Introduction
Standardization of products is a worldwide enterprise that forms an integral part of today’s manufacturing environment. Not surprisingly, safety was an early driver of standardization and certification in electrical products, but over the years, more aspects of product structure, composition, (Restriction of Hazardous Substances), function (e.g., EMC), and production quality control have received attention.
For a century, standardization and certification have operated to guarantee the quality and safety of products and installation. Initially, efforts in this were nationally based. For example, in France, the first certification mark, the “USE” mark, was applied to electric sockets in 1924. With the increasing globalization of the economy, there has been a greater trend towards harmonization of standards and approval processes. The net result of these trends is a complex landscape of economic agents, standards developers, product investigators, and regulators. This article reviews the organization of the certification process in France and worldwide, and discusses the value that it provides.
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The electrical world: tradition of harmonization
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1882 LCIE
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1906 CEI
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1907 USE (UTE) France
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1924 USE First certification mark in France
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1926 ISA (ISO)
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1968 Cenelcom (accords CCA)
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1973 Cenelec
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1973 Low Voltage Directive
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1974 First European mark HAR
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1985 CEE (accord IECEE) |
Figure 1
What are the decisive elements and who are the players in electrical product conformity?
We start by discussing the primary economic actors and the requirements their products face.
Characteristics of electrical products
Here are the important aspects to be taken into account in evaluating electrical products:
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Safety, particularly in the light of electrical risks to users and installations
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Ease of interconnection
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Interoperability conditions guaranteeing, in particular, the performance of installations
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The influence of the environment on product operation and the influence of the products on the environment, particularly in terms of electromagnetic compatibility
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Performance characteristics.
The players
The following are involved in the definition of product requirements:
Manufacturers, their subcontractors and the marketing circuits for their products. We will call the product suppliers the first party. They establish the characteristics of their products in response to the demands of their target markets, which may be driven by regulatory as well as market requirements.
The product users: retailers, installers, integrators, site operators or consumers, comprise the second party. They are the recipients of the products produced by the first parties. They make their selections in response to the products’ ease and safety of use, their conformity to applicable rules and regulations, and of course, their market appeal and differentiation from competing products.
Supervising the process are the regulatory authorities at the national (country) or regional level (European Union), who define the requirements for products to be marketed and installed in light of their objectives, particularly with respect to protection of consumers and users.
Reference documents: the expression of needs
Several types of reference documents have been to established express the requirements of the economic players:
The standards: All “parties” listed above develop reference documents on a basis of consensus defining the various important characteristics. This means that for the community concerned, they represent the common level of demands, a common reference. For electrical products, the community is international (International Electrotechnical Committee, IEC, IEC standards), regional at certain levels (CENELEC for Europe, EN standards) and national (UTE for France—NF standards, ANSI and/or UL for the United States).
Rules and regulations: the regulatory authorities develop mandatory rules and regulations spelling out requirements for products, whether standards-based or not, and the procedures for demonstrating conformity of the products to such requirements. The European Directives provide examples such as the Low Voltage Directive and the EMC Directive.
Specifications: Users or their representatives may define their own requirements.
Added value of third party certification
The value of a third party
The “first party” players want to upgrade the value of their products by a convincing demonstration of their conformity to reference documents. The “second party” players must feel complete confidence in this conformity, without necessarily verifying it by themselves. The independence of a third party, connected neither with first party suppliers nor with the second party users, solves this problem.
The impartiality of a third-party evaluator is not only of value to the producers and consumers; it provides assurance to the regulators as well. In many instances, the regulatory authorities require intervention by a third party, especially when safety is critical. One example of this is conformity assessment under the Directive governing equipment for use in explosive atmospheres (94/9/EC) requires use of a third party entity, called the “Notified Body”. Another area where third party involvement is required is in the Medical Device Directive.
So far, we have spoken of primarily of product certification, that is to say, activity by a third party to demonstrate product conformity to the reference document requirements. Quality Management System certification is another area subject to third party evaluation, but it does not concern products directly. Rather, it investigates the general organization of a company.
Product certification activity itself is governed by an international standard (ISO/IEC guide 65 or EN 45011), which describes the requirements that must be met by certification bodies:
The certification body must respect important requirements ensuring impartiality, independence, fairness, confidentiality, competence and transparency.
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The body must have a structure allowing participation by all parties concerned in development of the policies and principles related to content and operation of the certification system.
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The certification body not be involved in product supply or design, either directly or by way of related entities, and it must not provide other services that could represent a conflict of interest with certification.
