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Safety is crucial in the medical sector. For years, IECEE has based its assessment and certification of medical electrical equipment and devices on the IEC 60601 series of standards, accepted worldwide as a reference in that field.
FDA on board
IEC medical electrical equipment standards have been accepted in legislation throughout the world. For example, More than 60 IEC International Standards have been harmonized under the European Union’s Medical Device Directive 93/42/EEC and are recognized consensus standards by the US (United States) FDA (Food and Drug Administration).
The FDA has now recognized the third edition of IEC 60601-1, in the form of ANSI/AAMI/ES 60601-1, along with many collateral and particular parts of the 60601 series. The information was published in the US Federal Register on 10 June 2010. The FDA has set a transition period – until 30 June 2013 – for acceptance of declarations of conformity to the second edition of 60601, including amendments 1 and 2.
IEC provides universal reference in medical safety
The 1960s and the 1970s saw the emergence of new consumer and worker protection laws and regulations, mainly in industrialized countries. Many standards were developed to establish basic safety rules for various types of electrical devices and equipment, including medical electrical devices.
The medical sector was one where basic safety rules were badly needed. The greatest risk to hospital patients was often from electrical devices that malfunctioned or shut down unexpectedly.
The IEC had been aware of the urgency for a standard covering electrical equipment used in medical practice. Years of effort resulted in the publication, in January 1977, of the first edition of IEC 60601-1, Medical electrical equipment. Part 1: General requirements, which rapidly became the universal reference for the safety of medical electrical equipment.
Standards need Conformity Assessment and vice versa
But manufacturing products to standards is not sufficient guarantee of their safety. CA (Conformity Assessment) also plays an important role.
IECEE, the System of Conformity Testing and Certification for Electrotechnical Equipment and Components, has tested and certified millions of electrical products and systems to IEC International Standards. IECEE very early on incorporated the IEC 60601 series of International Standards into its CB Scheme for product test certificates. For many years manufacturers of medical electrical devices and equipment have counted on IECEE to demonstrate that their products are safe and reliable.
Evolution of IEC 60601-1
IEC 60601-1 has been revised twice. The second edition, published in 1988, made reference to safety in its title: Medical electrical equipment - Part 1: General requirements for safety.
Historically, the IEC approach had been to clearly separate basic safety standards from performance standards for electrical equipment in general, including medical devices. While working on the third edition of IEC 60601-1, the experts from IEC SC (Subcommittee) 62A: Common aspects of electrical equipment used in medical practice, recognized that the situation was different in the medical sector, with many items equally dependent on basic safety and essential performance. Examples include the accuracy with which equipment controls the delivery of energy or therapeutic substances to the patient or processes and displays physiological data that will affect patient management.
In 2005, the IEC published the third edition of IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. In addition to the general requirements for basic safety and essential performance of medical electrical equipment, it also contains requirements for reliable operation to ensure safety.
Certain clauses of the standard allow the use of risk management processes in lieu of pre-specified performance requirements, in which case a complete description and justification of the risk management process and results must be provided.

MRI (Magnetic Resonance Imaging) scanner
About FDA
The FDA, an agency of the United States Department of Health and Human Services, is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, veterinary products and cosmetics.
The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.
With headquarters in Silver Spring, Maryland, FDA has 223 field offices and 13 laboratories in the 50 states, the United States Virgin Islands and Puerto Rico. In 2008, the FDA started opening offices in foreign countries, including China, India, Costa Rica, Chile, Belgium and the United Kingdom.
Mr. Aleksander V. Zazhigalkin is replacing Mr. Sergey Pugachev as Head of NCB GOST RE.
To protect the value of global brands and defend price points, products have to function safely and as expected by the consumer.
Global competition in electrical and electronic goods is fierce. The need to cut costs and comply with national regulations worldwide represents a major challenge.
Since 1985, IECEE, the IEC System of Conformity Testing and Certification for Electrotechnical Equipment and Components, has grown to become a truly global CA (Conformity Assessment) system.
CB Scheme: A success story
The IECEE CB (Certification Body) Scheme is widely popular, with 54 participating countries, 71 NCBs (National Certification Bodies), 370 CBTLs (CB Testing Laboratories) and more than 500 000 certificates issued. The Scheme covers safety and performance of home and office equipment, home entertainment, medical devices, lighting, portable tools and much more. The Scheme has also put in place testing and certification for EMC (electromagnetic compatibility), PV (photovoltaics) and hazardous substances.
IECEE certification is widely recognized and accepted throughout the world. A sample product tested in one country will then be accepted in another country without the necessity of further testing.
The IECEE CB Scheme is an ISO/IEC System 1b. as defined in ISO/IEC Guide 67, Conformity assessment - Fundamentals of product certification. This system includes testing: sample products are assessed for conformity. The sampling covers the entire population of product. A certificate of conformity is given to each product represented by the sample.
This certification system includes the following:
- Samples requested by the certification body
- Determination of characteristics of the product through type testing
- Evaluation of the test report
- Certification decision and granting of the IECEE CB Test Certificate
Full Certification Scheme offers full certification
Most global companies launch their new products in many markets simultaneously. They need timely access to these markets and the elimination of trade obstacles. To achieve this, a speedy and cost-efficient CA is key. It ensures compliance with national technical regulations and helps in ensuring a homogeneous quality globally.
