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Eurofins >> Certifications & International Approvals

Certifications, International Approvals, Notified Body Services and Global Market Access

Your industry, our focus

Eurofins help you reducing your product's time to market and accessing the global marketplace

Each country or region has its own rules and regulations that dictate not only what requirements apply to products but how product compliance must be demonstrated. MET’s Global Market Access services for product safety help you to reduce the delays and costs of multiple testing to achieve market entry into a variety of global destinations – allowing your products to be certified once and ultimately accepted by others worldwide without the need for further product assessment.

Index:

  • Certificate of Conformity
  • Geprüfte Sicherheit , GS Body, GS Mark
  • SEV Mark
  • Photovoltaic
    • Swiss PV
    • CEI O-16/21
  • FCC TCB (USA)
  • ISED FCB (Canada)
  • NCB (IECEE-CB Scheme)
    • IECEE CB Scheme CBTL (Safety)
    • IECEE CB Scheme CBTL (EMC)
    • IECEE CB Scheme CBTL (Medical Devices)
    • IECEE CB Scheme NCB (Safety)
    • IECEE CB Scheme NCB (EMC)
    • IECEE CB Scheme NCB (Medical Devices)
  • NCB (IECEx CB Scheme)
    • CBTL (Explosive Atmosphere)
    • NCB (Explosive Atmosphere)
  • Global Certification Services
    • International Type Approval
      • CCC
      • SRRC
      • NAL
      • EAS CU Scheme
      • Minsvyaz
      • NOM
      • Other
    • KC (Korea)
    • RCM (Australia & New Zealand)
    • NRTL - MET (US, Canada)
    • RCB (MIC) (Japan)

 

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BQB (BQE)

Bluetooth Qualification Experts (BQB became BQE) - their involvement is optional but highly recommended by the Bluetooth SIG (Special Interest Group). BQE provide assistance and perform assessments in qualifying Bluetooth products to be listed on the QDL (Qualified Products List). Members who involve a BQE for assessment will not be subject to a random audit by Bluetooth SIG.

CB Scheme

The CB Scheme is based on the use of CB Test Certificates. These certify that representative specimen of a product have successfully passed tests to show compliance with the requirements of the relevant IEC standard. A supplementary report providing evidence of compliance with declared national differences in order to obtain national certification or approval may also be attached to the CB Test Report. Eurofins as German NCB (National Certification Body) is operating in the CB-Scheme accepted as an Issuing and Recognizing NCB. Such an NCB is prepared to recognize CB Test Certificates as a basis for certification or approval at national level for one or more categories of products. Furthermore an NCB is entitled to issue CB Test Certificates for the categories of equipment for which it recognizes CB Test Certificates.

For the following product groups Eurofins offers safety and EMC test and certification services according to the NCB and CBTLs recognition scheme:

  • Switches and Controls

  • Household

  • Measuring Instruments

  • IT and Office Equipment

  • Electronics Entertainment

  • Installation

  • Safety of Transformers

  • Lighting

Eurofins listing at IECEE.

CE Mark

Introduction

The CE mark is a prerequisite for a number of products for being marketed in the European Union. The EU Commission says:

By affixing the CE marking on a product, the manufacturer declares on his/her sole responsibility that the product is in conformity with the essential requirements of the directives that apply to it and that the relevant conformity assessment procedures have been fulfilled. Thus products bearing the CE marking benefit from free circulation in the European Market.

The required declaration of product properties are laid down in European norms issued by CEN.

Please note also another important remark on the website of the European Commission:

Not all products must have CE marking. It is compulsory only for most of the products covered by the New Approach Directives. It is forbidden to affix CE marking to other products.

Please note that a CE marking does not indicate that a product have been approved as safe by the EU or by another authority. It does not indicate the origin of a product either.

You can find information on CE marking tailored for manufacturers, importers, distributors and consumers.

CE mark is administered in a very different manner when compared between different product groups. This regards both how challenging the specifications are, and how tight is the net of monitoring and control by independent certification and inspection agencies, the so-called notified bodies. Any notified body has to be approved by a EU member state. The approval is valid only for a certain, well-defined area.

At present, several laboratories within Eurofins Group are operating such notified bodies for CE marking of toys, medical devices, construction products, personal protective devices, aspects of machinery safety, lifts and more.

For more details, please see our notifications at NANDO database:

Please see also a complete list of notified bodies, and for what areas they are approved, at NANDO database.

