Pierre,
I caution you against proceeding with IEC60601-1 (Electrical Medical Equipment) unless absolutely required. Your product sounds to me like a laboratory product to be evaluated to IEC61010-1 (Laboratory Equipment) = this is a much "easier" standard to comply with than IEC60601-1. The big question is: Where is the product used? = if it is used in the "lab" within a hospital it is "laboratory equipment" = IEC61010-1. If it is used anywhere in the patient room or where a patient could contact = IEC60601-1. The bigger question is: Is there anything in the Medical Device Directive that would mandate your product be covered under the MDD? If at all possible, you want to avoid the MDD like the plague. You would much prefer complying with the LVD & EMC Directives vs. Medical Device Directive. I advise everyone = avoid IEC60601-1 unless you absolutely have to. No sense in making the bar any higher than it needs to be. IEC61010-1 is one of the most lenient IEC standards so if you can fit the scope, this is the standard to use whenever possible. Regards, Bill Bisenius, N.C.E. E.D.& D. <mailto:[email protected]> [email protected] <file:///\\www.productsafeT.com> www.productsafeT.com 919-469-9434 From: Pierre Selva [mailto:[email protected]] Sent: Tuesday, March 22, 2005 5:57 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