The CB-FCS (Full Certification Scheme) is the perfect instrument for companies that plan global product rollouts. IECEE’s objective in establishing this Scheme was to offer the most comprehensive product certification scheme in the world, based on the principle of mutual recognition of CA certificates and factory inspections by its Members.
CB-FCS goes much further than the CB Scheme in that it combines the testing and certification of sample products with factory inspection and follow-up services related to the product, the assembly line and the factory itself. Based on the principle of mutual recognition of CA certificates by its Members, product testing, factory inspection and assessment of the factory's quality management system are centralized and further accepted by all members.
The CB-FCS is a ISO/IEC System No. 5 as defined in ISO/IEC Guide 67. This certification system includes the following:
- Samples requested by the certification body
- Determination of characteristics by testing representative sample(s) of the product
- Initial factory inspection of the production process and the quality system
- Evaluation of the test and factory inspection reports
- Certification decision and granting of the IECEE CA Certificate
- Licence
- Surveillance of the production process and quality system of the factory
- Regular re-testing or inspection of samples from the factory or the open market, or both
Going the extra mile and having IECEE CB-FCS certification thus provides globally active manufacturers with easier access to markets and helps reduce costs and obstacles to international trade.
 A computer production line
Harmonized procedures
The IECEE FIC (Factory Inspection Committee) has been tasked with the harmonization of the Factory Inspection procedures and forms. These include inspection report forms, guidance for the manufacturers and guidance and qualification requirements for factory inspectors. CB-FCS is based on the principle of mutual recognition of CA certificates by its participants. The general idea is to have one test, one factory inspection, and one certificate issued by a Member NCB and recognized by all other Member NCBs signatories of the CB-FCS MLA (Multilateral Agreement) without any further tests or factory inspections necessary.
Coming soon
A special CB-FCS meeting was convened in Geneva, Switzerland, on 28-29 April 2010 to review the Scheme and prepare recommendations for the IECEE CMC (Certification Management Committee). It proved to be extremely fruitful, and a majority of NCBs expressed their willingness to participate actively in the simplified CB-FCS upon approval of the harmonized documents by the IECEE CMC on 30 June-1 July at its meeting in Tel Aviv, Israel.
CBTL Zhejiang Fangyuan Test Group Co.,Ltd has changed name to Zhejiang test academy of quality and technical supervision.
The following article is based on an interview with Wolfgang Kreinberg,
Chairman of IECEE Factory Inspection Committee
Senior Consultant International Affairs, TÜV SÜD Product Service
For centuries, safety was not a matter of public concern. Accidents were regarded as inevitable. The perception began to change with the Industrial Revolution. Long hours, frequent injuries, unhealthy environment, dangerous machinery were the lot of the factory worker in those days. The second half of the 19th century saw the emergence of the first labour organizations fighting for better work conditions and compensations for on-the-job injuries. Laws were passed, measures were taken to offer better work conditions. But the evolution was slow. The turning point came after World War II. Safety became a growing concern for everyone, and not just in the workplace.
The concept of public and occupational safety took its full importance in the 1960s and 1970s. Occupational safety is concerned with risks in areas where people work: offices, manufacturing plants, farms, construction sites and commercial and retail facilities. Public safety deals with hazards in the home, in travel and recreation, and in other situations that do not fall within the scope of occupational safety.
IECEE brings safety and reliability to electrical equipment
Since 1985 when it was created, IECEE, the IEC System of Conformity Testing and Certification for Electrotechnical Equipment and Components, has ensured that electrical products and equipment are reliable and meet expectations in terms of performance, safety, durability and other criteria. IECEE certification, based on the principle of mutual recognition (reciprocal acceptance) by its members of test results for obtaining certification or approval at national level, is also essential in facilitating international trade.
In its 25 years, the IECEE has positioned itself as the global testing and certification system for electrotechnical equipment, issuing more than 500 000 certificates recognized worldwide. The system is still developing new programmes to provide manufacturers and consumers alike with the highest possible level of safety, performance and reliability.
Consistent product quality – all the time
Factory inspection is one such programme. When products are tested, only a few samples undergo the battery of tests. Factory inspection takes CA (Conformity Assessment) a step further, providing a thorough supervision of the production line to make sure all products that come out of it are of the same quality as the tested samples.
IECEE FIC (Factory Inspection Committee) was set up a few years ago first to examine the feasibility of such a venture under the IECEE System and then to establish the bases on which the programme could run. Wolfgang Kreinberg was appointed Chairman of FIC.
Kreinberg is no stranger to CA. He has been active in IECEE for some years, as a member of several WGs (Working Groups) and as a Lead Assessor and Trainer in Peer Assessments of the IECEE CB Scheme. He has spent most of his professional life working in inspection and approval bodies, first in Germany, then globally.
Wolfgang Kreinberg – A life dedicated to safety
In the early 1970s, after completing his studies in electrotechnical engineering, Kreinberg worked for two years on the development of the first European microprocessor at Olympia Braunschweig in Germany. In 1975, he went back to university for his doctorate. Through his scientific research at Hanover Medical University, coupled with his training in electronics, he quickly discovered that medical electrical equipment and devices used in operating theatres, for instance, were far from safe. They would inevitably malfunction or shut down, putting the life of the patient at risk.
