To my reading the MDD applies only to human patients.
Irrespective of the applicable Directive, you need to consider the suitabilty of the Standrd you choose to adopt. In this case 60601 must be more appropriate than 61010 - not least because safety provisions in the latter make no allowance for deliberate electrical connection of a living creature to your (presumably electronic) device. 61010 takes no account of the fact that a patient (in this case your mouse) is connected via an Applied Part(and so potentailly more suceptible to electric shock), nor that skin resistance is often deliberately reduced or even bypassed for this connection, nor that in the event that shock should occur then the patint is often unable to take any avoiding action. For these and other reasons the electrical safety requirements in 60601 are necessarily more stringent - the requirements in 61010 are inappropriate and inadequate for your application. (I've not checked, but I also assume that 61010 doesn't address other 'patient' safety issues suuch as biocompatibilty either). However, further risk assessment may still be required. The safety requirements in 60601 are based upon human responses to adverse agents - might mice be more sensitive (to leakge currents, for example) ? (Though the Standrd does still include animals as wellas humans in the definition of the 'Patient'). Even if - as you suggest -you are not concerned with preserving your mouse's life, you still have a requirement for the mouse to survive the duration of your expeeriment and, as others have already observed, for the mouse to be free from stresses which could affect your experimental results. On top of which you have an ethical obligation to ensure minimum suffering to the creature. I don't see how 61010 can satisfy these rquirements. Ged Dean > -----Original Message----- > From: [email protected] > [mailto:[email protected]]On Behalf Of Sam Davis > Sent: Wednesday, February 05, 2003 3:01 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 email and any files transmitted with it are confidential and intended solely for the use of the individual or entity to whom they are addressed. If you have received this email in error please notify the system manager. This footnote also confirms that this email message has been swept by MIMEsweeper for the presence of computer viruses. NCHT ********************************************************************** 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
