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Benny Hoff

TÜV NORD Sweden AB

PED and Swedish regulations

Contents

Background Involved parties PED – contents and structure PED – scope Rules for CE-marking PED - App. 2, 3, 1 and 4 AFS 2005:2 – equipment PED-assembly vs AFS 2005:2-installation Purchasing phase – important matters Tutorials – pressure vessel and piping

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History – mutual recognition

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European Court case 120/78 (Cassis de Dijon)

16% alcohol levelGermany 25%

agree on common standards

products in one EU country are also legal in other EU countries

Fundamental oblectives for ”New approach” and ”Global approach”

High level of safety, health and environment for technical products

Free movement within the common marketWiden the common market And towards third country

Reliable system for assesment and certification of conformity

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PED – Involved parties

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Manufacturer

Buyer

Contractor

Distributor

Notified body / Recognized third party organization

Involved parties (2)

Buyer - Sets additional requirements, checks CE-marking Manufacturer – Responsible for declaration of products and CE-

marking Distributor – checks manufacturer´s documents and CE-marking Contractor – acts as buyer and manufacturer Recognized third party organisation - certification of personnel

and procedures Notified body – certification of products, on behalf of the

manufacturer

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Pressure equipment in Sweden

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AFS 1999:4

PED 97/23/EG

AFS 2005:3

Inspection of pressure

equipment

AFS 2002:1

Use of pressure equipment

Exclusions of PED: AFS 2005:2 or MSBFS 2014:5 (storage tanks

for flammable liquids)

Design and manufacturing Installation and operation / maintenance

MSBFS 2014:5

SSM Special terms for ESS plant in Lund

PED – Structure

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EuropeanDirective97/23/EG Blue guide

(all directives)

NationalProvision

HarmonisedStandard or else(must fulfill Essential Safety Rrequirements)

HarmonisedStandard or else(must fulfill Essential Safety Rrequirements)

GuidelinesPED (WPG)GuidelinesPED (WPG)

LAW INTERPRETATION APPLICATION

PED - Contents

Scope, definitions, exclusions Classification (product (fluid) group, PS, V / DN,

figure, hazard category) Conformity assessment Technical requirements and CE-marking App. 1 Essential safety requirements App. 2 Figures 1-9 App. 3 Conformity assessments (modules) App. 4 Declaration of conformity

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PED – Scope

PS > 0.5 bar(g)Pressure vessels Piping Safety equipment Pressure equipmentPressure accessories

Assembly – option for manufacturer If not: Installation acc. to AFS 2005:2

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PED – exclusions

Some examples: Distribution piping between installations (sites), e.g

district heating systems ADR/RID (transport of dangerous goods) Equipment specially designed for nuclear use,

where failure could cause radioactive emmision

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PED - Piping, ”gas” group 2

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PED

PED - Article 3.3

Manufactured according to Sound Engineering Practice in any of the member states

No CE-marking Sufficient instructions for safe use

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PED – Conformity assessment procedures

Category I: A Piping for steam DN100 and PS 35 bar(g)

Manufacturer performs all inspections

Category II: A1, D1 or E1 Piping for steam DN 250 and PS 20 bar(g)

Manufacturer performs all inspections with unannounced visits by Notified body (A1) or assessment of manufacturer´s quality system

Category III: B1+D, B1+F, B+E, B+C1 or H Piping for steam DN >250 and PS x DN > 5000

Manufacturer performs all inspections. Design and manufacturing assessed by Notified body (B1+F and B+C1) or assessment of manufacturer´s quality system

Category IV: B+D, B+F, G or H1 Only for pressure vessels, accessories and safety equipment

Manufacturer performs all inspections. Design and manufacturing assessed by Notified body (B+F and G) or assessment of design and manufacturer´s quality system (B +D and H1)

 

 

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PED – Essential safety requirements

1 General (including hazard analysis and risk assessment)

2 Design

3 Manufacturing (including inspection and testing)

4 Materials

5 Special requirements for steam boilers and similar equipment

6 Special requirements for piping

7 Special quantitative requirements for certain pressure equipment

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Ovanstående tabell ger bara ett fåtal exempel på standarder i respektive kategori. En stödjande standard respektive materialstandard i tabellen, är inte direkt knutna till tabellens produktstandarder.

