Sam, A review of the MDD scope shows that if it is not to be used on humans, then the MDD is not the appropriate directive. So the LVD would be the applicable directive.
Nevertheless, I would say the the most appropriate standard to use is EN 60601-1, even though it is not an LVD harmonised standard. On the other hand, I doubt if you would have any trouble with the authorities if you were to use EN 61010, together with a written justification for doing this - "not to save the mouse's life, but using the mouse's life to learn how to save human's lives". Regards, Jon Griver http://www.601help.com The Medical Device Designer's Guide to IEC 60601-1 - >All, >'m trying to work up a quote for testing a product which monitors various >heart functions of living laboratory mice. Would this fall into the Medical >Directive under 60601, or the LVD, under 61010? I'm just looking at the >safety aspects, not EMC. > >The question comes up because the definition of "patient" in 601 (old >version at least) includes "human or animal". This is not veterinary >equipment (save the mouse's life), but laboratory equipment (use the mouse's >life to learn how to save human's lives). >Thanks, >Sam This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
