Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
An Introduction
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New Approach and Global Approach
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New Approach and Global Approach
Guidance
The Web:
http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/new-approach_en.htm
The Blueguide:
http://ec.europa.eu/enterprise/policies/single-market-goods/files/blue-guide/guidepublic_en.pdf
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Implementation
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EU Product Directive
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EU Product Directive
EU Product Directive
A Law passed by the EU that must be implemented by all EEA member states.
The law (Directive) is binding upon the member state as to the objective to be
achieved, with limited leeway as to how to achieve it.
Intended to remove technical barriers to trade by establishing a commonly
accepted level of safety.
Applies to
Example: Directive 97/23/EC covering Pressurised Equipment
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EU Product Directive
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‘New Method’ Directives
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Definitions
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Definitions (contd.)
Manufacturer
“Any natural or legal person who designs or
manufactures a product or who has such a
product designed or manufactured, and markets
that product under his name or trademark ”
Authorised representative
“Any natural or legal person established within the
Community, appointed by the manufacturer by a
written mandate, to act on his behalf in respect of
certain obligations of the manufacturer “
Importer
“Any natural or legal person established within the
Community, who places a product from a third
country on the Community market “
Ref.: http://ec.europa.eu/enterprise/policies/single-market-goods/free-movement-non-harmonised-sectors/
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Definitions (contd.)
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Product Directive/ National Legislation
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Principles
Products placed on the Community market shall comply with all applicable
legislation (product directives).
The manufacturer, having detailed knowledge of the design and production
process, is best placed to carry out the complete conformity assessment
procedure. Conformity assessment should therefore remain the obligation of the
manufacturer alone.
Standards and presumption of conformity
– EC directives define the "essential requirements", e.g., protection of health and
safety, that goods must meet when they are placed on the market.
– 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". See list on http://ec.europa.eu/enterprise/policies/european-
standards/documents/harmonised-standards-legislation/list-references/index_en.htm
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Principles (contd.)
Each harmonized standard will contain an annex stating which essential safety requirements it satisfies. The
advantage of using these standards is that no additional justification is required that essential
safety requirements have been met and providing the standards have been correctly applied the design of the
equipment can not be challenged.
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Annex ZA
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Principles (contd.)
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Non-compliant Product
User
Authority
Market
Manufacturer
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CE Marking
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Declaration of Conformity
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Pressure Equipment Directive 97/23/EC
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Pressure Equipment Directive 97/23/EC
PED Coverage
Began Transition period 29 November 1999
Became Mandatory from 29 May 2002
Applies to Pressure Vessels, Piping, and Pressure and Safety Accessories
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Pressure Equipment Directive 97/23/EC
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Scope and Definition
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Scope and Definition
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Scope and Definition
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Scope and Definition
Note:
Safety Accessories are normally Category IV. If purchased, should be CE marked by device manufacturer
(97/23/EC Annex II, cl 2)
EN ISO EN ISO 4126-1, Safety devices for protection against excessive pressure — Part 1: Safety valves
EN ISO EN ISO 4126-3, Safety devices for protection against excessive pressure — Part 3: Safety valves and bursting
disc safety devices in combination
EN 764-7, Safety systems for unfired pressure equipment
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Scope and Definition
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Scope and Definition
Flanges, fittings, plain pipe lengths, heads and other equipment that don’t have
an identifiable pressure housing (such as Thermowells) are considered as
“components” of pressure equipment and not equipment themselves, so they can
not be CE marked for compliance with PED. (guideline 4/9, 7/19)
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Scope and Definition
Case study I
safety valve safety accessory
cover, collar, gasket, flange, bolt components of a pressure equipment
sight glass with its frames components of a pressure equipment
flanges, fittings, plain pipe lengths components of a pressure equipment
thermowells components of a pressure equipment
valves, meters pressure accessory
connecting together piping components (flanges, pipes, fittings, reducers for
example) item of piping (guideline 2/31)
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Scope and Definition
Case study II
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Scope and Definition
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Classification
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Classification
Nominal Size (DN) means a numerical designation of size which is common to all
components in a piping system other than components indicated by outside
diameters or by thread size.
