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Copyright © 2014 Rockwell Automation, Inc. All rights reserved. Timothy Duffy Rockwell Automation April 2014 IEC Conformity Assessment Market Access Solutions

IEC Conformity Timothy Duffy Assessment Market Rockwell ... · Categories Products IEC Standards BATT 60086, 60095, 60099, 60254 ... 60502, 60702, 60800, 60840, 62067, 62275, CAP

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Page 1: IEC Conformity Timothy Duffy Assessment Market Rockwell ... · Categories Products IEC Standards BATT 60086, 60095, 60099, 60254 ... 60502, 60702, 60800, 60840, 62067, 62275, CAP

Copyright © 2014 Rockwell Automation, Inc. All rights reserved.

Timothy Duffy

Rockwell Automation

April 2014

IEC Conformity

Assessment Market

Access Solutions

Page 2: IEC Conformity Timothy Duffy Assessment Market Rockwell ... · Categories Products IEC Standards BATT 60086, 60095, 60099, 60254 ... 60502, 60702, 60800, 60840, 62067, 62275, CAP

Overview

• What tools are available to multinational companies in the management

of certifications and multiple conformity assessments required for market

entry?

• Is your company repeating testing for each market where your products

are sold?

• This webinar will review the Conformity Assessments Systems at the IEC

that could save you valuable time and money and could provide

solutions to your conformity assessment nightmares. We will cover the

organizational structure of the IEC Conformity Assessment Programs,

provide operational details of the IEC CA Systems and provide

information relative to conformity assessment tools available for access

to global markets.

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 2

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3

Agenda

1. Regulatory Compliance Trends

2. IEC Conformity Assessment Structure

3. IECEE

4. IECEx

5. IECQ

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 3

Page 4: IEC Conformity Timothy Duffy Assessment Market Rockwell ... · Categories Products IEC Standards BATT 60086, 60095, 60099, 60254 ... 60502, 60702, 60800, 60840, 62067, 62275, CAP

4

Agenda

1. Regulatory Compliance Trends

2. IEC Conformity Assessment Structure

3. IECEE

4. IECEx

5. IECQ

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 4

Page 5: IEC Conformity Timothy Duffy Assessment Market Rockwell ... · Categories Products IEC Standards BATT 60086, 60095, 60099, 60254 ... 60502, 60702, 60800, 60840, 62067, 62275, CAP

Solutions Systems Platforms Product

Geographic Market

Expansion

Regulatory Issues

- 1994 1995-2000 2000-2004 2005 -

North America Europe Asia -Pacific South America Africa

Electrical Safety UL, CSA

EU Low Voltage EU EMC EU Machinery

CE Mark GOST Mark Marine Cert.

EU WEEE / RoHS

EU Battery

EU Packaging

US Environment

GAMP / CFR 21

C-Tick Australia CCC China Res 92 Argentina NOM Mexico TuV Safety

EU REACH, EU EuP EU Metric Australia Waste, Energy Efficiency China Waste, IECEX Social Responsibility

Personnel Cert Security Cert,

Marks for Brazil (INMETRO)

MERCOSUR, Korea, GCC

= Government

= Industry

= National Marks

Regulatory Compliance Trends

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Page 6: IEC Conformity Timothy Duffy Assessment Market Rockwell ... · Categories Products IEC Standards BATT 60086, 60095, 60099, 60254 ... 60502, 60702, 60800, 60840, 62067, 62275, CAP

Environmental Regulations: Escalating Trend

6 Copyright © 2014 Rockwell Automation, Inc. All rights reserved.

Page 7: IEC Conformity Timothy Duffy Assessment Market Rockwell ... · Categories Products IEC Standards BATT 60086, 60095, 60099, 60254 ... 60502, 60702, 60800, 60840, 62067, 62275, CAP

Drivers Impacting Sale of Product

Global Sale of Product

New Market

Requirements Environmental

Issues

Changing

Standards

Emerging

Standards

Changing

Market

Requirements

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 7

Page 8: IEC Conformity Timothy Duffy Assessment Market Rockwell ... · Categories Products IEC Standards BATT 60086, 60095, 60099, 60254 ... 60502, 60702, 60800, 60840, 62067, 62275, CAP

Market Access Nightmares?: Mark du jour!

