Hi,
Per the FDA guidance on EMC http://www.fda.gov/cdrh/ode/638.pdf
The limit is 3 V/m. See the page numbered 25 of the document.
Note: This is for general medical equipment! There is a guidance document
for incubators http://www.fda.gov/cdrh/ode/incubator.html
It references IEC 60601-2-19 and 2-20. 2-19 and 2-20 both require the unit
to pass at 3 V/m and to pass or fail safe at 10 V/m.
Ned Devine
Program Manager III
Entela, Inc.
3033 Madison Ave. SE
Grand Rapids, MI 49548
616 248 9671 Phone
616 574 9752 Fax
ndev...@entela.com e-mail
-Original Message-
From: Ralph Cameron [mailto:ral...@igs.net]
Sent: Monday, August 27, 2001 5:33 PM
To: Antonio Sarolic; emc-p...@majordomo.ieee.org
Subject: Re: Susceptibility level of medical devices (incubator) - urgent!
Antonio:
I would say many incubators were manufactured when there were no concerns
and the susceptibility was a function of the design and very variable. I
have heard they vary from 0.1V/m to 10V/m but don't think there is any set
standard. The medical gurus prefer to isolate their equipment by physical
barriers and hope that something will not affect them
In Canada Health Canada could answer thequestion . In the U.S. I believe its
the Food and Drug Administration.
Ralph Cameron
EMC Consulting and Suppression of Consumer Electronics
(After sale).
- Original Message -
From: "Antonio Sarolic"
To:
Sent: Monday, August 27, 2001 11:59 AM
Subject: Susceptibility level of medical devices (incubator) - urgent!
>
> Hi
>
> I need urgent info on susceptibility level of medical electronic devices,
> especially baby incubators. Can anyone confirm if it is 1V/m (according to
> EU standards)? The EMI source is the GSM BS antenna (900MHz).
>
> Thanks very much.
> Antonio
>
> Antonio Sarolic, M.S.E.E.
> Faculty of Electrical Engineering and Computing
> Dept. of Radiocommunications and Microwave Engineering
> Unska 3, HR-1 Zagreb, CROATIA
> tel. +385 1 61 29 789, fax. +385 1 61 29 717
> E-mail: antonio.saro...@fer.hr
>
>
>
>
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