Lloyd’s Register Asia

Summary of PED Requirements

Lloyd’s Register Asia

S. T. Kim/Energy Korea

Lloyd’s Register Asia

Introduction

• Classification
• Conformity Assessment
9 Design review
9 Inspection and testing
9 Certification
• Role of Notified Body
• Declaration of Conformity

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Classification
• Four categories of pressure equipment

• Category determined by the pressure risk

• Classified in nine charts in Annex II by:

9 type of pressure equipment;

9 pressure, volume or nominal diameter;

9 class of fluid.

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Classification - class of fluid

• State of intended fluid - gas/liquid

• Group I • Group II
explosive others
extremely flammable
highly flammable
flammable
very toxic
toxic
oxidising

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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 Group1 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 (Annex II, table 1),

— for fluids in Group2, 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
(Annex II, table 2);

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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 Group1 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 (Annex II, table 3),
— for fluids in Group2 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 (Annex II, table 4).

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Category Sample

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Category Sample

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Category Sample

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Specific Classification

• Multi chambered vessels are classified according to the

highest chamber category.

• Equipment that can contain several fluids is classified

according to the fluid that requires the higher category.

• Where more than one Table is applicable, the equipment is

classified according to the Table that gives the highest
category.

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Conformity Assessment Modules

가능한 검사 모듈

동일한 용기를 각기 다른 동일한 용기를 각기 다른

연속 생산시 용기 생산시 연속 생산시 용기 생산시

카테고리 PED 시스템 인증 없는 경우 PED 시스템 인증 있는 경우

I A
II A1 D1 E1
B+E H
III B + C1 B1 + F
B1 + D
IV B+F G B+D H1

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Category I

• Module A - Internal Production Control

9 Manufacturer carries out obligations under the Directive and declares
conformity.
9 No ‘Third Party’ or Notified Body involvement in any aspect
9 Final testing of mass produced items may be done on a statistical basis

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Category II

• A1 - Manufacturers’ declaration with monitoring of final

inspection
9 Notified Body monitors compliance with Directive during unannounced
visits and conducts tests on samples at place of manufacture or
storage- NB identification number on each piece of equipment

• D1 - Production quality assurance

• E1 - Product quality assurance

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Category III

• B1 - Design examination PLUS

D - Production quality assurance

• B1 - Design examination PLUS

F - Product verification

• B - Type examination PLUS

E - Product quality assurance

• B - Type examination PLUS

C1 - Monitoring of final inspection

• H - Full quality assurance

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Category IV
• B - Type examination PLUS
D - Production quality assurance

• B - Type examination PLUS

F - Product verification

• G - Unit verification

• H1 - Full quality assurance with design examination and monitoring of

inspection

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Module B - EC Type Examination

• NB examines manufactures technical documentation for

design, manufacture, materials, joining & approved personnel

• NB witnesses agreed prototype tests on a representative

sample to ensure compliance with:
9 harmonised standards when chosen
9 ESR’s where harmonised standards not applied

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Module B - EC Type Examination

• Where type satisfies Directive Notified Body issues EC Type-

Examination Certificate, valid for ten years.
9 Certificate must include an index of the manufacturer’s Technical File

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Module B1 EC Design Examination

• NB examines manufactures technical documentation for

design, manufacture, materials, joining & approved personnel,
for compliance with:
9 harmonised standards where chosen
9 ESR where harmonised standards not applied

• Verify design solution by testing where harmonised standards

have not been used

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Module B1 EC Design Examination

• If design meets Directive requirements NB issues EC design-

examination certificate to the applicant

• Design examination is very similar to type examination except

for prototype test

• Design examination requires higher level of NB involvement

for production than type examination

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Module C1 Conformity to Type

• Applies to Category III equipment with an EC Type

Examination Certificate

• Notified Body monitors compliance with approved design

during unannounced visits and witnesses tests on random
samples at place of manufacture or storage:
9 Review of manufacturing records
9 Witness final examination
• NB identification affixed to each item

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Module F Product Verification

• Applies to Category III equipment with an EC Design

Examination Certificate, or Category IV equipment with an EC
Type Examination certificate.