New Approach

The declaration of conformity and the CE marking are the two instruments which allow the free circulation of products within Europe. In fact the need of removal of technical barriers which obstruct the free circulation of products is already established in the " Rome's Treaty" of 1957. Since 1985 many directives specifying properties of products followed the "General Approach", which, besides other issues:  

  • assert the principle according to which the needs of safety, health, and environmental prevention has to be harmonized in Europe;
  • affirm that a product which is legally commercialized in a member state can be commercialized also in other members's states;
  • fix the essential requirements of health, safety and environmental prevention;
  • identify, through harmonized standards, how to satisfy some or all the requirements requested by directive;
  • specify that the harmonized standards have to be transponded in national standards.
  • assign to manufacturer the responsibility to issue the CE Declaration of conformity and to affix the CE marking;
  • introduce the principle of presumption of conformity for the products which are CE marked and which are accompanied by Conformity's Declaration.

From 1993 the directives, written according to the so-called "New Approach", have introduced the modular scheme, which identifies in general principles and procedures for the conformity's evaluation and for the CE markings apposition. The conformity's evaluation can be attested though one or more certifications, according to the referring directive. With the exception of particular modules, all certifications require the involvement of a Notified Body which, according to the provided process, can:

  • verify and approve the conformity to requirements through exams and/or tests on product;
  • approve and supervise the system of warranty of the quality of the manufacturer.

Machinery

  • 2006/42/EC Machinery Directive
  • Technical control according to DLGS 81/08
  • Technical verifications: manufacturer
  • Technical verifications: user

Pressure equipment

  • Pressure equipment DirectivePED (97/23/CE Directive)
  • Transportable pressure equipment Directive T-PED (99/36/CE Directive)
  • Technical control according to DLGS 81/08
  • Technical verifications: manufacturer
  • Technical verifications: user

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Lifts

  • Lift directive, LD (95/16/CE Directive)

EMC, LVD, ATEX, RTTE

  • Electromagnetic Compatibility Directive (EMC 2014/30/EU Directive)
  • Low Voltage Directive (LvD 2014/35/EU)
  • Atmospheres explosives Directive (ATEX 94/9/CE Directive)
  • Radio Equipment Directive (RED 2014/53/EU)
  • Technical verifications: manufacturer
  • Technical verifications: user

Management systems

  • Third part Audit according to standard, directive, law or commercial specifications

PPE, NED, liability products

  • Personal Protective equipment DirectivePPE (89/686/CEE Directive)
  • Noise Emission of machineries working outdoorsDirectiveNED (2000/14/CE Directive)
  • Liability products
  • Verification of the conformity of the products to the essential requirement of the applicable European directives

Construction products

(see also the industry overview)

  • Construction Products Regulation (EU 2011/305), EN 16516

  • Road traffic noise reducing devices (noise barrier)
    EN 1 4388

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  • Windows and external pedestrian doorsets
    EN 14351-1

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  • Curtain walling EN 13830

  • Industrial, commercial and garage doors and gates
    EN 13241-1

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  • Handles and knobs
    EN 1906

  • External blinds and shutters
    EN 1932

  • Fixed, vertical road traffic signs, EN 12899-1

 

Medical Equipment

Toys

 

CE Marking for Construction Products 

CE marking in this context is the key tool of the European Construction Products Regulation (EU 2011/305) and means just and only that a Declaration of Performance (DoP) following the product was drawn up in accordance with the specifications in the corresponding harmonized European standard.

The product shall be followed by a Declaration of Performance with a common technical language, as specified in the corresponding harmonized European product performance standards. The actual requirements still are specified by each EU Member State on its own.

CE marking requires that the EU Commission issued a mandate to CEN to establish a harmonized product standard describing how to specify the basic requirements of a concerned product. The basic properties specified in a harmonized European product standard to be declared with CE marking can cover mechanical stability, resistance to fire, hygienic properties (such as emissions of formaldehyde and of VOCs into indoor air), environmental properties and sustainability.

The harmonized European product performance standards will be challenged by the Commission to include testing and declaration of emissions of volatile dangerous substances, and/or release of dangerous substances into water and soil, with next revision.

Verification systems within CE marking

The CE mark is accompanied by a Declaration of Performance (DoP) containing actual product data. For some products this will be done by declaration of the manufacturer. For other products this will need involvement of independent third-party notified bodies and/or notified laboratories. Eurofins Group operates a number of notified bodies for construction products.

