26/12/20151 Benny Hoff TÜV NORD Sweden AB PED and Swedish regulations.
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Transcript of 26/12/20151 Benny Hoff TÜV NORD Sweden AB PED and Swedish regulations.
21/04/23 1
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
2
History – mutual recognition
3
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
21.04.23 4
PED – Involved parties
5
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
6
Pressure equipment in Sweden
7
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
8
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
9
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
10
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
11
PED - Piping, ”gas” group 2
12
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
13
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)
14
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
15
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
16
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)
17
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
18
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
19
20
AFS 2005:2
Manufacturing of certain tanks, piping and installations No directive - National requirements Requirement G and K Installation Installation control (plant inspection) Declaration
21
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
22
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
23
Tanks
24
AFS 2005:2 – Figure 7 (gas group 2a)
25
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)
26
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
27
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)
28
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
29
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
30
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