• NB performs appropriate tests on each piece of equipment to

check conformity with the approved design:
9 Review of manufacturing records
9 Witness final examination

• NB issues EC Certificate of Conformity

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Module G EC Unit Verification

• NB must examine the design and construction of each item of

pressure equipment and during manufacture perform tests to
ensure compliance with:
9 harmonised standards where chosen
9 ESR’s where harmonised standards not applied

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Module G EC Unit Verification

• In particular the Notified Body must:

9 examine documentation relating to design and manufacturing
procedures
9 check or approve materials andjoining procedures
9 verify the qualifications of joining and NDE personnel
9 witness final inspection and examine safety devices if applicable

• NB issues an EC Certificate of Conformity for each item

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Sound Engineering Practice

• applies to equipment with PS or V or diameter below

specified thresholds
• design and manufacture in accordance with sound
engineering practice of a Member State
• must have adequate instructions for use
• manufacturer must be identified
• does not have CE Marking applied

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Question:
When is it possible for a manufacturer to apply a module from a higher
category and what are the consequences ?

Answer:
Article 10.1.4 states that manufacturers can choose to apply one of the
procedures which apply to a higher category if available.
If a module (or a module combination) from a higher category is chosen, all
the requirements of that module must be met, including the marking of the
identification number of the Notified body.
However, the use of a module (or a module combination) from a higher
category does not change the actual classification of the equipment.
The requirements of Annex I are those resulting from the actual classification
unless the module itself gives specific requirements.

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Question:
Article 10, section 1.4 states that a manufacturer may choose to apply one of
the conformity assessment procedures which apply to a higher (conformity
assessment ) category if available.
Does this mean that a manufacturer of pressure equipment covered by Article
3, section 3, referred to as Sound Engineering Practice (SEP), can choose to
apply Module A for example and hence apply a CE Marking?

Answer:
No. Article 9, section 1 deals with the classification of pressure equipment
referred to in Article 3, section 1 (not section 3) and Article 10 sets out how
the conformity assessment procedures should be determined for such
equipment. Therefore Article 10, section 1.4 does not apply to SEP pressure
equipment and it does not provide any derogation to the provision in Article 3,
section 3 that specifically prohibits CE Marking of SEP pressure equipment.

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Question:
How to classify pressure equipment containing one or more fluids when a
chemical or physical reaction takes place therein ?

Answer:
The classification shall be determined by the fluid which gives the highest
category taking into account the starting, intermediate and final fluids, which
could arise from all reasonably foreseeable conditions.

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Question:
Shall the manufacturer of pressure equipment submit operating instructions as
part of the conformity assessment by a Notified Body, and shall the Notified
Body verify the content?

Answer:
Yes.
PED requires the manufacturer to prepare operating instructions (see
guideline 8/3) and supply them together with the equipment.
Appropriate operating instructions are an essential safety requirement (ESR)
and shall therefore be part of the conformity assessment procedure

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Question:
There are many organisations that design pressure equipment that is
subsequently fabricated by another organisation.
Is it permissible for the company responsible for the design to obtain an EC
design examination certificate (B1) and the fabricator obtain an appropriate
certificate for the manufacturing phase, e.g. Product Verification (F).
Answer:
No.

Even if different organisations can be involved, the directive clearly indicates

that there can be only one "manufacturer" who is responsible for design,
manufacture and conformity assessment of the pressure equipment.

The "manufacturer" may subcontract tasks in relation to design and/or

manufacture but must retain overall control and have the necessary
competence to take the responsibility for the product.

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Question:
Must a Notified Body take into account a procedure of permanent joints
qualified by another Notified Body or a recognised third-party organisation?

Answer:
Yes, a Notified Body is not allowed to reject an approval of procedure of
permanent joints made on the basis of a precise reference and applying
competence in accordance with the PED.
Nevertheless, it is its responsibility to verify, if needed, that the joining process
and the reference to the manufactured product are adequate.

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Question:
If a manufacturer has a procedure for permanent joining approved by a
notified body or other recognized third-party organization at one site (location),
may that manufacturer use the same procedure at other sites for similar
applications?

