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CBTL Zhejiang Joysun Testing Technical Services Co., Ltd. previously under NCB UL (Demko) AS has been transferred under NCB TÜV Rheinland Japan Ltd. for product category HOUS
A few weeks ago, as I underwent eye surgery, I realized that I was much more worried about the outcome than about the operation itself. Why was that? Given the numerous problems caused by poor eyesight since I was a kid, I had difficulties imagining a world that wasn’t hazy and out of focus, a world in which I would see sharp outlines and well-defined silhouettes. As for surgery, I had total confidence in the skills of my ophthalmologist. I trust him.
Trust is essential in the doctor-patient relationship
A matter of trust
Trust is the key word here. It is essential in the doctor-patient relationship. I had trust in my doctor and in his diagnosis. I believed him when he told me that surgery was the only option open to me. Had I not trusted him, I would have seen another specialist.
But this goes further than the doctor-patient relationship. My ophthalmologist – and by extension any medical practitioner – has to trust the performance of the optometric apparatus he uses to make a diagnosis. And as a surgeon, he has to trust the reliability of the instruments and equipment used in the operation room, be they surgical lighting, lasers or magnifiers, to name but a few.
Surgical microscope (Photo: Zeiss)
A powerful tool
Manufacturers of medical electrical and electronic equipment – from well-established multinational companies to SMEs (small and medium enterprises) that specialize in high-technology niche markets – have a powerful tool at their disposal for ensuring that their products meet the strictest requirements in terms of safety, reliability and performance: IECEE.
IECEE (IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components) ensures that electrical and electronic devices and equipment are reliable and meet expectations in terms of performance, safety, durability and other criteria. This includes not only medical electrical equipment but also risk hazards for patients, those who operate the equipment – such as doctors and nurses – and maintenance personnel. IECEE has put a special emphasis on this sector in recent years.
Compliance with IEC International Standards
In the IECEE CB (Certification Body) Scheme, medical equipment has its own product category, MED, comprising dozens of IEC International Standards against which products are to be tested and certified. It includes the IEC 60601 series of standards on the safety and performance of medical electrical equipment, and in particular IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, which is widely accepted throughout the world. It can be said that compliance with IEC 60601-1 has become a de facto requirement for the commercialization of electrical medical equipment in many countries.
Emphasis on risk management
But IECEE has gone further. In 2007 it set up the IECEE MEE (Medical Electrical Equipment) Task Force whose responsibility is to deal with the implementation of risk management requirements in the third edition of IEC 60601-1, published in 2005.
The Task Force consists of about 20 members who represent various interests in the field of medical electrical equipment (industry, government agencies, certification bodies, IEC Technical Committees). The group meets once a year and is responsible for:
- developing guidelines and working instructions on how to implement the relevant clauses of IEC 60601-1 in helping manufacturers demonstrate compliance with the “risk management process” as defined in ISO (International Organization for Standardization) 14971, Medical devices - Application of risk management to medical devices
- establishing a consensus with methods that are acceptable for determining compliance with all the relevant clauses (in relation to ISO 14971) of IEC 60601-1
- developing a checklist aimed at assisting the medical equipment industry, official authorities and stakeholders around the world to test in the appropriate manner
- acting as an Advisory Group on the common understanding of ISO 14971 with respect to IEC 60601-1
- organizing specific training sessions dealing with risk management issues
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 and allowing direct access to the marketplace for regulators, vendors, retailers or buyers. It eliminates unnecessary duplicate testing and reduces the costs related to the certification process.
Since 1985, the IECEE has positioned itself as the global testing and certification system for electrotechnical equipment, issuing more than 500 000 certificates that are recognized worldwide. The system is still developing new programmes to provide manufacturers and consumers alike with the highest possible levels of safety, performance and reliability.
More information on IECEE: www.iecee.org
IECEE certification key to EV technologies
Although many automotive manufacturers have added EVs (electric vehicles) to their product lines in recent years, they remain very much a niche market, albeit one that is dynamic and developing steadily. And while potential buyers may still be somewhat concerned by the short range and long charges generally associated with EVs nowadays, industry is striving to come up with innovative solutions to remedy these problems.
The bigger picture
The EV industry is still in its infancy. Granted, they were first seen in the 1900s and then briefly in the 1970s, but since then, technologies have evolved at such a rapid pace that these previous experiments cannot really be taken into account.
Today’s EV development cannot be conceived without taking the bigger picture into account. EVs are not stand-alone products. Connection to the grid, two-way communications, energy storage, to name but a few issues, have to be taken into account. A broad roll-out of EVs will require significant investment into the energy and charging infrastructure.
IECEE was involved in the testing and certification of parts and components for the automotive industry long before it launched the EV programme...
Car manufacturers however are not alone in this still new venture. Governments increasingly push for electrified transportation and in many cases offer incentives for EV development.
Support also comes from the standardization and conformity assessment sector. The IEC in particular has recognized very early on the benefits that EVs could offer in terms of potential energy storage and environmental issues.
