WEL COME TO PRESENTATION

ON
PRESSURE EQUIPMENT DIRECTIVE
97/23/EC
AND CONFIRMITY ASSESSMENT FOR
VALVES

LOCATION: FOURESS Engineerinf

By Jayaprakash. R. Hiremath

INDIA DATE : 16.04.2011 & 17.04.2011

TUV NORD Group
(Formerly RWTUV Group)
 SYNOPSIS
• Introducing the Company – TUV India
(TUV NORD Group)
•Introduction to CE marking
• European Policy
•New Approach, Global Approach
• Harmonization
• Pressure Equipment Directive (PED)
• Articles, Scope, technical requirements, Grouping, Exemption
•Annex 1 ESR
•Annexure 2,
•Tables
•Conformity Assessment Modules
•Modules H
•Conformity Assessment of Valves
•EN 10204 certification
• questions
INDIA
TUV NORD Group
(Formerly RWTUV Group)
 WHAT IS CE
• CE is conformity marking, put on to the product by
manufacturer to declare that product meets all the
essential health, safety and environmental
requirements of applicable directive/directives.
• Letter CE is French phrase "Conformité
Européene" which literally means "European
Conformity"
• CE marking is allowed to put on to the product only
when applicable directive requires it.
 PURPOSE OF CE
• To allow the entry and free movement of goods
within the EFTA (European Free Trade
Association) & EU (European Union) and some
partnering nations ie. Free movement of goods.
• CE Marking on a product indicates product may
be legally placed on the market in EU countries.
• CE Marking on a product permits the withdrawal
of the non conforming products by customs and
enforcement/vigilance authorities
 NEW APPROACH
• Technical harmonisation to support the Common Market
• 19 sectors to date
• Define Essential Safety Requirements (ESRs)
• Establish hazard categories
• List Conformity Assessment Procedures
• Self certification / Notified Bodies Assessment
• Affix CE-mark
• Free movement within EEA
• Harmonised Standards to provide presumtion of
conformity
 NEW APPROACH

1. Directive :
• EC directives define the "essential requirements", e.g.,
protection of health and safety, that goods must meet when
they are placed on the market.
2. Harmonised Standard:
• The European standards bodies have the task of drawing
up the corresponding technical specifications meeting the
essential requirements of the directives, compliance with
which will provide a presumption of conformity with
the essential requirements. Such specifications are
referred to as "harmonised standards".
New Approach- Directives
fundamental principles
directives limited to the harmonization of
essential requirements

reference to standards
harmonized standards

conformity assessment policy

products conforming with harmonized standards are
presumed to conform with the essential requirements
 New Approach
It is voluntary -
the manufacturer can apply other
technical specifications to the
requirements viz. ASME, BS, DIN,
AD 2000
 Electromagnetic
compatibility
89/336/EEC Lifts
Simple pressure vessels 95/16/EC
87/404/EEC Telecommunications
terminal equipment and Pressure equipment
satellite station equipment 97/23/EC
98/13/EC
Non-automatic
Personal protective
weighing instruments
equipment
89/686/EEC New Approach 90/384/EEC

Medical devices
Directives Recreational craft
93/42/EEC 94/25/EC

Active implantable
medical devices
90/385/EEC
Harmonization of regulations and
standards
EC-Directives European standards

New Approach:
reference to

harmonized standards
support European
harmonized regulations Directives
(common regulations of
the EU)
 Legal Harmonization

• European directives have to be enforced in

every member state
• harmonized conformity assessment
procedures
• Europe wide recognition of the responsible
bodies (free trade of services)
• policy of certification
• Legal Liability
 List Directives
• 90/396/EEC Appliances burning gaseous fuels
• 00/9/EC Cableway installations designed to carry person
• 89/106/EEC Construction products
• 89/336/EEC Electromagnetic compatibility
• 94/9/EC Equipment and protective systems in potentially explosive atmospheres
• 93/15/EEC Explosives for civil uses
• 95/16/EC Lifts
• 73/23/EEC Low voltage equipment
• 98/37/EC Machinery safety
• 2004/22/EEC Measuring instruments
• 90/385/EEC Medical devices: Active implantable
• 93/42/EEC Medical devices: General
• 98/79/EC Medical devices: In vitro diagnostic
• 92/42/EEC New hot-water boilers fired with liquid or gaseous fluids ( requirements)
• 90/384/EEC Non-automatic weighing instruments
• 94/62/EC Packaging and packaging waste
• 89/686/EEC Personal protective equipment
• 97/23/EC Pressure equipment
• 99/5/EC Radio and telecommunications terminal equipment
• 94/25/EC Recreational craft Recreational craft
• 87/404/EEC Simple pressure vessels
• 88/378/EEC Toys Safety
 Global approach 1
• Complementary to the new approach
• Creating conditions for reliable conformity assessment
• Key elements:
– building of confidence through competence and transparency
– setting up of a comprehensive policy and framework for
conformity assessment
– See Council Resolution on a global approach
(90/C 10/01)
 Global approach 2
How to be implemented?
• By developing devising modules for the various phases of
conformity assessment procedures
• By laying down criteria for the use of these procedures, for
the designation of bodies operating these procedures, and
for the use of the CE marking
• By using European standards relating to quality assurance
(EN ISO 9000 series)
• By setting up of accreditation systems and the use of
intercomparison techniques (EN ISO 17000 series)
 MEMBER COUNTRIES
European Union
1.Austria, 14. Sweden
2.Belgium, 15. United Kingdom (Great Britain)
3.Denmark, 16. Estonia,
4.Finland,
5.France, 17. Latvia,
6.Germany, 18. Lithuania,
7.Greece, 19. Poland,
8.Ireland, 20. Czech Republic,
9.Italy, 21. Slovakia,
10.Luxemburg,
11.The Netherlands, 22. Hungary,
12.Portugal, 23. Slovenia,
13.Spain, 24. Malta,
European Free Trade Association
1.Iceland,
2.Liechtenstein
3.Norway
Pressure Equipment Directive
97/23/EC