Different construction products will require different verification and monitoring systems for CE marking. These are specified by the European Commission and laid down in the harmonized European standards. Not all construction products are under this regime.

Verification
System

Factory
Production
Control (FPC)

Further testing of samples taken by manufacturer

Assessment of performance, Initial type
testing

Initial inspection (plant and FPC)

Continuous surveillance

Audit - testing of samples taken by Notified Body

1+ + + +++ +++ +++ ++
1 + + +++ +++ +++  
2+ + + + +++ +++  
3 +   ++      
4 +   +      

+    : Manufacturer
++  : Notified laboratory
+++: Notified body

Further Information

Services

The Eurofins laboratories and notified bodies can help to find your way through conformity declaration, certification and CE marking, and support with related testing.

Important note:

A manufacturer can select a notified body freely and is not restricted to notified bodies in his own country.

Eurofins Product Testing A/S was involved in the development and validation of the harmonized testing method for emissions of volatile substances into indoor air in CEN Technical Committee TC 351, Working Group WG 2. This allows you to use the expertise of the world-wide largest VOC emissions testing laboratory also for CE marking, as soon as the respective harmonized product standards have been released by CEN.

The resulting standard CEN/TS 16516 was published in October 2013, and Eurofins Product Testing A/S is ISO 17025 accredited and notified for such testing. You may want to see a publication describing CEN/TS 16516, also in comparison with ISO 16000 and EN 717-1 testing (in English) - in Gefahrstoffe Reinhaltung der Luft 74 (2014) 3, 62-68, see www.gefahrstoffe.de. After additional validation steps, this is published as EN 16516 in 2017.

Eurofins Product Service Mark

The registered and recognized Eurofins Product Service Mark represents and markets the combination of different tests for the end customer. This is an optional service which does not suspend the single use of the other logos.  It is exclusively issued by members of the Eurofins Group. The logo increases consumer confidence into the tested products fulfillment of the requirements according to relevant technical standards.

All tests and certification services offered by Eurofins can appear in every desired combination in the logo.

EMC Testing according the Electromagnetic Compatibility Directive 2014/30/EU
Radio Generic term for Radio and wireless equipment
CB Testing (CBTL) and Certification (NCB) of the safety and electromagnetic compatibility of electrical and electronic products under the IECEE CB Scheme
E/e Testing of components or separate electrical/electronic technical units intended for use in vehicles according the Automotive Directive 2004/101/EC (Radio Interference - Electromagnetic Compatibility of Vehicles) to get the e-mark/E-mark
FCC/IC Conformity Assessment Body (CAB) and Telecommunication Certification Body (TCB / FCB) services for the Federal Communications Commission (FCC) of the USA and Industry Canada (IC)
GS Product Safety Testing and Certification according the German Equipment and Product Safety ACT (GPSG) to get the GS-mark ("Geprüfte Sicherheit")
GSM Global System for Mobile Communication in frequency bands of 850 MHz, 900 MHz, 1800 MHz and 1900 MHz
3GPP Third Generation Mobile Communication (UMTS / WCDMA)
LVD Testing according the directive for the harmonization of the laws of Member States relating to electrical equipment designed for use within certain voltage limits - Low Voltage Directive (2014/35/EU)
RED Directive on radio equipment and the mutual recognition of their conformity - RED (2014/53/EU)
SAR Specific absorption rate (SAR) is intended to indicate the amount of radio-frequency energy absorbed into human tissue by radio transmitter devices (SAR is expressed as energy flow -power- per unit of mass in units of W/kg)
RoHS Restriction of Hazardous Substances in electrical and electronic equipment (RoHS) compliance testing services

Safety

Testing against product safety standards

Requirements to the manufacturer:

The manufacturer must follow the Eurofins requirements, if he would like to put the logo on his product:

  • All products shall be marked by the manufacturer with product name, model/type, serial number and the name of the manufacturer or institution, who wants to put the product on the market.
  • The manufacturer must ensure that the Eurofins-Mark Logo is fixed on the product (incl. of all relevant markings within the logo which show the tests carried out).
  • The manufacturer may only use the logo if corresponding test reports are available, which justifies the use of the logo.
  • The Eurofins Mark logo shall be fixed on the product or on the product label. Additional the logo shall be fixed on each packaging and on all supporting documents (e.g. manuals) and in product-related commercials.

