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The UNECE Sectoral Initiative on Equipment for
Explosive Environments
A global legislative framework for Explosion Protection
The comprehensive approach of the
UNECE Model L Regulation
Why is the UN here?
• The UN aims at protecting the safety of workers,
citizens, consumers: Repeated testing means that
safe and reliable equipment is unaffordable for
countries that need it the most
• The UN promotes the participation of developing
countries and countries in transition in international
trade: Barriers to trade are lost opportunities for our
membership
1. Introduction
UNECE: A bit of history
• Created in 1947
• Original mission: To assist in the reconstruction and economic
development of post-war Europe
• UNECE was an important bridge between the two sides of the
Iron Curtain: this is why many technical issues are discussed
here
• Since the end of the cold war: integration of the newly formed
Central and Eastern European countries into the world economy
• Many UNECE deliverables are developed by top worldwide
experts and have global relevance
1. Introduction
UNECE Work Areas
Transport
Economic cooperation Statistics
Sustainable
energy
Housing
Trade
Environmental policy
Forests & timber
1. Introduction
1. Introduction
UNECE Working Party on Regulatory Cooperation and
Standardization Policies (WP. 6)
What we are:
• Intergovernmental body
• Participation by: authorities, regional & int’l organizations, business,
standards-setting bodies, certification bodies, test houses, civil society
• 1970 – 2015: 45 years
Our mandate:
• Forum for dialogue on:  Standardization  Technical regulations 
Conformity assessment  Accreditation  Metrology  Market
surveillance
Our activities:
• Share info & best practice
• Capacity-building
• Develop and maintain a set of recommendations
• Implement a set of initiatives on specific industrial sectors
1. Introduction
WP. 6 Main areas of work
Sectoral initiatives:
• Develop a common regulatory framework in specific sectors
• So far: Telecommunications, Earth-moving equipment, ExEquipment,
Pipeline Safety
Market surveillance:
• Develop and share best practice/Recommendations
• New recommendation on “Market Surveillance Policies”
• Develop a common terminology
• Advisory services/technical assistance
• Worldwide database of market surveillance authorities
Risk Management:
• Best practice/Recommendation on using risk management tools in
developing and implementing regulations
• 2 Recommendations on “Crisis Management” and “Risk management in
Regulatory systems”
• Book on “Risk Management in Regulatory Systems”
• Participation in the work of the ISO 31004
1. Introduction
WP.6 works towards
better and convergent regulations
• In sectors of high concern
• Governments define “common regulatory objectives” i.e.
they define legitimate government concerns (public health,
safety, protection of the environment, interoperability, etc)
• And agree on how to reach them
• By reference to international standards
• Specifying:
– how compliance is assessed
– which conformity assessment bodies are recognized as
competent,
– what competence criteria are to be fulfilled
1. Introduction
1. Introduction
…
1. Introduction
• Tabled for revision in November 2015
• A set of tools
• Countries can use to harmonize their technical
regulations and regulatory systems in any sector at a
regional or global level
• It has also been used to harmonize regulations in all
sectors between two countries or within a customs
union
• Builds on the principles of the WTO TBT Agreement
but goes further
Recommendation L
1. Introduction
In practice:
• Authorities decide to work together on a specific sector
• They agree on CROs
• They transpose the CROs into national technical
regulations
• Then, when products have been assessed in the
exporting country as compliant with the CROs they can
automatically be sold in other markets with no further
assessment.
1. Introduction
1. Introduction
ORGANIZATIONAL CHART OF THE WORKING PARTY
Working Party on Regulatory Cooperation & Standardization Policies
Chair: Ms. Marion Stoldt (Germany)
Vice-Chair: Mr. V.N. Koreshkov (Belarus)
Vice-Chair: Mr. M. Chloupek (Czech Republic)
MARS Group
Chair: Mrs. V. Despotovic
(Republic of Serbia)
START Team
Chair: Mr. C. Arvius, Special
Advisor to the Bureau (Sweden)
Group of Experts on
Risk Management
Chair: Mr. Kevin Knight
Coordinator: Mr. V. Nikonov
Mr. D. Macrae
Telecom Initiative
Coordinator:
Mr. P. Dofnas (Ericsson)
Earth-moving Initiative:
Coordinator: Mr. D. Roley
Equipment for
Explosive Environment
Initiative
Coordinator: Mr. F.Lienesch
(Germany)
Pipeline Safety Initiative
Acting Chair: Mr. Roman
Samsonov (Russia)
General Market Surveillance
Initiative:
Coordinator: Mr. I. Hendrikx
1. Introduction
 Kick off meeting 2007 in Geneva
Presentations of the various systems, Questionnaire
 2008 Geneva
Preparation of the Terms of Reference
 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
 2012 Dubai First Workshop
and at PCIC (Prague) a joint UNECE-IECEx-Paper
 2013 Fortaleza Update Questionnaire (Translation Spanish and Portuguese)
and the EU-Russia Industrialists’ Round Table (IRT)
 2014 Kuala Lumpur
Sector Initiative on Equipment for Explosive Environments (SIEEE)
Status Report:
1. Introduction
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
Fundament
Construction
Protection
Regulation
Manufacturer
Certification
Operator
Market
Surveillance
Knowledge, Research, Development
Principal of Ex-Business
Operation
Product
Standardization
1. Introduction
History/Structure
National InternationalEuropean
Up to the
seventies
Regulation
Standardi-
zation
“Old” “New”
Approach
Common Regulatory
Objectives (CRO)?
