___________________________________________________________________________ 2012/SCSC/WKSP/007 Risk Assessment in the IECEE CB Scheme Submitted by: IEC Workshop on Developing a Harmonised Electrical Equipment Regulatory Risk Assessment Tool Singapore 15-16 May 2012 Risk Assessment in the IECEE CB Scheme APEC EE JRAC Workshop Developing a Harmonised Electrical Equipment Regulatory Risk Assessment Tool – Dennis CHEW Regional Director IEC-APRC Singapore May 15 - 16 2012, Singapore IEC Structure IEC COUNCIL Full Member National Committees Management Advisory Committees CENTRAL OFFICE (The Executive) COUNCIL BOARD EXECUTIVE COMMITTEE (IEC Officers) STANDARDIZATION MANAGEMENT BOARD (SMB) Management of consensus International Standards work MARKET STRATEGY BOARD (MSB) Technology watch / market priorities Technical Committees Technical Advisory Committees Industry Sector Boards CONFORMITY ASSESSMENT BOARD (CAB) Management of Conformity Assessment operations and systems IECEE IECEx IECQ APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 2/69 1 The CAB & Conformity Assessment Systems CAB - Conformity Assessment Board IECEE IECEx System for Conformity Testing and Certification of Electrotechnical Equipment and Components System for Certification to Standards Relating to Equipment for use in Explosive Atmospheres IECQ Quality Assessment System for Electronic Components CB Scheme Ex Equipment CB-FCS CB FCS Scheme Ex Services Processes Ex Personnel HSPM PV Programme Active &Passive components E3 Energy Efficiency Hazardous Substances Avionics APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 3/69 What is the IEC? Founded in 1906 the INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC) is the leading global organization that prepares and publishes International Standards for all electrical, electronic and related technologies – collectively known as “electrotechnology”. The IEC also Th l operates t Conformity C f it Assessment A t Systems that provide third party testing and certification to products and systems against its International Standards. APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 4/69 2 What is the IECEE System? Fully integrated in the IEC, based in Geneva Founded in 1985 Based on the principle of Multi Lateral Agreement Operates third party C.A. Schemes and Programmes Facilitate trade and provides easy access to the Global Market Promotes harmonization but takes into account National Differences 5/69 APEC EE JRAC Workshop – May 15 - 16 2012, Singapore IECEE Member Bodies by Economies Finland Malaysia Slovakia France Mexico Slovenia Austria Germany N th l d Netherlands S th Africa South Af i Bahrain Greece New Zealand Spain Belarus Hungary Norway Sweden Belgium India Pakistan Switzerland Indonesia Poland Thailand Ireland Portugal Turkey Israel Romania Ukraine Chi China I l Italy Russian Federation United Arab Emirates Colombia Japan Saudi Arabia United Kingdom Croatia Kenya Serbia United States Czech Rep. Korea Rep. of Singapore Denmark Libya Argentina Australia Brazil Bulgaria Canada 53 Participating Economies APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 6/69 3 IECEE Membership IECEE is a voluntary C.A. System of National Member Bodies that fully represent electrotechnical l h i l interests i in i their h i economies i Government, industry, testing laboratories, academia, retailers, consumer groups… Membership – one Member Body per economy MB Unlimited number of Certification Bodies - NCBs Unlimited number of Testing Laboratories – CBTLs Unlimited number of Manufacturer’s Testing Laboratories - MTLs APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 7/69 Members of the IECEE System The Members of the IECEE System are: 53 Member Bodies - 1 per Economy 75 Certification Bodies - 1 or more per Economy 359 Testing Laboratories - 1 or more per Economy 47 ACTLs 2219 Manufacturer’s Testing Laboratories APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 8/69 4 The IECEE CB Scheme and FCS Scheme In recognition of the need to facilitate international trade in electrotechnical equipment, and components primarily intended for use in homes, homes offices offices, workshops healthcare facilities and similar locations, for benefit of consumers, industries, authorities etc, and to provide convenience for manufacturers and other users of the services provided by various National Certification Bodies (NCBs), two international Schemes are operated by the IECEE, known as the: CB Scheme CB-FCS Full Certification Scheme APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 9/69 IECEE Conformity Assessment Schemes The IECEE Schemes are based on the principle of mutual recognition (reciprocal acceptance) by its worldwide members of test results for obtaining certification or approval at national level. The IECEE Schemes in the last decade have naturally evolved and become « de facto » the most accepted proof of compliance by many Economies’ Authorities and Regulators as the passport to entry their markets without further testing. APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 10/69 5 IECEE facilitates International Trade The IECEE Schemes are intended to reduce obstacles to international trade which arise from having to meet different national certification or approval criteria. criteria APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 11/69 National IECEE facilitates Differences International Trade Where national standards are not yet completely based on IEC standards, declared national differences are taken into account. However, successful operation of the Scheme presupposes that national standards are reasonably harmonized with the corresponding IEC standards. APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 12/69 6 The scope the CB Scheme Scope ofofthe IECEE System APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 13/69 Household Appliances APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 14/69 7 