Pierre, >From the description you give the product is part a therapeutic system, and the tubular link gives the potential for leakage currents getting to the patient.
The standard covering this situation is IEC 60601-1-1:2000, the standard for electrical medical systems. Table BBB.201 of this standard describes how to handle both cases. i.e. whether the product complies with IEC 60601-1 or IEC 61010-1. Regards, Jon Griver http://www.601help.com The Medical Device Designer's Guide to IEC 60601-1 > 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
