I second this opinion for a different reason.  EN 61010-1 doesn't have any
tests that pertain to electrical connections that are intentionally connected
to a living thing, be it animal or human.  Going through 60601 would help to
show that the device won't harm or disturb the mouse, which may be important
to the user.  After all, the user would want to know that the mouse's heart
rate was going up because he saw a female mouse or a piece of cheese...not
because the heart rate monitor is giving him the juice.  

It seems as though EN 60601 would be the appropriate test standard to follow. 
The interpretation probably comes in when you try to determine how closely you
want to follow it.  There may be some "administrative" (follow on testing,
factory auditing...) aspects of EN 60601 which may have costs that are hard to
justify for a mouse tester.

Just an opinion from a semi-educated, non-medical-expert bystander; but I hope
it helps.

Chris Maxwell | Design Engineer - Optical Division
email [email protected] | dir +1 315 266 5128 | fax +1 315 797 8024

NetTest | 6 Rhoads Drive, Utica, NY 13502 | USA
web www.nettest.com | tel +1 315 797 4449 | 




> -----Original Message-----
> From: Chris K. Poore [SMTP:[email protected]]
> Sent: Wednesday, February 05, 2003 6:40 PM
> To:   [email protected]
> Subject:      RE: mouse heart monitor
> 
> 
> On the odd chance that some researcher (or other human / animal) trys to
> connect this to themselves -- it should be evaluated to the MDD.
> 
> Just a guess...
> 
> -----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
> 
> 


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