This first encounter with safety issues was a turning point in his career. Once he obtained his doctorate in 1979, he knew he had to get involved in medical device safety. He was hired by TÜV Hanover, the Technical Inspection Association that operated in northern Germany, to build up a service for medical safety that could conduct inspections of hospitals and medical practices. One thing leading to another during these inspections. Kreinberg and his team soon found out that some of the devices they were inspecting were badly constructed. This led TÜV Hanover to ask Kreinberg to set up a type testing laboratory for medical devices.
This project completed, Kreinberg wanted to go back to electronics and database development. TÜV Hanover had other plans for him, and over the next years asked him to restructure several of its laboratories and services.
From local to global
In 1989 Kreinberg was ready for a new challenge. He was approached by Wolfhart Hauser, head of TÜV SÜD (then TÜV Bavaria), who had heard of Kreinberg’s growing reputation in northern Germany. Hauser, who is now CEO and Chairman of Intertek, was at the time setting up a new worldwide approval company under the umbrella of the TÜV organization: TÜV SÜD Product Service. The move was bold and met with scepticism from all major international approval bodies.
Ten years later, in 1999, TÜV SÜD Product Service had become one of the leading firms in the field. The staff had grown from 50 to 500, the locations had grown from two – Munich and Hanover – to more than 70 worldwide. Kreinberg was Chief Technical Officer, responsible for worldwide testing and certification programmes. He was also instrumental in setting up the company as an NCB (National Certification Body) participating in the IECEE CB (Certification Body) Scheme.
Kreinberg also achieved something that had been deemed impossible: TÜV SÜD Product Service was recognized by the USA's (United States of America's) OSHA (Occupational Safety and Health Agency) as the only NRTL (Nationally Recognized Testing Laboratory) outside of North America.
Educating future engineers… and parliamentarians
From experience, Kreinberg knew that standards, safety issues or the legislation in place at any given time, were not part of the electrotechnical engineering curriculum in German universities. That is why, on a totally voluntary basis, he has spent nearly 30 years as a lecturer at Hanover University, teaching students how to use and incorporate standards and legal requirements in their projects, thus preparing them for their future professional life.
For many years Kreinberg has also been the representative of TÜV SÜD Product Service, both in Germany and at the European Union level, in charge of relations with parliament and government.
Still active
After the rapid growth of the first 10 years, TÜV SÜD Product Service consolidated its position on the global market and is still one of the major players worldwide. Kreinberg is now working as a Senior Consultant International Affairs for TÜV SÜD Product Service.
Switching a light on or off is such a routine task that we take it for granted. We can leave a light on for hours and it won’t overheat or ignite. We know what kind of light bulb to use thanks to the marking on the fixture. In short, we know it is safe.
This safety doesn’t come out of nowhere. People work behind the scenes to provide us with safe electric lighting fixtures. Industry, standardization, testing and CBs (Certification Bodies) all collaborate to ensure that the products we buy and use have the required safety levels.
International Standards for the lighting industry
A great number of IEC International Standards address the needs of the lighting industry in terms of requirements, tests, safety and EMC (electromagnetic compatibility) for lamps, lamp systems and all related accessories.
The standards cover product and systems specifications, safety, performance, interoperability, impact on the environment (both during production and until disposal) and everything in between.
Lamps, indicators and luminaires are built, wired and connected based on IEC International Standards for use in households, gardens and pools; public and private transportation; industrial complexes; hospitals, stadiums and urban environments; zoos and aquariums; film, photo and theatre production; and much more.
IEC Technical Committees – a systems approach
To produce an IEC International Standard for the lighting industry, many different IEC TCs (Technical Committees) are called to cooperate.
Lighting covers a vast number of applications and involves many different disciplines. Think power supply, batteries, wires, switches, transformers, converters, starters, enclosures, digital control systems in home networks, the colour rendering in monitors and more.
The leading TC for lighting is IEC TC 34: Lamps and related equipment. TC 34’s work is driven by rapid technological developments and changes in regulatory requirements that have to be continuously incorporated into new and existing International Standards. Areas where changes are especially rapid include the automotive industry, alternative light sources such as LEDs (light-emitting diodes) and new government regulations in the area of EMFs (Electromagnetic Fields).
Application designers, engineers, manufacturers and certification and testing bodies, but also retailers, consumers and government organizations, need IEC International Standards that apply the latest knowledge and technical know-how.
Industry today is very conscious of the need to develop products that have less impact on the environment. A special focus is directed towards the use of less toxic materials, substances and processes during manufacturing.
Several SCs (Subcommittees) of IEC TC 34 deal with special projects in the area of new technologies: LEDs, OLEDs (organic LEDs), electronic operation of metal halide lamps, controlgear design for fluorescent dimming, digital lighting interfaces, specifications for lampholders, automotive lamps, etc.
Initiatives such as the DALI (Digital Addressable Lighting Interface) protocol could help to significantly reduce light pollution where fluorescent lighting is installed, predominantly in commercial buildings. DALI, originally part of IEC/EN 60929, AC-supplied electronic ballasts for tubular fluorescent lamps - Performance requirements, was adopted by the United States of America in 2004 as NEMA (National Electrical Manufacturers Association) Standard 243-2004. The protocol allows for control options, including centralized systems (a personal computer or building automation system), as well as such local controls as manual dimmers, occupancy sensors and photosensors, automating lighting and turning off lights when workers leave.