The obligation of the manufacturer shall be defined by contract

Logo reproduction

  • The stipulated colors of the logo are blue, orange and white.
  • If the Eurofins Mark should be reduced or extended for different reasons, the proportions of the individual logo parts must remain unchanged.
  • The Eurofins Mark must be high at least 15 mm, unless the size of the product makes fixing impossible with this size.
  • The Eurofins Mark shall have the same size as other relevant logos (e.g. CE).

Using of the Eurofins-Mark logo in test reports:

The Eurofins-Mark logo is used only in test reports and certificates with test and certification results of Eurofins Product Service GmbH.

GS Mark

GS - "Geprüfte Sicherheit"


The GS Mark, introduced in 1977, is one of the leading safety marks. It is based on the "German Equipment Safety Law" (Geräte - und Produktsicherheitsgesetz - GPSG). It indicates that the product was tested and certified for safety by an accredited, independent institute - like Eurofins.

The GS mark is a type-approval mark, connected with periodic factory inspections observing the production quality. To maintain the GS mark, the law demands frequent checks (usually annually or every 2 years, depending upon the certificate) to ensure that the manufacturer is able to maintain all the specifications of the tested product in his mass production. During this factory inspection, Eurofins evaluates the implementation of the quality system, the production environment, and production related testing and measurement equipment.

The GS mark, although not required by law, makes a difference in cases where a product's malfunction leads to an accident for which its manufacturer could be held responsible under Germany's (and the EU's) strict product liability laws. It is also a convincing marketing statement, creating customer confidence and purchasing motivation. Manufacturers often find it convenient and economical to obtain the GS-mark together with the legally required CE Marking.

Eurofins offers following Testing and Certification
services regarding GS-Mark:

  • Electrical household appliances (Electric heating devices used in the household, Household devices, Kitchen devices)

  • Electric heaters

  • Personal care appliance

  • Luminaires

  • Measurement, test and sampling devices outside of the ATEX-D

  • Measurement devices for electrical parameter

  • Electric generators, Current transformer, Current storage devices

  • Consumer electronics

  • Hand-operated tools (Electric tools, Heating tools)

  • IT and office equipment (Office devices, Electronic data processing devices)

Basic GS mark requirements:

Item

Requirements

User manual / Instruction for use

1. in German language
2. available for each model listed on the GS license

Name and Address of manufacturer or representative or importer

provided on …
1. product or
2. package or
3. warranty card or user manual

EMC information

provided as …
1. test reports or
2. declaration or
3. statement in user manual

Ergonomic requirements

provided in German user manual

WEEE Symbol

printed visibly, legibly, indelibly

RoHS

declaration of compliance

PAH requirements

provided as …
1. test reports or
2. declaration or
3. statement in user manual

GS mark licenses are valid for a maximum of 5 years from the issue date of the first license sheet. As of January 1'st 2005, the validity cannot be extended by issuing an additional sheet. A new license with a new license number has to be issued for maintaining the validity of the GS mark certification for the product.

BAuA-Listing - German Federal Institute for Occupational Safety and Health

For a list of Eurofins accreditations, click here.

German Ü Mark

The German Ü mark for construction products is administered by DIBt (German Institute for Construction Technology) and shows that the Ü marked product conforms with the approved product - on the basis of additional German specifications, on top of European CE marking.

Ü stands for "Übereinstimmung" (conformity).

Successful application for the approval and the Ü mark is a prerequisite for entering ther German market - but only for the covered products. Please see our special page describing the application procedures.

Barrier to trade?

German DIBt agency lost at European Court where the European Commission claimed that Germany raised "barriers to trade" with its current rules and practices (Bauregellisten) concerning a specific German approval of construction products. This was said to "breach of EU Single Market rules". See our special page for reading what this will mean for the Ü mark in the future.

According to a recent communication by DIBt (on 06 January 2016):

  • A new regulation "ABG" will be in force after 15 October 2016.
  • Products that still can be DIBt approved must show compliance by showing that approval and carrying the Ü mark.
  • Products that no longer can be DIBt approved can show compliance by other means, where details are not yet specified.
    • The Ü mark MUST NOT BE affixed to products and packaging carrying a CE mark after 15 October 2016 any longer.
    • DIBt recommends to show a valid abZ approval as proof of compliance that is under annual surveillance until its maximum validity. Maximum possible validity of an abZ is April 2020.
      • Many manufacturers are using this possibility. They plan to use their valid abZ as marketing argument against competing products without an abZ.
      • New products do not have this possibility any longer.
      • This unequal treatment of old and new products will give severe problems, but nevertheless these are the present plans of the German authorities.
    • Other programs will be accepted as well.
    • The Eurofins operated Indoor Air Comfort certification program is a good choice for that purpose.

