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WP.6 SIEEE UNECE WP.6 SIEEE A global regulation approach 1. 2. 3. 4. 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 Regulation Up to the seventies “Old” “New” Approach Common Regulatory Objectives (CRO)? Standardization DIN DKE CEN Cenelec ISO IEC Certification Product Product Product + Production Product + Production Some basics of Ex-Equipment Levels Certification by Third Party Very High risk Zone 0 High risk Zone 1 Normal risk Zone 2 Yes Yes Yes/No 2. UNECE WP.6 SIEEE 2. UNECE WP.6 SIEEE Diagramm WP.6 Sector Initiatives Legal Metrology 2. UNECE WP.6 SIEEE 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 Paris Discussions of the answers of the Questionnaire 2008 Geneva Preparation of the Terms of Reference 2009 Stockholm Discussions about the approach of the CRO 2009 Melbourne Preparation of the CRO (proposal) 2009 Geneva Presentation of the Common Regulatory Objectives 2010 Berlin Presentation of the Workshop-Concept 2011 Split Presentation 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 Placing on the market IEC 60079-0 ISO/IEC 80079-0 Market Surveillance Repair ExEquipment IEC 60079-19 IEC 60079-17 Operator Life cycle approach Inspection and Maintenance Installation IEC 60079-10 IEC 60079-14 Regulators Jurisdiction 2. UNECE WP.6 SIEEE CRO Part 1: Requirement for the equipment Placing on the market » Elimination of possible ignition sources in accordance to intended use of the equipment, typical ignition sources are: » Hot surfaces EN 1127-1 » Electrical sparks 13 Ignition sources » Mechanical sparks » Electrostatic » Validated protection concepts (“Types of Protection”) have to be applied IEC/ISO 60079-”X” / 80079-”X” » 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) 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) Ex d e IIC T3 Gb » IEC-Zone Classification Concept (Zones for Gas and Dust) with the applicable Equipment Protection Levels IEC 60079 -10 » The equipment and its installation need to be inspected and maintained IEC 60079 -14, -17,-19 » 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” 2. UNECE WP.6 SIEEE CRO Part 1 and 2: Testing Production ISO/IEC 17025 IECEx 02 Certification ISO Guide 65 / 67 [ISO/IEC 17065] IECEx 02 ISO/IEC 17021 IEC ISO IECEx Service IECEx 03 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 » IECEx are 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 DubaiW 2012 W W 2012 Singapur W2013 Rio 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” Marketsurveillance Regulator Regulation Certif. Bodies “Test Labs” 1. 2. Manufacturer Definition/Jurisdiction a) Market Surveillance b) Certification Bodies c) Manufacturer d) Operator Interaction a. Cert. B. ↔ Manu. b. Manu. ↔ Oper. c. MS ↔ Oper. d. MS ↔ Manu. e. MS ↔ Insp. B. f. Cert. ↔ Insp. B. 3. IECEx IEC Structure IEC COUNCIL National Committees EXECUTIVE COMMITTEE (IEC Officers) COUNCIL BOARD MARKET STRATEGY BOARD Central Office (The Executive) Management Advisory Committees STANDARDIZATION MGMT BOARD CONFORMITY ASSESSMENT BOARD Management of International Consensus Standards Work Management of CA policy and Systems Current Systems SWG EEE Technical Committees IECEE SWG SLCA Tech. Advisory Cttees IECEx SWG Tech Watch Industry Sector Boards IECQ OIMLIECMoU 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 of demonstrating 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 2011 2010 2009 2007 2003 2002 2000 1999 1997-99 1996 1992 > 15’000 Reports and Certificates issued New Ex Certified Persons Scheme Launched UN Formal Endorsement of IECEx, via UNECE New Ex Scheme for Services/Repairs Commenced + IECEx Mark Of Conformity Introduced 1st IECEx Certificate issued via “On-Line” System Decision to move to next stage (issue IECEx Certificates) Exchange of Ex Test Reports Commence (no IEC Certificate) Commence Initial Phase (Transitional Arrangements) Develop Initial Structure + CB/ExTL qualification requirements 1st Meeting of the New Management Committee (Comprising TC 31 Experts) Concept of IEC International Scheme for Ex Considered by IEC TC 31 + Agreed IECEx Management and Governance Structure Standards Work STANDARDS MANAGEMENT BOARD (SMB) Conformity Assessment work CONFORMITY ASSESSMENT BOARD (CAB) IEC ExMC IEC TC 31 IEC TC 31 PTs, MTs, SCs Management Committee Member Countries IECEx ExTAG all ExCBs and ExTLs represented IECEx Marks Committee Set Policy and Oversees Systems Coordination Role for day to day Management, finance approves Rules,, CBs, TLs Comprise Industry experts CB Committee - Ensure common approach to Certification, eg Standard Test Report Forms, ExTRs, Decision Sheets Oversee operation of Mark License system Comprise industry experts 3. IECEx To view on-line certificates 24 3. IECEx IECEx - Certificates Type 5 Ex Equipment, Components + Systems Ex Equipment Unit Verification Ex Equipment Mark License Ex Services, eg Repair to IEC 60079-19 + Installation coming Ex Competent Person 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?