0045
Manufacturer: EFÜSTA
45138 Essen, Germany
Ident.-No.: 1234567
Type: we 234 vx
Year of manufacture: 2001
Pressure PS: 34 bar
Temperature TS 150°C
Volume: 130 l
 PED/ CE MARKING
INDIA
TUV NORD Group
(Formerly RWTUV Group)
 Pressure Equipment Directive 97/23/EC

• Ensures free movement of goods (PE),

a) for products which fall within its scope,
b) which meet the ESR,
c) having completed Conformity Assessment or are
Art 3.3 (SEP) equipment.

 PED harmonises the previously fragmented

European PE market
 Timetable for PED and national regulation
29.11.1999 29.05.2002

National regulation for National regulation for

manufacturing, manufacturing,
placing on the market, placing on the market, National regulation for
putting into service putting into service operation
and operation and operation

European Directive for European Directive for

manufacturing, manufacturing,
placing on the market placing on the market
and putting into service and putting into service
 Article 1

• Scope and definitions

• This directive applies to the design, manufacture and
conformity assessment of pressure equipment and
assemblies with a maximum allowable pressure PS
greater than 0,5 bar.

Applicable if,

1. Equipment is placed on the market or put into Service

2. Assemblies placed on the market and put into service

 Pressure Equipment Includes
1- Vessel : housing for containment of pressurised fluids

2- Piping : pipe or system of pipes mainly for transport

of fluids - includes hoses, expansion joints, fittings

3- Safety accessory : protection against exceeding allowable

limits, e.g. safety valves, temperature
switches
4- Pressure accessory : operational function e.g. valves,
flame arrestors
 Pressure Accessories
• Pressure accessory means a device with an operational
function and having an identifiable pressure-bearing
housing - i.e. the device has a function additional to that of
containing pressure.
• Can be attached to other parts of pressure equipment by
welding, brazing, bolting etc.
• Typical examples of pressure accessories are: valves,
pressure regulators, measurement chambers, pressure
gauges, water gauge glasses, filters, expansion joints and
manifolds.
 Assemblies
Several pieces of pressure equipment , provided
1. the result is integrated
2. the result is functional
3. they are a whole
4. they are assembled by one manufacturer

NOTE :
a- the assembly can be built in a workshop or on-site
b- there is no upper limit to an assembly
c- an assembly can be composed of smaller assemblies and items of pressure equipment
d- when not placed on the market, assemblies are not covered
 Assemblies: Examples
• Pressure cookers • Gas storage tanks
• Fire extinguisher • Boilers
• Bottles for breathing • Steam generators
apparatus • Destillation columns
• Autoclaves • Heat exchangers
• Valve systems • Refrigeration systems
• Pressure regulators • Air conditioning systems
• Pressure safety devices • Turn-key plants
• etc. • etc.
 PED Exclusions (examples) -1
Equipment covered by other Directives:
Simple pressure vessels (87/404/EEC)
Aerosol dispensers (75/324/EEC)
Motor vehicles (70/156/EEC, 74/150/EEC,
92/61/EEC)
Transportable pressure equipment TPED (99/36/EC), ADR,
RID, etc.
Machinery (MD)
Lifts
Low voltage (LVD)
Medical devices (MD)
Gas appliances (GAD)
Explosive atmospheres (ATEX)
 PED Exclusions (examples) -2
Equipment particularly intended for pipelines
Equipment for water distribution networks
Equipment for exploration and extraction industry
Equipment for nuclear applications / military applications
Carbonated drink containers (cans, bottles)
Equipment for which pressure is not a significant design factor
(e.g. turbines, combustion engines, compressors, pumps)
Radiators and pipes in central heating systems
pressure equipment for ships, planes, rockets, etc.
some very specific products
 Article 2, Market Surveillance

• Member States shall take all appropriate measures

to ensure that the pressure equipment and the
assemblies referred to in Article 1 may be placed
on the market and put into serivec only if,
• when properly installed and maintained and used
for their intended purpose, they do not endanger
the health and safety of persons and where
appropriate, domestic animals or property.
 Article 3 Technical Requirements
• Classification of pressure equipment

