Hello all, Thanks for your inputs. To clarify the subject: Yes, the product is in the patient environment. Yes, leakage currents have to be measured Yes, I believe, following your inputs, EN60601-1 has to be applied, mainly because product is close to the patient and it can be touched during operation. The product gives only information to the medical personnel. When it says that the dialyse could be stop, a blood analysis is performed and its result determines if the dialyse can be stop. So, conclusion, I will use 60601-1. Once again, many thanks Pierre
De : [email protected] [ ailto:[email protected]] De la part de Pierre Selva Envoyé : mardi 22 mars 2005 11:57 À : Forum Safety-emc Objet : 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
