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    HistoryTreaty of Rome (1957)

    Signed by the Member states ( Called asFounder Members

    Belgium, France, Germany, Italy,Luxembourg, Netherlands

    Achieve a Single European Market

    For Four Freedoms of the following:

    People ---Finance---Services----Goods..

    6

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    FEW MEMBER JOINED THE UNION,

    Denmark, Great Britain, Ireland in 1973

    &

    Greece in 1981

    10

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    The New Approach (1985)

    Resolution passed by the Member states

    General requirement to be achieved

    Directive to address Essential requirements

    The manufacturer decides the method:

    based on the directive

    conformity assessment module

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    FEW MEMBER JOINED THE UNION,

    Portugal & Spain in 1986

    &

    Austria, Finland & Sweden in 1995

    15

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    Pressure Equipment

    Directive Published in the Official Journal of the

    European Communities

    No. L 181 dated 9 July 1997

    Available from The Stationary Office

    Remove technical barriers to trade withinthe EEA related to pressure equipment bythe harmonisation of the laws of MemberStates

    New construction, 1st time putting intoservice /market requirements..

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    KEY DATES

    Adoption - 29 May 1997

    Transposition - 29 May 1999

    Entry into force - 29 Nov 1999

    Mandatory - 29 May 2002..

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    BIGGEST EVER BUNCH JOINED THE UNION,

    in May 2004

    Estonia, Latvia, Lithuania, Poland, Czech Republic,Slovakia, Hungary, Slovenia, Malta, Cyprus

    25

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    European Free Trade Association

    Iceland, Liechtenstein, Norway, Switzerland

    25 + 3

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    European Economic Area= European Union +

    European Free Trade area

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    Candidate States

    Rumania - Applied in 1997

    Bulgaria - Applied in 1995

    Turkey - Applied in 1987

    25+3+3

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    CE MARKING IS MUST FOR FOLLWING 22GROUPS OF PRODUCTS

    Appliances burning gaseous

    fuels

    Cableway installations to

    carry Persons

    Low voltage electrical

    equipment

    Construction products

    Equipments & protective

    Systems used in potentially

    explosive atmospheres

    Explosives for Civil usesHot Water boilers

    Household refrigerators &

    freezers

    Lift

    MachineryMarine Equipment

    Medical Devices

    Active Inplantable Medical

    Devices

    In vitro DiagnosticMedical

    DevicesNon-automatic weighing devices

    Radio & telecommunications

    terminal equipment

    Personal protective equipments

    Simple pressure vessels

    Pressure equipment

    Recreational craft

    Toys

    Trans European conventional rail

    system

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    THE PRESSURE

    EQUIPMENT DIRECTIVE..

    97/23/EC

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    Scope

    The Directive (No. 97/23/EC) aimed atharmonising regulations across Europe forthe design, manufacture and conformity

    assessment of pressure equipment andassemblies with a maximum allowablepressure (PS) greater than 0.5 barg (= 7.25psig)..

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    Definitions

    Vessels

    Piping

    Safety Accessories Pressure accessories

    Assemblies..

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    Vessels

    A housing designed and built to containfluids under pressure including its directattachments up to the coupling point

    connecting it to other equipment. A vesselmay be composed of more than onechamber..

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    Piping

    Piping components intended for thetransport of fluids when connectedtogether for integration into a pressure

    system..

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    Safety Accessories

    Devices designed to protect pressureequipment against the allowable limitsbeing exceeded.

    safety valves, bursting discs, etc...

    pressure and temperature switches, levelswitches that operate a shutdown orcorrection system..

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    Pressure Accessories

    Devices with an operational function andhaving pressure bearing housings.

    valves

    expansion bellows

    pipework fittings/flanges..

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    Assemblies

    Several pieces of pressure equipmentassembled by a manufacturer to constitutean integrated and functional whole.

    Does not apply to equipment assembledon site by, and under the responsibility of,the user..

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    Exclusions from the Directive

    Pipelines outside premises or installations

    Pressure tunnels for hydroelectric installations

    Simple Pressure Vessels

    Aerosols

    Equipment for vehicles covered by EC Directives

    Weapon systems and firearms

    Items designed for use in the nuclear industry..

