PED Presentation Material

Pressure Equipment Directive 97/23/EC (PED)
PED 97/23/EC
European Pressure Equipment Directive

http://ec.europa.eu/enterprise/sectors/pressure-andgas/documents/ped/index_en.htm
Contents of Directive
Article 1 Scope and definitions Article 2 Market surveillance Article 3 Technical requirements Article 4 Free movement Article 5 Presumption of conformity Article 6 & 7 Committee on Pressure Equipment Article 8 Safeguard clause Article 9 Classification of pressure equipment Article 10 Conformity assessment
HSB Global Standards 1
Article 11 European approval for materials Article 12 Notified bodies Article 13 Recognized third-party organizations Article 14 User inspectorates Article 15 & 16 CE marking Article 17 Member States Article 18 Decisions entailing refusal or restriction Article 19 Repeal Article 20 Transposition and transitional provisions Article 21 Addressees of the Directive
ANNEX I ANNEX II ANNEX III ANNEX IV ANNEX V ANNEX VI ANNEX VII
Essential Safety Requirements Conformity Assessment Tables Conformity Assessment Procedures Minimum Criteria to be met when ~ Criteria to be met when ~ CE Marking Declaration of Conformity
Guidelines
In order to ensure a coherent application of the Pressure Equipment Directive 97/23/EC (PED), Guidelines are developed and agreed by the Commissions Working Group Pressure (WGP). This working group, created as a result of Article 17 of the PED, which requests the Member States to cooperate in order to assist the functioning of this Directive, is composed of representatives of Member States, European federations, the Notified Bodies Forum and CEN and chaired by a representative of the Commission services.
Status of the guidelines

The PED Guidelines are not a legally binding interpretation of the Directive. The legally binding text remains that of the Directive. However, the PED Guidelines represent a reference for ensuring consistent application of the Directive. They y represent, unless indicated differently in the respective guideline text, the unanimous opinion of the Member States.
Classification of the guidelines

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Scope and Exclusions of the Directive (1/53) Classification and Categories (2/40) Assemblies (3/19) Evaluation Assessment Procedures (4/15) p of the Essential Safety y Requirements q on Design g ( (5/8) ) Interpretation Interpretation of the Essential Safety Requirements on Manufacturing (6/14) Interpretation of the Essential Safety Requirements on Materials (7/26) Interpretation of other Essential Safety Requirements (8/19) Miscellaneous (9/24) General-Horizontal Questions (10/6)
Guideline 1/8
Guideline related to: Article 1 paragraph 2.1.4 Question:
What is a pressure accessory?
Answer:
valves, , pressure p regulators, g , measurement chambers, , pressure p g gauges, g , water gauge glasses, filters, expansion joints and manifolds. The following examples are not pressure accessories: - safety valve ( a safety accessory) - cover, collar, gasket, flange, bolt (components of a pressure equipment) - sight glass with its frames (components of a pressure equipment) - Y-shape or similar fittings (piping components)
REFERENCE GUIDE for Pressure Equipment Directive
Member States of the European Community (EC)

Austria Belgium Bulgaria Cyprus Czech Republic Denmark Estonia Lithuania Luxembourg Malta Netherlands Poland Portugal Romania Slovakia
Finland France Germany Greece Hungary Ireland Italy Latvia
Slovenia Spain Sweden United Kingdom
11
Countries adopting Directives