Electric and electronic infrastructure
Many IEC TCs (Technical Committees) and thousands of experts work on the electric and electronic infrastructure that allows cars to operate as expected and connect safely to the grid. IEC standardization work includes:
- a multitude of components, switches, connectors, wires
- lighting and displays that are built into any modern car
- audio, video, in-vehicle communication and connection
- batteries, capacitors and fuel-cells
- connectors and charging infrastructure, electric accessories, inductive charging, and more
- functional safety of charging stations and vehicles
- overall electrical safety and protection from shocks, overvoltage and fires
- electromagnetic compatibility (EMC)
- interfaces and protocols for vehicle-to-grid communication, IT security and data protection
The IEC SMB (Standardization Management Board) has also set up a strategic group, SG 6: Electrotechnology for mobility, to investigate interactions between EVs on the one side and the electricity supply infrastructure on the other. The aim is to analyze market and industry developments, identify gaps and overlaps in IEC International Standards and to ensure that a timely delivery of the appropriate standards.
Certifying compliance to standards
However, compliance with IEC International Standards is only the first step. To make sure the parts and components used in manufacturing EVs are of the highest quality and reliability, they need to be tested and certified.
Here again the IEC, through its Conformity Assessment Systems, has the solution.
EV programme launched
In 2012, IECEE (IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components) launched a specific programme for EVs, called ELVH The IECEE CB Scheme, through its registered CBTLs (Certification Body Testing Laboratories), and NCBs (National Certification Bodies), can test and certify charging systems & stations and plugs against two series of IEC International Standards:
- IEC 61851, Electric vehicle conductive charging system
- IEC 62196, Plugs, socket-outlets, vehicle connectors and vehicle inlets
The new IECEE EV programme focuses on charging systems as well as plugs, socket outlets and inlets
EV charging standards
The IEC 62196 series comprises two International Standards. They define the plugs and sockets which can be used to charge an EV. IEC 62196-1 contains the general requirements while IEC 62196-2 standardizes three types of mains connecting systems, known as Types 1, 2 and 3. Which of these is appropriate depends largely upon the electrical infrastructure and regulatory conditions in each country.
These standards build upon IEC 61851-1 which defines the four modes of charging an EV from a power source. Modes 1 to 3 are estimated to allow an EV to be fully charged in between three and ten hours through direct connection to a mains supply. Mode 4 could fully charge an EV in under ten minutes, but as it uses off-grid batteries, it is the most expensive to implement.
The new general IEC 62196-1 standard applies to all four of these modes while IEC 62196-2 applies only to mains charging (Modes 1 to 3). A third standard, IEC 62196-3, is being developed to standardize DC (direct current) charging (Mode 4).
In addition, IEC 61851-1 defines three cable and plug setups which can be used to charge EVs: Case A, where the cable is permanently attached to the EV; Case B, where the cable is not permanently attached to anything; and Case C where the cable is permanently attached to the charging station.
IECEE-certified automotive parts and components
But IECEE was involved in the testing and certification of parts and components for the automotive industry long before it launched the ELVH category. Lighting, switches, electrical safety, EMC, hazardous substances have all belonged to the IECEE portfolio for many years.
...and that includes batteries
Relying on batteries
And so have batteries. Fuel-powered and hybrid cars, trucks, buses, locomotives and aircraft also rely on batteries to start their engine or, in some cases, the APU (auxiliary power unit).
When testing and certifying EV batteries, IECEE focuses on multiple aspects. Electrical energy storage is an important element that will have an impact on 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.
Through its standardization and conformity assessment work, the IEC offers a truly global platform that covers the electric and electronic infrastructure that allows cars to operate safely and helps the EV industry make the connection to the grid.
CBTL Eurocat GmbH has changed it's name to BSI Group Deutschland GmbH
MB, NCB and CBTL SABS have changed their names to South African Bureau of Standards (SOC) Ltd: Electrochnical Laboratories.
CBTL Zacta Technology Corporation Yonezawa Testing Center has changed it's name to TÜV SÜD Zacta Ltd. Yonezawa Testing Center
Specific IECEE EMC programme ensures safety and reliability of electrical and electronic devices
Lightning is a huge natural electrostatic discharge between electrically charged areas within a single cloud, from one cloud to another or between a cloud and the earth. The discharge is accompanied by a flash or strike, can result in serious injuries or fatalities when people are exposed to it, and can cause serious damage to equipment, installations and buildings when it hits the ground.
Keeping safe in a thunderstormy
We have all learned from an early age what we have to do in a thunderstorm. When outdoors, keep away from trees, tall objects, metal and water; try to find shelter in a building; spread out if in a group. When driving, stop at the side of the road or on a motorway’s hard shoulder, stay in the car and avoid touching metal. While indoors, stay away from windows, stop using phones and electrical equipment and unplug appliances and computers.
Close lightning strikes can also generate electromagnetic pulses
Telephones, modems, computers and other electronic devices can be damaged by lightning, as harmful overcurrent can reach them through the phone jack, Ethernet cable, or electricity outlet. Close strikes can also generate EMPs (electromagnetic pulses). All electronic devices are highly susceptible to these electromagnetic effects.