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Classification
Group 1 Group 2
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Classification
Refer to Table Table Table Table Table 5 Table Table Table Table
table 1 2 3 4 6 7 8 9
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Classification
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Classification
Table 1
Vessel for Group 1 gases or liquid
whose vapour pressure at the maximum
allowable temperature is greater than
0,5 bar above normal atmospheric
pressure
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Classification
Table 2
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Classification
Table 3
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Classification
Table 4
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Classification
Table 5
Steam Generators
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Classification
Table 6
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Classification
Table 7
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Classification
Table 8
Piping for Group 1 Liquids
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Classification
Table 9
Piping for Group 2 Liquids
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Classification
Determine the equipment category within PED (annex II) for the following
equipment:
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Classification
Evaluation Information:
Equipment Type = Vessel
Fluid state: = Liquid & Gas
Fluid group: =1
Annex II table =1
PS x V = 18,266 (24.13 x 757)
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Classification
PS = 24.13 bar
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49
Classification
PS = 24.13
V = 757 Litre
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Classification
PS x V = 18,266
PS x V > 1000
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Classification
PS x V = 18,266
PS x V > 1000
= category IV
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Materials
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Materials
Manufacturing Requirements
Designer must select materials that are suitable for the expected application and
intended lifetime
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Materials
Particular Material
Appraisal
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Materials
Harmonised Standards
EN 10213 Pt 1
EN 10213 Pt 2 Steel castings
EN 10028 Pt 1 EN 10213 Pt 3
EN 10028 Pt 2 EN 10213 Pt 4
EN 10028 Pt 3
EN 10028 Pt 4 Steel Plates
EN 10028 Pt 5 EN 10222 Pt 1
EN 10028 Pt 6 EN 10222 Pt 2
EN 10028 Pt 7 EN 10222 Pt 3 Steel forging
EN 10222 Pt 4
EN 10269 EN 10222 Pt 5
Fasteners
EN 12482 Aluminium
EN 12420
EN 12451 Copper EN 10216 Seamless &
EN 12452 EN 10217 welded tubes
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Materials
EAM
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Materials
NOTE: It is always the manufacturer’s responsibility to confirm the material is suitable for it’s intended use.
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Materials
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Materials
Manufacturing Requirements
NOTE: Some Notified Bodies will not accept ASME material properties or chemistry
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Materials
PMA Example
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Materials
Manufacturing Requirements
Materials must have appropriate properties for all reasonably foreseeable operating
and test conditions, in particular concerning ductility and toughness. Where
appropriate, material characteristics should meet: (accordance with 97/23/EC
Annex I clause 4 and clause 7.5)
Elongation after rupture exceeds 14%
Charpy impact energy is not less that 27J, at temperature not higher than lowest
scheduled operating temperature, but not higher than 20°C
Sufficiently chemically resistant to the fluid contained in the equipment
Not sufficiently affected by ageing
Suitable for the intended processing procedures
Selected in order to avoid significant undesirable effects when put together with
other materials
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Materials
Material Documentation
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Materials
Case Study IV
For PED Category I and II, the PMA is under the responsibility of the
equipment manufacturer
For PED Category III and IV, the PMA is appraised by the nominated
Notified Body
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Welding
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Welding
The properties of welded joints must meet the minimum properties for the base
materials joined
Welding procedures must be supported with qualification tests
Welding procedures and personnel for (pressure welds) on Category II, III
and IV equipment must be approved by either a Notified Body or a Recognized
Third Party Organisation (Annex I 3.1.2)
NOTE: Third Party Organizations may appoint organisations according to Article 13 of the Directive, for specific tasks
related to approval of welding procedures, personnel, and NDE operators. These appointments are listed with the
Commission, in the same way as Notified Body appointment.
WQ= Welder Qualification
WPS= Welding Procedure Specification
PQR= Procedure Qualification Record
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Welding
NOTE :Welding consumables are treated as materials and must fulfil the relevant requirements of: 4.1, 4.2(a),
4.3 First paragraph, Certificate of conformance required
Welding consumables are defined by trade name, designation and relevant EN classification standard.
Inspection documents of welding consumables should give test results, for technical characteristics
according to designation and classification standard, such as:
Chemical composition of welding filler metal or all-weld metal as appropriate
Tensile properties of all-weld metal: tensile and yield strength, elongation
Impact properties of all-weld metal at temperature according to designation. Test results are based on non
specific inspection and testing. They can be given for example as typical values based on quality control
tests.
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Welding
Note: EN ISO 15614-1 replaced EN 288-3 (Specification and approval of welding procedures for metallic materials )
EN 287-1 was to be replaced by EN ISO 9606-1, but agreement could not be reached.