Please follow our VOC Blog to stay updated on this issue.

Market: North America

Telecommunication

Telecommunication in North America is a fast growing market with an annual turnover of more than 7.800 Million US$. Every year, more than 15.000 new telecommunication products are certified by the national authorities of the USA and Canada. The region is a very dynamic place for product development, but also for certification requirements. It is one of the leading markets with regard to consumer safety and information. Tests for Hearing Aid Compatibility (HAC), Specific Absorption Rate (SAR) , Radar detection for UNII WLANs, OTA measurements by PTCRB/CTIA require very specific knowledge, test equipment and trained staff. The strict Eurofins training and seminar philosophy, memberships in telecommunication boards and evaluation test circles ensure the high quality of our measurement and certification services.

The Federal Communication Commission (FCC) is the US authority for the certification of telecommunication equipment. The certification of Telecommunication Equipment in Canada is handled by the Industry Canada (IC) authority. Eurofins is a recognized Conformity Assessment Body (CAB) by Mutual Recognition Agreement (MRA) between the European Union and the North American Countries. It enables Eurofins to offer complete market access for North America.

Interior finishing products and furniture

There are a number of certification systems available for showing low VOC or formaldehyde emissions from floorings, coatings, wall structures and furniture. Some examples are CARB, BIFMA, FloorScore, Indoor Advantage, CRI Green Label Plus, Greenguard and more. Most of these are used for showing compliance with credit criteria for LEED rating system for sustainable buildings. Eurofins supports with testing and consulting for most of these.

IC Canada

Telecommunication Product Certification and the FCB Program

Eurofins is a designated Foreign Certification Body (FCB), accredited by German BMWi and the Industry Canada to issue IC Grants under the Mutual Recognition Agreement between Canada and the European Union. The scope of recognition is "All Radio Standards Specifications (RSS) and Broadcasting Equipment Technical Standards (BETS) in the Category 1 Equipment Standards List. Please see the scope of laboratory accreditations.

The Eurofins measurement facilities comply with RSS_Gen and are registered with Industry Canada. List of O.A.T.S. Filings, IC assigned code 3470.

FCC-USA

The TCB Program

In accordance with the terms of the Mutual Recognition Agreement between the United States of America and the European Union, theEuropean Union has designated and the FCC has accepted several Conformity Assessment Bodies (CABs) that may either certify or test radio frequency and telephone terminal equipment for compliance with FCC regulations. The United States of America and the European Union signed a Mutual Recognition Agreement (US-EU MRA) in May 1998, covering multiple product sectors, including equipment subject to mandatory Telecommunications and Electromagnetic Compatibility (EMC) regulations. The US-EU MRA entered into force on December 3, 1998; and the Telecommunications and EMC annexes became fully operational on January 16, 2001. The agreement facilitates trade by allowing manufacturers to bring products to market quicker. Some of the CABs designated by the EU and accepted by the FCC are Telecommunication Certification Bodies (TCBs). Eurofins is a TCB under the US-EU MRA and has been authorized by the German BMWi and the FCC to issue FCC Grants pursuant to Part 2.960 of 47 CFR starting on 26 February 2003. Eurofins operates under the requirements of 47 CFR Part 2.962. Please consult these FCC rule sections for a more detailed description of the program requirements.

Product certifiers operating under the program are required to perform product surveillance audits of certified equipment.

The TCB Scope

Certification of telecommunication equipment by TCBs is classified in scopes. TCBs can apply for three main scopes comprise different compositions of telecommunication technology. Eurofins is an accredited TCB for all three scopes allowing the comprehensive testing and certification service for all kind of telecommunication equipment.

