation referred to in point 2,

-

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

data, qualification reports on the personnel concerned, etc.

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

manufacturer maintains and applies the quality system and provide the

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

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

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

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

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

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

control system

-

the category of the equipment,

-

the results of previous surveillance visits,

-

the need to follow up corrective action(s),

-

special conditions linked to the approval of the system, where

applicable,

-

significant changes in manufacturing organisation, policy or techniques.

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

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

functioning correctly. The notified body shall provide the manufacturer with

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

7. CE marking and EU declaration of conformity

7.1. The manufacturer shall affix the CE marking and, under the responsibility of

the notified body referred to in point 5.1, the latter’s identification number

to each individual item of pressure equipment that satisfies the applicable

requirements of these regulations.

7.2. The manufacturer shall draw up a written EU declaration of conformity for

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

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

market. The EU declaration of conformity shall identify the pressure

equipment model for which it has been drawn up.

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

relevant authorities upon request.

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

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

national authorities

-

the documentation referred to in point 5.1,

-

the change referred to in point 5.5, as approved,

-

the decisions and reports of the notified body referred to in points 5.3,

5.5, 6.3 and 6.4.

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

approvals issued or withdrawn and shall periodically or upon request, make

available to its notifying authorities the list of quality system approvals

refused, suspended or otherwise restricted.

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

approvals which it has refused, suspended or withdrawn, and, upon request,

of quality system approvals which it has issued.

10. Authorised representative

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

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

responsibility, provided that they are specified in the mandate.

9. MODULE F: CONFORMITY TO TYPE BASED ON PRESSURE

EQUIPMENT VERIFICATION

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

PRESSURE EQUIPMENT

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

4.1. All pressure equipment shall be individually examined and appropriate tests

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

carried out in order to verify conformity with the approved type and

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

requirements of 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.

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

examinations and tests carried out, and shall affix its identification number

or have it affixed under its responsibility to each approved item of pressure

equipment.

The manufacturer shall keep the certificates of conformity available for

inspection by the national authorities for 10 years after the pressure

equipment has been placed on the market.

5. CE marking and EU declaration of conformity

5.1. The manufacturer shall affix the CE marking and, under the responsibility of

the notified body referred to in point 3, the latter’s identification number to

each individual item of pressure equipment that is in conformity with the

approved type described in the EU-type examination certificate and satisfies

the applicable requirements of these regulations.

5.2. The manufacturer shall draw up a written EU declaration of conformity for

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

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

market. The EU declaration of conformity shall identify the pressure

equipment model for which it has been drawn up.

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

relevant authorities upon request.

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

the manufacturer may also affix the notified body’s identification number to

the pressure equipment.

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

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

equipment during the manufacturing process.

7. Authorised representative

The manufacturer’s obligations may be fulfilled by his authorised

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

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

manufacturer’s obligations set out in point 2.

10. MODULE G: CONFORMITY BASED ON UNIT VERIFICATION

1. Conformity based on unit verification is the conformity assessment

procedure whereby the manufacturer fulfils the obligations laid down in

points 2, 3 and 5, and ensures and declares on his sole responsibility that the

pressure equipment concerned, which has been subject to the provisions of

point 4, is in conformity with the requirements of 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

PRESSURE EQUIPMENT

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

5.1. The manufacturer shall affix the CE marking and, under the responsibility of

the notified body referred to in point 4, the latter’s identification number to

each item of pressure equipment that satisfies the applicable requirements of

these regulations.

5.2. The manufacturer shall draw up a written EU declaration of conformity and

keep it at the disposal of the national authorities for 10 years after the

pressure equipment has been placed on the market. The EU declaration of

conformity shall identify the pressure equipment for which it has been

drawn up.

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

relevant authorities upon request.

6. Authorised representative

The manufacturer’s obligations set out in points 2 and 5 may be fulfilled by

his authorised representative, on his behalf and under his responsibility,

provided that they are specified in the mandate.

11. MODULE H: CONFORMITY BASED ON FULL QUALITY ASSURANCE

1. Conformity based on full quality assurance is the conformity assessment

procedure whereby the manufacturer fulfils the obligations laid down in

points 2 and 5, and ensures and declares on his sole responsibility that the

pressure equipment concerned satisfies the requirements of 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

3.1. The manufacturer shall lodge an application for assessment of his quality

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

concerned.