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NDE
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NDE
NOTE: Operators with certificates from other schemes than EN ISO 9712 will in most cases not be approved by a RTPO
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Final Assessment
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Final Assessment
Final Inspection
Equipment must undergo a final inspection and documentation review. Final
inspection must be carried out internally and externally on every part of the
equipment (at the appropriate stage of manufacturing).
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Final Assessment
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Final Assessment
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Annex I - ESRs
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Annex I - ESRs
General Requirements
The manufacturer is under an obligation to analyse the hazards, in order to identify those which apply to his equipment;
the he must design and construct it taking account of his analysis.
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Annex I - ESRs
Hazard Analysis
Start
Determine
Equipment
Boundaries
No
Is
Risk
Evaluation
Equipment
Safe? Yes
END
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Annex I - ESRs
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Annex I - ESRs
Design Requirements
Two methods for adequate design strength:
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Annex I - ESRs
Design Requirements
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Annex I - ESRs
Design Requirements
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Annex I - ESRs
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Annex I - ESRs
Safety Accessories
Must be designed and constructed to be reliable and suitable for the intended
duty: SIL (safety integrity level)
Be independent of other functions
Comply with appropriate design principles, such as, fail-safe modes, redundancy,
diversity and self-diagnosis
Pressure limiting devices must not allow the equipment to see short duration
pressure surge exceeding 10% of allowable working pressure.
Temperature monitoring devices must have an adequate response time,
consistent with the measurement function.
Note: Safety Devices are normally Category IV. If purchased, should be CE marked by device manufacturer
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Annex I - ESRs
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Annex I - ESRs
Operating Instructions
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Conformity Assessment Modules
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Conformity Assessment Modules
Module for
Conformity Assessment Process
Type Pressure Equipment Category Conformity
per Annex III of the PED
Assessment
I A Internal Process Control
Internal Process Control with Monitoring
A1
Piping by Notified Body
II D1 Production Quality Assurance
E1 Product Quality Assurance
B1+D EC Design Production Quality Assurance
E.g.
Pressure B1+F Examination + Product Verification
and Breathing Equipment
Pressure EC Type
Accessories, B+C1 Examination + Conformity to Type
Pressure
H Comprehensive Quality Assurance
Assemblies
B+D EC Type Production Quality Assurance
Examination +
Accessories
IV G EC Individual Testing
Full Quality Assurance with Design Examination
H1 and Special Surveillance of the Final Product
examination
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Documentation – General Guideline
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TCF Content – Design Review
ESR-EVALUATION
RISK ANALYSIS
To be drawn up if non harmonised
standards are used
TECHNICAL SPECIFICATION
Description of the pressure equipment DRAWINGS
- Pressure (Highest/lowest) Shall contain information showing:
- Temperature (Highest/lowest) - All manufacturing details
- Volume - Joint efficiencies
- Fluid (Specification, Fluid group, Density) - Marking plate
Following information can be presented
on the drawings alternative on separate
documentation:
- WPS
- Forming procedures
CALCULATIONS - Heat treatment
Description of the relevant load cases: - Coating&Painting
- Fatigue (Number of/allowable number of load - Brazing
cycles) - Inspection schedule
- Creep (Max operation time in creep range) - Tests to be done
- Static loads - Materials
- Dynamic loads - Marking of welds
Design Standard and Method
Special regulations
Customer Specifications
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TCF Content – Manufacture Control
OPERATION MANUAL
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Assemblies - Documentation
1. P & ID
P & ID should as a minimum include:
– document number
– document revision
– tag on equipment
– flow direction
– reference to other P & ID
– specification on piping
– shutdown functions
– control system should be comprehensible
– position on valves in normal operation
– Legend/ symbol description
2. Piping specification/ design pressure and temperature for the piping used
3. Flexibility analysis of the piping system
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Assemblies - Documentation
5. Process datasheet for Pressure Relieving Devices or any other form which
includes information about required rate, set pressure and maximum allowable
overpressure
6. Risk analysis/ HAZOP/ Safety Analysis Tables
7. Vendor documentation on Pressure Relieving Device including relieving rate and
maximum allowable pressure
8. Line sizing calculation upstream and downstream of Pressure Relieving Devices
according to EN 764, Part 7, Section 8.2.2 and 8.2.3 or equivalent
9. If not shown on the P & ID the ESD system is needed and in addition the cause
and effect diagram
10.Functionality description of the system
11.Piping isometric drawings - composite & detailed
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TCF Content
Traceability!
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Questions
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www.dnvgl.com
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