In IEC/EN60601 the definition of PATIENT reads: "Living being (person or
animal) undergoing medical investigation or treatment". So I would say,
that IEC/EN60601 is the correct standard.
John Radomski
Schneider Electric
Ned Devine
<[email protected]> To: "'Sam Davis'"
<[email protected]>, [email protected]
Sent by: cc:
owner-emc-pstc@majordo Subject: RE: mouse heart
monitor
mo.ieee.org
02/06/2003 09:20 AM
Please respond to Ned
Devine
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
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