DIN DKE CEN Cenelec ISO IEC
Product
+
Production
Certification Product
+
Production
ProductProduct
Some basics of Ex-Equipment
Very High risk
Zone 0
Normal risk
Zone 2
High risk
Zone 1
Levels
Certification
by
Third Party
Yes Yes Yes/No
1. Introduction
Installation
Maintenance
Repair
Intention of the Common Regulatory Objectives (CRO)
 to cover comprehensively all relevant issues
in order to achieve a globally accepted safety level
 to provide a global „Best Practice“ model as 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/Operator
 Open for ongoing maintenance and modification
2. Common Regulatory Objectives
White paper approach
Intention of the Common Regulatory Objectives (CRO)
Ex-Equipment
(Installed basis)
Installation
Inspection and
Maintenance
Repair
Life cycle approach
Market Surveillance
Regulators JurisdictionOperator
Manufacturer Placing on the
market
Zone classification
(“Risk Assessment”)
EN/IEC 60079-ff
EN/IEC 80079-ff
EN/IEC 60079-10
EN/IEC 60079-14
EN/IEC 60079-17
EN/IEC 60079-19
2. Common Regulatory Objectives
Interaction/Relationship within the SIEEE-System
1. Definition/Jurisdiction
a) Market Surveillance
b) Certification Bodies
c) Manufacturer
d) Operator
2. Interaction
a. Cert. B. ↔ Manu.
b. Manu. ↔ Oper.
c. MS ↔ Oper.
d. MS ↔ Manu.
e. MS ↔ Insp. B.
f. Cert. B.↔ Insp. B.
Regulation
Market-
surveillance
Certification
Bodies
Operator
Manufacturer
2. Common Regulatory Objectives
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
» 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)
13 Ignition sources
IEC/ISO 60079-”X” / 80079-”X”
IECEx-02
IEC/ISO 60079-”X” / 80079-”X”
2. Common Regulatory Objectives
CRO Part 2: Safe use of the equipment
» Classification of the explosive 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
IECEx-05
IECEx-03
2. Common Regulatory Objectives
IEC
ISO
IECExCertification
Testing
Persons
Competency
ISO Guide 65 / 67
[ISO/IEC 17065]
IECEx 02
ISO/IEC 17025
IECEx 02
Service
IECEx 03
ISO/IEC 17024
IECEx 05
Production
ISO/IEC 17021
CRO Part 1 and 2:
2. Common Regulatory Objectives
CRO Part 3: Standards reference list
» Accepted Standards (ISO/IEC) are listed in an annex to the regulation
(State of the Art)
» 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. Common Regulatory Objectives
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. Common Regulatory Objectives
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. Common Regulatory Objectives
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. Common Regulatory Objectives
Procedure for the Regulation
Example: Standardization
IEC/ISO: DC, CD,
CDV -Standard
Mandate
Manufacturer
Regulator
Operator
Certification Body
Consultant
(UNECE- Steering Committee)
FDIS -
Standard
Accepted
Standard
3. Procedures
Manufacturer
Operator
Certification Body
Notify
Procedure for Manufacturer
Example: placing on the market
Product, Manual
Import
Production
Assessment
Manufacturer
Certification
Body
Operator
Certification
Body
Dealer
Export
2. Manufacturer
Buy
Own product
development
3. Procedures
Procedure for Certification Bodies
Examples: Accreditation
Certification
Body
Product
Personal competency
Service facilities
Repair shops
Regulator
Accreditation
Body (ILAC/IAF)
Production Audit
Comparison /
Proficiency testing
3. Procedures
Procedure for Ex-market surveillance (Ex-GMSP)
Example: Possibly faulty product
Possibly faulty
product
Market
Surveillance
Accident
Operator
Competitor Manufacturer
Certification
Body
Result with
Consequences
Independent
Certification Body
(Notified by Regulation)
Support
Inspection
3. Procedures
Procedure for Ex-market surveillance (Ex-GMSP)
Example: Alert System, Arbitration board,…
Product
Market
Surveillance
Manufacturer
Certification
Body
Faulty
product
Regulator
(Steering Committee)
Withdraw Withdraw
Certificate
Web Publication
of the Product
3. Procedures
Guidelines for the Ex-Market Surveillance
Contents:
1. Introduction:
2. Actions of the MS
2.1 Pro Active
2.2 Reactive
3. Cooperation and Exchange of Experience (with other stakeholder)
3.1 Internet-Platform
3.2 Arbitration Board
3.3 Alert-System
4. Definition of Ex-Products and the boundary conditions
4.1 Zone Concept (Essential Requirements)
4.2 Types of Protection (Applicable Standards)
