In a message dated 9/26/00, John Juhasz writes:

>  Personally I see this as a Medical Device with 'Telecommunications 
Feature'.
>  Therefore, I envision the application of the applicable Medical Device
>  standard with a separate test (report addendum) on the telecom port 
utilizing an
>  appropriate telecom standard.


Peter, John:

I agree with John's interpretation above.  A couple of years ago I worked on 
a portable defibrillator/EKG device that had a modem in it for sending data 
back to the hospital.  We used the relevant requirements for a medical 
product, but did supplementary testing for the telecom interface using EN 
60950 and UL 1950.  

For Europe, you might even consider EN 41003 (if it is still around), since 
that was intended to cover the generic case of connection to the telecom 
network.  For most products the ITE safety standard EN 60950 has superseded 
EN 41003, but for a medical product EN 41003 might be a good match.


Joe Randolph
Telecom Design Consultant
Randolph Telecom, Inc.
http://www.randolph-telecom.com

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