If manufacturer does not apply to a harmonised standard, it must be proven that other means offers the equal level of safety.

EAM XXX PMA

Product standards EN 13445 EN 13480

Supporting standards EN 10217-2 EN 287-1

Material standards EN 10028-7 LDX 2101 ASTM A106

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PED - Harmonised standards

XXX

PED – CE-marking

Scope of PED? Classification I, II, III or IV? Conformity assessment procedure? Notified body? How to fullfil ESR´s? Additional requirements? Design, manufacturing, inspection and testing Documentation incl. Declaration of conformity and

instructions for use CE-mark and warning signs (if any)

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PED – Declaration of conformity

Name and address of manufacturer or representative Description of PE or assembly Conformity assessment (module(s)) Name and address of NoBo(s), if any Reference to EC-type or EC-design review certificate, if any Reference to used harmonised standard(s), if any Reference to other way to fullfil appendix 1, if any Identification of signatory, empowered to sign the DoC

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2014/68/EU, Time schedule

Published in OJ AFS 2015:1 Regulation for Chemicals 100% new 1272/2008

17/7 2014 28/2 2015 1/6 2015 19/7 2016

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AFS 2005:2

Manufacturing of certain tanks, piping and installations No directive - National requirements Requirement G and K Installation Installation control (plant inspection) Declaration

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AFS 2005:2 Scope

Manufacturing of new ”certain tanks” and certain piping *) Minor change / repair of pressure equipment Manufacturing of new installations and change / repair of

installations

*) pipelines between sites

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AFS 2005:2 - Exclusions

Pressure equipment acc to PED Simple pressure vessels Storage tanks for flammable liquids – MSBFS 2014:5 Piping for water with TS max 65oC Nuclear power plants Piping for natural gas ADR/RID (transport of dangerous goods) Assemblies acc to PED

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Tanks

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AFS 2005:2 – Figure 7 (gas group 2a)

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AFS 2005:2 - section 7 General requirements

Equipment not classified as G or K Corresponds to PED:s article 3.3 Sound Engineering Practice within EES Beware of local conditions (e.g. outside temperature)

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AFS 2005:2 – section 8 Essential safety requirements

Tanks and pipelines which is classified as requirement G shall fullfil the essential requirements acc. to appendix 1

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AFS 2005:2 – section 9-11Inspection of tanks and piping

Tanks and pipelines which is classified as requirement K shall fullfil the essential requirements acc. to appendix 1. They shall also undergo inspections as follows:

Design review: Material, design, scope of NDT, welding procedures shall be verified by third party (accredited acc. to AFS 2005:2)

Manufacturing inspection: documents from manufacturing shall be reviewed, VT shall be performed and pressure test shall be witnessed by third party (accredited acc. to AFS 2005:2)

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AFS 2005:2 – section 12-13 Delivery documents and marking

Requirement G (and K): Marking acc to chapter 3.3 in appendix 1 Declaration acc to section 8 in AFS 2005:2 Exclusion: Tanks who are CE-marked acc to CPR

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AFS 2005:2 – section 13Assurance

Name and address of manufacturer Description of the equipment Identification of the equipment In what way has the ESR´s been fullfilled? Name and address of accredited inspection body Reference to used standards and other ordinances Reference to other technical specifikations Identification of signatory, empowered to sign the assurance

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Purchase of pressure equipment

Which provision? PED or others? Which standard(s)? E.g. EN13445 or AD2000? Additional technical requirements? Additional required documentation? Except DoC and instructions for use Would you like to be notified about or influence the risk analysis? Language? Who shall perform inspections and when? ITP? Additional requirements in addition to periodic inspections and testing?

Assembly acc to PED or Installation acc to AFS 2005:2

Assembly - Installation

Assembly One manufacturer (not the end

user) Classification acc to PED, IV PED app. 1

CE-marking of complete system Declaration of Conformity Instructions for use

Installation inspection (AFS 2005:3) when aasebly is connected to another pressure equipment (A or B) or to safety equpment outside of the assembly

Installation End user ”manufacturer” G (self) or G+K (Third party) AFS 2005:2 app.1

No CE-marking of complete system

Certificate of plant inspection (G+K)

Instalaltion inspection of all equipment acc to inspection class A and B (AFS 2005:3)

IV

II

I

II

§8Assembly CE-mark (IV)

Installation no CE-mark