European Free Trade Association (EFTA)
Norway, Iceland & Liechtenstein
Associated Countries
Switzerland
EC Candidate Countries
Croatia & Turkey
Requiring / Accepting PED
Directives
73/23/EEC Low voltage equipment 89/686/EEC Personal protective equipment 93/42/EEC Medical devices 95/16/EC Lifts 96/98/EC Marine Equipment 97/23/EC Pressure Equipment 98/37/EC Machinery 2004/22/EC Measuring Instruments 2009/48/EC Toys Safety et cetera
CE Marking
The CE Marking symbolises the conformity of the product with the applicable Community requirements imposed on the manufacturer Th The CE Marking M ki affixed ffi d t to products d t i is a d declaration l ti b by the person responsible that:
The product conforms to all applicable Community provisions The appropriate conformity assessment procedures have been completed
CE Marking
CE Marking will be performed on Complete Equipment CE Marking cannot be performed on
Materials Incomplete I l equipment i Below Category 1 there is Sound Engineering Practice (SEP)
The CE marking shall be affixed in a visible, easily legible and indelible fashion to each
item of pressure equipment, or assembly
Implementation of the PED
Mandatory as of May 29, 2002 Transition period began November 29, 1999 Issued May 29, 1997 Introduced May 1985
Terminology
CEN European Committee for Standardization EC European Community EN European Standard PS(bar) Maximum allowable pressure DN Norminal size ESR Essential Safety Requirements PMA Particular Material Appraisal NoBo Notified Body appointed by a Member State RTPO Third Party Organization recognized by a Member State
Harmonized Standards (EN)

Prepared by CEN Committees with the specific aim of meeting ESRs Unfired Pressure Vessels EN 13445 Water Tube Boilers EN 12952 Shell Boilers (Firetube) EN 12953 Qualification of Welding Procedures EN 15614 Qualification Test of Welders EN 287 NDE Personnel Qualification and Certification EN 473
www.newapproach.org
Harmonized Standards (EN)

The use of Harmonized European Standards(EN) is not mandatory. Very little interest in the use of the product Harmonized Standards
Manufacturers content with Known international standards ASME Those adopted to PD5500, DODAP, AD2000
However, pressure equipment manufactured using harmonized standards is presumed to comply with the Essential Safety Requirements of the PED.
Who is Responsible?
A manufacturer is the person who is responsible for design and manufacturing a product with a view to placing pressure equipment on the Community market on his own behalf. And the manufacturer is responsible for carrying out conformity assessment in accordance with the procedures laid down by the directive. No allowance for Manufacturer to share responsibility.
To be a Manufacturer
Responsible for design and manufacturing Responsible for carrying out Conformity Assessment The item must be Whole The item must be tested
If any of the above are not met, the fabricator is considered a Subcontractor
Subcontractors
A fabricator who cannot fulfill the scope, design and pressure test requirements of a Manufacturer is defined as a Subcontractor. Subcontractors have responsibility for welding and NDE qualifications, and possibly material procurement. Material selection is the responsibility of the Manufacturer.
Manufacturers Responsibilities
Design and manufacture the product in accordance with essential requirements laid down by the directive Selection of the Notified Body and Module(s)
All subcontractors must use the selected Module and Notified Body Except for welding and NDE approval
Pressure Testing CE-Marking Declaration of Conformity
Declaration of Conformity
The manufacturer, or his authorized representative established within the Community, must affix the CE marking to each item of pressure equipment and draw up a written declaration of conformity. The manufacturer, or his authorized representative established within the Community, must keep a copy of the declaration of conformity for a period of ten years after the last of the pressure equipment has been manufactured.
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Pressure Equipment Directive Overview
Article 1 Scope and definitions
All Pressure Equipment

PS > 0.5 bar
Pressure equipment meets all requirements of the Directive

Pressure Equipment means
Vessels Piping Safety accessories
- Safety valves, fluid level, pressure or temperature switches
Pressure accessories
- Valves, pressure gauges, water gauge glasses - Operational function

Pressure Equipment means
Where applicable, pressure equipment includes elements attached to pressurized parts
- flanges, flanges nozzles nozzles, couplings couplings, supports supports, lifting lugs lugs, etc etc.
Assemblies
- Several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole.

Pressure
relative to atmospheric pressure, i.e. gauge pressure.
Maximum allowable pressure PS

The max. pressure for which the equipment is designed, as specified by the manufacturer manufacturer.
Maximum/Minimum allowable temperature TS

The max./min. temperature for which the equipment is designed, as specified by the manufacturer.
Volume (V)
The internal volume of a chamber, including the volume of nozzles to the first connection for weld and excluding the volume of permanent internal parts.