As the market in electronic goods has increased rapidly and steadily over the past 30 years, so the need for protective measures against such effects has grown.
Lightning protection standardized
In 1979, the IEC established TC (Technical Committee) 81
: Lightning protection, to prepare International Standards and guides for lightning protection for structures and buildings as well as for persons, installations, and contents in or on them.
Lightning strikes can cause serious damage to equipment, installations and buildings
TC 81 has provided other IEC TCs with guidance on the protective measures to be taken against electromagnetic effects produced by lightning.
EMC tested and certified by IECEE
As part of its CB (Certification Body) Scheme, IECEE
(IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components), has put in place the mechanisms to ensure, through assessment, testing and surveillance, that products conform to the specified requirements of the appropriate EMC standards. The service provides testing and certification in compliance with IEC International Standards prepared, among others, by IEC TC 77
: Electromagnetic compatibility, and CISPR
: International special committee on radio interference.
EMC chamber (Photo: Philips)
The main features of the IECEE EMC compliance services as provide by the CB Scheme and the CB FCS include, as appropriate:
•Third-party testing and certification for products based on IEC International Standards
•Testing of products by internationally approved laboratories
•Regular surveillance of quality systems and products through factory inspection to ensure that quality products comply with the relevant IEC International Standards
Using the IECEE EMC programme and obtaining IECEE certificate of compliance offers multiple benefits for manufacturers. Among them are faster access to market, cost and time saving, a competitive advantage at the national, regional and international level, and ultimately customer confidence that the product purchased meets all safety and reliability requirements.
CBTL Shanghai Electrical Appliance Testing Laboratory (SEATL) has changed it's name to Technical Center for Mechanical and Electrical Product Inspection and Testing of SHCIQ (SMEC)
Cooperation agreements with other standardization and conformity assessment bodies have been on the IEC agenda for many years. One such agreement, made between the Commission’s three CA (Conformity Assessment) Systems, IAF (International Accreditation Forum) and ILAC (International Laboratory Accreditation Cooperation) has proved highly rewarding, with levels of collaboration increasingly constantly.
From day one, cooperation between the three organizations has evolved extremely positively on a number of technical and administrative fronts. These collaborative efforts culminated in the three organizations signing a MoU (Memorandum of Understanding) in October 2010. In 2012, the high level of confidence established between them led the IEC CA Systems and the members of ILAC and IAF to expand the scope of the first tripartite MoU.
From left: Peter Unger, ILAC Chairman, Pierre de Ruvo, IECEE Executive Secretary and COO, and Randy Dougherty, IAF Chairman
The new MoU was signed in Rio de Janeiro, on 25 October 2012, by ILAC Chairman Peter Unger, IAF Chairman Randy Dougherty and IECEE Executive Secretary and COO Pierre de Ruvo, on behalf of IEC General Secretary and CEO Frans Vreeswijk.
The aim of the initial agreement was to maximize efficiency when dealing with common CB (Certification Body) and TL (Testing Laboratory) clients. One means of achieving this was by re-assessing these CBs and TLs jointly to avoid duplication of processes. Under the new agreement, collaboration will not be limited to joint re-assessments, but will also cover initial assessments and surveillance as appropriate.
Under the IECEE CB Scheme, test laboratories can perform all types of electrcal testing...
To ensure that collaboration is as full as possible, the three organizations have agreed to coordinate the application of standards and guidance documents for the assessment of the CBs and TLs accredited by IAF and ILAC and operating in the IEC CA Systems.
The MoU also stipulates that joint training and workshops should be organized for the pool of technical assessors that are entitled to perform unified assessments of CBs and TLs.
...for example circuit-breaker testing
High-level Steering Committee
In the wake of the 2010 MoU, the IEC-IAF-ILAC Steering Committee was formed to explore the possibilities for further harmonization of the three organizations' assessments and related activities. The Steering Committee is chaired by IECEE Executive Secretary and COO Pierre de Ruvo.
The Steering Committee is responsible for developing the cooperation strategy; establishing working parties to deal with specific issues pertaining to the three organizations; monitoring, reviewing and providing assistance for agreed projects; approving changes to these projects; resolving conflicts and making decisions on formal acceptance of project deliverables.
A dedicated website has been developed to provide information on the tripartite agreement, the Steering Committee and its task forces, relevant documentation and a list of the re-assessments performed since the first MoU came into force.
CBTL LTA Co., Ltd. previously under MET has been transferred to responsible NCB TÜV Rheinland Japan for product category OFF & TRON.
CBTL EMITECH Angers has been transferred from NCB Intertek Semko AB to responsible NCB IMQ S.p.A. for product category OFF.
CBTL EMITECH Ile de France has been transferred from NCB Intertek Semko AB to responsible NCB IMQ S.p.A. for product category MEAS.
ACTL Advanced Compliance Solutions Inc. has been transferred from NCB NEMKO AS to responsible NCB TÜV SÜD Product Service GmbH for product category OFF.
NCB TÜV InterCert GmbH has changed name into TÜV InterCert GmbH - Group of TÜV Saarland