• Increasing number of

economies are

establishing or

revising certification

systems

• New Marks may be

required for each new

system

Norway Denmark Finland Sweden

China Korea

Taiwan

Saudia Arabia

Argentina

Brasil Mexico

Hong Kong

Australia Russia Germany GS Mark

Singapore Switzerland

CE Marking - EU

Can I make our

products bigger

to accommodate the

marks ?

• New Certifications may require

testing, evaluation in-country & only

by in-country laboratories

• More time & money to determine

requirements & demonstrate

compliance

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Page 9: IEC Conformity Timothy Duffy Assessment Market Rockwell ... · Categories Products IEC Standards BATT 60086, 60095, 60099, 60254 ... 60502, 60702, 60800, 60840, 62067, 62275, CAP

Market Access Goal 1-1-1

• Manufacturer’s goal is to design and build one product that is accepted in

all markets of the world

– use harmonized standards (one standard)

– redundant testing eliminated (one test)

– ease of access to markets (one compliance activity)

• reduced tariffs

• minimal or reduced regulations on products

– Some regulations may be necessary for Health, Safety, Environment

• acceptance of previous evaluation(s) / certification(s)

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 9

Additional testing and certification does not necessarily make for a safer product and increases cost to our customers

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CA Confidence & Acceptance

• Current Mechanisms to Achieve Confidence in (and acceptance) of

Conformity Assessments Performed in Other Countries:

– MRAs between Governments

• least successful with regards to Product Certification

– National Treatment of Conformity Assessment Bodies (CAB) e.g., US-CAN

– Arrangements Between CABs, Assessors or Accreditors

– Supplier’s Declaration of Conformity

• Manufacturers have greater control in the Certification process and thus time

to market

• EU and Australia are current examples

• May utilize third party organizations

• Confidence in system derived through market forces and surveillance

– CA Bodies’ Participation in Data Exchange Schemes (IECEE CB Scheme)

Copyright © 2010 Rockwell Automation, Inc. All rights reserved. Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 10

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One Standard

• Harmonized Standards as the Basis for Conformity Assessment

• Benefits of Country adopted IEC Standards

– One product or system accepted in multiple markets

– Lower production and inventory cost

– Lower cost of needed conformity assessments

• IEC Standards in the Global Marketplace

– Global Standards are the ideal –

• One standard, one product, one test with worldwide acceptance & worldwide

protection

– Different Climate, Culture, Infrastructure may Require National/Regional Differences

• Initiative within IEC (Global Relevance) would include differences related to

climate / infrastructure within the standard

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One Test

• Manufacturer’ Goal – eliminate redundant testing (one test)

• Methods of achieving maximum test acceptance worldwide….

– Further harmonization of standards to the IEC standards

– Reduction of National Differences

– One product designed to Harmonized International Standard (IEC)

– Expanded country participation in international test programs like the IECEE CB

Scheme and IECEx System

– Identify new standards for inclusion in the Systems

– Increase participation by non-IEC countries in the IEC Conformity Assessment

Schemes

– Increase participation in and use of the IECEx Scheme

Copyright © 2010 Rockwell Automation, Inc. All rights reserved. Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 12

Page 13: IEC Conformity Timothy Duffy Assessment Market Rockwell ... · Categories Products IEC Standards BATT 60086, 60095, 60099, 60254 ... 60502, 60702, 60800, 60840, 62067, 62275, CAP