 Lamps, indicators and luminaires are built, wired and connected based on IEC International Standards
IECEE ensures compliance to IEC standards
Without testing and certification, standards remain theoretical. IECEE, the System of Conformity Testing and Certification for Electrotechnical Equipment and Components, has been testing and certifying lighting products for many years. The IECEE CB Scheme ensures compliance with the impressive list of IEC International Standards developed for the lighting industry.
Testing and certification in that area address performance and safety issues for a wide variety of products and their accessories. Lamps and luminaires in general, single- and double-capped fluorescent lamps, floodlights, LED modules for general lighting, cords, lampholders, switches, insulation, temperature control, wiring and earthing are some examples of the products and related equipment that undergo testing.
Certificates for lighting products much in demand
Lighting is in the top 10 product categories for the number of issued CB test certificates. With 2 032 certificates issued in 2009, it is in fourth place right behind IT (Information Technology) and office equipment; household and similar equipment; and electronics/entertainment.
The IECEE CTL (Committee of Testing Laboratories) has established several ETFs (Expert Task Forces) that provide high-level expertise for each of the IECEE product categories. ETFs are responsible for the interpretation and uniform application of International Standards with a view to establishing harmonized testing procedures.
The ETFs are coordinated by convenors and under complete management of the CTL, which approves whatever provisional decisions they make. ETF 5 is in charge of the lighting sector.
The complete list of International Standards on which the IECEE testing and certifying is based is available from the IECEE website.

Electric cars were popular at the turn of the century as witnessed by this United States
of America postage stamp issued in 1984
Electric cars were popular around the turn of the 20th century when they had the technical edge over fuel-powered cars. Their ensuing role in the development of the automotive industry was small. They resurfaced in the 1970s, but remained a minority until the 1990s with the emergence of environmental concerns about fossil fuels.
In the first years of the 21st century, many car manufacturers designed and produced their own full electric vehicles (FEVs) or hybrid electric vehicles, combining a conventional (usually fossil fuel-powered) powertrain with some form of electric propulsion.
Modern electric cars are equipped with lead-acid, NiMH (nickel-metal hydride) and, increasingly, lithium-ion batteries.
Manufacturers today invest heavily in research to develop lithium-ion batteries that are made of non-toxic materials, as well as more effective, recyclable and environmentally-friendly. Those elements, as well as energy storage capacity and safety, will help consumers make the decision to move away from fuel-powered cars and go all electric.
IEC Standards for EV batteries
IEC TC (Technical Committee) 21: Secondary cells and batteries, and its SC (Subcommittee) 21A: Secondary cells and batteries containing alkaline or other non-acid electrolytes, are developing International Standards that deal with batteries used in electric vehicles.
While SC 21A is working on future standards that take into consideration the need for environmentally-friendlier batteries, be they NiMH or lithium-ion, IEC TC 21 has developed the IEC 61982 series of International Standards on secondary batteries for the propulsion of electric road vehicles.
The standard has three parts:
- IEC 61982-1 specifies the values of the various parameters, such as voltage, current, power and temperature, to be used in the testing of battery cells, monoblocs and modules used for the propulsion of electric road vehicles. The standard also defines certain test conditions and procedures.
- IEC 61982-2 specifies tests and requirements for capacity and endurance tests for secondary batteries used for vehicle propulsion applications. Its objective is to specify certain essential characteristics of cells and batteries used for propulsion of electric road vehicles together with the relevant test methods for their specification. The tests may be used specifically to test batteries developed for use in vehicles such as light passenger vehicles, motorcycles, light commercial vehicles and so forth.
- IEC 61982-3 is applicable to performance and life testing of electrical energy storage systems for general purpose, traffic compatible and light urban use electric road vehicles that are designed for transportation of passengers or goods in city centre driving.
IECEE certifies compliance to IEC Standards
IECEE, the IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components, is another essential player when it comes to certifying EVs (electric vehicles). The IECEE CB Scheme, through its registered CBTLs (Certification Body Testing Laboratories), and NCBs (National Certification Bodies), can test and certify the batteries used in EVs against IEC International Standards, the IEC 61982 series in particular.
When testing and certifying EV batteries, IECEE focuses on multiple aspects. Electrical energy storage is an important element that will impact the EV range and battery-charging frequency. Endurance and lifespan are also under scrutiny.
To avoid risks such as overheating and short circuits, parameters such as voltage, current, power and temperature also need to be measured and tested.
The IECEE has also started a conformity assessment programme for hazardous substances. Consumers may be at risk when using defective batteries, through leakage of dangerous substances, for example. In addition, these substances can be harmful to the environment when they are disposed of at the end of their life-cycle. Legislation covers many hazardous substances, but there are manufacturers of low-quality products that do not take these legal requirements into account.
CBTL ITS Coquitlam has been transferred from NCB ITS Canada to NCB Intertek Semko for category HOUS and to NCB ITS USA for categories MEAS & OFF
The Korean Member Body has a new contact person:
Mr. Park, Joo Seung (Director)
Email: psd0@korea.kr
Tel: +82-2-507-6075
Fax: +82-2-507-6657
The BAHRAIN STANDARDS & METROLOGY joins the IECEE and becomes the Bahrain Member Body. The IECEE Community is pleased to welcome the 54th Member Country and wishes BSM the very best for their future operation in the truly worldwide Conformity Assessment Scheme, IECEE.
