Hi David -- The general rule is that repairing, refurbishing or reconditioning -- in other words, products are NOT CHANGED from what already is installed at the customer's location -- is OK. You are just fixing what is broken or about to wear out on equipment that was previously accepted.
However, upgrading, reconfiguring, improving, adding options or upgrades (even if they have existed for a while) or updating -- in other words, product that ARE CHANGED from what already is installed -- is NOT OK after the DOW for the applicable standard -- without having the whole thing recertified. A big pain is that sometimes a company can't manage to do the former without changing the model or part number, which implies it is doing the latter. Authorities generally want to use model numbers to decide "OK or not OK" and don't have the resources to investigate, decide every case separately and make exceptions. Get together with Sales & Marketing (or whoever decides the product IDs) and explain the consequences. Somewhat the same story as when equipment bundles are sold under new part numbers and then people wonder why retesting may be necessary. Good luck! -- John McBain [email protected] . From: Garnier, David S (MED) <[email protected]> To: <[email protected]> Sent: Friday, February 20, 2004 10:09 AM Subject: (Reconditioned, refurished, reconfigured as new apparatus) RE: EU's EMC directive 89/336/EEC > > 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) > This message is from the IEEE EMC Society Product Safety 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: http://www.ieeecommunities.org/emc-pstc