5. Explanation of the objectives of the surveillance activities (Compliance Criteria)
5.1 Labeling and Conformity Declaration
5.2 Manual
5.3 Technical Inspection
6. List of References
3. Procedures
Procedure for Operators
Examples: Operation of a plant, Maintenance, Repair, Training, …
Product
Regulation
Inspector
Operator
Explosion Protection
Document
Manufacturer
Installation
Initial
Inspection
Repair
Overhaul
Operators Personnel
Service Provider
Documentation
of each Product
Inspection
Maintenance
Operators Personnel
Service Provider
3. Procedures
The workshop idea: Regulators Dialogue Group
Dubai 2012
Fortaleza 2013
Kuala Lumpur 2014
Outputs:
• Comprehensive description of the methodology of the system
• Guidance documents for the various stakeholders (Regulators,
Market Surveillance, Manufacturer, Operator, Inspection bodies)
4. Summary
Den Haag 2014
Gdansk 2015
4. Summary
6 Common Regulatory Objectives
Regulation
Certification
ExNB
European Commission
UNECE WP.6 (UNECE-ExSC)
TC 305
TC 31
Ex-Dienst
Namur
ADCO
BG
ZVEI
IECEx
VDMA
CENELEC
CEN
IEC/ISO
UNECE-
MARS
Orgalime
United Nation
UNECE
United Nations Economic
Commission for Europe
Working Party 6
SIEEE
Sector Initiative Equipment
Explosive Environments
Common Regulatory Objectives
One of Five Regional Commissions
56 Countries
One of X Working
Parties
One of Four Initiatives
Integrates 193 Nations
4. Summary
4. Summary

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The UNECE Sectoral Initiative on Equipment for Explosive Enviroments

  • 1. The UNECE Sectoral Initiative on Equipment for Explosive Environments A global legislative framework for Explosion Protection The comprehensive approach of the UNECE Model L Regulation
  • 2. Why is the UN here? • The UN aims at protecting the safety of workers, citizens, consumers: Repeated testing means that safe and reliable equipment is unaffordable for countries that need it the most • The UN promotes the participation of developing countries and countries in transition in international trade: Barriers to trade are lost opportunities for our membership 1. Introduction
  • 3.
  • 4. UNECE: A bit of history • Created in 1947 • Original mission: To assist in the reconstruction and economic development of post-war Europe • UNECE was an important bridge between the two sides of the Iron Curtain: this is why many technical issues are discussed here • Since the end of the cold war: integration of the newly formed Central and Eastern European countries into the world economy • Many UNECE deliverables are developed by top worldwide experts and have global relevance 1. Introduction
  • 5. UNECE Work Areas Transport Economic cooperation Statistics Sustainable energy Housing Trade Environmental policy Forests & timber 1. Introduction
  • 7. UNECE Working Party on Regulatory Cooperation and Standardization Policies (WP. 6) What we are: • Intergovernmental body • Participation by: authorities, regional & int’l organizations, business, standards-setting bodies, certification bodies, test houses, civil society • 1970 – 2015: 45 years Our mandate: • Forum for dialogue on:  Standardization  Technical regulations  Conformity assessment  Accreditation  Metrology  Market surveillance Our activities: • Share info & best practice • Capacity-building • Develop and maintain a set of recommendations • Implement a set of initiatives on specific industrial sectors 1. Introduction
  • 8. WP. 6 Main areas of work Sectoral initiatives: • Develop a common regulatory framework in specific sectors • So far: Telecommunications, Earth-moving equipment, ExEquipment, Pipeline Safety Market surveillance: • Develop and share best practice/Recommendations • New recommendation on “Market Surveillance Policies” • Develop a common terminology • Advisory services/technical assistance • Worldwide database of market surveillance authorities Risk Management: • Best practice/Recommendation on using risk management tools in developing and implementing regulations • 2 Recommendations on “Crisis Management” and “Risk management in Regulatory systems” • Book on “Risk Management in Regulatory Systems” • Participation in the work of the ISO 31004 1. Introduction