Copyright © 2010 Rockwell Automation, Inc. All rights reserved. 13

Agenda

1. Regulatory Compliance Trends

2. IEC Conformity Assessment Structure

3. IECEE

4. IECEx

5. IECQ

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 13

Page 14: IEC Conformity Timothy Duffy Assessment Market Rockwell ... · Categories Products IEC Standards BATT 60086, 60095, 60099, 60254 ... 60502, 60702, 60800, 60840, 62067, 62275, CAP

82 Members 83 Affiliates

IEC Family – 165 Countries

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Page 15: IEC Conformity Timothy Duffy Assessment Market Rockwell ... · Categories Products IEC Standards BATT 60086, 60095, 60099, 60254 ... 60502, 60702, 60800, 60840, 62067, 62275, CAP

IEC Management Structure

COUNCIL (C) (Full Member National Committees)

COUNCIL BOARD (CB)

CENTRAL

OFFICE (The Executive)

STANDARDIZATION

MANAGEMENT

BOARD (SMB)

Management of

International Standards

work

Technical

Committees

Strategic Groups

CAB Working Groups Special Working

Groups

Technical Advisory

Committees

MARKET

STRATEGY

BOARD (MSB) Technology watch /

market priorities

CONFORMITY

ASSESSMENT

BOARD (CAB) Management of conformity

assessment policies,

activities and systems

EXECUTIVE COMMITTEE (EXCO) (IEC Officers)

Management

Advisory

Committees

Systems Work

IECEE

IECEx

IECQ

IECRE

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 15

Page 16: IEC Conformity Timothy Duffy Assessment Market Rockwell ... · Categories Products IEC Standards BATT 60086, 60095, 60099, 60254 ... 60502, 60702, 60800, 60840, 62067, 62275, CAP

IEC Conformity Assessment Programs

• IECQ - Quality Assessment for Electronic Components

• IECEx System – Scheme for Certification to Standards for Safety of

Electrical Equipment for Explosive Atmospheres (TC31)

• IECEE System - (CB Scheme) - Conformity Testing Scheme for

Recognition of Results of Testing to Standards for Safety of Electrical

Equipment

• IECRE – Renewable Energies System

– Wind Turbines (TC88)

– Marine Energy (TC114)

– Solar Photovoltaic (TC82)

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 16

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IEC Conformity Assessment Board

Conformity Assessment

Board

IECRE &

Future

Schemes

ExMC

ExTL

CMC

ICC

IECEx

Scheme

IECQ CB Scheme &

CB-FCS

IECEE

CMC CTL

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 17

Page 18: IEC Conformity Timothy Duffy Assessment Market Rockwell ... · Categories Products IEC Standards BATT 60086, 60095, 60099, 60254 ... 60502, 60702, 60800, 60840, 62067, 62275, CAP

One test to IEC Standards (including national differences) to reduce or eliminate retesting

in member countries

…...

Faster to market!!!

IEC CA Schemes - Purpose

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 18

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19

Agenda

1. Regulatory Compliance Trends

2. IEC Conformity Assessment Structure

3. IECEE

4. IECEx

5. IECQ

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 19

Page 20: IEC Conformity Timothy Duffy Assessment Market Rockwell ... · Categories Products IEC Standards BATT 60086, 60095, 60099, 60254 ... 60502, 60702, 60800, 60840, 62067, 62275, CAP

IECEE System

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 20

CB Scheme Mutual recognition of test certificates

CB FCS (Full Certification Scheme) Mutual recognition of conformity

assessment certificates

IECEE System www.iecee.org

Page 21: IEC Conformity Timothy Duffy Assessment Market Rockwell ... · Categories Products IEC Standards BATT 60086, 60095, 60099, 60254 ... 60502, 60702, 60800, 60840, 62067, 62275, CAP

CB Scheme Overview

• International system for acceptance of test reports for electrical products.

– Essentially a data exchange program based on mutual trust

• Allows a manufacturer to transport work done at a third party laboratory in one

country to a participating laboratory in another country

• Purpose of the exchange is to obtain the certification or CA mark that is

required for market access in the second country.

