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WP.6 SIEEE. UNECE WP.6 SIEEE A global regulation approach. Introduction UNECE WP.6 SIEEE IECEx-Scheme Conclusion and Discussion. Frank Lienesch Physikalisch-Technische Bundesanstalt. 1. Introduction. Interest of the Industry using Ex-Products.
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WP.6 SIEEE UNECE WP.6 SIEEE A global regulation approach • Introduction • UNECE WP.6 SIEEE • IECEx-Scheme • Conclusion and Discussion Frank Lienesch Physikalisch-Technische Bundesanstalt
1. Introduction Interest of the Industry using Ex-Products • Users in the chemical and petroleum industry act more and more • globally with a single engineering approach for their plants • to earn savings of engineering, installation and maintenance costs • to buy the equipment in a larger number and to get a better price per piece • to have benefit from the global competition under manufacturers • Barriers against this tendency are domestic rules and regulations • which require special engineering for the plants from country to • country.
1. Introduction Interest of the Industry manufacturing Ex-Products • Manufacturers want to sell and manufacture their products • without additional national differences for the product and delays to the market • in accordance to one global standard (IEC / ISO) • without double-testing of their product • without formal restrictions to place it on the market Barriers against this tendency are domestic rules and regulations which require special differences for the product from country to country.
1. Introduction History/Structure National European International Up to the seventies “Old” “New” Approach Common RegulatoryObjectives (CRO)? Regulation Standardi- zation DIN DKE ISO IEC CEN Cenelec Product + Production Product + Production Certification Product Product Some basics of Ex-Equipment Levels Very High risk Zone 0 High risk Zone 1 Normal risk Zone 2 Certification by Third Party Yes Yes Yes/No
2. UNECE WP.6 SIEEE Diagramm WP.6 Sector Initiatives Legal Metro-logy
2. UNECE WP.6 SIEEE Sector Initiative on Equipment for Explosive Environments (SIEEE) Status Report: • Kick off meeting 2007 in Geneva Presentations of the various systems, Questionnaire • 2008 ParisDiscussions of the answers of the Questionnaire • 2008 GenevaPreparation of the Terms of Reference • 2009 StockholmDiscussions about the approach of the CRO • 2009 MelbournePreparation of the CRO (proposal) • 2009 Geneva Presentation of the Common Regulatory Objectives • 2010 BerlinPresentation of the Workshop-Concept • 2011 SplitPresentation of various Regulation Systems and Market Surveillance Aspects
2. UNECE WP.6 SIEEE Intention of the Common Regulatory Objectives (CRO) • to cover comprehensively all relevant issues in order to achieve an globally accepted safety level • to provide a global „Best Practice“ model as a template for national regulation • Focus to the main objectives • Easy to understand • Open for national modifications • Specify the distributed roles and related responsibilities of the involved parties: • Regulator • Market Surveillance • Certification Body • Manufacturer • End user • Open for ongoing maintenance and modification
2. UNECE WP.6 SIEEE Intention of the Common Regulatory Objectives (CRO) Manufacturer IEC 60079-0 ISO/IEC 80079-0 Placing on the market Market Surveillance Ex- Equipment Repair Installation IEC 60079-19 IEC 60079-10 IEC 60079-14 IEC 60079-17 Inspection and Maintenance Operator Regulators Jurisdiction Life cycle approach
2. UNECE WP.6 SIEEE CRO Part 1: Requirement for the equipmentPlacing on the market • Elimination of possible ignition sources in accordance to intended use of the equipment, typical ignition sources are: • Hot surfaces • Electrical sparks • Mechanical sparks • Electrostatic • Validated protection concepts (“Types of Protection”) have to be applied • Instructions (manual) about the intended use, installation and repair • Conformity assessment procedure in accordance to an international certification scheme such as IECEx (IECEx procedure can be seen as a reference) EN 1127-1 13 Ignition sources IEC/ISO 60079-”X” / 80079-”X”
2. UNECE WP.6 SIEEE CRO Part 2: Safe use of the equipment • Classification of the substances in accordance to: • Ignition Temperature • Explosions Groups (Ignition Energy) • IEC-Zone Classification Concept (Zones for Gas and Dust) with the applicable Equipment Protection Levels • The equipment and its installation need to be inspected and maintained • Requirements for the competency of persons (selection, installation, use of the equipment) • Requirements for service facilities (e.g. repair workshops) • The Explosion risk assessment of an individual plant needs to be documented in the “Explosion Protection Document” Ex d e IIC T3 Gb IEC 60079 -10 IEC 60079 -14, -17,-19
2. UNECE WP.6 SIEEE CRO Part 1 and 2: Testing Production ISO/IEC 17025 IECEx 02 ISO/IEC 17021 IEC ISO IECEx Service Certification IECEx 03 ISO Guide 65 / 67 [ISO/IEC 17065] IECEx 02 Persons Competency ISO/IEC 17024 IECEx 05
2. UNECE WP.6 SIEEE CRO Part 3: Standards reference list • Accepted Standards (ISO/IEC) are listed in an annex to the regulation • The standards has to be accepted by a Standard Acceptance Group • After the acceptance the Standards can be applied by manufacturers and end users to show compliance with the regulation • All countries which have implemented the Regulation enjoy the advantages like barrier free trade of explosion protected equipment and equal conditions for operating a plant bearing explosion risks
