I’m no medical device expert; so this question is just out of curiosity…
For clarity, I’ll call the system under test the DUT. The email that started this thread mentions a “tubular link with liquid”. Depending upon the ionic content (conductivity) of the liquid; couldn’t the liquid be considered an electrical connection between the DUT and the haemodialysis system? How could electrical isolation be proven with a liquid flow between the systems? By measurement of some sort of insulation resistance through the liquid?? Possibly by design… i.e. you guarantee that the liquid only contacts non conductive plastic tubes, plastic pump impellors within the DUT…??? What about physical isolation of the liquids? Wouldn’t there have to be some kind of analysis to consider whether the liquid flowing between the DUT and the haemodialysis system mixes with the body fluids being exchanged between the haemodialysis system and the patient? I’m just a curious bystander; but maybe answering these questions will help with the initial post as well. Chris Maxwell Nettest _____ From: [email protected] mailto:[email protected]] On Behalf Of Ronald R. Wellman Sent: Tuesday, March 22, 2005 10:25 AM To: Pierre Selva; Forum Safety-emc Subject: RE: Medical or laboratory product ? Hello Pierre, It sounds like the product is being used to monitor a state of the haemodialysis system that requires a medical practioner to make a judgment to stop a medical procedure. Since it is part of a haemodialysis system, 60601-1 would apply. Best regards, Ron Wellman From: [email protected] mailto:[email protected]]On Behalf Of Pierre Selva Sent: Tuesday, March 22, 2005 2:57 AM To: Forum Safety-emc Subject: Medical or laboratory product ? Hello all, One of my customers is making a product which is intended to make measurement on liquid issued from a haemodialysis system. The product is close to the haemodialysis system, and it give only information on the liquid quality to indicate if it’s time to stop the dialyse procedure. It doesn’t have capability to stop the system, It gives only information to medical personnel. There is no electrical links between products, only a tubular link with liquid. Product is not an In Vitro Diagnostic system. My question is : What is the most appropriate standard to be use ? 60601-1 or 61010-1 ? Many thanks for your inputs, Best regards, Pierre Pierre SELVA Responsable certifications produits EMITECH Rhône Alpes 1 rue des Essarts 38610 GIERES Ph : +33 (0)4 38 370 007 Fx : +33 (0)4 38 371 004 GSM : +33(0)6 76 63 02 58 [email protected] <http://www.emitech.fr> www.emitech.fr ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to [email protected] Instructions: http://listserv.ieee.org/listserv/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas [email protected] Mike Cantwell [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 ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to [email protected] Instructions: http://listserv.ieee.org/listserv/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas [email protected] Mike Cantwell [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 ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to [email protected] Instructions: http://listserv.ieee.org/listserv/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas [email protected] Mike Cantwell [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