Contact:
President of the Bahrain Member Body of the IECEE - Mrs. Mona AlZeera, Director of the Bahrain Standards & Metrology
Tel: 00973 17 574871
Fax: 00973 17 530730
E-mail: malzeera@moic.gov.bh
Secretary of the Bahrain Member Body of the IECEE - Mrs. Wasan Khalaf, Senior Standards Specialist
Tel: 00973 17 574871
Fax: 00973 17 530730
E-mail: wkhalaf@moic.gov.bh
Bahrain, one of the latest countries to join the IEC, hosted on 7-8 December 2009 an international conference on standardization and CA (Conformity Assessment) in electrotecFhnology. GICSE (Gulf IEC – IECEE International Conference for Standardization and Conformity Assessment in Electrotechnology) was organized by the GSO (GCC Standardization Organization), together with the Bahraini Ministry of Industry and Commerce, the IEC and the IECEE (the IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components). GCC stands for Gulf Cooperation Council.
(from left to right)
Abdulsalam Al-Mutlaq, Chairman of Board Directors of Al-Fanar Co.
GSO General Secretariat, Anwar Al-Abdullah
Hasan Abdulla Fakhro, Minister of Industry & Commerce in Bahrain
Abdullah Al-Saif - Chief Executive officer of Motabaqah Co.
The event gathered key players from manufacturing, testing laboratories and government bodies from Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and the United Arab Emirates. The Bahraini Minister of Industry and Commerce, His Excellency Hassan Abdulla Fakhro, opened the conference and was followed by several speakers from government and industry.
 Anwar Al-Abdullah, GSO General Secretariat

Basim Salamah, Electrotechnical expert, Al-Fanar Co
"The conference is the first of its kind in the Middle East," said the Minister, stressing the importance of the electrotechnical sector for national economies and customers.

Ahmed Muati Al-Mutairi, Director of Technical Services Deptartment, GSO (left) with Enno Liess, IEC Vice-President

Ahmed Muati Al-Mutairi, GSO (left) with Pierre de Ruvo, IECEE Executive Secretary, Mona Alzeera, Director Standards & Metrology, Bahrain Standards & Metrology Directorate
Further e-tech reading (see articles below):
Bahrain conference stresses need for safe and reliable electrical equipment in Gulf region
Added value of the IECEE CB Scheme for Panasonic
About IECEE
The IECEE is a worldwide multilateral certification system that is based on International Standards prepared by the IEC.
The IECEE System includes certification for electrical and electronic (electrotechnical) products as well as an exclusive quality mark for photovoltaic products and systems, the PV GAP Mark.
The IECEE System was put in place to facilitate international trade in electrotechnical equipment and components for use in homes, offices, workshops, health-care facilities and similar locations.
The IECEE operates two schemes:
- CB Scheme for Mutual Recognition of Test Certificates for Electrotechnical Equipment and Components
The fundamental principle of the CB Scheme is that a manufacturer can obtain a CB Test Certificate for a defined product from a NCB (National Certification Body). To do so he submits samples of his product. The test results are registered.
The manufacturer can then present this certificate together with product samples to the NCBs in other Member countries whose certification marks he wants for his products. Tests may not be repeated but additional tests may be required for national differences.
- CB-FCS Scheme for Mutual Recognition of Conformity Assessment Certificates for Electrotechnical Equipment and Components
FCS stands for Full Certification Scheme. This is an extension of the IECEE CB Scheme in that it also includes factory audits and inspections. This scheme goes far beyond product testing. It includes a complete quality system and surveillance methods at the factory that produces a certified product. This can insure consistency of design and construction.
This scheme substantially reduces the number of steps required to obtain certification at the national level worldwide. It is particularly interesting for manufacturers who export fast-moving consumer goods to many global markets.
Exclusive to IECEE: the PV GAP Mark
PV GAP Mark, the global approval programme for the certification of photovoltaic products and systems, is exclusively provided by the IECEE through its NCBs.
The Mark is the worldwide reference for manufacturers and suppliers of photovoltaic components and equipment. It ensures that solar equipment and components are compliant with IEC International Standards in terms of safety and performance.
For more information on IECEE: www.iecee.org
About GSO
The GCC (Gulf Cooperation Council) Standardization Organization is a financially and administratively independent entity that is concerned with standardization, conformity verification procedures, accreditation and measurements among the GCC Member States, which are:
- Saudi Arabia
- United Arab Emirates
- Bahrain
- Oman
- Qatar
- Kuwait.
Saudi Arabia, Qatar and Bahrain are Members of the IEC. Saudi Arabia is also a Member of the IECEE, and Bahrain has applied for IECEE membership. Other countries are expected to apply for IEC membership shortly.
Standards and Conformity Assessmenta
Hot oven doors, innocent hands, faulty switches, unprotected sockets, non-standardized circuits, fires in buildings that not only cost billions of dollars to local economies but also endanger the lives of thousands. In the GCC (Gulf Cooperation Council) region, 30 % of building fires are caused by short circuits, faulty wiring and poor-quality products.
