Del, I'm not an R&TTE expert, but from the MDD side under the 2nd edition of 60601-1-2 (2001), the function of the card and it's communications would have to be evaluated. If it falls under the ESSENTIAL FUNCTION of the medical device, it would be subject to the requirements of 60601-1-2. These requirements are somewhat more stringent than the R&TTE directive. That probably doesn't help much, but it's a bit more information. Regards, Brent DeWitt
From: owner-emc-p...@majordomo.ieee.org [mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of D.Han Sent: Friday, July 18, 2003 4:20 PM To: emc-p...@majordomo.ieee.org Subject: R&TTE for Medical Devices? Hi All, I would appreciate your thoughts on the following scenario: Company A designs a medical product that incorporates a wireless device, lets say, a wireless PCI card. The wireless card is manufactured by Company B and has been evaluated to the R&TTE directive and thus CE-marked. This wireless card is installed in the end medical product, unmodified and according to manufacturers instructions. Company As name goes onto the end product, but Company Bs name, markings, labeling etc. remain on the wireless card. Would Company A need to consider R&TTE (in addition to the MDD) for their end product? If yes, what additional testing would this encompass? Thanks! Del _____ Do you Yahoo!? SBC <http://pa.yahoo.com/*http://rd.ya oo.com/evt=1207/*http://promo.yahoo.com/sbc/> Yahoo! DSL - Now only $29.95 per month!