2. UNECE WP.6 SIEEE CRO Part 4: Conformity assessment bodies • The accreditation body has to be a member of ILAC/IAF • The accreditation of • Conformity Assessment Bodies • Test Laboratories has to follow the applicable ISO/IEC-Standards • One member of the assessor team needs competence in the field of explosion protection (see e.g. the list of approved IECEx assessors). • Procedures and Rules of the IEC Conformity Assessment System IECEx is to take as a reference for conformity assessment
2. UNECE WP.6 SIEEE CRO Part 5: Steering Committee • An Explosion Protection Steering Committee is to formed and operated under the umbrella of UNECE WP.6 (ExSC) to monitor the application experiences • All member having implemented the CROs can participate in the Explosion Steering Committee (ExSC) • ExSC notifies the members of the Standard Acceptance Group • Observers like • Standardization Organization (IEC/ISO) • Market Surveillance • IECExare also invited to attend the meetings
2. UNECE WP.6 SIEEE CRO Part 6: Market surveillance • A Market Surveillance network specialized in Ex-Equipment is to be formed and operated (UNECE-ExMars) • For critical non-conformance of Ex-Equipment an Alert-System is necessary Ex - Market Surveillance Concept based on the general concept of the „MARS“ Group • Strategy: • Developing a general procedure for market surveillance (GMSP) • Increasing cooperation with stakeholders and sharing the work of Market Surveillance internationally • Increasing the visibility of Market Surveillance to the outside world
2. UNECE WP.6 SIEEE The workshop idea: Regulators Dialogue Group W W W Dubai 2012 W Singapur 2012 W W Rio 2013 • Outputs: • Comprehensive description of the methodology of the system • Guidance documents for the various stakeholders (Regulators, Market Surveillance, Manufacturer, Operator, Inspection bodies)
2. UNECE WP.6 SIEEE Interaction/Relationship within the SIEEE-System Operator“User” Market- surveillance • Definition/Jurisdiction • Market Surveillance • Certification Bodies • Manufacturer • Operator • Interaction • Cert. B. ↔ Manu. • Manu. ↔ Oper. • MS ↔ Oper. • MS ↔ Manu. • MS ↔ Insp. B. • Cert. ↔ Insp. B. Regulator Regulation Certif. Bodies “Test Labs” Manufacturer
Central Office (The Executive) Management Advisory Committees MARKET STRATEGY BOARD STANDARDIZATION MGMT BOARD Management of International Consensus Standards Work Technical Committees SWG EEE Tech. Advisory Cttees SWG SLCA Industry Sector Boards SWG Tech Watch 3. IECEx IEC Structure IEC COUNCIL National Committees EXECUTIVE COMMITTEE (IEC Officers) COUNCIL BOARD CONFORMITY ASSESSMENT BOARD Management of CA policy and Systems OIML-IEC- MoU Current Systems IECEE IECEx IECQ
3. IECEx What is IECEx? The single International IEC System with Schemes covering Certification to Standards that relate to Equipment and Services in areas relating to Explosive Atmospheres, to provide an Internationally accepted means ofdemonstrating claimed compliance with International Standards IECEx is a “Conformity Assessment Tool” providing confidence that Products, Services and Personnel covered by an IECEx Certificate meet specified requirements, (International Standards) “IECEx is the International Standard way of doing Ex Certification”
3. IECEx Outline of IECEx History - Timeline > 15’000 Reports and Certificates issued 2011 New Ex Certified Persons Scheme Launched 2010 UN Formal Endorsement of IECEx, via UNECE 2009 New Ex Scheme for Services/Repairs Commenced + IECEx Mark Of Conformity Introduced 2007 1st IECEx Certificate issued via “On-Line” System 2003 Decision to move to next stage (issue IECEx Certificates) 2002 Exchange of Ex Test Reports Commence (no IEC Certificate) 2000 Commence Initial Phase (Transitional Arrangements) 1999 Develop Initial Structure + CB/ExTL qualification requirements 1997-99 1st Meeting of the New Management Committee (Comprising TC 31 Experts) 1996 Concept of IEC International Scheme for Ex Considered by IEC TC 31 + Agreed 1992
IECEx Management and Governance Structure Conformity Assessment work Standards Work CONFORMITY ASSESSMENT BOARD (CAB) STANDARDS MANAGEMENT BOARD (SMB) Set Policy and Oversees Systems Coordination Role for day to day Management, finance approves Rules,, CBs, TLs Comprise Industry experts IEC ExMC Management Committee Member Countries IEC TC 31 CB Committee - Ensure common approach to Certification, eg Standard Test Report Forms, ExTRs, Decision Sheets IEC TC 31 PTs, MTs, SCs IECEx ExTAG all ExCBs and ExTLs represented IECEx Marks Committee Oversee operation of Mark License system Comprise industry experts
3. IECEx To view on-line certificates 24
3. IECEx IECEx - Certificates Ex Equipment Unit Verification Ex Services, eg Repair to IEC 60079-19 + Installation coming Ex Competent Person Ex Equipment, Components + Systems Ex Equipment Mark License Type 5 25
4. Conclusion and Discussion • Key elements: • Accreditation of Conformity Assessment Bodies : • ILAC/IAF, • Competent Assessor • Certification of Product and Production: • Type 5 (17067), Intercomparisons • Accepted and Listed Standards (Procedures) • Market Surveillance: • Alert-System for non-conformance, Communication platform • Regulation: • Steering Committee + Observers • Problems: • National Variation, National Acceptance, Peer Assessment … => Sector Initiative Legal Metrology of UNECE WP.6?