Safety-Performance-Environmental Safety IEC Standards for electrical safety Energy efficiency Environmental IEC Standards for energy Protection efficiency IECEE H Hazardous d Substances Program APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 15/69 The CB Scheme and CB-FCS Processes CB-FCS Sample request CB requests sample(s) and sets the testing programme Testing CBTL’s Staff performs the measuring and testing programme Inspection CB’s Staff performs the Factory Inspection Evaluation CB’s Staff evaluates the Test Report Decision CB’s officer takes the Certification decision Licence CB issues the CB Test Certificate and Test Report APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 16/69 8 IECEE System in action Conformity NCB- Certification Body A issuing Analyzing… Assessment Typetest test Type Certificate program program Laboratory Test Report Conformity Assessment National National Report differences differences Factory applicable) Inspection (if(if applicable) Factory Audit Report National differences National differences (if applicable) Testing… (if applicable) Application documents APPLICANT Conformity Assessment Factory Certificate Audit Report Conformity Assessment Report Auditing… Factory Audit Report National differences Factory (if applicable) NCB Economy B1 15 working days Recognizing Market Regulators NCB Economy B2 Retailers/Vendors Buyers Recognizing NCB Economy B3 Recognizing APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 17/69 IECEE Membership 400 350 300 250 Countries Certification Bodies Testing Laboratories 200 150 100 50 0 APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 18/69 9 IECEE CB Scheme…a success story 70'000 60'000 50'000 40'000 30'000 20 000 20'000 10'000 '0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 Certificates re-issued over the publication of new editions of standards APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 19/69 Energy Consumption Energy Performance Noise Level APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 20/69 10 The use of the IECEE System… Ensures that the product are safe Prevents redundant testing Facilitate trade Support regulatory policies …provides a competitive edge! APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 21/69 Way forward in 2012 More Affiliate Plus economies Training on regional basis /Virtual training Expand p mentoring g programme p g Cooperation with regional bodies Reach out to Pacific Islands and West Africa Adoption event with ISO New benefits in conformity assessment APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 22/69 11 History of the Affiliate Programme In 2001 IEC had stable membership (since 1906!) but membership requirements were 1906!), deterring developing economies World Trade Organization was looking for ways “to ensure effective participation of Members, and particularly of developing economy Members M b in i [international [i t ti l standardization organizations] activities.” The IEC found a unique approach to ensuring that participation. APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 23/69 IECEE AFFILIATE ECONOMIES Removing trade barriers Through its global reach, the IEC Affiliate E Economy P Programme results lt in i increased i d awareness, use and adoption of IEC International Standards in developing and newly industrialized economies. It also helps develop trade with these new markets, as participants adopt IEC International Standards and use the IEC Conformity Assessment Systems, in particular IECEE, the IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 24/69 12 IECEE AFFILIATE ECONOMIES Benefits This is of particular interest to industry, which can export to and import from these areas with the assurance that their products and services will operate safely and efficiently. APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 25/69 IECEE AFFILIATE ECONOMIES Benefits This is also of particular interest to Affiliate Economies, which can set the basis in their own economies to build the necessary Conformity Assessment structures to ensure that importing p g electrical goods g are compliant with IEC International Standards in terms of safety and efficiency. APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 26/69 13 The IECEE CB Scheme….m… Ensures that the products are safe and efficient Minimizes the risk to property and persons Contributes to the environmental aspects & public health Supports regulatory policies APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 27/69 THANK YOU! Any question? www.iecee.org WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 14 Technical Committee 61 SAFETY OF HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES IEC approach to Risk Assessment Standards Methodology Singapore - 2012-05-15 Derek Johns Chairman IEC/TC 61 WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 15 Contents Aim Conclusions Guides Types of Standards Fire Hazard Risk Reduction Accessible Surface Temperature Risk Reduction APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 31/69 Contents Aim Conclusions Guides Types of Standards Fire Hazard Risk Reduction Accessible Surface Temperature Risk Reduction APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 32/69 16 Aim of Risk Assessment at the microlevel To achieve a level of tolerable risk Balance between absolute safety and demanded performance of the appliance Suitability of purpose Benefit to the user Cost effective Conventions of society concerned APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 33/69 Methodology Identify the hazard usually via risk analysis Electric shock Mechanical Explosion Ionising and Non-ionising radiation Fire Temperature Biological and Chemical Unattended operation Electricity supply system faults Other APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 34/69 17 Risk analysis Using risk analysis – a lack of incident history does not equate to low risk APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 