The application shall include

-

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

lodged by the authorised representative, his name and address as well,

-

the technical documentation for one model of each type of pressure

equipment intended to be manufactured. The technical documentation

shall, wherever applicable, contain at least the following elements

-

a general description of the pressure equipment,

-

conceptual design and manufacturing drawings and diagrams of

components, sub-assemblies, circuits, etc.,

-

descriptions and explanations necessary for the understanding of those

drawings and diagrams and the operation of the pressure equipment,

-

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

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

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

safety requirements of these regulations where those harmonised

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

harmonised standards, the technical documentation shall specify the

PRESSURE EQUIPMENT

parts which have been applied,

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

test reports,

the documentation concerning the quality system, and

a written declaration that the same application has not been lodged with

any other notified body.

3.2. The quality system shall ensure compliance of the pressure equipment with

the requirements of 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

w r i t t e n p o l i c i e s , p r o c e d u r e s a n d i ns t r u c ti o n s . T h a t q u a l i t y s ys te m

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.

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

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

conformity with those requirements in respect of the elements of the quality

system that comply with the corresponding specifications of the relevant

harmonised standard.

In addition to experience in quality management systems, the auditing team

shall have at least one member experienced as assessor in the pressure

equipment technology concerned, and knowledge of the applicable

requirements of 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.

3.4. The manufacturer shall undertake to fulfil the obligations arising out of the

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

efficient.

3.5. The manufacturer shall keep the notified body that has approved the quality

system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether

the modified quality system will continue to satisfy the requirements

referred to in point 3.2 or whether a reassessment is necessary.

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

the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

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

fulfils the obligations arising out of the approved quality system.

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

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

shall provide it with all necessary information, in particular

-

the quality system documentation,

-

the quality records provided for by the design part of the quality system,

such as results of analyses, calculations, tests, etc.,

-

the quality records provided for by the manufacturing part of the quality

system, such as inspection reports and test data, calibration data,

qualification reports on the personnel concerned, etc.

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

manufacturer maintains and applies the quality system and shall provide the

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

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

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

manufacturer.

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

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

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

control system

-

the category of the equipment,

-

the results of previous surveillance visits,

-

the need to follow up corrective action(s),

-

special conditions linked to the approval of the system, where

PRESSURE EQUIPMENT

applicable,

-

significant changes in manufacturing organisation, policy or techniques.

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

tests, or have them carried out, in order to check the proper functioning of

the quality system. It shall provide the manufacturer with a visit report and,

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

5. CE marking and EU declaration of conformity

5.1. The manufacturer shall affix the CE marking and, under the responsibility of

the notified body referred to in point 3.1, the latter’s identification number

to each individual item of pressure equipment that satisfies the applicable

requirements of these regulations.

5.2. The manufacturer shall draw up a written EU declaration of conformity for

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

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

market. The EU declaration of conformity shall identify the pressure

equipment model for which it has been drawn up.

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

relevant authorities upon request.

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

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

national authorities

-

the technical documentation referred to in point 3.1,

-

the documentation concerning the quality system referred to in point

3.1,

-

the change referred to point 3.4, as approved,

-

the decisions and reports of the notified body referred to in points 3.3,

3.4, 4.3 and 4.4.

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

approvals issued or withdrawn, and shall, periodically or upon request, make

available to its notifying authorities the list of quality system approvals

refused, suspended or otherwise restricted.

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

approvals which it has refused, suspended or withdrawn, and, upon request,

of quality system approvals which it has issued.

8. Authorised representative

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

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

responsibility, provided that they are specified in the mandate.

12. MODULE H1: CONFORMITY BASED ON

FULL

QUALITY

ASSURANCE PLUS DESIGN EXAMINATION

1. Conformity based on full quality assurance plus design examination and

special surveillance of the final assessment is the conformity assessment

procedure whereby the manufacturer fulfils the obligations laid down in

points 2 and 6, and ensures and declares on his sole responsibility that the

pressure equipment concerned satisfy the requirements of the Directive that

apply to it.

2. Manufacturing

The manufacturer shall operate an approved quality system for design,

manufacture and final product inspection and testing of the products

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

specified in point 5. The adequacy of the technical design of the pressure

equipment shall have been examined in accordance with point 4.

3. Quality system

3.1. The manufacturer shall lodge an application for assessment of his quality

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

concerned.

