While I am an EMC guy, not a safety expert, it would seem this device is clearly "patient connected" via the liquid, so 60601-1 would apply. with respect, Brent DeWitt IEC SC62A MT-23 member
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
