Joe,
I've given this topic a fair amount of thought. I believe the intent of the
new approach directives is only for equipment being put into service for the
first time. My understanding is if the repair is only a repair and not an
upgrade of any kind, then you may simply put it back into service at the
same place where it was originally placed into service.
There are a number of documents that give good guidance at:
http://europa.eu.int/comm/enterprise/newapproach/index.htm
There are a number of documents linked to this page and I suggest a full
reading before deciding a course of action. I got the most useful
information at:
http://europa.eu.int/comm/enterprise/newapproach/legislation/guide/legislati
on.htm
This is a guide to the implementation of the new approach directives and
there is a single PDF version near the top of the page. In this guide I
found several items of interest plus a fairly good clarification of exactly
what is "placing on the Community market" (or put into service) for the
first time. This would seem to exclude repair, refurbishment or renovation
of products. The implications are many and here are a few that come to
mind,
1) I believe products which have been repaired without changing the original
performance, purpose or type, are not subject to further assessment.
2) I also understand that if you are installing any sort of upgrade to the
product which was made available after the applicable directive came into
force, then the entire product needs to be assessed to current requirements.
3) I do not believe you or the company doing the repair are allowed to keep
an inventory of refurbished service spares on hand as the guidance document
seems to indicate that the original (serialized) unit must remain where it
was first put into service (i.e. no stock piling).
4) Exactly how one provides markings and a declaration for this situation, I
cannot say ...
5) Applicable product directives take precedence over provisions set out in
this guide. For example, if you are using products to the Medical Equipment
Directive, then you should be familiar with discussion it has on repair and
refurbishment.
Regards,
-doug
-----------
Douglas E. Powell, Compliance Engineer
Advanced Energy Industries, Inc.
Mail stop: 203024
1626 Sharp Point Drive
Ft. Collins, CO 80525
mailto:doug.pow...@aei.com
-----------
-----Original Message-----
From: Joe P Martin [mailto:marti...@appliedbiosystems.com]
Sent: Tuesday, July 16, 2002 7:13 PM
To: emc-p...@majordomo.ieee.org
Subject: EMC Directive/Repaired Apparatus
To all,
The following scenario is in regards to the EMC Directive.
We are a manufacturer located in the US. We have various products that
were placed on the EU market prior to the enforcement of the EMC Directive.
We need to repair some of these products. The repairs will not modify the
product to an "as new" piece of apparatus. We want to have the products
repaired in the US.
Questions:
1. Following the repairs, do we need to meet the requirements of the
Directive? If so, why?
2. If not, how do we get the products back into the EU without the CE
Marking?
Hopefully someone has had some experience with this issue.
All responses are appreciated.
Regards
Joe Martin
EMC/Product Safety Engineer
Applied Biosystems
marti...@appliedbiosystems.com
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