• A manufacturer utilizing a CB Scheme test report issued by one organization

may obtain national certification from ALL other member countries of the CB

Scheme.

• Countries may only participate if there is a national standard, based on

the IEC standard, with minimal deviations (Harmonized Standards)

• Operation requires reciprocal recognition of test results to simplify

certification or approval at national levels

• Downside – Still requires additional Certification Marks.

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 21

Page 22: IEC Conformity Timothy Duffy Assessment Market Rockwell ... · Categories Products IEC Standards BATT 60086, 60095, 60099, 60254 ... 60502, 60702, 60800, 60840, 62067, 62275, CAP

IECEE participating countries

Korea Rep. of

Libya

Malaysia

Mexico

Netherlands

New Zealand

Norway

Pakistan

Poland

Portugal

Romania

Russian Federation

Saudi Arabia

Serbia

Finland

France

Germany

Greece

Hungary

India

Indonesia

Iran

Ireland

Israel

Italy

Japan

Kazakhstan

Kenya

Argentina

Australia

Austria

Bahrain

Belarus

Belgium

Brazil

Bulgaria

Canada

China

Colombia

Croatia

Czech Rep.

Denmark

Singapore

Slovakia

Slovenia

South Africa

Spain

Sweden

Switzerland

Thailand

Turkey

Ukraine

United Arab Emirates

United Kingdom

United States

Viet Nam

56 participating countries

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Page 23: IEC Conformity Timothy Duffy Assessment Market Rockwell ... · Categories Products IEC Standards BATT 60086, 60095, 60099, 60254 ... 60502, 60702, 60800, 60840, 62067, 62275, CAP

MBs map

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Page 24: IEC Conformity Timothy Duffy Assessment Market Rockwell ... · Categories Products IEC Standards BATT 60086, 60095, 60099, 60254 ... 60502, 60702, 60800, 60840, 62067, 62275, CAP

CB Scheme – Categories of Products

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 24

Categories Products IEC Standards

BATT Batteries 60086, 60095, 60099, 60254, 60571, 60622, 60623, 60783, 60785, 60896,

60952, 61133, 61809, 61951, 61960, 61982, 62133, 62257, 62259, 62281,

62282, 62660,

CABL Cables and Cords 60227, 60245, 60502, 60702, 60800, 60840, 62067, 62275,

CAP Capacitors as components 60252, 60384, 60831, 60939, 61048, 61049, 61071, 61881,

CONT Switches for appliances and

automatic controls for electrical

household appliances

60255, 60691, 60730, 60934, 61095, 61508, 61810,

E3 Energy Efficiency 60299, 60311, 60312, 60350, 60379, 60436, 60442, 60456, 60496, 60508,

60530, 60535, 60619, 60661, 60665, 60675, 60705, 60879, 60969, 61121,

61254, 61309, 61591, 61592, 61683, 61817, 61855, 61923, 62018, 62040,

62075, 62087, 62301, 62473, 62552, 62587, 62611, 62612, 62617, 62623,

ELVH Electric Vehicles 61851, 62196, 62660,

EMC Electromagnetic Compatability 60034, 60118, 60204, 60255, 60533, 60601, 60728, 60870, 60945, 60947,

60974, 61000, 61131, 61204, 61326, 61543, 61547, 61800, 61812, 62003,

62040, 62041, 62052, 62053, 62054, 62153, 62236, 62311, 62493, CISPR 11,

CISPR 12, CISPR 13, CISPR 14, CISPR 15, CISPR 16, CISPR 20, CISPR 22, CISPR

24, CISPR 25, CISPR 32, CISPR/TR 16, IEC CISPR 61000,

HOUS Household and similar

equipment 60204, 60311, 60312, 60335, 60342, 60350, 60436, 60456, 60530, 60580,

60661, 60704, 60705, 60967, 61011, 61121, 61591, 61770, 61817, 62233,

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CB Scheme – Categories of Products