• Type of pressure equipment:

pressure vessel, steam boiler, piping, accessories, assemblies

• Working Medium :
- Condition / Phase  gas
 liquid, solid

• physical–chemical and toxical characteristics:

in to groups (acc. to directive 67/548/EEC)

a. Group 1, Dangerous
b. Group 2, Other than Dangerous

On the Basis of above characteristics conformity tables are selected

 Article 3
• Energy stored:
- PS x V (vessel, steam boiler, Pressure
accessory etc.)
- PS x DN (piping, Pressure accessory)
• On the basis of energy stored equipments are
categorized
• Total nine tables are defined in Annex 2 to PED
• Table 1-4 for Vessels
• Table 5 for Steam Generators
• Table 6-9 for piping
 Determination of applicable category
Classification Group I fluid Group II fluid
vessels gaseous Table 1 Table 2
liquid Table 3 Table 4
piping gaseous Table 6 Table 7
liquid Table 8 Table 9
Pressure volume according to table 1-4
accessories DN according to table 6-9
Safety general Category IV
accessories specific Category of respective equipment
Assemblies According to highest element (except safety acc.)
 Category selection Pressure Equipment

Pressure Vessel Steam Boiler

Art. 3, Kap. 1.1 Art. 3, Kap. 1.2
Druckgeräte
Art. 3

gaseous liquid
Fluidart
Art. 3
Art. 3, Kap. 1.1 a Art. 3, Kap. 1.1 b

Fluidgruppe Fluidgruppe
Art. 9 Art. 9

Group 1 Group 2 Group

Fluidgruppe 1
1 Group
Fluidgruppe2
2

PS (bar) PS (bar) PS (bar) PS (bar) PS (bar)

V=2
V = 10
V=1

10 000 10 000 10 000 10 000 I Kategorie II 10 000

PS = 3 000
II Kategorie III
PS = 1 000 PS*V = 25 PS*V = 50 PS = 1 000
1 000 1 000 1 000 1 000 PS = 500 1 000 Kategorie IV
PS*V = 200 PS = 500 500
PS*V = 50 500 PS
V=1

Art. 3 Abs. 3
PS = 200 * V PS*V = 50
200 PS*V = 1 000 200 PS =
PS*V = 200
100 100 10
V=1

100 100 *V 100 PS*V = 200

50 PS*V = 1 000 50 PS*V = 3 000 = II 00 I PS = 32
20 0 32 PS*V = 3 000
25 0
Kategorie PS = 10 PS = 10
10 Kategorie IV 10 IV 10 10 10

V = 1 000
PS = 4 Art. 3 Abs. 3 Art. 3 Abs. 3
Art. 3 Abs. 3
Art. 3 Abs. 3 I II III I II III I I II III
1 1 1 1 1
0,5 PS = 0,5 0,5 PS = 0,5 0,5 PS = 0,5 0,5 PS = 0,5 0,5 PS = 0,5

0,1 V (l) 0,1 V (l) 0,1 V (l) 0,1 V (l) 0,1 V (l)
0,1 1 10 100 1 000 10 000 0,1 1 10 100 1 000 10 000 0,1 1 10 100 1 000 10 000 0,1 1 10 100 1 000 10 000 0,1 1 10 100 1 000 10 000

Table 1 Table 2 Table 3 Table 4 Table 5

V= l V= l V= l V= l V= l
PS = bar PS = bar PS = bar PS = bar PS = bar
PS V = bar l PS V = bar l PS V = bar l PS V = bar l PS V = bar l
 Category selection
Pressure Equipment

piping accessories
Druckgeräte
Art. 3, Kap. 1.3 Art. 3 Art. 3, Kap. 1.4

gaseous Fluidart liquid

Art. 3 pressure safety
Art. 3, Kap. 1.3 a Art. 3, Kap. 1.3 b
accessories accessories

Fluidgruppe Fluidgruppe
Fluidgruppe 1
Group 1 Art. 9 Fluidgruppe 2
Group 2 Group 1
Fluidgruppe 1 Art. 9
Group 2
Fluidgruppe 2

PS (bar) PS (bar) PS (bar)

PS (bar)

Categorie IV
DN = 25

DN = 100

DN = 25
DN = 100
DN = 250
DN = 32

DN = 200
10 000 10 000 10 000
10 000
Kategorie III
Kategorie II
1 000
II Kategorie III
PS*DN = 1 000
1 000

I II Kategorie III
1 000
PS = 500 1 000 PS = 500 Table 1to 9 or by way of
100 PS*DN = 3 500 100
PS*DN = 1 000
PS*DN = 3 500
100
PS
*D
N
II

PS = 10
100
PS
*D
N
I

PS = 10
acc. to exeption,
10 10 10 = =
10

annex II
2 5
DN = 100

DN = 350

00
PS*DN = 5 000 00
same
I
Art. 3 Abs. 3 I Art. 3 Abs. 3 0 Art. 3 Abs. 3 0
Art. 3 Abs. 3
1 1
1 1
0,5 PS = 0,5 0,5 PS = 0,5

Directive
0,5 PS = 0,5 0,5 PS = 0,5

0,1
0,1 1 10 100 1000 10 000
DN 0,1
0,1 1 10 100 1000 10 000
DN
0,1
0,1 1 10 100 1000 10 000
DN
0,1
0,1 1 10 100 1000 10 000
DN Categorie as
Table 6 Table 7 Table 8 Table 9 97/23/EC equipment
DN = mm DN = mm DN = mm DN = mm they
PS = bar PS = bar PS = bar PS = bar
PS DN = bar mm PS DN = bar mm PS DN = bar mm PS DN = bar mm
protected
 PS (bar) Article 15
Marking of pressure equipment ( for example table 2)
10 000
PS = 3 000
PS*V = 50
1 000
V=1 PS*V = 200
200 PS*V = 1 000
100
50 PS*V = 3 000
Category
10 IV
PS = 4
Art. 3 Sect. 3
I II III
1
0,5 PS = 0,5

