Frequently Asked Questions
|Are my choices limited for US and Canadian Safety Approval?
If your products need US and Canadian safety approvals, you may be faced with the concern over which mark do you use and what mark is accepted in the field. There are many myths that your choices are limited to certain marks issued by UL, CSA, FM, ETL, AGA, or CGA.
To sell your product in the United States, a laboratory that is accredited by OSHA as a Nationally Recognized Testing Laboratory (NRTL) can and should evaluate it. When your product bears a Mark from an NRTL, you are telling the Authorities having Jurisdiction (AHJ)and consumers that it complies with the applicable requirements set by ANSI, ASTM, NEMA, and UL standards.Likewise, when you sell your product in Canada, the law requires that you have it approved by a Certification Organization (CO) accredited by the Standards Council of Canada (SCC). Once your product is evaluated against the applicable Canadian requirements, it will bear a mark specifically designated for Canada.
What is CE Marking?
CE Marking is the manufacturer’s claim that the product meets the essential requirements for European Directives (which apply to the product). Testing, system assessments, and technical file assessments are often mandatory. If a manufacturer has a CE Marking on a product and has not verified the claim – the manufacturer is liable to be prosecuted if the CE marked product does not comply.
What is an apparatus?
A final product with an intrinsic function intended for the final user and intended to be placed on the European Union market as a single commercial unit. One or more devices may define the final user product.
For a product to be classified as an apparatus it must meet four (4) criteria:
Additional clarification may be found in the following document, Guideline on the application of Council Directive 89/336/EEC on the approximation of the laws of the member states relating to Electromagnetic Compatibility amended by Directives 92/31/EEC and 93/68/EEC.
How can I demonstrate compliance with the EMC Directive?
A. Self Declaration- Subject your apparatus to the tests specified by European Normalized Standards. Compile a technical file to contain the apparatus’ technical information and test results. Issue a Declaration of Conformance (DoC), affix the mark and hold a copy of the Declaration of Conformance.
B. Technical Construction File(TCF) – for equipment not covered by standards or that is impractical to test. The manufacturer compiles a Technical Construction File containing information required to assess the EMC characteristics of the apparatus. The completed file is submitted to a Notified Body to determine if the file demonstrates that the apparatus will comply with the intent of the requirements. The Notified Body issues a report either indicating the apparatus is in compliance or detailing deficiencies. If deficiencies are noted, corrective action is taken by the manufacturer and the apparatus resubmitted for evaluation. If the Notified Body indicates that the apparatus is in compliance, the manufacturer can issue a Declaration of Conformance, affix the mark and hold a copy of the Declaration of Conformance.
C. Notified Body- for apparatus for which Normalized Standards do not exist a Notified Body may recommend appropriate testing. This testing would be conducted by a Competent Body and reviewed by a Notified Body. When the Notified Body is satisfied that the apparatus is in compliance, the manufacturer compiles a technical file to contain the apparatus’ technical information and test results. The manufacturer issues a Declaration of Conformance, affixes the mark and holds a copy of the Declaration of Conformance.
Who are the country members of the European Union?
Austria, Belgium, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, and Sweden. Additional countries that have expressed interest in joining the EU include: Czech Republic, Hungry, Norway, Poland, Slovakia and Turkey.
Are the European Union national laws consistent for all members?
Yes the European Union national laws are consistent and are mandated by the EU.
Am I required to provide any documentation to support the marking?
Yes. The mark on the product is required to be substantiated with a Declaration of Conformity (DoC). The Declaration of Conformity (DoC) needs to be supported with documentation kept on file by the manufacturer. The DoC must be ” held at the disposal of the Competent Authority.
What is a Declaration of Conformity (DoC)?
A Declaration of Conformity (DoC) is a standardized document used to summarize the details of the apparatus’ compliance and signal by an Authorized Representative of your company.
How do I hold my DoC “at the disposal of the Competent Authority”?
One approach is to provide the DoC as part of the owner’s manual
Can a third party issue a Declaration of Conformity (DoC)?
No. The manufacturer is required to issue the Declaration of Conformity (DoC) and is responsible for it’s content. All other third party references and signatures have no legal standing.
What are Harmonized Standards?
For a standard to be harmonized it must meet three criteria: A. It must be identified by an “EN” designation. B. It must be published in the “Official Journal of the European Communities” (OJ). C. It must be adopted by at least one of the member states.
What is “the mark”?
“The mark” is a symbol, specified by law, which identifies an apparatus as complying with all applicable directives. All apparatus offered for sale within the EU must have the mark or they cannot be sold. Failure to have “the mark” can result in legal penalties. In this case “the mark” is the CE mark.
Who can affix the mark to my apparatus?
The mark may be affixed by the manufacturer after demonstrating compliance with all applicable Directives.
What is a Notified Body?
A Notified Body is an organization, appointed by the EU member’s National Authority (a.k.a. Competent Authority), which has the technical competence to evaluate compliance to a directive. They do not necessarily have test capabilities.
If a Notified Body does not have test facilities, can they designate their authority?
A Notified Body may only direct testing to designated laboratories on apparatus for which no Normalized Standards exist. The Notified Body then notifies the European Commission of the designated laboratory. These laboratories are designated as Competent Bodies. A Competent Body cannot certify your apparatus, the authority remains with the Notified Body.
What approvals are required to test in accordance with the European Harmonized Standards?
Contrary to the abundant marketing hype, no certification, accreditation, approval, European ownership or myriad of other supposed prerequisites exist.
Who can conduct testing in accordance with European Harmonized Standards?
Once a standard is adopted anybody, including the manufacturer themselves, may conduct testing in accordance with the Harmonized Standards.
Where can I get the “Official Journal of the European Communities”?
To obtain a subscription to the “Official Journal of the European Communities” by calling 900-274-4888 or contact the US Department Of Commerce, EC Affairs Office.
Can I have testing performed by a US laboratory, self certify, and affix the mark?
Yes, but is important to remember that the liability for the accuracy and completeness of the testing always remains with you as the manufacturer or your importer.
Who should conduct my testing?
Most manufacturers benefit from utilizing the services of an independent third party test laboratory. F2 Labs are your technical experiences in the application of European test methods.
Glossary of Terms – What Is?
F2 is committed to provide our customers with knowledge tools. For some standard definitions of industry terms, see the table below. We are in the process of adding more terms to our library.