Hi, I vote for LVD and IEC 61010-1.
The definition of a medical device in the MDD and IVD includes "... intended by the manufacturer to be used for human beings for the purpose of..." So, the MDD and IVD don't apply. In IEC 60601-1, the definition of Patient (Clause 2.12.4) does include animals. But, the definition for Medical Electrical Equipment (Clause 2.2.15) states "...intended to diagnose, treat, or monitor the Patient under medical supervision...". So, from the purpose that you described, I don't think IEC 60601-1 is the correct standard. IEC 61010-1:2001, does not limit its scope to humans. The scope for electrical laboratory equipment includes "...measures, indicates, monitors or analyses substances, or is used to prepare materials,...". This sounds like the purpose of your device. Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 Phone: 616 248 9671 Fax: 616 574 9752 e-mail: [email protected] www.entela.com Entela, Inc. A Certified Woman Owned Business From: Sam Davis [mailto:[email protected]] Sent: Wednesday, February 05, 2003 5:01 PM To: [email protected] Subject: mouse heart monitor 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