Nominal Size (DN)
A numerical designation of size which is common to all components in piping system other than components indicated by outside diameters or by thread size.
Fluid
Gases, liquids and vapours in pure phase as well as mixtures thereof.
Permanent Joints
Joints which cannot be disconnected except by destructive methods.
European approval for materials

A technical document defining the characteristics of materials.
Article 3 Technical Requirements

The pressure equipment must satisfy the essential requirements set out in Annex I Type of Equipment
Vessel Steam Generator Piping Safety and pressure accessories
Article 3 Technical Requirements

Type of Fluid
- Gases, liquefied gases, gases dissolved under pressure, vapors and those liquids whose vapor pressure at max. allowable p is g greater than 0.5 bar above normal atmospheric p temperature pressure (1,013 mbar). - Liquid having a vapor pressure at the max. allowable temperature of not more than 0.5 bar above normal atmospheric pressure (1,013 mbar).
Article 9 Classification of Pressure Equipment

Pressure equipment referred to in Article 3
(vessel, Steam Generator, Piping, Safety and Pressure Accessories)
shall be classified by category in accordance with Annex II, according to ascending level of hazard.
Category C I I, II II, III or IV
For the purposes of such classification fluids shall be divided into two groups.
Group 1 Group 2
Article 9 Classification of Pressure Equipment

Group 1 Dangerous Fluids (Directive 67/548/EEC)
Explosive, Extremely flammable, Highly flammable, Flammable (where the maximum allowable temperature is above flashpoint), - Very toxic, - Toxic, - Oxidizing
Group 2 All other Fluids
Article 10
Conformity assessment
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. The conformity assessment procedures to be applied to an item of pressure equipment with a view to affixing the CE marking shall be determined by the category in which the equipment is classified.
Article 10
The conformity assessment procedures to be applied for the various categories are as follows:
Category I Module A Category II Module A1 Module D1 Module E1
Article 10
Category III Module B1 + D Module B1 + F Module B + E Module B + C1 Module H Category IV Module B + D Module B + F Module G Module H1
Article 10
Pressure equipment shall be subjected 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.
ANNEX I Essential Safety Requirements

1. 2. 3. 4. 5. General Design Manufacturing Materials Fired or otherwise heated pressure equipment with a risk of overheating as referred to in article 3 (1) 6. Piping as referred to in Article 3, Section 1.3 7. Specific quantitative requirements for certain pressure equipment
ANNEX II Conformity Assessment Tables

Table 1 ~ 9 The references in the tables to categories of modules are the following: III III IV Module A Modules A1, D1 & E1 Modules B1+D, B1+F, B+E, B+C1 or H Modules B+D, B+F, G or H1
ANNEX III Conformity Assessment Procedures

Module A/A1 Module B/B1 Module C1 Module D/D1 Module E/E1 Module F Module G Module H/H1
ANNEX VI CE MARKING
The CE marking consists of the initials CE taking the following form:
ANNEX VII Declaration of Conformity

Name and address of the manufacturer Description of the pressure equipment or assembly Conformity assessment procedure followed Name and address of the notified body A reference to the EC type type-examination examination certificate certificate, EC design-examination certificate or EC certificate of conformity The references of the harmonized standards applied Other technical standards and specifications used The references of the other Community Directives applied
Pressure Equipment Directive Classification
Hazard Categories
Type of Pressure Equipment Type of Fluid:
Group 1 = Dangerous Group 2 = Non-dangerous
Nature of Fluid:
Gas Liquid
Pressure (in bar) Volume (in liters) / Nominal Size (DN)
Selection of Tables
Type Vessel
Phase Gas Gas Liquid Liquid
Group 1 2 1 2 1 2 1 2
Table Table 1 Table 2 Table 3 Table 4 Table 5 Table 6 Table 7 Table 8 Table 9
Steam Gen. Gas Piping Gas Liquid Liquid
Conformity Assessment Tables