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    Exclusions from the Directive

    Oil/gas drilling equipment upstream of theChristmas Tree

    Casings or machinery where the main design

    considerations are strength, rigidity and stability

    Equipment for the production and casting of steeland non-ferrous metals

    Enclosures for high-voltage electrical equipment

    Pressurised pipes for the containment oftransmission systems..

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    Exclusions from the Directive

    Pressure equipment consisting of a flexible casing

    Exhaust and inlet silencers

    Bottles and cans for carbonated drinks for finalconsumption

    Vessels designed for the transport anddistribution of drinks

    Equipment for the transport of dangerous goodsin accordance with the ADR, RID, IMDG & ICAO

    conventions

    Radiators and pipes in warm water heatingsystems

    Ships, rockets, aircraft & mobile off-shore units..

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    Exclusions: contd...

    Equipment which is classified no higherthan Category I also covered by thefollowing Directives:

    Machinery 89/392/EEC Low Voltage 73/23/EEC

    Lifts 95/16/EC

    Medical Devices 93/42/EEC

    Gas Appliances 90/396/EEC

    Explosive Atmospheres 94/9/EC..

    Cl ifi ti

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    Classification

    Four categories & sound engineering practice

    (SEP) dependant on the level of risk.

    Category IV being the highest, SEP lowest.

    Classified in nine tables in Annex II by:

    type of pressure equipment

    pressure, volume or nominal diameter

    fluid Gas/ liquid (Group I & 2)..

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    Classification - class of

    fluid (67/548/EEC) Group 1

    explosiveextremely flammable

    highly flammableflammablevery toxictoxicoxidising

    Group 2others

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    PRODUCT CATEGORY

    Based onVolume

    (liter)

    SteamGenerator

    nominaldiameter

    (DN)

    State ofcontents

    Gas Liquid Gas Liquid

    Fluid

    group

    1 2 1 2 1 2 1 2

    Table 1 2 3 4 5 6 7 8 9

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    VESSEL TABLES

    Vessel for Group 1 gases

    Vessel for Group 2 gases

    Vessel for Group 1 liquids Vessel for Group 2 liquids..

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    Table 1 -Vessels for Group 1 Gases

    0.5

    200

    1000

    SEPI II III

    IV

    PS=1000

    PS=200

    1 100 1000 1000 V(l)

    10

    100

    PS=0.5

    V=1

    bar

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    Table 2 -Vessels for Group 2 Gases

    0.5

    1000

    3000

    SEPI II III

    IV

    PS=3000

    PS=1000

    1 100 1000 10000 V(l)

    10

    100

    PS=4

    PS=0.5

    bar

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    Table 4 -Vessels for Group 2 Liquids

    PS

    0.5

    1000

    SEP

    I

    II

    PS=500

    1 100 1000 V(l)

    10

    100PS=10

    PS=0.5

    I

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    STEAM TABLE

    Steam Generators..

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    PIPING TABLES

    Piping for Group 1 gases

    Piping for Group 2 gases

    Piping for Group 1 liquids Piping for Group 2 liquids..

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    Table9 -Group 2 Liquids (diameter)

    1 10 100 1000

    0.5

    1

    10

    100

    5001000

    DN

    PS = 0.5

    PS = 10

    PS = 500DN=

    200

    PS(bar)

    I

    II

    SEP

    10000

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    Classification

    Multi chambered vessels are classifiedaccording to the highest chamber category.

    Equipment that can contain several fluidsis classified according to the fluid thatrequires the higher category.

    Safety accessories are classified as category

    IV, unless specific to an item of pressureequipment of a lower category..

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    Manufacturer chooses one conformity

    Assessment module based on category

    Category Module

    I A

    II A1 D1 E1

    III B1+D B1+F B+E B+C1 H

    IV B+D B+F G H1

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    Directive Requirements

    Satisfy Essential Safety Requirements

    Compile a Technical File

    Follow appropriate conformity assessmentroute

    Place CE marking on equipment

    Issue Declaration of Conformity..

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    Essential SafetyRequirements

    Detailed in Annex 1 of the Directive

    Mandatory

    Must be addressed where a hazard existsunder operational or reasonablyforeseeable conditions

    Requires some form of Risk Assessment toestablish relevant hazards..

    E ti l S f t

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    Essential Safety

    Requirements

    Design

    Manufacture

    Materials

    Testing

    Marking and Labeling

    Instructions..

