1. Pressure Equipment (PED) --- Baltic Pressure Equipment Workshop
Directive 97/23/EC on
Pressure Equipment (PED)
---
Baltic Pressure Equipment Workshop
Riga, November 2003

2. Fundamentals Roots at the times of the Industrial revolution
Technically one of most complex areas
Involves severe hazards
Highly regulated
Rather heterogenious legislation
Economically substantial (approx 90 bio €)
 Need to have a harmonized regulatory framework

3. 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

4. Pressure Equipment Directive
Ensures free movement of goods (PE),
for products which fall within its scope,
which meet the ESR,
having completed Conformity Assessment
or are Art 3.3 (SEP) equipment.
 PED harmonises the previously fragmented European PE market

5. Scope Pressure vessels Piping Pressure accessories Safety Accessories
and Assemblies
Limited to:
- pressure hazard
- pressure greater than 0.5 bar
- equipment placed on the market OR put into service
- assemblies placed on the market AND put into service

6. Assemblies Several pieces of pressure equipment , provided
the result is integrated
the result is functional
they are a whole
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

7. Assemblies: Examples Pressure cookers Fire extinguisher
Bottles for breathing apparatus
Autoclaves
Valve systems
Pressure regulators
Pressure safety devices
etc.
Gas storage tanks
Boilers
Steam generators
Destillation columns
Heat exchangers
Refrigeration systems
Air conditioning systems
Turn-key plants
etc.

8. Essential Safety Requirements (ESRs)
General obligations for manufacturer
e.g. to carry out hazard analysis incl. reasonably foreseeable misuse
- to establish technical documentation file
- Design and calculation
- Manufacturing
- manufacturers capabilities
- manufacturing/joining procedures
- Materials
- Specific requirements
- for fired or otherwise heated pressure equipment
- for piping
- Specific quantitative requirements (general rule)

9. Conformity Asessement
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

10. Determination of applicable category
Classification
Group I fluid
Group II fluid
vessels
gaseous
Table 1
Table 2
liquid
Table 3
Table 4
piping
Table 6
Table 7
Table 8
Table 9
Pressure
accessories
volume
according to table 1-4 DN
according to table 6-9
Safety
general
Category IV
specific
Category of respective equipment
Assemblies
According to highest element (except safety acc.)

11. Conformity assessment tables (A)
Vessels for dangerous gases Vessels for non-dangerous liquids
(Table 1) (Table 4)

12. Conformity assessment tables (B)
Piping for dangerous gases Piping for non-dangerous liquids
Table Table 9

13. Conformity assessment for assemblies
Global procedure
- assessment of each item making up the assembly
(when not CE-marked)
- proper integration of these items - essential requirements 2.3,
2.8 and 2.9 of Annex I
- protection against exceeding permissible operating limits -
essential requirements 2.10 and of Annex I

14. 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

15. „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

16. 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

17. Legal aspects Transposition into national Law by MSs
Notification of NBs and TPOs by MSs
Publication of Harmonized Standards in the Official Journal of the European Community
Obligation to MSs not to prohibit, restrict or impede placing on the market of complying PE
Obligation to manufacturer, not to place non-compliant, unsafe or unduly CE-marked products on the market
Safeguard clause procedure against unsafe products
Formal objection of non-complying Harmonized Standards
Obligation to MSs to do Market Surveillance

18. Potential pitfalls
Inappropriate expectation of „authorization of deviations“ e.g. for „economic reasons“
„History oriented“ rules for in-service inspection periods
Following short-cutting advice
„Abreviated“ hazard analysis
Sole reliance on previous procedures
==> maintain professional proportionality

19. Hierarchy of Terms
NB: The table should illustrate the general situation and therefore provides a simplified picture without any details and exceptions.

20. PED: Hot Topics Interface of ”placing on the market“ and “operation“
European versus national responsibility
New concepts of “New Approach” legislation
Integration of SPVD in PED
User Inspectorates : future scope & tasks
Promotion of European Standardisation
Trade aspects of pressure equipment
European Approvals for Materials

21. European Approval for Materials
First Set of EAMs on Nickel 201 published in OJ 2003/C 233/10, see reference list at
Guiding Principles and standard form downloadable at
Orgalime support facilitating drafts of EAMs (EU contract):

22. Further information Commission web-site : http://ped.eurodyn.com
PED WGP Guidelines
National Authorities
Euro Info Centers
Industry Associations
Notified Bodies
Directive text itself