35/69 Solutions Assess the level of harm caused by the hazard Slight (reversible short term) High (reversible long term) Serious (irreversible – possibly death) Apply a risk reduction solution to the design Inherently safe design measures Safeguarding Information for use to cover residual risk Training Clear instructions Use of protective equipment APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 36/69 18 Contents Aim Conclusions Guides Types of Standards Fire Hazard Risk Reduction Accessible Surface Temperature Risk Reduction APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 37/69 Guides IEC Guide 116 - Guidelines for safety related risk assessment and risk reduction for low voltage equipment ISO/IEC Guide 50 - Safety aspects — Guidelines for child safety ISO/IEC Guide 51 - Safety aspects — Guidelines for their inclusion in standards ISO/IEC Guide 71 - Guidelines for standards developers to address the needs of older persons and persons with disabilities IEC Guide 117 - Electrotechnical equipment – Temperatures of touchable hot surfaces APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 38/69 19 Contents Aim Conclusions Guides Types of Standards Fire Hazard Risk Reduction Accessible Surface Temperature Risk Reduction APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 39/69 Types of Standards Basic safety publications - publication on a specific safetyrelated matter,, applicable pp to many y electrotechnical p products IEC 60695 series, IEC 60664 series, IEC 61508 series Group safety publications - publication covering all safety aspects of a specific group of products within the scope of two or more product TCs IEC 61010 series, IEC 60825, IEC 61558 series t d d on ffundamental d t l principles, i i l Horizontal standards - standard concepts, terminology or technical characteristics, relevant to a number of technical committees and of crucial importance to ensure the coherence of the corpus of standardization documents IEC 60050 series (IEV), IEC 60417 database APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 40/69 20 Types of standards Product safety publications - publication covering all safety aspects of one or more products within the scope of a single product TC IEC 60204 series (machines) IEC 60335 series (appliances) IEC 60598 series (luminaires) ( ) IEC 60601 series (medical electrical equipment) IEC 60745 series (hand-held tools) IEC 60950 series (IT equipment) APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 41/69 Contents Aim Conclusions Guides Types of Standards Fire Hazard Risk Reduction Accessible Surface Temperature Risk Reduction APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 42/69 21 Fire Hazard in Appliances - Example Motor start capacitor in refrigerator APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 43/69 Fire Hazard in Appliances - Example Fan heater APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 44/69 22 Fire Hazard Risk Reduction Selected parts of the IEC 60695 series of basic safety standards are used This allows for An end-product test option A material pre-selection test option These options are alternatives to reduce the fire hazard risk posed by appliances they are not equivalents APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 45/69 Which end-product test option standard is used ? Test standard used is: IEC 60695-2-11 Fire Hazard Testing – Part 2-11: Glowing/hot wire based test methods – Glow-wire flammability test method for end products APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 46/69 23 Risk Assessment For appliances, the glow-wire test severity is selected according to the risk presented by a given type of appliance. The fire hazard risk is assessed based on three criteria – Whether the appliance is attended or unattended during normal use; – The rms value of current passing through an electrical connection during normal use; – The proximity of non-metallic material to such connections. APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 47/69 Selection of Test Severity For all appliances and regardless of current a minimum severity of 550 °C is specified as being applicable to nonmetallic material. material For attended appliances the break point current is 0,5 A for testing non-metallic material in proximity to a connection – – Severity is 750 °C if the current > 0,5 A Severity is 650 °C if the current ≤ 0,5 A For unattended appliances the break point current is 0,2 A for testing non-metallic material in proximity to a connection – – Severity is 850 °C and 750 °C if the current > 0,2 A Severity is 650 °C if the current ≤ 0,2 A APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 48/69 24 Consequential Testing If the test specimen emits flames during the application of the glow-wire, the consequential fire hazard created may necessitate further tests using other ignition sources such as a needle-flame applied to those parts which are reached by the emitted flames. For unattended appliances, the reported results off the 750 °C and 650 °C glow-wire tests related to the test specimen are used to decide whether further fire hazard tests are necessary APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 49/69 Material Pre-selection test option standards IEC 60695-2-12, 60695 2 12 Glow-wire Glow wire flammability index (severities selected from 550 °C, 650 °C, 750 °C or 850 °C depending on the glow-wire test severity specified in IEC 60335-1) IEC 60695-2-13, Glow-wire ignition temperature ((severities selected from 675 °C or 775 °C depending on the glow-wire test severity specified in IEC 60335-1 for the consequential test decision for unattended appliances APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 50/69 25 Material Pre-selection test option for the Needle Flame Test IEC 60695-11-10, 50 W Flame Tests HB40 classification required as a pre- selection option for the 550 °C glow-wire test At least V-1 classification required for the pre-selection option for the needle flame test APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 51/69 Which Option to Choose The choice of option (end product test or material pre-selection) is not specified in IEC 60335-1 The choice is strictly a commercial decision to be made by the appliance manufacturer APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 52/69 26 Options to Avoid the Consequential Test Use the g glow-wire ignition g temperature p prep selection option; Use the 50 W flame test pre-selection option; Use of V-1 rated flame barriers; Appropriate placement of parts with respect to current carrying connections. APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 53/69 Contents Aim Conclusions Guides Types of Standards Fire Hazard Risk Reduction Accessible Surface Temperature Risk Reduction APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 54/69 27 Temperature Hazard in Appliances Example Under bench glass oven door 11 Days after oven door contact APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 55/69 Temperature Hazard in appliances Example Hair straightener APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 56/69 28 Accessible Surface Temperature Risk Reduction Selection of surface temperature rise limits for non-functionally heated surfaces Non-functionally heated surfaces are: Non-functional surfaces that can be touched when the equipment is operated during normal use APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 57/69 Which Document is Used ? The document used for guidance on surface temperature rise selection is IEC Guide 117: Electrotechnical equipment – Temperatures of touchable hot surfaces The data in this Guide is based on ISO 13732-1: Ergonomics of the thermal environment — Methods for the assessment of human responses to contact with surfaces — Part 1: Hot surfaces APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 58/69 29 Risk Assessment The temperature rise limits are selected based on: Persons expected to touch the surface Thermal inertia of surface material, (product of density, thermal conductivity and specific thermal capacity) Acceptable burn threshold Expected Touch time Texture of surface (smooth or not smooth). For rough surfaces 2 °C is added to the smooth surface threshold upper limit APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 59/69 Selection of temperature rise limits Persons expected to touch the surface are selected from healthy adults, people with physical disabilities and children Expected Touch times are generally selected from 0,5 s to 15 s depending on the persons expected to touch the surface Burn thresholds for short contact periods (up to 10 s) are given as spreads because knowledge of the boundary between a non-burn and onset of a burn is incomplete 60/69 APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 30 Relationship between burn threshold and contact period Surface temperature spreads ‐ touch times for different materials Surface ttemperature °C 100 90 1 2 80 70 3 60 50 40 0.1 0.5 1 10 15 60 100 1000 10000 600 Contact period (s) 100000 28800 APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 61/69 Burn Threshold Spreads The key to the data shown in the previous slide is 1 Plastics and wood 2 Ceramics, glass and stone material 3 Uncoated metal The burn threshold for water is derived from the lower limit of the burn threshold spread established for uncoated metal APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 62/69 31 Selection of Limits Within a Spread For healthy adults, elderly people and people with physical disabilities, a figure in the middle of the spread can be chosen For children, F hild a figure fi more towards t d the th lower end of the spread should be chosen. For products specifically made for children, the value on the lower end of the spread is used. APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 63/69 Probability and Consequences of Touching The higher the probability of touching a hot surface, the more should a figure towards the lower end of the spread be chosen The lower the probability of touching a hot surface, the more can a figure towards the upper end of the spread be chosen The more severe the consequences of touching a h t surface, hot f the th more essential ti l that th t a figure fi towards t d the lower end of the spread shall be chosen The less severe the consequences of touching a hot surface, the more a figure towards the upper end of the spread can be chosen APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 64/69 32 Contents Aim Conclusions Guides Types of Standards Fire Hazard Risk Reduction Accessible Surface Temperature Risk Reduction APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 65/69 Conclusions The micro micro-risk risk assessment applied to specify safety requirements in international standards is robust compliments the macro-risk assessment for product selection requiring enhanced regulatory intervention leads to prudent solutions to address identified hazards APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 66/69 33 T-Factor Conclusions The two examples given show how some of the macro-risk macro risk assessment T factors are addressed T-Factor: Product is likely to be used by unsupervised children T-Factor: Product that has hot accessible nonworking surfaces T Factor: Product is commonly used locally in T-Factor: an unattended mode but classified internationally as used attended APEC EE JRAC Workshop – May 15 - 16 2012, Singapore 67/69 P-Factor Conclusion P-Factor :The applicable international standard is considered to be inadequate Solution: Become involved with the IInternational t ti l standards t d d process and d make the standards adequate APEC EE JRAC Workshop – May 15 - 16 2012, Singapore WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 68/69 34 Thank you for your attention. WTO-Symposium on the 15th Anniversary of the Information Technology Agreement 35