  • 9. WP.6 works towards better and convergent regulations • In sectors of high concern • Governments define “common regulatory objectives” i.e. they define legitimate government concerns (public health, safety, protection of the environment, interoperability, etc) • And agree on how to reach them • By reference to international standards • Specifying: – how compliance is assessed – which conformity assessment bodies are recognized as competent, – what competence criteria are to be fulfilled 1. Introduction
  • 12. • Tabled for revision in November 2015 • A set of tools • Countries can use to harmonize their technical regulations and regulatory systems in any sector at a regional or global level • It has also been used to harmonize regulations in all sectors between two countries or within a customs union • Builds on the principles of the WTO TBT Agreement but goes further Recommendation L 1. Introduction
  • 13. In practice: • Authorities decide to work together on a specific sector • They agree on CROs • They transpose the CROs into national technical regulations • Then, when products have been assessed in the exporting country as compliant with the CROs they can automatically be sold in other markets with no further assessment. 1. Introduction
  • 14. 1. Introduction ORGANIZATIONAL CHART OF THE WORKING PARTY Working Party on Regulatory Cooperation & Standardization Policies Chair: Ms. Marion Stoldt (Germany) Vice-Chair: Mr. V.N. Koreshkov (Belarus) Vice-Chair: Mr. M. Chloupek (Czech Republic) MARS Group Chair: Mrs. V. Despotovic (Republic of Serbia) START Team Chair: Mr. C. Arvius, Special Advisor to the Bureau (Sweden) Group of Experts on Risk Management Chair: Mr. Kevin Knight Coordinator: Mr. V. Nikonov Mr. D. Macrae Telecom Initiative Coordinator: Mr. P. Dofnas (Ericsson) Earth-moving Initiative: Coordinator: Mr. D. Roley Equipment for Explosive Environment Initiative Coordinator: Mr. F.Lienesch (Germany) Pipeline Safety Initiative Acting Chair: Mr. Roman Samsonov (Russia) General Market Surveillance Initiative: Coordinator: Mr. I. Hendrikx
  • 16.  Kick off meeting 2007 in Geneva Presentations of the various systems, Questionnaire  2008 Geneva Preparation of the Terms of Reference  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  2012 Dubai First Workshop and at PCIC (Prague) a joint UNECE-IECEx-Paper  2013 Fortaleza Update Questionnaire (Translation Spanish and Portuguese) and the EU-Russia Industrialists’ Round Table (IRT)  2014 Kuala Lumpur Sector Initiative on Equipment for Explosive Environments (SIEEE) Status Report: 1. Introduction
  • 18. 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
  • 19. 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
  • 21. History/Structure National InternationalEuropean Up to the seventies Regulation Standardi- zation “Old” “New” Approach Common Regulatory Objectives (CRO)? DIN DKE CEN Cenelec ISO IEC Product + Production Certification Product + Production ProductProduct Some basics of Ex-Equipment Very High risk Zone 0 Normal risk Zone 2 High risk Zone 1 Levels Certification by Third Party Yes Yes Yes/No 1. Introduction Installation Maintenance Repair
  • 22. Intention of the Common Regulatory Objectives (CRO)  to cover comprehensively all relevant issues in order to achieve a globally accepted safety level  to provide a global „Best Practice“ model as 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/Operator  Open for ongoing maintenance and modification 2. Common Regulatory Objectives White paper approach
  • 23. Intention of the Common Regulatory Objectives (CRO) Ex-Equipment (Installed basis) Installation Inspection and Maintenance Repair Life cycle approach Market Surveillance Regulators JurisdictionOperator Manufacturer Placing on the market Zone classification (“Risk Assessment”) EN/IEC 60079-ff EN/IEC 80079-ff EN/IEC 60079-10 EN/IEC 60079-14 EN/IEC 60079-17 EN/IEC 60079-19 2. Common Regulatory Objectives
  • 24. Interaction/Relationship within the SIEEE-System 1. Definition/Jurisdiction a) Market Surveillance b) Certification Bodies c) Manufacturer d) Operator 2. Interaction a. Cert. B. ↔ Manu. b. Manu. ↔ Oper. c. MS ↔ Oper. d. MS ↔ Manu. e. MS ↔ Insp. B. f. Cert. B.↔ Insp. B. Regulation Market- surveillance Certification Bodies Operator Manufacturer 2. Common Regulatory Objectives