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    Standards

    No requirement to use any particularstandard - only to comply with theEssential Safety Requirements.

    CEN have been given a mandate by theCommission to prepare standards thataddress the Directives requirements.

    These Harmonised Standards may not beavailable until about the time the Directivebecomes mandatory..

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    Design

    Design for adequate strength based onappropriate loading

    Design must incorporate appropriatesafety factors

    Design must be based on either:

    calculation method

    experimental method..

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    Design

    Safe handling and operation

    Means of examination

    Means of draining, venting, filling anddischarge

    Corrosion, wear and chemical attack

    Protection against exceeding allowablelimits..

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    Design

    Safety Accessories must be:

    Reliable and suitable for intended duty

    Independent of other functions Pressure limiting devices must prevent the

    max. allowable pressure beingpermanently exceeded

    Temperature monitoring devices musthave adequate response time..

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    Design

    Additional requirements also apply to:

    Fired or otherwise heated equipment

    Piping..

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    Example - Factor of Safety

    97/23/EC: 2.4

    ASME IV: 5

    ASME I/ VIII Div. 1: 4, 3.5

    ASME VIII Div. 2: 3

    Above values are generally consideringUTS, where yield strength governs it maybe different..

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    Manufacturing

    Manufacture must be by appropriatetechniques and procedures

    Joining (welding):

    Must be of equivalent strength as parentmaterial

    By qualified personnel

    Qualified procedures

    Approval of procedure & personnel to becarried out by Notified Body or recognisedthird party for cat II, III and IV equipment..

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    Manufacturing

    Non-destructive examinations must becarried out by qualified personnel,approval for category III & IV to be carried

    out by Recognised third party. Heat treatment, if required, must be

    applied at the appropriate stage in the

    manufacturing process..

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    Manufacturing

    Final Assessment:

    Visual inspection of equipment

    Document review

    Proof pressure test

    Inspection of safety devices..

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    Manufacturing

    Operating instructions must includerelevant safety information on:

    Installation

    Putting into service

    Use

    Maintenance..

    M t i l

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    Materials

    Suitable for intended use and lifetime

    Certified and traceable

    Must either:

    comply with a harmonised standard be subject to a European Approval for

    Materials by a Notified Body

    be subject to a Particular Materials Appraisal( for Cate. III & IV this to be carried out by

    the same Notified Body involved in

    conformity assessment)..

    Materials for construction

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    Materials for construction

    Harmonised

    No

    Particular appraisal

    European approval

    Yes, use straight way,

    None available now

    For category I , by the

    manufacturer For category II,

    III, IV by the Notified Body

    Yes, use straight way

    very few material

    available

    No

    Material

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    Materials

    Main pressure-bearing parts of equipmentin category II, III & IV must have either

    Certificate of specific product control

    where the material manufacturer has an

    appropriate quality-assurance system,

    certified by a competent body..

    Materials for construction

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    Materials for construction

    Must have

    certification

    where the material manufacturer has an appropriate quality-

    assurance system, certified by a competent body

    e.g., ISO 9000 certification.

    Certificate of specific

    product control

    e.g., EN 10204 3.1 C

    Material for category II, III &

    IV

    or

    either

    ASME Materials

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    ASME Materials

    Harmonised

    No

    Particular appraisal

    European approval

    Yes, use straight way

    (None yet)

    For category I , by the

    manufacturer For category II,

    III, IV by the Notified Body

    Yes, use straight way

    (Some material)

    No

    Material

    f

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    European Approval for

    Materials Issued at the request of a manufacture(s)

    of material or equipment by a NotifiedBody.

    NB reviews documentation defining thecharacteristics of materials which are notcovered by any harmonised standard.

    NB advises Member State, the NotifiedBodies and the Commission - published inOfficial Journal..

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    Specific Quantitative

    Requirements For equipment with risk of overheating

    and piping

    Safety factors to be applied for: Allowable stresses

    Weld joint factors

    Pressure surge

    Hydrostatic test pressure..

    Allowable stresses

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    Allowable stresses

    Ferritic steel the lower of:

    2/3 Ret or 5/12 Rm

    Austenitic steel:

    if elongation > 30%: 2/3 Ret

    if elongation > 35%: 5/6 Ret or 1/3 Rmt..