0,1 V (l)
0,1 1 10 100 1 000 10 000
 Article 4 : Free Movement

• Member States shall not, on grounds of the hazards

due to pressure, prohibit, restrict or impede the
placing on the market or putting into service under the
conditions specified by the manufacturer of pressure
equipment or assemblies referred to in Article 1 which
comply with this Directive and bear the CE marking
indicating that they have undergone conformity
assessment in accordance with Article 10 or pressure
equipment which comply with Article 3 (3).
• Member States may require, to the extent that it is
needed for safe and correct use of pressure equipment
and assemblies,
• the information referred to in Annex I sections 3.3 and
3.4 to be provided in the official language (s) of the
Community which may be determined in accordance
with the Treaty by the Member State in which the
equipment or assembly reaches the final user.
 Article 5 : Presumption of Conformity
• Member States shall regard pressure equipment and
assemblies bearing the CE marking provided for in
Article 15 and the EC declaration of conformity
provided for in Annex VII as conforming to all the
provisions of this Directive, including the conformity
assessment provided for in Article 10.
• Pressure equipment and assemblies which conform to
the national standards transposing the harmonized
standards the reference numbers of which have been
published in the Official Journal of the European
Communities shall be presumed to conform to the
essential requirements referred to in Article 3.
 Harmonized Standards
• Developed following Mandate /071 from the EC to CEN
• Designated by CEN as Candidate for Harmonization
• Substantiating/providing technical solutions to the
Essential Safety Requirements of the PED
• Providing a means of fulfilling at least one ESR
• Containing an Annex ZA to provide a reference between
the pertaining section of the EN and the ESRs of the PED

•  Giving Presumption of Conformity to the adressed

ESRs of the PED when published in the OJEU
 Article 6 Committee on technical standards and regulations

• Where a Member State or the Commission considers that

the standards referred to in Article 5 (2) do not entirely
meet the essential requirements referred to in Article 3, the
Member State concerned or the Commission shall inform
the Standing Committee set up by Article 5 of Directive
83/189/EEC giving the reasons therefor.
• The Committee shall issue an opinion as a matter of
urgency.
• Taking into account the Committee's opinion, the
Commission shall notify the Member States as to whether
or not those standards should be withdrawn from the
publications referred to in Article 5 (2).
 Article 7 Committee on Pressure Equipment

• The Commission may take any appropriate measure to implement the

following provisions:

• Where a Member State considers that, for very serious safety reasons,
• item or family of pressure equipment referred to in Article 3 (3) should be
subject to the requirements of Article 3 (1), or
• assembly or family of assemblies referred to in Article 3 (3) should be
subject to the requirements of Article 2), or
• item or family of pressure equipment should be classified, by way of
derogation from the requirements of Annex II, in another category, shall
submit a duly substantiated request to the Commission and ask it to take
the necessary measures.
• Those measures shall be adopted in accordance with the procedure laid
down in paragraph 3.
 Article 8 Safeguard clause
• 1. Where a Member State ascertains that pressure equipment or
assemblies referred to in Article 1, bearing the CE marking and used in
accordance with their intended use are liable to endanger the safety of
persons and,
• where appropriate, domestic animals or property, it shall take all
appropriate measures to withdraw such equipment or assemblies from
the market, prohibit the placing on the market, putting into service or
use thereof, or restrict free movement thereof.
• The Member State shall immediately inform the Commission of any
such measure, indicating the reasons for its decision and, in particular,
whether non-conformity is due to:
(a) failure to satisfy the essential requirements referred to in Article 3;
(b) incorrect application of the standards referred to in Article 5 (2);
(c) shortcomings in the standards referred to in Article 5 (2);
(d) shortcomings in the European approval of pressure equipment
materials as referred to in Article 11.
• 2. The Commission shall enter into consultation with the parties concerned
without delay.
• Where the Commission considers, after this consultation, that the measure is
justified, it shall immediately so inform the Member State which took the
initiative and the other Member States.
• Where the Commission considers, after this consultation, that the measure is
unjustified, it shall immediately so inform the Member State which took the
initiative and the manufacturer, or his authorized representative established
within the Community.
• Where the decision referred to in paragraph 1 is based on a shortcoming in the
standards or in European approvals for materials and where the Member State at
the origin of the decision maintains its position the Commission shall immediately
inform the Committee referred to in Article 6 in order to initiate the procedure
referred to in the first paragraph of Article 6.
• 3. Where pressure equipment or an assembly which does not comply bears the CE
marking, the competent
• Member State shall take appropriate action against the person(s) having affixed
the CE marking and shall so inform the Commission and the other Member
States.
• 4. The Commission shall ensure that the Member Sates are kept informed of the
progress and outcome of this procedure.
 Article 9 Classification of pressure equipment

• Classification of Fluids
2.1 Group 1 comprises fluids defined as:
- explosive
- extremely flammable
- highly flammable
- flammable
- very toxic
- toxic
- oxidizing
2.2 Group 2 comprises all other fluids not referred to in 2.1
• 3. 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.
 Article 10 Conformity assessment