These were the starting points for the first GICSE (Gulf IEC – IECEE International Conference for Standardization and Conformity Assessment in Electrotechnology) held on 7-8 December 2009 in the Persian Gulf region. The main topics on the agenda were the safety of household appliances, electrical appliances and buildings, as well as the role of CA in improving the quality and performance of electrotechnical products and systems in these countries.
Safety and welfare are key
Speakers underlined the importance of the event and the essential need for electrotechnical standards. Standards and CA have a significant effect on all segments of trade, from the designer and the manufacturer to the importer and the consumer in the Gulf region. They have a major impact too on governments and regulators. All speakers stressed the need to increase awareness of standards and safety requirements among the general population. Improving the safety of fixtures and appliances in turn improves the safety and welfare of the people. Standards and CA protect people from unsafe products and unsafe buildings.
Standards also promote scientific and industrial development. The harmonization of standards results in added efficiency, cross-border cooperation and economies of scale in manufacturing. These are all extremely important elements for regional economic trade and exchange.
Increase participation in IEC and IECEE activities
One of the aims of the conference was to provide the Gulf region with the tools to play a key role in both the development of IEC International Standards and participation in the IECEE, the IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components.
The IECEE is a trusted mechanism in many developed countries. It encourages the exchange of information, ideas and expertise.
Electrical consumption is growing extremely rapidly in the region. Standards will encourage the development of local manufacturing and the drive for more energy-efficient buildings.
The region is the third most important trade platform in the world. It is also said to have the highest share of copied products, some of these produced locally. This affects the price of quality products, endangers the manufacturing and brands and, above all, puts consumers and users at risk.
One good example of the current situation in the region is given by the modern buildings and structures. They strike visitors as being very advanced and state-of-the-art. But the way they are designed and built often ignores standards. The same is true for the quality and reliability of electrical products and installations. Poor-quality products can be found anywhere in the world, and the region is no exception. It has a high percentage of low-quality electrical products.
The GICSE conference is a step in the direction to introduce International Standards and CA to key players from government and industry in the region.

By Toshiyuki Kajiya
Chair, IECEE Japan National Committee
Executive Manager, Corporate Quality Administration Division, Panasonic Corporation
To protect the value of global brands and defend price points, products have to function safely and as expected by the consumer.
Global competition in electronic goods is fierce. The need to cut costs and comply at the same time with national regulations worldwide represents a major challenge.
In a globally active company such as Panasonic, many different nationalities participate in R&D (Research and Development), procurement and production. Every individual needs to work towards the same high standards to make certain that the end product conforms to market and consumer needs and expectations.
However, there are also competitive needs for a company like Panasonic. One of the most important is timely access to many markets and the elimination of trade obstacles. To achieve this, a speedy and cost-efficient Conformity Assessment is key. They need to ensure compliance with national technical regulations and help in ensuring a homogeneous quality globally.
The IECEE CB Scheme for product test certificates is the tool that allows Panasonic to access cost-efficient product certification that satisfies both regulatory and voluntary standards. IECEE is the IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components.
The IECEE CB Scheme provides economies of scale to Panasonic. As an example: for a TV set, 74 countries require compliance with safety requirements that are fully or partially based on IEC International Standard 60065, Audio, video and similar electronic apparatus – Safety requirements. Thirty-two markets require mandatory certification prior to product marketing. Forty-two countries accept manufacturer or supplier self-verification. To satisfy the requirements for worldwide marketing of a product, the use of the IEC International Standard in product design and the use of IECEE CB Scheme in conformity testing are essential.
Panasonic generally launches new products simultaneously in many markets around the globe. The one-stop testing with the IECEE CB Scheme allows Panasonic to successfully market products in this way, while minimizing duplication and unnecessary testing in the markets it sells to.
Panasonic has an in-house laboratory that is accredited by ILAC (International Laboratory Accreditation Cooperation) and APLAC (Asia Pacific Laboratory Accreditation Cooperation) and recognized for EMC (Electromagnetic Compatibility) and SMT (Supervised Manufacturer’s Testing) for safety aspects. Much of Panasonic testing will be done in-house, following strict quality guidelines. This is very convenient because there is no need to transport products across borders. The interpretation of standards and requirements can be discussed internally.
To streamline global activities and reduce cost, Panasonic will, from the very start of product planning, investigate all applicable technical regulations for all markets the product is intended to be sold in.
Panasonic will design products with conformity in mind. To do so it collects market information and will design toward IEC and Panasonic in-house safety standards.
Verifications involve periodical reviews of product design and the use of the IECEE-CB Scheme. All suppliers are audited for continued conformity.
Factory inspections during manufacturing are the rule. Any potential problem in the market place is traced and tracked via the serial number. Panasonic has the records and information to ensure continued compliance, and this is part of the most important element of its manufacturing activity.
In summary, the IECEE CB Scheme allows Panasonic to comply with national regulators’ requirements, to conduct Conformity Assessments that take into account national differences and to obtain certificates that are internationally recognized. The Scheme also allows Panasonic to comply with the principles of the WTO TBT (Technical Barriers to Trade) Agreement in all member countries. A particular advantage is the freedom to choose an NCB (National Certification Body) that is conveniently located for a manufacturer operating a global business.