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 25

Categories Products IEC Standards

HSTS Hazardous Substances Testing

Service 62321,

INDA Industrial Automation 61010,

INST Installation accessories and

connection devices

60083, 60309, 60320, 60364, 60423A, 60423, 60614, 60669, 60670,

60684, 60799, 60807, 60884, 60974, 60998, 60999, 61058, 61076,

61084, 61210, 61238, 61242, 61316, 61386, 61534, 61535, 61537,

61800, 61950, 61984, 61995, 62080, 62094, 62103, 62196, 62208,

62444, 62477, CEE,

LITE Luminaires 60064, 60081, 60155, 60238, 60357, 60360, 60400, 60432, 60570,

60598, 60838, 60901, 60921, 60923, 60925, 60927, 60929, 60968,

60969, 61047, 61048, 61049, 61050, 61184, 61195, 61199, 61228,

61347, 61549, 62031, 62035, 62257, 62384, 62471, 62532, 62560,

62612, 62717, 62722, 62778,

MEAS Measurement, Control and

Laboratory equipment 60044, 60414, 61010, 61131, 61204, 61243, 61557,

MED Electrical equipment for

medical use

60601, 60613, 60976, 61223, 61676, 62220, 62304, 62353, 62366,

62462, 62467, 62563, 80601,

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CB Scheme – Categories of Products

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 26

Categories Products IEC Standards

MISC Miscellaneous 60077, 60515, 60519, 60747, 60768, 60825, 60846, 60900, 60938,

61318, 61340, 61482, 62257, 62386, 62395, 62471,

OFF IT and office equipment 60950, 61204, 62040, 62310, 62368,

POW Low voltage, high power

switching equipment

60158, 60265, 60439, 60947, 61439, 61851, 62019, 62026, 62271,

62314,

PROT Installation protective

equipment 60099, 60127, 60257, 60269, 60282, 60898, 61008, 61009, 61540,

61643, 62423, 62606, 62640,

PV Photovoltaics 60891, 60904, 61194, 61215, 61345, 61646, 61683, 61702, 61721,

61727, 61730, 61829, 61853, 62093, 62108, 62109, 62116, 62124,

62257, 62446, PVRS 5A, PVRS 7A, PVRS11A, PVRS11, PVRS5, PVRS6A,

PVRS6, PVRS7,

SAFE Safety transformers and similar

equipment 60044, 60076, 60704, 60742, 61558, 61869,

TOOL Portable tools 60745, 61029, 61939,

TOYS Electric Toys 62115,

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The CB Scheme

• International network of certification bodies and their testing laboratories

• Each participating nation has 1 or more NCB

• Manufacturer specifies conditions and desired markets

• Certification Body conducts evaluations to IEC Stds + National Differences in

countries of choice

• Certification Body conducts product testing and certification

• Certification Body provides CB Test Certificate and CB Test Report

• Chosen Certification Body can assist the manufacturer in obtaining the CA

mark needed for market access.

• IEC Schemes have been expanded to non-IEC countries

• Manufacturer’s testing is allowed

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 27

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Manufacturer's Testing Laboratories

NCB

SMT Supervised Manufacturer Testing

TMP Testing at Manufacturer Premises

WMT Witness Manufacturer Testing

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 28

Page 29: IEC Conformity Timothy Duffy Assessment Market Rockwell ... · Categories Products IEC Standards BATT 60086, 60095, 60099, 60254 ... 60502, 60702, 60800, 60840, 62067, 62275, CAP

CB Scheme Conformity Assessment Process

• TMP or WMT –

– Test product at a manufacturer’s facility with a representative from NCB/CBTL

witnessing 100% of tests.

– Laboratory must meet certain criteria of ISO/IEC 17025.

– NCB/CBTL will review test data and issue CB Scheme certificate/report.

• SMT

– Evaluate and certify a manufacturer’s laboratory facilities and staff for compliance to

ISO/IEC 17025.