• 1.1. Before placing pressure equipment on the market, the

manufacturer shall subject each item of equipment to one of
the conformity assessment procedures described in Annex III,
according to the conditions given in this Article.
• Furthermore he has to declare that the essential
safety requirements are fulfilled and shall CE-mark
each item of pressure equipment.
 Annexure II
Conformity assessment of procedure are defined in Various
modules, Various modules can be selected on the basis of
category of Pressure equipment from the table below
Choice of module is manufacturers responsibility
The references in the tables to categories of modules are the
following:
• Category I = Module A
• Category II = Module A1, D1, E1
• Category III = Modules B1 + D, B1 + F, B + E, B + C1, H
• Category IV = Modules B + D, B + F, G, H1
• The demarcation lines in the following conformity
assessment tables indicate the upper limit for each category.
 Conformity Assessment

• Category I : Manufacturer Self Assessment

• Category II, III, IV : Notified Body Assessment
• Categories established depending on Hazard Level
• 13 different CA Modules available
• Simplified assessment when using Harmonized
Standards
• Specific provisions for the application of a QMS
 Modules Under PED
• Module A Internal production Control
• Module A1 Iinternal manufacturing checks with
monitoring of the final assessment
• Module B EC Type Examination
• Module B1 EC Design examination
• Module C1 Conformity to Type
• Module D Production Quality Assurance
• Module D1 Production Quality Assurance
• Module E Product Quality Assurance
• Module E1 Product Quality Assurance
• Module F Product Verification
• Module G EC Unit Verification
• Module H Full Quality Assurance
• Module H1 Full Quality Assurance and special
surveillance of the final assessment
 Module Concept acc. To PED

Module Module Module Module Module Module

Modul
A/A1
A B B B1 G H/H1
H
Design

EEC-Con- Conformity EEC-Con-

formity EC- type -
EC-type EC-design-
examination declaration formity
declara- examination examination of the declara-
tion of the notified tion of the
manufac- body manufac-
turer Module Module Module Module turer
design
C1
C D/D1D E/E1
E F verification
EEC-Con-
EEC-Con- EEC-Con- EEC-Con- Conformity of the
formity
formity formity formity declaration notified
Internal
Production

declara-
declara- declara- declara- of the body
manu- tion to tion to tion to notified
tion to
facturing type type/design
type type body to
type
checks to PED to PED type/
with monitoring design QA-
Internal
monitoring of the System
QA- QA-
pro-final
of the final after after Design &
System System
duction
assess- assess- Production Product product product Production
control
ment ment ISO
ISO9002+Δ
9002 ISO
ISO9003+Δ
9003 ISO9001+Δ
verification verification ISO 9001
 Article 12 Requirements of Notified Body
• Independent of manufacturer, designer, supplier, installer, user,
authorized representative

• Highest degree of professional integrity, free from inducements,

pressures

•availability of personnel and required equipment

• independence and impartiality of the personnel

• technical competence to carry out the conformity

assessment, sound technical and vocational training

• to have a secrecy policy

• Knowledge of the requirements

• to take out personal liability insurance

 Different requirements of Notified
Bodies in the Member States
Germany England

EN 45001 Testing Laboratories

EN 45011 Product Certification

EN 45004 Inspection Body
EN 45012 System Certification

EN 45013 Personnel Certification

 ANNEX I
ESSENTIAL SAFETY REQUIREMENTS

• The essential requirements laid down in the Directive are compulsory.

• The obligations laid down in these essential 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.
• ESR, General Obligations to Manufacturer
• Conduct hazards analysis in order to identify those which apply to his
equipment on account of pressure; he must then design and construct it
taking account of his analysis.
 ESR General
• Design: The pressure equipment must 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 must incorporate appropriate safety coefficients using
comprehensive methods which are known to incorporate adequate safety
margins against all relevant failure modes in a consistent manner.
• Design for adequate strength must be based on:
• - as a general rule, a calculation method, and supplemented if
necessary by an experimental design method as described or
• - an experimental design method without calculation, If when the
product of the maximum allowable pressure PS and the volume V is
less than 6 000 bar L or the product PS x DN less than 3 000 bar.
 Way‘s to fulfil the requirements of the
Pressure Equipment Directive
AD-Regelwerk
+ 1
Other Codes
AD-2000
+ 4

Pressure
Equipment Directive
European
Harmonized 97/23/EC User´s
Standard Specification

British
ASME + 3 (Standard) + 2
PD 5500
 ESR’s in Manufacturing
• 3.1.1. Preparation of the component parts
• Preparation of the component parts (e.g. forming and chamfering) must
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 must be free of any surface or internal
defects detrimental to the safety of the equipment.
• The properties of permanent joints must meet the minimum properties
specified for the materials to be joined unless other relevant property values
are specifically taken into account in the design calculations.
• For pressure equipment, permanent joining of components which contribute
to the pressure resistance of equipment and components which are directly
attached to them must 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 must be approved by a competent third party which, at the
manufacturer's discretion, may be:
- a notified body,
- a third-party organization recognized by a Member State as provided for in
Article 13.
• To carry out these approvals the third party must perform examinations and
tests as set out in the appropriate harmonized standards or equivalent
examinations and tests or must have them performed.
• 3.1.3. Non-destructive tests
• For pressure equipment, non-destructive tests of permanent
joints must be carried out by suitable qualified personnel.
• For pressure equipment in categories III and IV, the
personnel must be approved by a third-party organization
recognized by a Member State pursuant to Article 13.