Scope A -- Unlicensed Radio Frequency Devices :

  • A1 -- Transmitters on frequencies < 1 GHz
  • A2 -- Transmitters on frequencies > 1 GHz
  • A3 -- Unlicensed PCS
  • A4 -- Unlicensed NII spread spectrum devices

Scope B -- Licensed Radio Service Equipment

  • B1 -- Personal Mobile Radio Services
  • B2 -- General Mobile Radio Services
  • B3 -- Maritime and Aviation Services
  • B4 -- Microwave Radio Services

Get the FCC Grant

In order to carry its responsibilities under the Communication Act and various treaties and international regulations, and in order to promote efficient use of the radio spectrum, the FCC has developed technical standards for radio frequency equipment and parts or components thereof. Such equipment must be authorizedfrom the Commission by one of the following procedures: "Verification", "Declaration of Conformity (DoC)" or "Certification".

Certification of equipment by a TCB shall be based on an application with all the information specified in this part. The TCB shall process the application to determine whether the product meets the Commission's requirements and shall issue a grant of equipment authorization. The grant shall identify the TCB and the source of authority for issuing it.

LEED compliance

LEED (Leadership in Energy and Environmental Design), the US originated rating system for sustainable buildings, is requested by more and more building planners in the USA, Asia, Europe and the Gulf.

The US version and the global version are operated by U.S. Green Building Council (USGBC), a non profit organization. Projects are certified by GBCI Green Building Certification Institute, founded by US GBC.

Copies and modified versions of that rating system can be found in the Gulf region, in Italy, in Australia, and in some Asian regions. Some of these regions apply modified versions of LEED.

Why use LEED?

Motivation for having LEED certification of a building is to achieve higher value of a building in the balance, or better sales or better rental price with sustainability as additional argument, or to promote public perception of the company operating a LEED certified building, or to promote environment and health. The procedure is to collect points by fulfilling "credits" for proper consideration of environmental aspects (e.g. saving of energy and of resources, recyclability, indoor air quality and more).

Motivation to show LEED compliance of a product is to show to LEED building projects that use of a specific product helps collecting points in the certification process. This may give access to LEED projects that typically are large buildings with high material consumption. Demonstrating LEED compliance of a product can be an important tool in marketing strategy.

Eurofins also offers post-construction Indoor Air Monitoring services for LEED projects.

LEED versions 2009 and v4

The new version LEED v4 is available since November 2013. The new version brings substantial changes and improvements. During a transition period until October 2016, building projects still can run with the present LEED version, LEED 2009. In that period, and until all such buildings are finished, manufacturers of products will face requests whether their products comply with LEED both with respect to the old and the new version. And US GBC declared that projects that run under LEED 2009 may decide to apply the low VOC credit of LEED v4.

 US GBC operates a list of common low VOC rating systems that allow showing product compliance. Some of them are directly compliant, such as the Indoor Air Comfort GOLD program; other ones are compliant only if the test report shows low formaldehyde emissions of max. 10 µg/m³ after 28 days the reference room, in line with the French A+ class. The French A+ class alone is sufficient only for Composite Wood products, not in general. The list of compliant rating systems can be seen on the US GBC website.

Further Information

Further information regarding LEED:

Eurofins VOC related services

Eurofins offers documentation of compliance with the specifications on emissions of VOC and aldehydes by independent and ISO 17025 accredited testing, and if relevant also with external surveillance (inspections, re-testing), and certification, e.g. in combination with the Eurofins operated certification programme Indoor Air Comfort - certified products.

Eurofins operates both an accredited and notified test house and an approved ÜZ certification body. VOC emissions testing for any program or regulation can be easily combined with tests for other regulations or labels such as Belgian VOC regulationFrench VOC regulationsGerman VOC regulationsEMICODE, German Blue Angel, Finnish M1 and US tests. Such combinations allow to save money compared with separate testing for each of these purposes. One example is the Eurofins Pan-European test package.

Certification and testing services for Ü markCE mark and the Eurofins certification program Indoor Air Comfort - certified products can be ordered in parallel for use on different market segments - there will be significant costs saving when compared to ordering these services separately.

Market: European Union

EMC - Electromagnetic Compatibility

For more information on EMC testing, please click here.

RED - Radio Equipment Directive

Based on the Radio Equipment Directive 2014/53/EU Eurofins has been accredited as Notified Body by the Federal Network Agency of Germany (Bundesnetzagentur) and assigned the EC-registration - number 0681.

Eurofins is able to assess radio Equipment regarding the essential requirements, namely effective use of radio frequency spectrum, EMC, electrical safety and health requirements. Basis of the assessment is the Technical Construction File (TCF). This TCF shall contain all technical information of the device including test reports about EMC, effective use of radio frequency spectrum, electrical safety and health (for further details see paragraph below).