The IECEE CB Scheme is essential to enable Panasonic to operate globally in an efficient and cost-effective way.
 Toshiyuki Kajiya displaying the diploma presented during the conference
Where IEC International Standards and Conformity Assessment count
Electrical appliances are found in most households today. Whether at home or in the workplace, from the coffee or tea we prepare in the morning, to the computer we work on, or the television we watch at night, they are part of our lives, often taken for granted.
Many of these appliances represent serious potential hazards to children and adults alike. Electricity can not be heard, seen or smelt. It can, however, be felt. Faulty appliances can cause overheating and catch fire. It's crucial to be aware of the risks of using electrical appliances.
Electric shock
Electric shocks can happen as a consequence of heat, humidity and moisture. Different environments can change how current travels through and over the surfaces of appliances. In warmer climates many cases of electrocution are due to fans that are badly earthed. People also get electrocuted because there are insufficient distances between live parts and touchable surfaces.
Fire and heat hazards
Many electrical fires are caused by dirty appliances. While bread crumbs in a toaster do not transfer current, they can constitute a fire hazard. The same is true of a bathroom fan that has not been cleaned for many years.
Pollution can creep into insulated surfaces and ignite when exposed to electrical sparks. Sometimes only luck prevents the destruction of homes. As an example, a recent case involved an unwelded joint in a dishwasher door switch. Over time this joint collected pollution, which, when the door was not closed completely, ignited and melted the switch. Luckily the dishwasher itself didn’t catch fire.
Careless use of appliances is another source of fires. Simply leaving a pot of cooking oil unattended on a switched-on stove may have dramatic consequences. Frequent sources of fires include electric blankets that are incorrectly installed, or electric room heaters that have been inadvertently covered.
Many electrical fires can be traced to faulty cords, outlets and switches. Overloading extension cords or running several fixtures from a single outlet can all equally cause short circuits and fires.
 Many electrical fires can be traced to faulty cords
"White goods", i.e. domestic appliances such as a dishwasher, dryer or washing machine, should always be plugged directly into an outlet. A dryer for instance can produce enough heat to melt or set fire to a lightweight extension cord.
Any switch or outlet that sparks or gives a shock when touched in the normal course of operation should be repaired or replaced immediately.
Outlets should always be installed in the wall rather than in the floor, where they could get wet and then short-circuit.
Burn hazards
Surface walls of many appliances can constitute serious burn hazards due to ineffective thermal insulation.
Low-quality products normally have less insulation material. Their surfaces can give serious burns, especially to babies and children. Hot oven doors are a typical example of a child hazard.
However, the burn effects of different materials can vary widely. At a similar surface temperature, wood will produce a different burn effect to that of glass, metal or ceramics. This is related to the thermal conductivity and conductive capacity of a given material.
The severity of burns will also depend on the thickness of skin and its moisture content. Children usually have thin skin and a high level of moisture, which gives them a clear disadvantage. Other aspects resulting in more or less severe burns include the potential contamination of skin with grease and the duration and force with which the hot surface is touched.
IECEE tests reduce risks
The IECEE, the IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components, tests all touchable surfaces of appliances, including those that are meant to be held, such as handles, knobs or grips. It also tests those parts that are held for short periods of time, such as switches or the outer walls of a given appliance. The tests are carried out to ensure that specified temperature limits are not exceeded.
Abnormal operation
Abnormal operation of an appliance can produce electric shocks, burns or fire hazards. Conditions of abnormal use form a part of IECEE tests.
CA (Conformity Assessment) tests also take into account temperature controls that malfunction, moving parts, such as rotors, motors or contacts of a relay that block, and failure of electronic components or software. Sometimes, such abnormal operation requires a protective electronic circuit to mitigate the effects.
Dangerous parts
Not all hazards of operating electrical or electronic systems are obvious. The IECEE also looks at the accessibility of dangerous parts, such as rotors and blades. This is particularly important when small children, curious about everything, are keen to touch anything within reach.
The tests evaluate the crushing forces of doors and gates and the pinch points in playground equipment for example. Many of these hazards can be reduced with sensors, such as infrared detectors, and pressure pads. The IECEE verifies the dimensions of these sensors, where they are placed and how they function.
Faulty sensors can cause serious damage. A faulty sensor in a supermarket caused an elderly lady to break her hip. The supermarket doors failed to notice her arrival, closing on her.
The interaction of hazardous liquids and gases with electric systems, especially within non-conforming appliances, is the cause of many explosions every year. Take the example of a refrigerator, produced to lowest standards. When a small amount of flammable refrigerant, less than 50 grams, leaked onto a thermostat, it created an explosion that destroyed a whole kitchen.
And then there are the mechanical hazards linked to the design of an appliance. Children can get trapped in refrigerators or tumble dryers. The danger needs to be identified and intuitive escape mechanisms applied.
The IECEE also tests for hazardous substances, radiation and toxicity that may harm users. Many hazardous substances are controlled by legislation, but low-quality products may not take into account such legislation. Appliances can produce toxic substances that will make them unsafe to operate in certain enclosed environments.
Many countries legislate with regard to household appliances to protect the health and safety of their citizens. IEC International Standards, in conjunction with CA, can help them to do so.
