Hello Sam, I am not familiar with EU requirements for veterinary medical devices. However, you may want to see what the FDA has to say about them at:
http://www.fda.gov/cvm/index/consumer/regofdevices.htm Best regards, Ron Wellman At 04:01 PM 2/5/2003 -0600, Sam Davis wrote: >All, >I'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 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