Answer:
Yes, provided the other sites are under the same technical and quality
management.

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Question:
For pressure equipment in categories III and IV, can Non-Destructive Testing
personnel holding qualifications other than those satisfying criteria of the
harmonised standards (e.g. EN 473:2000 General principles for qualification
and certification of NDT personnel) be approved by Recognised Third Party
Organisations (RTPO) notified by a member state under Article 13 paragraph
1?
Answer:Yes.

NDT personnel certified under standards, other than the harmonised

standards, may be approved by a RTPO provided it is satisfied that
certification criteria equivalent to the harmonised standards have been met,
and that the scope of certification is relevant to the testing of permanent joints
in pressure equipment.

A RTPO may sub-contract part of its work, within the provisions of the New
Approach guide, but shall keep the full responsibility and issue the approval.
The approval of the personnel shall be done by a RTPO on an individual basis.

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Question:
What is a "competent body" for the certification of the quality (assurance)
systems of material manufacturers?
Answer:
A "competent body" for certification of the quality systems of material
manufacturers can be any third party body established as a legal entity within
the Community which has recognized competence in the assessment of
quality (assurance) systems for the manufacture of materials and in the
technology of the materials concerned.
Competence can be demonstrated, for example, by accreditation. See also
guideline 7/7.

Note 1: A body not established as a legal entity within the Community, even if
it has a recognition agreement through the International Accreditation Forum,
does not comply with the requirements of Annex I section 4.3.

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Note 2: A notified body may perform this task only if it has a recognized
competence in the field of quality assurance, materials and related process
technology.
For this certification, the possible use of the notification number for PED is
irrelevant.

Note 3: The certificate of quality system shall make reference to the legal
entity established in the Community and its address

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Question:
Shall welding consumables and other joining materials comply with
harmonised standards, European approvals of materials or particular material
appraisal ?.

Answer : No

Reason: The PED does not require that these materials fulfil the requirement
of Annex I. 4.2b).

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Question:
The Directive 97/23/CE considers the case of “a material manufacturer who
has an appropriate quality-assurance system, certified by a competent body
established within the Community and having undergone a specific
assessment for materials”. How should this requirement be understood in
practice ?

Answer:
In practice, this requirement is satisfied when the material manufacturer has a
quality management system of at least ISO 9002:1994 type, certified by a
competent body (according to the definition given in guideline 7/2) established
as a legal entity within the European Community, and when the field of validity
of the certification specifies production of material indicating the relevant
material types.
The specific assessment of the quality system shall properly cover all the
relevant processes and material properties referred to in the material
specifications, and at-tested in the material certificates.

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Question:
What approach can be used to decide if a steel grade selected for a
pressurized part requires specific impact properties?

Answer:
1. The philosophy of the approach outlined below takes account of the hazard
analysis performed by the manufacturer in relation to the toughness
necessary for the identified failure modes (e.g. brittle fracture) in the finished
pressure equipment.
2. The exception concerns “ductile materials which are not subject to a
ductile/brittle transition at the foreseeable conditions the equipment will be
exposed to”.
Examples of such materials are: austenitic stainless steels.

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Some design codes provide specific rules for the avoidance of brittle fracture
that takes account of the anticipated or actual operating conditions prevailing,
e.g. material, thickness, temperature, etc.

Where the application of these rules indicate that the material will not behave
in a brittle manner and all aspects of the chosen design code have been
followed, sufficient confidence is gained in the behaviour of the material not to
require specified impact properties.

When these design codes are applied also other items need to be taken into
account (see item 3 below).

3. The justification for omission of the impact properties shall be based on the
most adverse possible combination of all elements of the steel grade
specification, such as:
9the full permissible range of the chemical analysis,
9the extreme mechanical properties,

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Question:
If the hydrostatic pressure test required by Annex I section 3.2.2 is replaced
by a pneumatic pressure test because filling with water is harmful or
impractical, what value has to be used for the pressure test?

Answer:
Either the values given in Annex I section 7.4 are to be used for the pneumatic
pressure test or the manufacturer has to achieve an equivalent level of safety
using other appropriate means.

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Any questions?

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