– Conduct tests under Supervised Manufacturer’s Testing (SMT) program.

– NCB/CBTL will review test data, audit/witness tests, and issue CB Scheme

certificate/report.

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 29

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Peer Assessment - Confidence is Key

• Method to verify competence and build confidence

– develop confidence in other laboratories abilities to allow acceptance of testing

data without additional checks

• Peer Assessment - Why It Works:

– Goes further than ISO/IEC 17025 and 17065

– Uses true experts in Testing and Certification (lead assessors)

– Uses Qualified assessors in every product category

– Receives permanent feedback from TCs and CTL

– Counterchecks the test reports

• Mutual Acceptance of Test Certificates and Test Reports

– Each report verified / accepted to help build confidence

• Promotes confidence among the Members of the Scheme

– ensures that a level of safety is maintained by all participating labs

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 30

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Bilateral Recognition Peer Assessment

Multilateral

H

A

B

C

D

E

F

G

H

A

B

C

D

E

F

G

CB Scheme

Peer Assessment Agreements

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Transportable Conformity Assessment

Country A

Sector 1

NCB (I)

Conformity

Assessment

SUPPLIER

Country B

Sector 1

NCB (R)

Product

Certification

SDoC based on

NCB (I) Conformity

Assessment

Acceptance of NCB (I)

Conformity Assessment

via G – 2 – G MRA

Satisfaction of Market / Regulatory

demands for Conformity Assessment:

Market Acceptance National

Certification

CBTC

Case: Flow of a CB Test Report (CBTR)/CB Test Certificate (CBTC)

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IECEE Statistics

• 56 participating countries

• 74 National Certification Bodies

• 447 Testing Laboratories

• 2491 Manufacturer’s Testing Laboratories

• CB Test certificates p.a. = More than 70 000.

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IECEE New Work Areas / Offerings

• Development of Factory Audit / Inspection Report & Procedures

• Workshops for Software Evaluation and Risk Management in Medical

area

• Statement of Test Results for product testing of Hazardous Substances

(RoHS)

• Energy Efficiency Statement of Test Results

• New Industrial Automation Category

• Reviewing potential for Functional Safety and Cyber Security

– Products

– Systems

– Services

– Personnel Certification

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 36

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37

Agenda

1. Regulatory Compliance Trends

2. IEC Conformity Assessment Structure

3. IECEE

4. IECEx

5. IECQ

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 37

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IECEx System

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 38

Page 39: IEC Conformity Timothy Duffy Assessment Market Rockwell ... · Categories Products IEC Standards BATT 60086, 60095, 60099, 60254 ... 60502, 60702, 60800, 60840, 62067, 62275, CAP

31 IECEx Participating Countries

Copyright © 2014 Rockwell Automation, Inc. All rights reserved. 39

Australia (AU)

Brazil (BR)

Canada (CA)

China (CN)

Croatia (HR)

Czech Republic (CZ)

Denmark (DK)

Finland (FI)

France (FR)

Germany (DE)

Hungary (HU)

India (IN)

Italy (IT)

Japan (JP)

Korea (KR)

Malaysia (MY)

Netherlands (NL)

New Zealand (NZ)

Norway (NO)

Poland (PL)

Romania (RO)

Russia (RU)

Singapore (SG)

Slovenia (SI)

South Africa (ZA)

Spain (ES)

Sweden (SE)

Switzerland (CH)

Turkey (TR)

United Kingdom (GB)

United States (US)

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What is IECEx?

• The IECEx Scheme is an International Conformity Assessment Scheme covering

Electrical Apparatus for Explosive Atmospheres, as the Internationally accepted means

of demonstrating conformity with IEC Standards prepared by IEC TC31

• Objective of the IECEx System is to facilitate international trade in equipment and

services for use in explosive atmospheres. Current Scheme offerings:

– Certified Equipment Scheme (IECEx 02)

– Certified Service Facilities Scheme (IECEx 03)

– Conformity Mark Licensing System (IECEx 04)

– Certification of Personnel Competencies Scheme (IECEx 05)

• Why IECEx?