CBTL & ACTL GAI have been transferred from NCB ULC & NCB Nemko to NCB TUV SUD PS
The LIBYAN NATIONAL ELECTROTECHNICAL COMMITTEE (LNEC) AT THE LIBYAN NATIONAL CENTER FOR STANDARDIZATION AND METROLOGY (LNCSM) joins the IECEE and becomes the Libyan Member Body. The IECEE Community is pleased to welcome the 53rd Member Country and wishes LNEC the very best for their future operation in the truly worldwide Conformity Assessment Scheme, IECEE.
Contact:
President of the Libyan Member Body of the IECEE - Prof. Abdalla I. Fadel, President the Libyan National Electrotechnical Committee
Tel: +218 913 750 207
Fax: +218 214 630 338
E-mail: fadel_abdalla@yahoo.com
Secretary of the Libyan Member Body of the IECEE - Eng. Hussein A. Alsghir, Secretary of the Libyan National Electrotechnical Committee
Tel: +218 925 401 221
Fax: +218 214 630 338
E-mail: hussin_sms@yahoo.com
CBTL ITACS has been transferred from NCB SAI GLOBAL to NCB TUV RH JP for categories HOUS OFF SAFE. CBTL & ACTL ITACS have been transferred from NCB SAI GLOBAL to NCB MEEI for categories INST LITE POW PROT
NCB LGA and NCB TÜV Rheinland GmbH merged and changed name into TÜV Rheinland LGA Products GmbH
The new Managing Director of TÜV Rheinland LGA Products GmbH is Mr. Joerg Maehler, together with Mr. Hans-Hermann Ueffing.
CBTL TUV RH PS GmbH changed name into CBTL TÜV Rheinland LGA Products GmbH.
CBTL TUV RH PS GmbH Berlin changed name into CBTL TÜV Rheinland LGA Products GmbH Berlin.
CBTL LGA QualiTest GmbH changed name into CBTL TÜV Rheinland LGA Products GmbH Nürnberg
Safe electrical products of good quality can only be produced if they are manufactured according to well-organized processes.
The objective of factory inspections is to evaluate the capability of a plant to produce uniform-quality products by means of consistent manufacturing processes. Inspections help establish that a manufacturer has set up the conditions allowing him to manufacture electrical products. They show he has met the relevant quality assurance requirements for systematic monitoring and evaluation of different aspects of the production process, which in turn ensure standards of quality.
A factory inspection serves to ensure that a given manufacturer controls the quality of his overall production. It examines the consistency of assembly operations and the ability to manufacture a product of consistent quality. In short, it demonstrates that the whole manufacturing process can be relied on.
But the process doesn’t stop at the product. The inspection takes into consideration incoming goods and supplies, equipment and assembly lines and the general manufacturing processes. At the end of the assembly line, the inspection includes product safety tests and random checks of certain product features. Part of the process also entails a close look at the manufacturer’s QMS (Quality Management System). Then there are periodic, unannounced follow-up inspections of production and testing of samples from the factory and from the open market.
 Inspection of electrical automation system
Testing, certification and inspection through IECEE CB and CB-FCS Schemes
Many manufacturers rely on the IECEE, the IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components, for the testing and certification of their products. The IECEE, through its CBs (Certification Bodies) and CB FCSs (Full Certification Schemes), provides testing and certification services for a vast array of consumer goods. It also provides factory inspection services as part of the CA (Conformity Assessment) elements through the CB FCS.
Factory Inspection Report
The IECEE factory inspection service can be performed as a stand-alone service, unrelated to the CB FCS. In this case, it provides manufacturers with a FIR (Factory Inspection Report) they can include in their Technical File. The report attests that the production line is under third-party control.
Manufacturers may be asked to provide a FIR as part of the paper work necessary for entering certain markets. The report ensures that (within accepted manufacturing tolerances) all certified products are identical to the sample for which the product certification was originally granted. This document represents minimum acceptable standards. Compliance with these requirements is checked during factory inspections.
Whether it is part of the CB FCS or a stand-alone service, the process has numerous benefits. It provides considerable cost reduction by eliminating the need for multiple testing and inspections in many different markets. It reinforces the confidence in the safety of a specific product, reduces obstacles to international trade and helps manufacturers retain a competitive edge.
IECEE Factory Inspection Committee
The main objective of the IECEE FIC (Factory Inspection Committee) is to develop harmonized factory inspection procedures and associated reports to eliminate the need for multiple factory audit inspections. The FIC is made up of experts in factory audit, inspection and follow-up services, and aims to achieve common understanding and uniform factory inspection techniques for generalized recognition of FIRs.
Recent decisions on factory inspection requirements
After meetings in Milan, Italy, and Cologne, Germany, at the invitation of TÜV SÜD Product Services GmbH, the IECEE FIC held its 3rd plenary meeting on 26-27 October 2009 in Munich, Germany. The meeting was attended by 23 delegates and observers from 20 countries. They made significant progress in identifying national differences and requirements for factory inspections. The meeting also provided them with the opportunity to draft the technical content of key documents and the qualification requirements for assessors, essential for market acceptance. At the same time, the FIC created a new Working Group, FIC WG 2, to deal with the harmonization of requirements for photovoltaic factory inspections.
The next meeting of the FIC is scheduled for February 2010.
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