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    Joint coefficients

    100% NDE : 1.0

    Random NDE : 0.85

    No NDE (visual only) : 0.7..

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    Hydrostatic Pressure Test

    The test pressure must be the greater of:

    P = 1.25 x (fa/ft) x PS

    orP = 1.43 x PS..

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    Technical Documentation

    Volume in Litre 1 US gallon = 3.785 l

    Temp in deg. C C = (F-32)/ 1.8

    Nominal size (mm) for piping in DN

    Pressure in bar ( 1 bar = 14.5 psi)

    Mass in kg ( 1 lb = 0.4536 kg)

    Power in kW, Energy in J (1 ft.lbf = 1.356 J)

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    Technical Documentation

    The technical documentation must:

    Demonstrate the conformity of thepressure equipment with the Essential

    Safety Requirements of the Directive.

    Address the design, manufacture andoperation of the pressure equipment.

    Be retained for ten years after the last dateof manufacture..

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    Technical Documentation Contents

    A general description of the equipment

    Conceptual design and manufacturingdrawings

    Details of any standards applied

    Results of calculations etc.

    Test reports..

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    Technical Documentation Contents

    Details of tests and inspections duringmanufacture

    Joining and NDE qualifications and

    approvals

    Details of the Quality ManagementSystem..

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    DESIGN DATA FROM

    VENDOR

    DEPOSITORY

    CERTIFICATE FROM

    CUSTOMER

    DRAWINGS

    DESIGN APPRAISAL FROM NOTIFIED BODY

    DESIGN CALCULATIONS AS PER

    INTERNATIONAL STANDARD

    PARTICULAR MATERIAL APPRAISAL

    HAZARD ANALYSIS

    INSTRUCTIONMANUAL

    MANUFACTURING & PURCHASING

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    Graphite

    Fabrication

    Steel

    Fabrication

    Purchasing

    Bought-outs

    Permanent Jointing

    procedure &

    Qualification

    Imperviousness Test

    Reports of

    Components

    Material Heat chart

    Material Heat Chart

    Production Test coupon report

    Weld Coupon, Permanent Jointing

    procedure & Qualification

    Radiographic layout & reports

    Visual Inspection Reports

    Pad test report

    Material Heat Chart

    FINAL ASSEMBLY

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    FINAL HYDROTEST & DIMENSIONAL REPORT BY US

    FINAL INSPECTION REPORT BY LLOYDS

    RUB OFF STAMPING & PHOTOCOPY OF NAME PLATE

    AS BUILT DRAWING

    DECLARATION OF CONFORMITY BY US.

    FINAL DOCUMENTATION

    FINAL INSPECTION REPORT BY LLOYDS

    CE CERTIFICATE BY NOTIFIED BODY

    Design Documents Instruction Manual

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    Conformity Assessment

    Based on Council Decision 93/465/EECModules

    Choice of modules depending on category

    ranging from:

    self- certification;

    third party inspection, by Notified Body;

    quality assurance;

    combination..

    PRESSURE EQUIPMENT CLASSIFICATION

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    PRESSURE EQUIPMENT CLASSIFICATION

    AND CONFORMITY ASSESSMENT

    PS > 0.5bar

    Excluded from PEDAnnex A

    PED does not apply

    PED does not apply

    NO

    YES

    YES

    Type of PE

    NO

    AssembliesPressure AccessoriesSafety Accessories

    Vessel Steam Generator Piping

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    STEAM GENERATORS

    CategorySEP

    IIIIIIIV

    Module (Annex E)Sound Engineering Practice

    AA1, D1, E1

    B1+D, B1+F, B+E, B+C1,HB+D, B+F, G, H1

    Choose the required module for the categoryZ

    Determine conformity assessment category

    Determine PS (bar) and Volume (L)

