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.
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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.
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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.
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How can I determine if my product is
a component or an apparatus?
For a product to be classified as an apparatus it must
meet four (4) criteria:
A. It must be a finished product.
B. It is intended to be placed on the market as a single commercial unit.
C. It presents EMC hazards against which protection is justified.
D. It delivers a direct function.
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.
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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.
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Are the European Union national laws consistent for all
members?
Yes the European Union national laws are consistent and
are mandated by the EU.
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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.
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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.
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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.
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How long must I hold my DoC "at the disposal of the
Competent Authority"?
You must hold your DoC "at the disposal of the
Competent Authority" for ten (10) years after the product enters the
market.
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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.
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What are Normalized Standards?
For a standard to be normalized 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.
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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.
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Who can affix the mark to my
apparatus?
The mark may be affixed by the manufacturer after
demonstrating compliance with all applicable Directives.
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What is a Competent Authority?
A Competent Authority (a.k.a. National Authority) is
generally the member state's government agency responsible for control of the
RF spectrum.
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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.
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Who are the Notified Bodies?
Notified Bodies are those organizations that were formally
the national experts. A complete list of Notified Bodies is published in the
"Official Journal of the European Communities."
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Do I have to use a Competent Body to
test my product to the Normalized Standards?
When there are Normalized Standards, which are applicable
to your apparatus, you do not need to utilize a Competent Body.
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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. |
Who are the Competent Bodies?
A Competent Body is an organization, located within the
same member state as the Notified Body, that is authorized to conduct
specific testing. A list of Competent Bodies is published in the
"Official Journal of the European Communities."
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Can a company or organization not
located in an EU member country become a Competent or Notified Body?
A Competent Body is an organization,
located within the same member state as the Notified Body that is authorized
to conduct specific testing.
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What approvals are required to test
in accordance with the European Normalized Standards?
Contrary to the abundant marketing hype, no certification,
accreditation, approval, European ownership or myriad of other supposed
prerequisites exist.
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Who can conduct testing in accordance
with European Normalized Standards?
Once a standard is adopted anybody, including the
manufacturer themselves, may conduct testing in accordance with the
Normalized Standards.
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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 800
274-4888 or contact the US Department Of Commerce, EC Affairs Office.
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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.
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Who should conduct my testing?
Most manufacturers benefit from utilizing the services of
an independent third party test laboratory. F-Squared Laboratories are your
technical experiences in the application of European test methods.
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Can I have my apparatus certified by
a third party that is not a Notified Body?
No. Only a Notified Body has the authority to certify an
apparatus. The EU system does not allow for third party certifications,
accreditation or approval unless the organization is operating under a mutual
recognition agreement negotiated between the EU and government authorities of
the third country
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Why shouldn't I utilize the services
of a Competent or Notified Body anyway?
A. Convenience - Competent and
Notified Bodies are located in Europe. F-Squared is located in the United
States in Damascus, MD and in Burton, OH –which is very convenient for
manufacturers.
B. Cost - The added cost
of sending your equipment, associated fees, and sending personnel to Europe
is unnecessary. F-Squared, located
domestically, can help you save in cost while achieving successful product
compliance.
C. Technical Expertise Communication – F-Squared has over 100 years of combined technical
expertise. We not only help
manufacturers achieve compliance but can also provide training and
communication to internal engineering and project teams.
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