ANNEX II The demarcation lines in the following conformity assessment tables indicate the upper limit for each category. category
Conformity Assessment Table 1
Classification of Pressure Equipment

Example : Type of Equipment : Pressure Vessel Content = Liquid Ethanol
Liquid is considered if its vapor pressure as at max allowable temperature is not more than 0 0.5 5 bar above normal atmospheric pressure (1013 mbar) mbar), pD<0.5bar @ T max)
Design Pressure = 7500 psi (517 bar) Volume = 26 gallons (100 liters) From the provided design data listed above, the equipment fall under Art 3 para 1.1(b) and then using Table 3 of Annex II
57
Classification of Pressure Equipment

Classification of Pressure equipment (hazard category) is based upon 4 items (Cont.) Example:
Pressure equipment With Hazard Category III
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Sound Engineering Practice (SEP)

Article 3 Paragraph 3 Sound Engineering Practice
Pressure equipment and/or assemblies below or equal to the limits must ; Design and Manufacturing with a construction Code Accompany by adequate instructions for use Marking identification of the manufacturer with Design Data No CE Marking
Out of Scope of PED
Category I
Module A - Self declaration by the Manufacturer CE Marking with no Notified Body involvement, selfcertifying
Category II
Module A1 - Manufacturers declaration with random monitoring by Notified Body Module D1 - Production QA with technical documentation (ISO 9002) M d l E1 - Product Module P d t QA with ith technical t h i ld documentation t ti (ISO 9003 / Each Item examined and tests) CE Marking with Notified Body involvement.
- The Notified Body will either perform unexpected visits or audit a quality system. - The quality system is similar to ISO 9000 - Certification to ISO 9000 is not required.
Category III
Module B1+D - Design examination plus production QA Module B1+F - Design examination plus final examination Module B+E - EC type examination plus product QA Module B+C1 - EC type examination plus random final examination Module H - Full QA (ISO 9001)
Category III
CE Marking with Notified Body Involvement For this category, the Notified Body is required to approve the design or type for all Conformity A Assessment t Procedures, P d with ith exception ti of fM Module d l H H. For Module H, the manufacturer has an approved quality system that is equivalent to ISO 9001 and includes procedures for design control.
Category IV
Module B+D - EC type examination plus production QA Module H1 - Full QA plus design examination & special surveillance Module B+F - EC type examination plus final examination Module G - Unit verification (Most similar to traditional ASME AI) CE Marking with Notified Body involvement. For this category, the Notified Body is required to review or approve the design or type for all Conformity Assessment Procedures.
Pressure Equipment Directive Conformity Assessment Procedure
Flow chart of Conformity Assessment Procedure
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Conformity Assessment Modules

The directive provides for a choice between
1.Direct Inspection based assessment Modules
Module A1, C1, F, G, H1
F & G NoBo inspects each item and issue Certificate of Conformity A, C1, H1 NoBo monitoring only by means of Unexpected Visit
2.Quality Assurance based assessment Modules

Modules D, D1, E, E1, H and H1
Full QA similar to ISO 9001 (H/H1) Production QA similar to ISO 9002 (D/D1) Product QA similar to ISO 9003 (E/E1) Requires a Design Approval for H1 HSBIs policy is to review the first Module H design as a desk top audit
When used with Hazard Category III or IV pressure equipment
67

Module A :
Internal Production Control Self declaration by the Manufacturer Without involvement of NoBo CE Marking without NoBo involvement
68

Module A1:
Internal manufacturing check with monitoring of final assessment. g apply: pp y In addition to Module A, the following
Final assessment must be performed by the manufacturer and monitored by means of unexpected visits by a notified body chosen by the manufacturer. Should one or more of the items of pressure equipment not conform, the notified body must take appropriate measures. On the responsibility of the notified body, the manufacturer must affix the former's identification number on each item of pressure equipment
69

Module B:
EC Type examination NoBo duties
review technical documentation verify conformance to ESRs perform examination & tests issue EC-type exam certificates
Valid for 10 years CE Marking with NoBo Number
70

Module B1:
EC Design Examination NoBo duties
review technical documentation verify conformance to ESRs perform examinations to verify that manufacturer meets ESR issue EC design examination certificate
Valid for 10 years CE Marking with NoBo Number
71

Module C1:
Conformity to Type NoBo duties
monitors the final assessment of the manufacturer by y unexpected visits and takes samples (like module A1).
Must be combined with Module B CE Marking with NoBo Number
72

Module D:
Production Quality Assurance NoBo duties
fully y (re-)assesses ( ) the quality q y assurance system y every y three years and periodically audits it in between.
Must be combined with Module B or Module B1 CE Marking with NoBo Number
73

Module D1:
Production Quality Assurance (ISO 9002) NoBo duties
CE Marking with NoBo Number
74

Module E:
Product Quality Assurance NoBo duties
fully y (re-)assesses ( ) the quality q y assurance system y every y three years and periodically audits it in between. Must be combined with Module B
75

Module E1:
Product Quality Assurance NoBo duties
76

Module F:
Product Verification NoBo duties
verifies the approvals pp of p personnel and the material certificates and carries out the final assessment of each item of pressure equipment
Must be combined with Module B or B1 CE Marking with NoBo Number
77

Module G:
EC Unit Verification NoBo duties
examines the technical documentation, materials, p procedures and qualifications, checks the individual item of pressure equipment accordingly and carries out its final assessment.
78

Module H:
Full Quality Assurance (ISO 9001) NoBo duties
79

Module H1:
Full Quality Assurance (ISO 9001) NoBo duties
Design g Examination and special p surveillance. Final assessment is subject to increased surveillance in the form of unexpected visits by the notified body. CE Marking with NoBo Number
80
Notified Body Involvement

MODULE A A1 TITLE Internal Production Control Internal Production Control with Monitoring of Final Assessment EC type -Examination APPLICABLE CATEGORY I II CE MARK? Yes, without Notified Body #. Yes NOTIFIED BODY INVOLVEMENT? No Yes
B must be combined with C1, D, E or F
III, IV
Yes
B1
EC design- Examination
I, II (Table 4) and III
Yes
Yes- ascertains and attests that a representative example of production meets PED. Yes ascertains and attests that design meets PED
81

MODULE TITLE APPLICABLE CATEGORY III CE MARK? NOTIFIED BODY INVOLVEMENT? Yes
C1 Monitoring of Final must be combined Assessment with B D Q Quality y Assurance (Q (QA) ) must be combined for Production, Final with B or B1 Inspection and Testing D1 QA for Production, Final Inspection and Testing
Yes
III, IV
Yes
Yes
II
Yes
Yes
E QA for Final Inspection must be combined and Testing with B
III
Yes
Yes
82