    Chart 5

    From accessories

    and assemblies

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    PIPINGDetermine state of

    fluid contentsY

    Group 1

    Gas

    Chart 7Chart 6

    Group 2

    CategorySEP

    IIIIIIIV

    Module (Annex E)Sound Engineering Practice

    AA1, D1, E1

    B1+D, B1+F, B+E, B+C1,HB+D, B+F, G, H1

    Choose the required module for the categoryZ

    Determine conformity assessment category

    Determine fluid group

    Determine PS (bar) and nominal size DN

    Group 1

    Liquid

    Chart 9Chart 8

    Group 2

    Determine fluid group

    From accessories

    and assemblies

    PRESSURE ACCESORIES

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    PRESSURE ACCESORIES

    The nominal size DN and the volumeare equally appropriate

    Compare the output category starting from X,

    with that from Y and take the higher category

    Go to Z

    The nominal size DN ismore appropriate the volume

    The volume ismore appropriate the DN

    Go to X

    Go to Y

    Yes

    Yes

    No

    No

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    SAFETY ACCESSORIES

    Classified in the samecategory as the

    equipment it protects

    Manufactured forspecific equipment

    Yes No

    Choose a module

    from Category IV

    Choose the required module for the category

    CategorySEP

    IIIIII

    IV

    Module (Annex E)Sound Engineering Practice

    AA1, D1, E1

    B1+D, B1+F, B+E, B+C1,H

    B+D, B+F, G, H1

    Z

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    ASSEMBLIES

    Assessment of each item in the assembly accordingto its category

    Assessment of the integration of its componentsagainst sections 2.3, 2.8 and 2.9 of the Essential

    Safety Requirements as determined by the highestcategory applicable to the items.Other than for safety Accessories.

    Assessment of the protection of an assembly against

    exceeding the permissible operating limits asreferred in sections 2.10 and 3.2.3 of the EssentialSafety Requirements

    Go to Z

    C t I

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    Category I

    A - Manufacturers declaration

    Notified Bodys involvement notrequired..

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    Category II (Any one module)

    A1 - Manufacturers declaration withmonitoring of final inspection

    D1 - Production quality assurance: ISO 9002

    E1 - Product quality assurance: ISO 9003..

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    Category III (Any one block of modules)

    B1 - Design examinationD - Production quality assurance (ISO 9002)

    B1 - Design examinationF - Product verification

    B - Type examinationE - Product quality assurance (ISO 9003)

    B - Type examinationC1 - Monitoring of final inspection

    H - Full quality assurance (ISO 9001)..

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    Category IV (Any one block of modules)

    B - Type examination

    D - Production quality assurance (ISO 9002)

    B - Type examination

    F - Product verification

    G - Unit verification

    H1 - Full quality assurance (ISO 9001) withdesign examination and special

    surveillance of the final inspection..

    NBs Involvement

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    Category I - No NB involvement

    Category II - QA Approval orSurveillance by NB

    Category III - Type or design Exam. and

    surveillance by NB or QAApproval

    Category IV - Type Examination andverification by NB or QAApproval (plus additionalrequirements)..

    Sound Engineering Practice

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    g g

    applies to equipment with PS or V or

    diameter below specified thresholds

    design and manufacture in accordancewith sound engineering practice of a

    Member State must have adequate instructions for use

    manufacturer must be identified

    no Notified bodys involvement

    does not have CE Marking applied..

    C

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    CE Marking

    The CE marking must not be smaller than5 mm.

    The CE marking must be accompanied bythe identification of the notified bodyinvolved at the production control stage..

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    CE Marking

    Must be accompanied by name and address of manufacturer

    year of manufacture

    identification (serial no, batch...) essential min./max. allowable limits

    Any information or warnings necessary

    for safe operation..

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    Declaration of Conformity

    Name and address of manufacturer

    Description of equipment or assembly

    Conformity assessment procedurefollowed

    Name and address of any Notified Bodies

    Reference to any EC Certification..

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    Declaration of Conformity

    Harmonised Standards applied

    Other standards applied

    Other applicable EC Directives Particulars of person signing declaration..

    S f C

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    Safeguard Clause Member State may withdraw or prohibit

    placing on market, putting into service oruse of equipment bearing CE mark andused as intended, which it considers

    unsafe.

    Member State must advise Commission ofmeasures taken, with reasons.

    If justified: Commission consults withparties concerned. If not: all MemberStates and specific manufacturer advised

    of findings..

    Conclusion

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    Conclusion

    The Directive will be law in all MemberStates

    Manufacturer will be responsible forcomplying with the Directive

    The Directive aims to harmonise existingsafe practice

    The Directive requires set documentation

    Apply common sense