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The certification system defines the procedures for conformity assessment of the products according to given reference documents. The information about such procedures is made available to the public and hence is known both to potential applicants for certification (manufacturers) and to product users. Those procedures must guarantee fairness to any user, without discrimination.
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In addition, transparency is guaranteed through publication by the certification body of the updated list of certified products.
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For electrical products, as for many other product categories, conformity is established by testing in accordance with the reference documents, and possibly by audits and inspections of the manufacturing site. Evaluation of product conformity is carried out on the basis of the results of that work. To guarantee a high level of independence and impartiality, even if third parties do all of that work, the final certification decision is taken by a different person than the one who performed the evaluation.
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Moreover, needless to say, the certification body must have a competent and qualified staff, and offer complete confidentiality.
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Finally, steps must be taken to deal with disputes and complaints.
An accreditation body checks observance by the certification body of these requirements. Such bodies also grant accreditation of testing laboratories, Quality Management System certification bodies, and inspection bodies. Thus, LCIE is accredited as a certification body by COFRAC, the accreditation body in France, itself a third party. Here are two examples of the accreditation/certification body relationship in the United States:
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In the area of workplace product safety, OSHA (The Occupational Safety and Health Administration) is the accreditation body for the Nationally Recognized Test Laboratories of the NRTL program, which certify the safety of products
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In the area of telecommunications—including radio-frequency transmitting equipment and terminal equipment—the TCBs (Telecommunications Certification Bodies) work under the overall supervision of the FCC, but the details of accreditation are handled by the National Institute of Standards and Technology (NIST) and the American National Standards Institute (ANSI).
Certificates and certification marks provide visibility of certification.
Once product conformity is demonstrated, the form of its material expression varies depending on the extent of product distribution.
For widely distributed products, particularly consumer products, the conformity determined by third party certification is generally shown by a certification mark placed on the product. Therefore, the consumer or the user is informed, when seeing the product, that its conformity has been verified under a third party certification system.
For a product distributed on a smaller scale under a “Business to Business” relationship, a single document, the type certificate, will often be enough. It indicates that the certification body has found that a representative sample of the product is in compliance with the reference document.
Type certification relies on the results of testing of a product sample on the basis of the concerned reference document. The certificate identifies precisely the product and indicates the reference document under which the conformity is certified. The supplier presents the type certificate to the purchaser and guarantees the conformity of the manufactured products to the certified sample.
Certification procedures for mark certification
Certification by mark is based on the following approach:
For the manufacturer to affix the mark on its products, a sample must be tested on the basis of the reference document and meet its requirements. The tests are carried out by a third party laboratory or by the manufacturer’s laboratory under conditions controlled by the certification body so that they are equivalent to third party tests.
In addition, an inspection of the production plant is carried out by a third party in order to determine whether future products will retain the conformity characteristics verified for the tested sample. That inspection includes a quality system audit (complete or partial conformity to ISO 9001, depending on the conformity marks), and an inspection specific to the manufacturing processes and product production control. This is called audit/inspection. . The first time a manufacturer works with a certification body, its factory will undergo a comprehensive review, known as the initial plant inspection, or, as it is often called, an “IPI.”
The test of the product as well as the inspection must be satisfactory for the product to be certified.
To maintain the continued right to use the mark, several elements are necessary:
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The manufacturer must agree to inform the certification body about any changes relating to the nature or production of the products as well as in the organization of its business that might affect product conformity.
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Periodic audits/inspections, at least annual, must continue to be satisfactory. In the safety area, the ongoing inspections are known as “follow up services,” or FUS.
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Tests of products taken as samples from production and also on the market must remain satisfactory (the degree of production line testing and ongoing market surveillance will vary with the product and the standard to which it is certified.).
The Conformity Reference Documents for Certification
Certification has to a large extent been driven by the need for electrical safety standards. Needless to say, to meet safety objectives those standards include performance and durability requirements, particularly when the equipment has potential safety issues. Interactions with the environment are also covered by standards, particularly as regards electromagnetic compatibility (EMC). The latter is dealt with separately in specific standards and, for certain products (e.g. medical equipment), integrated in the product standards rather than treated separately.
In the electrical sector, the development of harmonized common standards has increased markedly at European level – the European Directives have contributed to speeding up harmonization – and at the IEC international level. Depending on countries and products, the international standards can be commonly applied (for instance, for information technology equipment, IEC 60950) or may be used only as a specific modified and additional basis (household appliances, IEC 60335). In electrical installations, infrastructures have different characteristics depending on the country and region, so harmonization is less developed.
Performance reference documents are used as a complement to safety standards. For instance, for room and water heating equipment in France, the NF Electricité Performance mark refers to specifications concerning performance and the corresponding energy consumption, and helps highlight the performance characteristics of the certified products.
To meet their specific needs, professions or particular users can develop their own reference documents. In France an example would be EDF’s (the French Electricity company) HN specifications.
Third party certification and CE marking for electrical products
In the European Union, a product can be subject to multiple directives. To simplify the task of marking a product for compliance, the New Approach was developed. Under the New Approach a a manufacturer or his representative indicate compliance with all directives relevant to their product by affixing the CE mark. Rather than contain detail performance standards, these Directives proceed by laying down the essential requirements that must be met as well as the overall procedures to follow in order to ascertain conformity. Often, conformity to the essential requirements may be demonstrated by taking the “standards route,” that is, checking the product’s compliance to a list of standards which is published and updated in the Official Journal of the European Union from time to time. It is the essential requirements that are important—the standards can provide a convenient way of demonstrating that the essential requirements are met, but the use of the standards is not absolutely essential. Conformity to the standards is not required as long as the conformity to the Directive’s essential requirements is demonstrated—although use of the standards is often the easiest way to provide this demonstration.
According to the Low Voltage Directive (73/23/EEC) and the Electromagnetic Compatibility Directive (89/336/EEC and more recently, its revision 2004/108/EC), the manufacturer or his representative may assess himself the conformity of the product that he markets (manufacturer’s self-declaration). However, with respect to a CE marking based on self-declaration, a third party certification guarantees independence and impartiality in the assessment.
For product categories for which the safety impact is of major importance, intervention of a third party Notified Body is required by the Directives (e.g., equipment for explosive atmospheres, medical systems, and under the Machinery Directive: certain types of machines and their safety components).
Access to international markets: organization of certification of electrical products in Europe and in the World
Historically speaking, certification marks were known as “national” marks for several reasons. Often, certification under the country’s safety standard was mandatory. Early in a country’s regulatory development, there might be only be a single governmental certification body. It is only relatively recently in many countries that certification has become privatized and the number of certification bodies has multiplied.
With the trend towards privatization has come a relaxation on mandatory certification marking. Today, in numerous countries certification marks no longer mandatory for the majority of products. For example, in the countries of the European Union, including the recently admitted members from Eastern Europe, compliance with the European Directives is mandatory, but third party certification marks are voluntary for most products. Still, a national or local mark may remain significant when specific safety or installation related standards are involved. For example, in France, only products governed under a few specific safety regulations (e.g., public buildings or those involved in transport of dangerous materials) require the NF mark.
Some countries are at an earlier stage in this process. For example, in recent years, mandatory certification has been adopted in the last few years in Argentina and Jordan. China, too requires mandatory product certification, although it has modified its certification requirements to be more transparent after it joined the World Trade Organization.
So, worldwide, the situation with regards to marking is quite variable. Depending on the country and the product, a certification mark may be mandatory from the regulatory viewpoint, may be indispensable to meet a market need (but not legally required), or may merely be a “plus” in differentiating a product from its competition.
International Certification. The CB Certificate: a Worldwide Passport
To make it easier to obtain marks in the various countries in which products are marketed without duplication of testing and audit/inspection, certification bodies have developed mutual recognition agreements. A pioneer and leader in this area is known as the CB Scheme.
At world level, under the aegis of the IEC, the IECEE certification system (IEC worldwide system for conformity testing and certification of electrical equipment) groups 59 certification bodies in 43 countries and concerns about 300 international standards.
Here is how it works: Based on tests covered by a type certificate (CB certificate, from a Certification Body) issued by a signatory body, another body in a different country issues its certification mark. For each country, as long as national differences from the IEC standard are declared and therefore known, the certification body, identified as the “issuer”, initiates tests based on the requirements laid down in the IEC standard and any national deviations of the countries from which certification marks are desired. This allows a test campaign by a single laboratory to obtain all marks necessary to market the product in a selection of target countries. Note that the “recognizing” certification bodies may request samples for partial verifications or tests in order to assure itself of the product’s qualification to bear their mark.
This mutual recognition is based on trust between certification bodies (that have signed a multilateral agreement to apply the established rules collectively in cooperation with the manufacturers represented by the IEC national committees (in France, the French Electrotechnical Committee UTE). Moreover a system of peer assessment allows mutual verification of proper application by all the signatories.
The CB certificates are recognized not only by certification bodies granting voluntary marks (e.g., NF in France, VDE in Germany, UL and CSA in the United States and Canada) but also by the authorities issuing mandatory marks for marketing in their country (such as CCC in China, GOST in Russia, PSB in Singapore). CB certificates are also recognized by the customs agencies in numerous countries and by the authorities of certain countries that require certification, such as Jordan and Hong Kong.
The relation of the CB Scheme to products entering the United States deserves particular comment. The regulations governing workplace safety (OSHA) require a that the product be certified by a U. S. Nationally Recognized Testing Laboratory, or NRTL. There are sixteen such NRTLs, and of these, seven are signatories of IECEE and recognize CB certificates.
The IECEE scheme, which has focused on electrical safety, has recently been extended to include electromagnetic compatibility. The system is supplemented by more complete agreement (Full Certification Schemes) to take account of audits/inspections and avoid possible test repeats.
Other similar certification systems at IEC level have been established for explosive materials (IECEx) and electronic components (IECQ). The IECQ scheme (www.iecq.org) may play an important part in the near future in component suppliers’ declarations that their product meet the materials restrictions of the RoHS (Reduction of Hazardous Substances) Directive.
Europe
European recognition agreement: CCA; marks of European certification bodies
The certification bodies from countries affiliated to CENELEC developed the CCA, “Cenelec Certification Agreement”, more than thirty years ago and still use it today.
On the basis of certification work (testing, inspection, certification marking) carried out by a CCA signatory certification body according to a harmonized European standard, the certification mark of another signatory body can be obtained without duplication of work. The French signatory of this agreement is LCIE.
European marks. European certificates
To further simplify access to certifications at European level, several European marks have been created under agreements among European certification bodies. Those marks show conformity to EN European standards or HD harmonized documents, are delivered and monitored by a signatory body, and are equivalent to all of each country’s “national” certification.
The manufacturers involved in development of such European certification systems wanted to define different marks depending on the application sectors.
The first European mark (1973) HAR is specific to cables and conductors.
The ENEC mark (1994) mainly concerns luminaires and luminaire components, some associated equipment, and information technology equipment.
The Keymark concerns home appliances. This certification mark is also used for non-electrical products according to CEN standards.
An EMC mark specific to the electromagnetic compatibility standards is also available.
The certification rules for the various marks are developed in cooperation with all parties concerned, particularly the European trade organizations. Those rules have substantial similarities, but also little differences due to the history of such marks as well as to the expression of different needs.
In the electrical industrial equipment sectors, some agreements on European-type certificates were concluded in the 1990s: LOVAG for Low Voltage, and STLA for Medium and High Voltage. ASEFA is the French signatory of those agreements.
Certification of Electrical Products in France
In France, the NF Mark indicating conformity to the French standards was created in the mid-20th century. AFNOR, Association Française de Normalisation, owns the NF mark.
NF Marks are available in the following electrical areas:
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NF marks in the electrical field
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Electrical conductors and cables
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Conduits, mounting rails and similar products for electrical ducting systems
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Electronic Components
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Electrical equipment for domestic and analogue use
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Emergency lighting
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Household appliances
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Luminaires
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Communication network infrastructure
As to type certification, LCIE as well as ASEFA, specifically recognized for industrial equipment, issue certificates.
The German GS mark : a voluntary mark governed under German law
Until the arrival of the “New Approach” European Directives, the GS safety mark was obligatory in Germany in numerous product categories. It is no longer mandatory, but remains as a voluntary certification mark, sometimes requested for certain markets, and its operating rules are defined in German regulations.
Some non-German certification bodies are authorized by the German authorities to grant this mark.
Conclusion
The electrical standardization and certification world has taken shape over the last century and has continuously adapted to technical changes, world trade development, and the needs of producers, certifiers, and regulators. The resulting system goes far towards ensuring product safety and quality, but is complex and non-uniform across different regions and countries.
This complexity makes careful planning at the outset of product specification and development important. With proper planning, a test campaign can be developed which takes all requirements into account in advance, leading to efficient product testing, certification, and launching onto the market. A knowledgeable certification body can provide a good deal of support in the early, planning stages as well as later in the product development cycle. g
List of major useful websites
LCIE: www.lcie.fr
ASEFA: www.asefa-cert.com
Marque NF: www.marque-nf.com
UTE: www.ute.asso.fr
IECEE: www.iecee.org
IECQ: www.iecq-cecc.org
IECEx: www.iecex.com
CEI: www.iec.ch
Information about CCA and European Marks: www.eepca.org
LOVAG: www.lovag.net
Cenelec: www.cenelec.org
About the Author
Isabelle Heller is Certification Director of LCIE France.