Group,
 
 
 CTL decisions are not relevant within the EC compliance system.
 
Whether a manufacturer chooses to declare compliance based or not based on a
CTL decision is simply not relevant as long as a compliance justification falls
within a harmonised  standard.  If a test method can be carried out two
ways, well then so be it.
The consensus in veryfing compliance of a certain type of equipment is to
follow the test
method the manufacturer carried out, and not an alternative, whether CTL
exists or not.
 
CTL  are relevant within the mutual recognition schemes between CB's only,
and possibly as an input towards standard improvements.
 
CB are private organistions, and decisons taken by them need no consideration
by an regulatory system, and therefore need not be denied by EC or CENELEC.
 
The system is simple, and remains simple, in spite of any powers trying
to complicate affairs.
 




Regards,

Gert Gremmen
Approvals manager
======================================================
ce-test, qualified testing
Member of EMC committee CENELEC/IEC

+ Independent Consultancy Services
+ Compliance Testing and Design for CE
+ Improvement of product quality and reliability
+ Testing services according to:
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  Medical Devices                             93/42/EC
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Website:  www.cetest.nl (english)
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Phone :  +31 10 415 24 26
Fax :    +31 10 415 49 53
======================================================

  

 
 
 


From: owner-emc-p...@majordomo.ieee.org
[mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of John Allen
Sent: Thursday, December 18, 2003 10:09 AM
To: 'richhug...@aol.com'; emc-p...@majordomo.ieee.org
Subject: RE: CTL Decisions - the situation for Europe


Richard
 
I do realise that you are probably correct in suggesting that we close the
general thread at this point, but I do also want to raise one additional issue
related to Europe & CENELEC which I cannot see having been addressed:
 
There appears to be a very serious issue if a CTL decision exists and is
signed up to by one or more EU test house - but is not published as a common
deviation in the relevant EN version of a standard, nor published elsewhere
within the "official" EU public domain ?
 
In these circumstances, a test house could fail a product on the basis of a
CTL decision, whilst the manufacturer (or another test house) could pass the
product because it did not know of, or chose to ignore, that CTL decision.
Therefore in the latter case, the manufacturer could prepare his DoC in "good
faith" - but yet this could be challenged at a later date, based on an opinion
>from the first test house (say as a result of an accident) that it did not
comply with the CTL.
 
That is a serious problem for the test house(s) and the manufacturer in
question, and the EU Directives compliance system in general.
 
Therefore, it seems to me, that CTL decisions which could affect EN versions
of standards MUST either:
- be officially discussed and agreed in CENELEC TC's, and then published
officially in the relevant standards or some other official publication
(Harmonisation Documents, or even the OJ itself?)
OR
- be the subject of an official Commission and/or CENELEC policy statement to
the effect that they are not valid in Europe, and shall not be taken into
account in deciding on the compliance status of a product.
 
If this issue has not already been raised at Commission Level, then how can it
be done (possibly via the UK DTI?)
 
John Allen, 
Technical Consultant
EMC and Safety Engineering
ERA Technology Ltd.
Cleeve Road
Leatherhead Surrey KT22 7SA
UK
Tel: +44-1372-367025 (Direct)
+44-1372-367000 (Switchboard)
Fax: +44-1372-367102




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