• 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 must be applied at the appropriate stage of
manufacture. Governed by Design Code
• 3.1.5. Traceability
• Suitable procedures must 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.

• 3.2.1. Final inspection

• Pressure equipment must undergo a final inspection to assess visually and by
examination of the accompanying documents compliance with the
requirements of the Directive. Test carried out during manufacture may be
taken into account.
• As far as is necessary on safety grounds, the final inspection must 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).
• Final assessment of pressure equipment must 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 7.4.
• 3.3. Marking and labelling
• Must be on name plate
• CE marking referred to in Article 15
- the name and address or other means of identification of the manufacturer
and, where appropriate, of his authorized representative established within the
Community,
- 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;
• Additional information as 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 product group;
• where necessary, warnings fixed
• 3.4. Operating instructions
• (a) When pressure equipment is placed on
the market, it must be accompanied, 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;
 Materials
• Materials used for the manufacture of pressure equipment must be suitable for
such application during the scheduled lifetime unless replacement is foreseen.
• Welding consumables and other joining materials need fulfil only the relevant
requirements of 4.1, 4.2 (a) and the first paragraph of 4.3, in an appropriate
way, both individually and in a joined structure.
• 4.1. Materials for pressurized parts must:
• (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 must comply with the requirements of 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 must be taken;
• (b) be sufficiently chemically resistant to the fluid contained in the pressure
equipment; the chemical and physical properties necessary for operational
safety must 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. (a) The pressure equipment manufacturer must define in an appropriate
manner the values necessary for the design calculations referred to in 2.2.3 and
the essential characteristics of the materials and their treatment referred to in
4.1;
• (b) the manufacturer must provide in his technical documentation elements
relating to compliance with the materials specifications of the Directive in one
of the following forms:
• - by using materials which comply with harmonized standards,
• - by using materials covered by a European approval of pressure equipment
materials in accordance with Article 11,
• - by a particular material appraisal; Verification of material properties to meet
all and specific requirements of PED and to meet design conditions
• (c) for pressure equipment in categories III and IV, particular appraisal
as referred to in the third indent of (b) must be performed by the
notified body in charge of conformity assessment procedures for the
pressure equipment.
• 4.3. The equipment manufacturer must 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 must be obtained for all
materials.
• For the main pressure-bearing parts of equipment in categories II, III
and IV, this must 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 Community and having undergone a specific assessment for
materials, certificates issued by the manufacturer are presumed to
certify conformity with the relevant requirements of this section.
 Specific requirements
• 7.5. Material characteristics
• Unless other values are required in accordance with other criteria that must be taken into
account, a steel is considered as sufficiently ductile to satisfy 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 ºC but not higher than the lowest scheduled operating
temperature.

• 7.2. Joint coefficients

• For welded joints, the joint coefficient must 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 must also be taken into account.
• 7.4. Hydrostatic test pressure
• For pressure vessels, the hydrostatic test pressure
referred to in 3.2.2 must be no less than:
- 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, or
- the maximum allowable pressure multiplied by the
coefficient 1,43, whichever is the greater.
 Conformity Assessment Module G
• The manufacturer must apply to a notified body of his choice for unit verification.
• The application must contain:
- the name and address of the manufacturer and the location of the pressure equipment,
- a written declaration to the effect that a similar application has not been lodged with
another notified body,
- technical documentation.
• The technical documentation must contain:
- 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 the said drawings and
diagrams and the operation of the pressure equipment,
• - a list of the standards referred to in Article 5, applied in full or in part, and descriptions
of the solutions adopted to meet the essential requirements of the Directive where the
standards referred to in Article 5 have not 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 sections
3.1.2 and 3.1.3 of Annex I.
 Notified body responsibility in module G
• In particular the notified body must:
- 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
harmonized standards or with a European approval for pressure equipment
materials, and check the certificate issued by the material manufacturer in
accordance with section 4.3 of Annex I,
- approve the procedures for the permanent joining of parts or check that they
have been previously approved in accordance with section 3.1.2 of Annex I,
- verify the qualifications or approvals required under sections 3.1.2 and 3.1.3
of Annex I,
- carry out the final inspection referred to in section 3.2.1 of Annex I, perform
or have performed the proof test referred to in section 3.2.2 of Annex I, and
examine the safety devices, if applicable.
• 4.1. The notified body must affix its identification
number or have it affixed to the pressure
equipment and draw up a certificate of conformity
for the tests carried out. This certificate must be
kept for a period of ten years.
• 4.2. The manufacturer, or his authorized
representative established within the Community,
must ensure that the declaration of conformity and
certificate of conformity issued by the notified
body can be made available on request.
 „Sound engineering practice“

For Article 3.3 (SEP) products (i.e. below category I), the
manufacturer must ensure the safe use of the equipment :

- design and manufacture must take into account all relevant factors,
influencing safety during intended lifetime (safe to be used)
- adequate instructions for use
- identification of manufacturer or authorized representative