MODULE E1 TITLE QA for Final Inspection and Testing Product Verification APPLICABLE CATEGORY II III, IV CE MARK? Yes Yes NOTIFIED BODY INVOLVEMENT? Yes Yes
F must be combined with B or B1 G Unit Verification
IV
Yes
H H1
Full QA Full QA with Design Examination and Monitoring of Final Assessment
III IV
Yes Yes
Yes with Certificate of Conformity Yes Yes
83
PED Annex I Essential Safety Requirements
1. General
Pressure equipment must 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 manufacturers instructions, or in reasonably foreseeable conditions.
2. Design
Design for adequate strength Provisions to ensure safe handling and operation Means of examination Means of draining and venting C Corrosion i or other th chemical h i l attack tt k Wear Assemblies Provisions for filling and discharge Protection against exceeding the allowable limits Safety accessories External fire
3. Manufacturing
Manufacturing procedures
Preparation of the component parts Permanent joining Non-destructive tests Heat treatment Traceability
Final assessment
Final inspection Proof test Inspection of safety devices
Marking and labeling Operating instructions
3. Manufacturing
Permanent Joining
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. Welding/Brazing Tube Expanding
3. Manufacturing
Permanent Joining
For pressure equipment in categories II, III and IV, operating procedures and personnel must be approved by a competent third party which
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(EN15614/EN287) or equivalent examinations and tests or must have them performed.
3. Manufacturing
Non-destructive tests
For pressure equipment, non-destructive tests of permanent joints must be carried out by suitable qualified personnel. in categories III and IV, The personnel must be approved by a third-party organization recognized by a Member State.
3. Manufacturing
Proof test
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. For Category I series-produced pressure equipment, this test may be performed on a statistical basis.
3. Manufacturing
7.4. Hydrostatic test pressure
For pressure vessels, the hydrostatic test pressure referred to in 3.2.2 Proof test must be no less than:
that corresponding g to the maximum loading g 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 it the greater
3. Manufacturing
Marking and labeling
In addition to the CE Marking for all pressure equipment:
Manufacturers name and address The y year of manufacture Identification / Serial Number of the pressure equipment Essential maximum/minimum allowable limits Notified Body Identification Number, where required per Module
3. Manufacturing
Marking and labeling
Additional Requirements, When Applicable
Volume(L) or Nominal Size(DN) Pressure Test(bar) ( ) and Date Safety Device Set Pressure(bar) Output(kW) Supply Voltage(volts) Intended Use Filling Ration(kg/L) Maximum Filling Mass(kg) Tare Mass(kg)
4. Materials
Materials for pressurized parts must: 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.
4. Materials
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 testpiece is no less than 27J, at a temperature not greater than 20 but not higher than the lowest scheduled operating temperature.
4. Materials
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 standards, By using materials covered by a European approval of pressure equipment materials in accordance with Article 11, By a particular material appraisal
4. Materials
Harmonized Standard Material
A Only as listed in the harmonized Product Standard (e.g. EN 13445, EN 12952 & EN 12953) No ASTM, ASME or other non-EN materials Harmonized Product Standards will allow use of these materials through Particular Material Appraisal
4. Materials
EAM
Shall be presumed to conform to the applicable essential requirements of Annex I. The notified body shall issue and withdraw the EAM Published in the Official Journal of the European Communities http://ec.europa.eu/enterprise/sectors/pressure-andgas/documents/ped/materials/published/index_en.htm
4. Materials
PMA
Performed by manufacturer for Categories I & II Approved by Notified Body for Categories III & IV Must meet ESRs for material Applicable for repeated use by that manufacturer only, within specified limits Keep list of PMAs issued and their ranges of approval
http://ec.europa.eu/enterprise/sectors/pressure-and-gas/files/pe-0328-guiding-principles-for-the-content-of-pma_en.pdf
4. Materials
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.
4. 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.
Main M i pressure-bearing b i parts t

Shells Ends Main body flanges Tube sheet of exchangers Tube bundles
4. Materials
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.
4. Materials
Competent body
Can be any third party body established as a legal entity within the Community A notified body may perform this task only if it has a recognized competence in the field of quality assurance assurance, materials and related process technology. The certificate of quality system shall make reference to the legal entity established in the Community and its address.
Pressure Equipment Directive Roles & Responsibilities
Pressure Equipment Manufacturer

The PE Manufacturer is under an obligation to analyze the hazards 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. Designing and Manufacturing the product in accordance with essential requirements laid down by the PED. Carrying out conformity assessment in accordance with the procedures laid down by the PED.
106

In choosing the most appropriate solutions, the PE Manufacturer must apply the principles set out below in the following order:
Eliminate or reduce hazards as far as is reasonably practicable 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.
107

Must ensure the competent execution of the provisions set out at the design stage by applying the appropriate techniques and relevant procedures. Perform P f the th Final Fi l assessment t Final Fi l i inspection, ti P Proof ft test t
& Check of the safety devices for assemblies
Affix the CE marking to each item of pressure equipment and draw up a written declaration of conformity.
108

Materials for pressurized parts Providing in his technical documentation elements relating to compliance with the materials specifications of the PED 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.
109