– Reductions of costs associated with:

• Multiple/Re-Testing/Assessments

• Delays in accessing markets

• Access to new products and technology by smaller markets.

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Areas where Ex equipment are used

• Automotive refueling stations or petrol stations

• Oil refineries, rigs and processing plants

• Chemical processing plants

• Printing industries, paper and textiles

• Hospital operating theatres

• Aircraft refueling and hangars

• Surface coating industries

• Underground coal mines

• Sewerage treatment plants

• Gas pipelines and distribution centres

• Grain handling and storage

• Woodworking areas

• Sugar refineries

• Metal surface grinding, especially aluminum dusts and particles

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Core Elements of IECEx Certification

Testing of Samples

(Type Test)

Initial Assessment of

Manufacturer’s Quality

System (factory audit)

On-going Surveillance

(factory audits)

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• Official CoC on IECEx website

• iPhone App for easy verification

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Testing of

Sample(s)

Conduct Testing to IEC

Standard(s)

Compile & issue an

ExTR =

Initial

Factory Audit = Document Review and

on-site factory audit of

manufacturer, by ExCB

– same as CCC, UL, …

QAR is produced

Surveillance

Factory audit = ExCB, IECEx CoC issuer,

responsible for On-site

factory audit - same as

CCC, UL, …

Core Elements of IECEx Certification

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IECEx Developments

• New services

– Personnel Certification launched – market demand

– Others planned

• Direct market entry to many countries, including

non-IECEx member countries

• On-line IECEx resource:

– Public access to IECEx Certificates

– Facility for selecting Ex apparatus and repairers.

• Increased level of industry participation in IECEx

• Industry and regulatory support increases yearly

• 1st Conformity Mark License issued in 2009

• IECEx now endorsed by UN as “Best Practice” model for Ex field.

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45

Agenda

1. Regulatory Compliance Trends

2. IEC Conformity Assessment Structure

3. IECEE

4. IECEx

5. IECQ

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IECQ – 14 Member Bodies

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IECQ System

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IECQ AC Scheme

Approved Component Products, Related Materials & Assemblies Scheme

IECQ HSPM QC 080000 Scheme Hazardous Process Management

IECQ System www.iecq.org

ECMP Scheme Electronic Component Management Plan (Avionics + Others, railways, medical)

IECQ ITL Approval

(Independent Testing Laboratories Operating in IECQ)

Approved Process Certification Scheme Processes, Contractors, ESD etc IECQ 03-2 Rules of Procedure

IECQ 03-4 Rules of Procedure

IECQ 03-5 Rules of Procedure

IECQ 03-6 Rules of Procedure

IECQ 03-1 General Rules of

Procedure, all Schemes

IECQ ESD Scheme

Electrostatic Discharge

IECQ AQP Scheme

Automotive LED Approval Scheme

IECQ 03-2 Rules of Procedure

IECQ 03-7 Rules of Procedure

IECQ 03-TBD Rules of Procedure

IECQ 03-1, 03-3 Rules of Procedure

IECQ 001004 IECQ Specifications

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IECQ

• Worldwide approval and certification system covering the supply of

electronic components and associated materials, assemblies and

processes

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IECQ

• Covers many areas

– Active components, including integrated circuits

– Passive components

– Hybrid integrated circuits

– Printed boards

– Electromagnetic components

– Electro-optic components

– Electromechanical components

– Wires and cables.

• Three Groups of Programs

– Electronic components certification and associated materials, assemblies and

processes

– Avionics electronic component management plans (ECMP) certification

– Hazardous substance process management (including Lead-Free, WEEE, REACH,

EuP, Battery and Packaging) certification.