No Declaration of Conformity, Compliance Statement recommended

 Formal/documentation requirements
Always
• Perform hazard analysis
• Compile technical file
• Perform conformity
assessment
• Obtain material certificate
• Produce instructions for
use
For higher categories
• Involve Notified Body
• Have welding methods/
welders approved by TPO
• Have NDT personnel
approved by TPO
• Certificate of specific
product control for
materials
 Legal aspects
1. Transposition into national Law by MSs
2. Notification of NBs and TPOs by MSs
3. Publication of Harmonized Standards in the Official
Journal of the European Community
4. Obligation to MSs not to prohibit, restrict or impede
placing on the market of complying PE
5. Obligation to manufacturer, not to place non-compliant,
unsafe or unduly CE-marked products on the market
6. Safeguard clause procedure against unsafe products
7. Formal objection of non-complying Harmonized Standards
8. Obligation to MSs to do Market Surveillance
 Uncertainty of unspecified order
Welding Heat-
consumables Cold -
Material used treatment
streching

Safety factor add. Material

thickness
Joint coefficient
Black (corrosion, erosion)

Material
box resistance

Design

Non
Design number Manufacturing Results of destructing
of cycles procedures calculation testing
The misunderstanding of the - Mark

• safety requirements are fulfilled

• free trade, placing on market
• best condition for operation
• quality mark
• product mark
• best technology
 Summary
The main problems with the use of PED are :
• different requirements of notified bodies,
• lack of harmonized standards ( for some products ),
• different requirements for operation and in-service-inspection
in every Member State,
• partly higher costs when using PED,
• uncertainty of the customer (user) due to unknown rules and
different aims of customers and manufacturers. Guidelines
• Lack of Information/ Knowledge amongst non-european mfrs.
• Longer gestation / payback period for implementation
• SOLUTIONS ? : Market Surveillance in Europe
PED and valves
Particular aspects
 PED and valves
• Valves are defined as pressure accessories
• Pressure accessories defined as devices with
an operational function and having pressure
bearing housings
 Classification of valves
• Determine:
– pressure
– volume or diameter
– fluid
• Classification based on volume:
use table 1 - 4 Choose outcome
• Classification based on diameter
representing
use table 6 - 9 the highest risk
 Useful definitions
from the viewpoint of the Machinery
Directive
• Machine: ready to use
e.g. turning machine, hydraulic excavator, compressor,
hydraulic jack
• Safety component: primary function contributes to
safety machine
e.g. limiting (pressure switches, SRMCR) and pressure
limitation devices (safety valves, CSPRS)
• Component: all pressure equipment parts and
machinery parts placed on the Community market
e.g. vessels, valves, flanges, hoses, couplings
 Machinery Directive and valves
(1)
NOT considered as machinery:
• Valves without actuator
• Valves with actuator, but without controls
• Valves with hand wheels
• Valves which cannot function independently
(safety dependent on incorporation in system)
 Machinery Directive and valves
(2)

Considered as machinery are:

• Powered valves with actuators, control and
power circuits etc. intended for a specific
application (stand alone usability)
• Safety components containing (powered)
valves (no CE on basis of Machinery Directive!)
 Machinery Directive and valves (3)

• Components (other than safety components)

– valves are usually placed on the Community
market as components
– the Machinery Directive does not cover
components
– components however can be covered by other
directives such as:
• Pressure equipment, Gas appliances, General products
safety, Atex
 More about
Pressure Equipment Directive
97/23/EC

0045
Manufacturer: EFÜSTA
45138 Essen, Germany
Ident.-No.: 1234567
Type: we 234 vx
Year of manufacture: 2001
Pressure PS: 34 bar
Temperature TS 150°C
Volume: 130 l
 Examples of Conformity Assessment
Conformity assessment procedure:

Module H

Full Quality Assurance

For Pressure Equipment and accessories

Falling in Category III

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 Module H

This module describes the procedure

whereby the manufacturer who satisfies
the obligations of section 2 ensures and
declares that the pressure equipment in
question satisfies the requirements of
Directive which apply to it.

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 Module H (contd.1)
The manufacturer must affix the CE mark
and draw up a written declaration of
conformity. The CE marking must be
accompanied by the identification number
of the notified body responsible for
surviellance as specified in sevction 4.

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 Module H (contd.2)
The manufacturer must implement an
approved quality system for design,
manufacture, final inspection and
testing as specified in section 3 and
be subject to surveillance as specified
in section 4.

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 Module H – Quality System
•The quality system must ensure compliance of the
pressure equipment with the requirements of the
Directive which apply to it.
•All the elements, requirements and provisions adopted
by the manufacturer must be documented in a systematic
and orderly manner in the form of written policies,
procedures and instructions. This quality system
documentation must permit a consistent interpretation of
the procedural and quality measures such as programs,
plans, manuals and records.