  • 25. 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 » 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) 13 Ignition sources IEC/ISO 60079-”X” / 80079-”X” IECEx-02 IEC/ISO 60079-”X” / 80079-”X” 2. Common Regulatory Objectives
  • 26. CRO Part 2: Safe use of the equipment » Classification of the explosive 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 IECEx-05 IECEx-03 2. Common Regulatory Objectives
  • 27. IEC ISO IECExCertification Testing Persons Competency ISO Guide 65 / 67 [ISO/IEC 17065] IECEx 02 ISO/IEC 17025 IECEx 02 Service IECEx 03 ISO/IEC 17024 IECEx 05 Production ISO/IEC 17021 CRO Part 1 and 2: 2. Common Regulatory Objectives
  • 28. CRO Part 3: Standards reference list » Accepted Standards (ISO/IEC) are listed in an annex to the regulation (State of the Art) » 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. Common Regulatory Objectives
  • 29. 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. Common Regulatory Objectives
  • 30. 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. Common Regulatory Objectives
  • 31. 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. Common Regulatory Objectives
  • 32. Procedure for the Regulation Example: Standardization IEC/ISO: DC, CD, CDV -Standard Mandate Manufacturer Regulator Operator Certification Body Consultant (UNECE- Steering Committee) FDIS - Standard Accepted Standard 3. Procedures Manufacturer Operator Certification Body Notify
  • 33. Procedure for Manufacturer Example: placing on the market Product, Manual Import Production Assessment Manufacturer Certification Body Operator Certification Body Dealer Export 2. Manufacturer Buy Own product development 3. Procedures
  • 34. Procedure for Certification Bodies Examples: Accreditation Certification Body Product Personal competency Service facilities Repair shops Regulator Accreditation Body (ILAC/IAF) Production Audit Comparison / Proficiency testing 3. Procedures
  • 35. Procedure for Ex-market surveillance (Ex-GMSP) Example: Possibly faulty product Possibly faulty product Market Surveillance Accident Operator Competitor Manufacturer Certification Body Result with Consequences Independent Certification Body (Notified by Regulation) Support Inspection 3. Procedures
  • 36. Procedure for Ex-market surveillance (Ex-GMSP) Example: Alert System, Arbitration board,… Product Market Surveillance Manufacturer Certification Body Faulty product Regulator (Steering Committee) Withdraw Withdraw Certificate Web Publication of the Product 3. Procedures
  • 37. Guidelines for the Ex-Market Surveillance Contents: 1. Introduction: 2. Actions of the MS 2.1 Pro Active 2.2 Reactive 3. Cooperation and Exchange of Experience (with other stakeholder) 3.1 Internet-Platform 3.2 Arbitration Board 3.3 Alert-System 4. Definition of Ex-Products and the boundary conditions 4.1 Zone Concept (Essential Requirements) 4.2 Types of Protection (Applicable Standards) 5. Explanation of the objectives of the surveillance activities (Compliance Criteria) 5.1 Labeling and Conformity Declaration 5.2 Manual 5.3 Technical Inspection 6. List of References 3. Procedures
  • 38. Procedure for Operators Examples: Operation of a plant, Maintenance, Repair, Training, … Product Regulation Inspector Operator Explosion Protection Document Manufacturer Installation Initial Inspection Repair Overhaul Operators Personnel Service Provider Documentation of each Product Inspection Maintenance Operators Personnel Service Provider 3. Procedures
  • 39. The workshop idea: Regulators Dialogue Group Dubai 2012 Fortaleza 2013 Kuala Lumpur 2014 Outputs: • Comprehensive description of the methodology of the system • Guidance documents for the various stakeholders (Regulators, Market Surveillance, Manufacturer, Operator, Inspection bodies) 4. Summary Den Haag 2014 Gdansk 2015
  • 40. 4. Summary 6 Common Regulatory Objectives Regulation Certification ExNB European Commission UNECE WP.6 (UNECE-ExSC) TC 305 TC 31 Ex-Dienst Namur ADCO BG ZVEI IECEx VDMA CENELEC CEN IEC/ISO UNECE- MARS Orgalime
  • 41. United Nation UNECE United Nations Economic Commission for Europe Working Party 6 SIEEE Sector Initiative Equipment Explosive Environments Common Regulatory Objectives One of Five Regional Commissions 56 Countries One of X Working Parties One of Four Initiatives Integrates 193 Nations 4. Summary