Component acceptability for CE product Safety

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Component acceptability for CE product Safety
Technical Note 37
The following component status table applies to the general approval of electrical or electronic
safety critical components (e.g. transformers, motors, fuses, mains cables, etc) for use in
equipment that is CE marked in accordance with a EU product safety directive (e.g. LVD,
R&TTE). Separate rules may apply, in addition, for qualification of the fire resistance of such
components – see relevant equipment standard for details.
Status
2
3
4
Risk to CE
compliance
Third party certified to a relevant EN/IEC standard by a recognised EU
body (e.g. FI, VDE, TUV). Supplied with supporting reports or certificates
(including conditions of use/acceptability, where appropriate). CE marked.
Minimum
Tested in application by TRaC. CE marked.
Minimum
Third party tested to a relevant EN/IEC standard by a recognised body (i.e.
UKAS or equivalent ISO17025/ISO guide 25 laboratory or an EU Notified
Body operating such a laboratory). Supplied with supporting reports or
certificates (including conditions of use/acceptability, where appropriate).
CE marked.
Third party certified or tested to a foreign standard by a recognised body
(e.g. UL, CSA) with demonstrable equivalence to a relevant EN/IEC
standard. Supplied with supporting reports or certificates (including
conditions of use/acceptability, where appropriate). CE marked with
declaration of conformity to relevant EN standard.
Low
Low
Marked as certified by a recognised EU body (e.g. TUV, VDE, BSI). CE
marked with declaration of conformity to relevant EN standard.
Medium
6
Tested to a relevant EN/IEC standard by the manufacturer or other
unaccredited test laboratory. Supplied with detailed test reports. CE marked
with declaration of conformity to relevant EN standard.
Medium
7
Marked as certified to a foreign standard by a recognised body (e.g. UL,
CSA). CE marked with declaration of conformity to relevant EN standard.
8
CE marked with declaration of conformity to relevant EN standard.
9
CE marked only.
No CE mark.
High
Very high
Not
acceptable
Probably
illegal to
use.
10
(worst)
Med./high
Possible to CE mark on the basis of
a report stating that insufficient data
was available to confirm compliance.
5
Notes
Acceptable for a fully compliant test report. CE
mark fully supported by independent data.
1 (best)
Explanation of requirements to achieve status
Note that acceptability is dependent upon a component being rated and tested to the level
required for the particular application in the equipment (e.g. input voltage (230Vac), operating
temperature, cooling requirements), as determined by the equipment standard.
Guidelines for selection of safety critical components
What is safety critical?
Components that are critical to the safety of equipment are known as “safety critical
components”. Safety critical components perform functions that protect against electric shock,
explosion, mechanical hazards, fire, etc. Examples of safety critical components would include
mains cable, mains switches, transformers, X and Y capacitors, power supplies, fuses and fuse
holders. As a general rule, all mains connected parts with some form of insulating or special
protective function are considered to be safety critical components. However, a component does
not have to be mains connected to be safety critical. Examples would be PTC devices or fuses in
secondary circuits or interlocked door switches.
Why does a safety critical component need to be approved?
A safety critical component is essential to the compliance of your equipment. You therefore need
to be sure that it will perform its safety function reliably when it is required to do so. Independent,
third party testing or certification to a recognised standard ensures that the component will
satisfy this requirement. Note that testing by the
manufacturer alone may not ensure compliance and therefore for many certification and test
schemes a certificate from a recognised third party is required. Certified components are not
only independently tested but benefit from regular and independent audit of the manufacturing
process.
How do I know that the component is approved?
An approved component is normally marked with the “mark” of the third party certification body.
In addition there will be a certificate detailing the limits of the approval (e.g. voltage. temperature,
etc) and a full supporting test report. In some cases the component may not be marked but will
be supported by a certificate or report.
It is essential that you obtain the approval certificate to ensure that the parameters of the
approval are suitable for your application. You cannot assume that the “mark” covers all of the
rated values of the component nor that the component standard encompasses all of the
requirement of the equipment standard.
A list of common safety approval marks issued by EU bodies and suitable for demonstrating CE
compliance are shown later in this document.
Will a “CE approved” component be enough to demonstrate EU compliance?
The CE Marking should not be included here in dealing with safety marks because it is not a
safety mark. This is because it is not (generally) necessary to use an independent third party
body to attest to the safety performance of the product. It is also illegal to sell many electrical
components without a CE mark and therefore “de facto” all components (good or bad) carry this
mark. Hence the mark is not a useful guide to compliance.
Where there is no independent third party evidence of compliance then a CE mark with
accompanying declaration of conformity may be the best that you can obtain. Under these
circumstances you may opt to CE mark but you should be aware of the increased risk of
following this route.
Can I use my UL or CSA approved component to demonstrate EU compliance?
Not normally. It is important to be aware that safety markings relating to foreign (i.e. non EU
standards - UL, CSA) have little or no relevance in the EU because:
•
•
•
the operational conditions are different;
the local history of hazards are different, and;
there are significant technical differences between the European and non-European
standards.
Notwithstanding this general rule, there are some standards that have been harmonised
between North America and the EU. Where an equivalence can be established then the foreign
approval may in some cases be acceptable.
Some examples of foreign approval marks (including some from the USA and Canada) are
shown at the end of this document.
Can I use my EU approved component for UL, CSA or NRTL approval?
No. For the same reasons as above, EU approvals have little or no relevance in the USA or
Canada. In addition, equipment approval is mandatory for many product areas and hence
specifically approved UL or CSA approved components are often required. The same principal of
course applies for CE marked components.
Apart from the standards, an important difference between US/Canadian approval schemes is
the requirement for regular inspection of the manufacturing process as part of the certification
scheme. These inspections can be up to four times per year – a factor not common in EU
approval programmes.
Can I use a foreign certified safety critical component to demonstrate EU compliance?
Many foreign certification bodies work to international (IEC) standards that are technically
equivalent to an EN standard (in fact many EN standards are identical to their equivalent IEC).
Also, many of these foreign certification bodies are members of the international CB scheme.
For this reason, where the certification body is recognised and operates under an ISO17025/IEC
Guide 25 quality system, then an IEC certificate may be acceptable for use in equipment tested
for EU compliance. Additional supporting documents may be required to ensure that all EU
deviation shave been addressed.
Examples of safety approval marks issued by EU bodies
Examples of safety approval marks issued by EU bodies (continued)
Examples of safety approval marks issued by foreign certification bodies
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