The scopes of our experience comprise the procedures according to Annex III, Annex IV.

Contents of TCF/TD (Technical Construction File/ Technical Documentation)

  • a general description of the product
  • conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.
  • descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product
  • a list of the standards referred to in Article 5, applied in full or in part, and descriptions and explanations of the solutions adopted to meet the essential requirements of the Directive where such standards referred to in Article 5 have not been applied or do not exist
  • results of design calculations made, examinations carried out, etc.
  • test suite (if applicable acc. to Annex II)
  • test reports
  • declaration of conformity
  • EU Type Examination of the Notified Body (if issued)

LVD - Low Voltage Directive

Eurofins offers Services according to the Low Voltage Directive (2014/35/EU). The LvD is covering all risks arising from the use of electrical equipment, including not only electrical ones but also mechanical, chemical, health aspects of noise and vibrations and ergonomic aspects.

Since 2007 these regulations are legally binding - only compliant devices can be brought onto the market.

The Electrical Equipment (Safety) Regulations (LVD) applies to all electrical equipment designed for use with a voltage rating of between 50 and 1000 V AC and between 75 and 1500 V DC. Plugs and Sockets are covered by separate legislation namely the Plugs and Sockets etc. (Safety) Regulations 1994 (SI 1994 No. 1768).

LVD - testing and certification service offered:

  • Consumer electronics
  • Office equipment
  • Alarm devices
  • Luminaries
  • Personal hygiene appliances
  • Electrical heaters
  • Measurement devices
  • Electronic data processing equipment
  • Current transformers and accumulators
  • Electronic toys (see also: Directive 88/378/EEC on the Safety of Toys and RED 2014/53/EU)

E-mark - Automotive Electromagnetic Compatibility Directive

The Automotive Electromagnetic Compatibility Directive 95/54/EC (AEMCD) in their latest revision 2004/104/EC is one of the European Directives which are intended to promote free trade throughout the European Union.

The AEMCD has a different approval mark from the CE mark directives. Instead of the CE logo, products approved to the AEMCD should carry the e-mark. This mark consists of a rectangle surrounding the letter 'e' followed by the distinguishing number (see list below) of the Member State which has granted type-approval.

Eurofins is accredited by the "Kraftfahrt Bundesamt (KBA)", the German Federal Motor and Transport Authority to perform measurements according to the AEMCD. All tests, reports and documents for the e-mark type approval can be handled by our specialist to fulfill all requirements.

The following list gives an overview of all necessary exhibits:

  • Official Certificate of Registration of the company or excerpts from the craftsman register or corresponding documents, in the case of natural persons the official registration, confirmation or an analogous document of all participants in the type approval procedure (documents are accepted in German or English, for documents in another language please add an official certified translation into German)
  • A copy of the certification documents of ISO 9001/9002 OR in case of no / unaccepted ISO certificate a Manufacturers Report (see Annex 1 of MAB document of KBA). This route requires an assessment by KBA.
  • Form A3 of MAB document of KBA (Nomination of authorized Agent)
  • Form A5 of MAB document of KBA (in case of KBA assessment)
  • Form A7 of MAB document of KBA (in case of KBA assessment)
  • Picture or photo of fix place for e-mark on the product
  • Complete set of technical documentation such as circuit diagram, PCB layout, Bill Of Material (parts list), user manual, technical specifications (each number, letter etc. must be of readable quality. Documents must contain company name, product description, model number, Revision number, issue date. All the information has to be an integral part of the documents and not copied into it after printing or even hand written. Whoever prints a document at manufacturers side, must have the same document as submitted) Electronic format preferred
  • Two test reports (provided by Eurofins)
  • Three Appendices IIb (provided by Eurofins)

List of member state numbers:

1 Germany 17 Finland
2 France 18 Denmark
3 Italy 20 Poland
4 Netherlands 21 Portugal
5 Sweden 23 Greece
6 Belgium 24 Irland
7 Hungary 26 Slovenia
8 Czech Republic 27 Slovakia
9 Spain 29 Estonia
11 UK 32 Latvia
12 Austria 36 Lithuania
13 Luxemburg 49 Cyprus
  50 Malta

 

Eurofins is your partner for international type approval and certification of electronics, consumer products, toys, medical devices, and interior finishing products worldwide.

Regional:

International:

Eurofins offers support for several certification systems and ecolabels:

Further details: