Chris,

Firstly I provided on what the LVD and the associated Guidance document
says.  So don't shoot the messenger.

Secondly, the fanciest electronic means of documentation available isn't
worth a bean if it cannot be accessed in the EU.  Perhaps you are thinking
of a means whereby your technical documentation is available on-line,
probably stored in multiple locations so that if one server goes down then
one or more others can take over: in such cases it may be that you could
always pull the technical file over, print it out in the EU, and the
surveillance authorities would never know any difference.  In such cases it
would be pretty surprising if the said surveillance authority were to
complain that the paperwork hadn't  actually been sitting on some shelf in
the EU gathering dust.  Nevertheless, the LVD still says what the LVD says.

Thirdly, a problem with technical files is having the required software to
read it or turn it into paper.  Of course, having the technical file
available as a PDF helps, but there is still a requirement to have the
technical file available "for a period ending at least 10 years after the
last product has been manufactured."  Some companies certainly do have the
means to maintain and access electronic files for the requisite 10+ years
(e.g. 20 years for a product with a 10 year production life): others,
however, do not.

Finally, please do not get confused between standardisation and regulations.
CENELEC is a standards body (like ANSI) and they do not tell the law makers
and enforcement bodies (read Capitol Hill, OSHA/FDA) what to do.  Each
Member State in the EU has its own way of enforcing the national legislation
that approximates EU directives.  However, there is a mechanism for sharing
information between Member States and the Commission on products that have
been taken off the market on safety grounds - and guess what, neither
CENELEC, CEN or ETSI play any part in it. 

Regards,

Richard Hughes


-----Original Message-----
From: Chris Maxwell [mailto:chris.maxw...@nettest.com]
Sent: 11 December 2002 18:49
To: Gary McInturff; Nick Williams; Stephen Irving
Cc: emc-p...@majordomo.ieee.org
Subject: RE: Location of CE DoCs - electronic copies



Gary,

I'm with you on this one.  I consider electronic availability to be equal
to, if not superior to, having the documents on "European Soil".   

My feeling is that: as long as the documentation explains what the CE mark
means; and points the user in the right direction for getting the files;
then files can be emailed at a moment's notice; and the reader is guaranteed
to get the latest revision as stored in our Document Control system.  

I don't think that you can make the equivalent statements about any method
of keeping paper copies at any location.

Of course, these are just my opinions and interpretations.  I haven't had to
tell them to a judge (does CENELEC have a judge?); but I believe that the
reasoning is sound.

Chris Maxwell | Design Engineer - Optical Division
email chris.maxw...@nettest.com | dir +1 315 266 5128 | fax +1 315 797 8024

NetTest | 6 Rhoads Drive, Utica, NY 13502 | USA
web www.nettest.com | tel +1 315 797 4449 | 




> -----Original Message-----
> From: Gary McInturff [SMTP:gary.mcintu...@worldwidepackets.com]
> Sent: Wednesday, December 11, 2002 10:38 AM
> To:   Nick Williams; Stephen Irving
> Cc:   emc-p...@majordomo.ieee.org
> Subject:      RE: Location of CE DoCs - electronic copies
> 
> 
>       Does electronic storage of the documents make any difference? The
DoC, the test reports, BOM's, drawings and Design verification tests are all
stored electronically and can be dumped from any printer in the world.
Obviously, they would have electronic signatures.
>       Gary
>       
> 
> 

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