Hello,
Thank you all for replying to my question
concerning the MDD (EMC directive 89/336/EEC)
As funny as this may seem - yesterday was the
first day I had ever seen and read that document.
* Warning, my personal questions expressed here *
* does not represent my employer's past, present, *
* future activities or frame of mind!!! *
Note, This pesky technician is just trying to
better understand this process... ((Dang those
liberals who believe in free thought and
thinking!))
Since sales of medical equipment into the EU is
governed by IEC 60601-1-2 2nd edition, all new
medical equipment shipping into the EU after Nov
of 2004 must be certified compliant to this
document. Nov 2004 EU sales of pre Rev 2 equipment
is NOT allowed (grand-fathering is NOT allowed.)
Background:
We design and manufacture large medical products
which at times contains "large" sub-systems.
Many questions have come up concerning reconfiguring
(EU installed equipment) to an "as new apparatus"
be it pre IEC 601-1-2 first edition or post to
60601-1-2 2nd edition manufactured date.
QUESTION, Is the Council Directive 89/336/EEC
the right document to define or address questions
of reconditioning, refurnished or reconfigured
installed base (large sub-systems) to "as new
apparatus"?"
SCENARIO 1, There is a large installed base of
EU first edition product that still wants currently
produced hardware "options or upgrades." What
happens after Nov 2004? Can those "options or
upgrades" remain as first edition status and
still be sold?
SCENARIO 2, If they have to be "re-worked" for
second edition compliance, opps, we have created
a new part-number plus a new catalog item which
therefore implies a new product!
Dang, doesn't that mean having to re-certify this
"new" configuration (the whole product verses the
options or upgrades) as second edition??? Dang,
this may not be profitable to do, factoring in
the EMC fixes and EMC test times. Dang,
Thank you in advance for your replies, what a
great resource.
Regards,
dave garnier
David Garnier
e GE Medical Systems
___________________________________________
David S. Garnier
Senior Technician
Functional & CT Engineering
3000 N. Grandview Ave - M/S W-1250
Waukesha, Wi. 53188
Tel: 262.312.7246
Cel: 414-899-7580 (NEW)
From: Ned Devine [mailto:[email protected]]
Sent: Thursday, February 19, 2004 9:39 AM
To: Garnier, David S (MED); [email protected]
Subject: RE: EU's EMC directive 89/336/EEC
Dave,
As you alluded to, the MDD takes precedence over the EMC Directive.
" Whereas the electromagnetic compatibility aspects form an integral
part of the safety of medical devices; whereas this Directive should
contain specific rules on this subject with regard to Council Directive
89/336/EEC of 3 May 1989 on the approximation of the laws of the Member
States relating to electromagnetic compatibility (8);"
Ned Devine
Entela Inc
From: [email protected]
[mailto:[email protected]] On Behalf Of Garnier, David S
(MED)
Sent: Thursday, February 19, 2004 9:15 AM
To: [email protected]
Subject: EU's EMC directive 89/336/EEC
Gentlemen,
I just searched this document for the word "medical" or
"medical device" and I found zero occurrences!
Pardon my ignorance but is this an oversight?
Or does the IEC60601 medical series documents take prescience?
Thank You,
dave garnier
David Garnier
e GE Medical Systems
___________________________________________
David S. Garnier
Senior Technician
Functional & CT Engineering
3000 N. Grandview Ave - M/S W-1250
Waukesha, Wi. 53188
Tel: 262.312.7246
Cel: 414-899-7580 (NEW)
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Technical Committee emc-pstc discussion list.
Visit our web site at: http://www.ieee-pses.org/
To cancel your subscription, send mail to:
[email protected]
with the single line:
unsubscribe emc-pstc
For help, send mail to the list administrators:
Ron Pickard: [email protected]
Dave Heald: [email protected]
For policy questions, send mail to:
Richard Nute: [email protected]
Jim Bacher: [email protected]
All emc-pstc postings are archived and searchable on the web at:
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