Pierre, If the apparatus is in the patient environment then you must treat it as medical apparatus. It sounds to me as though this apparatus is in the patient environment, so EN60601-1 is the standard to use. Much of the standard will be non-applicable in view of the nature of the apparatus. Best regards, Neil R. Barker C.Eng. MIEE FSEE MIEEE Manager Compliance Engineering e2v technologies (uk) ltd 106 Waterhouse Lane Chelmsford Essex CM1 2QU UK Tel: +44 (0)1245 453616 Fax: +44 (0)1245 453410 e-mail: [email protected] Web: http://www.e2v.com <http://www.e2v.com/>
From: Pierre Selva [mailto:[email protected]] Sent: 22 March 2005 10:57 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