The application shall include

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

lodged by the authorised representative, his name and address as well,

the technical documentation for one model of each type of pressure

equipment intended to be manufactured. The technical documentation

shall, wherever applicable, contain at least the following elements

a general description of the pressure equipment,

conceptual design and manufacturing drawings and diagrams of

components, sub-assemblies, circuits, etc.,

descriptions and explanations necessary for the understanding of those

drawings and diagrams and the operation of the pressure equipment,

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

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

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

safety requirements of 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.

3.2. 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

w r i t t e n p o l i c i e s , p r o c e d u r e s an d i n s t r u c t i o n s . T h i s q u a l i t y s y s t e m

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

PRESSURE EQUIPMENT

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.

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

satisfies the requirements referred to in point 3.2.

It shall presume conformity with those requirements in respect of the

elements of the quality system that comply with the corresponding

specifications of the relevant harmonised standard. In addition to experience

in quality management systems, the auditing team shall have at least one

member experienced as an assessor in the relevant pressure equipment field

and pressure equipment technology concerned, and knowledge of the

applicable requirements of 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.

3.4. The manufacturer shall undertake to fulfil the obligations arising out of the

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

efficient.

3.5. The manufacturer shall keep the notified body that has approved the quality

system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether

the modified quality system will continue to satisfy the requirements

referred to in point 3.2 or whether a re-assessment is necessary.

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

the conclusions of the examination and the reasoned assessment decision.

3.6. Each notified body shall inform its notifying authorities of quality system

approvals issued or withdrawn, and shall, periodically or upon request, make

available to its notifying authorities the list of quality system approvals

refused, suspended or otherwise restricted.

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

approvals which it has refused, suspended or withdrawn, and, upon request,

of quality system approvals which it has issued.

4. Design examination

4.1. The manufacturer shall lodge an application for examination of the design of

each item of p ressure equipmen t not covered by a p revious d esign

examination with the notified body referred to in point 3.1.

4.2. The application shall make it possible to understand the design, manufacture

and operation of the pressure equipment, and to assess the conformity with

the requirements of 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.

PRESSURE EQUIPMENT

4.3. 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.

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

acknowledged state of the art which indicate that the approved design may

no longer comply with the applicable requirements of 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.

4.5. Each notified body shall inform its notifying authorities of the EU design

examination certificates and, or any additions thereto which it has issued or

withdrawn, and shall, periodically or upon request, make available to its

notifying authorities the list of certificates and, or any additions thereto

refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of the EU design

examination certificates and, or any additions thereto which it has refused,

withdrawn, suspended or otherwise restricted, and, upon request, of the

certificates and, or additions thereto which it has issued.

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

request, obtain a copy of the EU design examination certificates and, or

additions thereto. On request, the Commission and the Member States may

obtain a copy of the technical documentation and of the results of the

examinations carried out by the notified body.

The notified body shall keep a copy of the EU design examination

certificate, its annexes and additions, as well as the technical file including

the documentation submitted by the manufacturer until the expiry of the

validity of the certificate.

4.6. The manufacturer shall keep a copy of the EU design examination

certificate, its annexes and additions together with the technical

documentation at the disposal of the national authorities for 10 years after

the pressure equipment has been placed on the market.

5. Surveillance under the responsibility of the notified body

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

fulfils the obligations arising out of the approved quality system.

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

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

shall provide it with all necessary information, in particular

-

the quality system documentation,

-

the quality records as provided for by the design part of the quality

system, such as results of analyses, calculations, tests, etc.,

-

the quality records as provided for by the manufacturing part of the

quality system, such as inspection reports and test data, calibration data,

qualification reports on the personnel concerned, etc.

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

manufacturer maintains and applies the quality system and shall provide the

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

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

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

manufacturer.

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

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

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

control system

-

the category of the equipment,

-

the results of previous surveillance visits,

-

the need to follow up corrective action(s),

-

special conditions linked to the approval of the system, where

applicable,

-

significant changes in manufacturing organisation, policy or techniques.

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

tests, or have them carried out, in order to check the proper functioning of

the quality system. It shall provide the manufacturer with a visit report and,

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

5.5. Special surveillance of the final assessment

Final assessment as referred to in section 3.2 of 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

6.1. The manufacturer shall affix the CE marking and, under the responsibility of

the notified body referred to in point 3.1, the latter’s identification number

to each individual item of pressure equipment that satisfies the applicable

requirements of these regulations.

6.2. The manufacturer shall draw up a written EU declaration of conformity for

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

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

PRESSURE EQUIPMENT

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,

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 -

* It is optional for the manufacturer to assign a number to the declaration of conformity.

PRESSURE EQUIPMENT

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.