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 It must contain in particular an adequate description of:
• the quality objectives and the organizational structure,
responsibilities and powers of the management with regard
to the quality of the design and to product quality,
• the technical design specifications, including standards,
that will be applied and, where the standards referred to in
Article 5 are not applied in full, the means that will be used
to ensure that the essential requirements of the Directive
which apply to the pressure equipment will be met,

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 • the design control and design verification techniques,
processes and systematic measures that will be used when
designing the pressure equipment, particularly with regard
to materials in accordance with section 4 of Annex I,
• the corresponding manufacturing, quality control and
quality assurance techniques, processes and systematic
measures that will be used, particularly the procedures for
the permanent joining of parts as approved in accordance
with section 3.1.2 of Annex I,
• the examinations and tests to be carried out before, during,
and after manufacture, and the frequency with which they
will be carried out,

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 • 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 sections 3.1.2 and 3.1.3 of Annex I,

• the means of monitoring the achievement of the

required pressure equipment design and quality and the
effective operation of the quality system.

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 •The notified body must assess the quality system to
determine whether it satisfies the requirements referred to
in 3.2. The elements of the quality system which conform
to the relevant harmonized standard are presumed
•to comply with the corresponding requirements referred
to in 3.2.

•The auditing team must have at least one member with

experience of assessing the pressure equipment
technology concerned. The assessment procedure must
include an inspection visit to the manufacturer's premises.
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 • The manufacturer must undertake to fulfil the obligations
arising out of the quality system as approved and to ensure
that it remains satisfactory and efficient.

• The manufacturer must inform the notified body that has

approved the quality system of any intended adjustment to
the quality system. The notified body must assess the
proposed changes and decide whether the modified quality
system will still satisfy the requirements referred to in 3.2
or whether a reassessment is required.

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 Surveillance under the responsibility of the notified body
4.1. The purpose of this surveillance is to make sure that the
manufacturer duly fulfils the obligations arising out of the
approved quality system.
4.2. The manufacturer must allow the notified body access
for inspection purposes to the locations of design,
manufacture, inspection, testing and storage and provide it
with all necessary information, in particular:
— the quality system documentation,
— the quality records provided for in the design part of the
quality system, such as results of analyses, calculations,
tests, etc.,

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 — the quality records provided for in the manufacturing
part of the quality system, such as inspection reports and
test data, calibration data, reports concerning the
qualifications of the personnel concerned, etc.
The notified body must 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.

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 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 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,
— special conditions linked to the approval of the
system, where applicable,
— significant changes in manufacturing organization,
policy or techniques.
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 • During such visits the notified body may, if
necessary, carry out or have carried out tests to verify
that the quality system is functioning correctly.

• The notified body must provide the manufacturer

with a visit report and, if a test has taken place, with a
test report.

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The manufacturer must, for a period of ten years after the last of
pressure equipment has been manufactured, keep at the disposal
the national authorities:
— the documentation referred to in the second indent of the seco
subparagraph of 3.1;
— the adjustments referred to in the second subparagraph of 3.4
— the decisions and reports from the notified body which are
referred to in the last subparagraph of 3.3, the last subparagraph
3.4, and in 4.3 and 4.4.

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 • Each notified body must communicate to the Member
States the relevant information concerning the quality
system approvals which it has withdrawn, and, on request,
those it has issued.

• Each notified body must also communicate to the other

notified bodies the relevant information concerning the
quality system approvals it has withdrawn or refused.

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 Module H1 (full quality assurance with design
Examination and special surveillance of the final
assessment): For Pressure Equipment in Category IV
1. In addition to the requirements of module H, the
following apply:
(a) the manufacturer must lodge an application for
examination of the design with the notified body;
(b) the application must enable the design, manufacture and
operation of the pressure equipment to be understood, and
enable conformity with the relevant requirements of the
Directive to be assessed.

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Notified Body‘s certificate

Full Quality Assurance

acc. to Module H (PED)

0045
 ANNEX VII
DECLARATION OF CONFORMITY
The EC declaration of conformity must contain the
following particulars:
— name and address of the manufacturer or of his
authorized representative established within the
Community,
— 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,

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 — where appropriate, name and address of the notified
body which carried out the inspection,
— where appropriate, a reference to the EC type-
examination certificate, EC design-examination
certificate or EC certificate of conformity,
— where appropriate, name and address of the notified
body monitoring the manufacturer's quality assurance
system,
— where appropriate, the references of the harmonized
standards applied,

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 — where appropriate, other technical standards and
specifications used,
— where appropriate, the references of the other
Community Directives applied,
— particulars of the signatory authorized to sign the
legally binding declaration for the manufacturer or his
authorized representative established within the
Community.

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 Legal Harmonization
conformity assessment procedures
module concept acc. to directive 93/465/EEC
• Design and production have to be
approved
• Manufacturer can decide according to
– nature of the danger / type of products /
economic effects
- which module he uses
• Single directives could set (define) special
demands
• Product Liability – Manufacturer
• – Notified Body
 PED - References
• Guide to the implementation of Directives based on the
New Approach and the global Approach, European
Commission.
• http://ec.europa.eu/enterprise/pressure_equipment/index_e
n.html
• Pressure Equipment Directive 97/23/EC of the European
Parliament and of the council of 29 May 2007
• List of Harmonized Standards
CE marking
 CE marking
When CE?
• On machines: always CE,
• On pressure equipment: always CE,
except for article 3(3) products and equipment
showed at trade fairs or not placed on market
• CE marking always possible on the basis of other
directives
 Thank you
for your interest!
QUESTIONS
For more help contact
sandeep@tuv-nord.com
hiremath@tuv-nord.com

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