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. For Pressure Equipment, there is only one Manufacturer.
110
Notified Body
Approve operating procedures and personnel for pressure equipment in categories II, III and IV at the manufacturers discretion. Perform a particular material appraisal in charge of conformity assessment procedures for pressure equipment in categories III and IV. The CE marking must be accompanied by the ID No. of the notified body for the pressure equipment applied to the conformity assessment procedures among those laid down for the categories II, III & IV.
111
Recognized ThirdThird-Party Organization

RTPO
Approve operating procedures and personnel for pressure equipment in categories II, III and IV at the manufacturers discretion. Approve the personnel who perform non-destructive tests of permanent joints for pressure equipment in categories III and IV.
112
Notified Body & RTPO

They may not become directly involved in the design, construction, marketing or maintenance of the pressure equipment or assemblies, nor represent the parties engaged in these activities. Must carry out the assessments and verifications with the highest degree of professional integrity and technical competence. Must be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of the inspection.
113

Must have at its disposal the necessary personnel and possess the necessary facilities to enable it to perform properly the technical and administrative tasks connected with the inspection and surveillance operations, it must also have access to the equipment required to perform special verifications. Must take out liability insurance unless its liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the inspections.
114

For permanent joining
A competent third party which may be a Notified Body or a RTPO must approve operating procedures and personnel for pressure equipment in categories II, III and IV at the manufacturers discretion. 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.
115
Category
NoBo /RTPO Approval of Permanent Joining Procedure & Personnel No No Yes Yes Yes
RTPO Approval of NDE Personnel No No No Yes Yes
Material with Certificate of Specific Product Control No No Yes Yes Yes
PMA accepted by NoBo
0(SEP) I II III IV
No No No Yes Yes
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Pressure Equipment Directive 97/23/EC (PED)

European Pressure Equipment Directive

HSB Global Standards 1

ANNEX I ANNEX II ANNEX III ANNEX IV ANNEX V ANNEX VI ANNEX VII

HSB Global Standards 2

Status of the guidelines

Classification of the guidelines

HSB Global Standards 3

REFERENCE GUIDE for Pressure Equipment Directive

Member States of the European Community (EC)

Finland France Germany Greece Hungary Ireland Italy Latvia

Slovenia Spain Sweden United Kingdom

Countries adopting Directives

Requiring / Accepting PED

HSB Global Standards 4

HSB Global Standards 5

Implementation of the PED

Harmonized Standards (EN)

HSB Global Standards 6

Harmonized Standards (EN)

HSB Global Standards 7

Pressure Testing CE-Marking Declaration of Conformity

HSB Global Standards 8

Pressure Equipment Directive Overview

Article 1 Scope and definitions

All Pressure Equipment

Pressure equipment meets all requirements of the Directive

Article 1 Scope and definitions

HSB Global Standards 9

Article 1 Scope and definitions

Article 1 Scope and definitions

Maximum allowable pressure PS

Maximum/Minimum allowable temperature TS

Article 1 Scope and definitions

European approval for materials

HSB Global Standards 10

Article 3 Technical Requirements

Article 3 Technical Requirements

Article 9 Classification of Pressure Equipment

HSB Global Standards 11

Article 9 Classification of Pressure Equipment

Group 2 All other Fluids

HSB Global Standards 12

ANNEX I Essential Safety Requirements

HSB Global Standards 13

ANNEX II Conformity Assessment Tables

ANNEX III Conformity Assessment Procedures

HSB Global Standards 14

ANNEX VII Declaration of Conformity

Pressure Equipment Directive Classification

Pressure (in bar) Volume (in liters) / Nominal Size (DN)

HSB Global Standards 15

Phase Gas Gas Liquid Liquid

Steam Gen. Gas Piping Gas Liquid Liquid

Conformity Assessment Tables

Conformity Assessment Table 1

HSB Global Standards 16

Conformity Assessment Table 2

Conformity Assessment Table 3

Conformity Assessment Table 4

HSB Global Standards 17

Conformity Assessment Table 5

Conformity Assessment Table 6

Conformity Assessment Table 7