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IECQ - Benefits

• Assurance that electronic components, related material, and processes meet conformity assessment requirements

– Supplier Approval

• Manufacturers

• Distributors

• Specialist contractors

– Qualification Approval

– Capability Approval

– Technology Approval

– Specialist Contractor Approval

– Independent Testing laboratory Approval

– Automotive LED Component Approval

– ESD Process Approval

– Counterfeit Avoidance Program Approval

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51

IECQ

• Management System, Product and Process Certification

• Responding to Industry demands

– Hazardous Substances Process Management (HSPM) Program

– Electronic Component Management Plan (ECMP), e.g. Avionics, now a requirement by Boeing Airbus.

– Electronic Component Counterfeit Avoidance, Detection, Mitigation and Disposition

• Strong demand for IECQ HSPM continues

• Strong & Growing demand for IECQ CAP.

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Market Benefits of IEC CA Schemes

• Australia – – IECEx Scheme – direct to market with certificate

– IECEE CB Scheme – direct to market for some products categories

• 47 declared items – circuit breaker and residual current devices

• China Certification – CCC Certification required – Active participation in IECEE CB Scheme

• Will accept CB Certificates with in-country differences to gain CCC Mark

– Mandatory Ex Certification – Active participation in IECEx System

• Russia – GOST-R – Certification required – current options

• Work with local Russia importer

• Utilize Certification Body as agent – requires CB Scheme style report

• Work directly with Russian Government agency

• CB Scheme report – accepted with little or no additional effort

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Market Benefits of IEC CA Schemes

• Brazil – INMETRO for IECEx – In-country testing

– Certification required for equipment used in Ex environment

– IECEx Scheme participation

• Argentina S-Mark – Cross purpose products stopping shipments

– Import documentation now requiring certification review by accredited labs

– IECEE CB Scheme accepted

• South Africa – SABS Import Certificate – Import documentation (RCC) with certification review required

– Attestation products are safe to connect to grid

– CB Scheme report & certificate easiest method

• ATEX – Required for EU

– Meeting requirements for IECEx Scheme meets ATEX requirements

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Globalization Summary

• Globalization and competition are leading to rapid changes, we need to

continue to:

– Reduce technical barriers to trade

– Continue to harmonize standards

– Reduce or Eliminate redundant testing and certification

– Reduce costs to all stakeholders…

– Allow for shorter time to market (short life cycle of products)

– Allow multiple mechanisms for market access

• Design, Manufacturing, Distribution and Sales Authority for global

companies are distributed in different countries

– Local access to Certification products should be available for each authority within a

company

– As manufacturing companies are distributed, certification products must also be

distributed

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Summary of IEC CA Systems Advantages

• Acceleration of Product Acceptance

• More rapid certification

– One stop testing even though certification / product acceptance still has to be

obtained country by country

• Expanded markets

• Faster product movement from plants to markets

– Speeds market access by reduced testing and easier access to CA Marks

– Reduction of trade barriers and opening up of new markets.

• Gets manufacturer’s products to market faster & cheaper.

– Manufacturers must still comply with the requirements of the body the issues the CA

mark

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Data acceptance is the key to

increasing the flow of goods

Flow of Goods

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Market Access Recommendations

• What’s a manufacturer to do??

– Early identification of markets (geographic / industry / application) required,

associated standards used and certifications needed.

• Design to IEC Standards

• Specify National Differences required

– Specify the use of the CB Scheme and Ex Scheme in all new certifications

– Work with Certification Body participating in IEC CA Systems

• Ask for national difference testing for affected markets

– Budget the money in the NOW to avoid pain, retesting and additional time later.

IECEE CB Scheme and IECEx Scheme represent the most cost effective mechanism for certification for multiple markets

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Questions

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Copyright © 2014 Rockwell Automation, Inc. All rights reserved.

Thank you Timothy T. Duffy

Senior Manager, Conformity Assessment

Rockwell Automation

[email protected]

phone (414) 382-1031

fax (414) 382-1656