GPRS (General Packet Radio Service) and EMC

#1
Hello everybody.
We have a medical device which sends via a GPRS module data to a server.
The GPRS module is designed to comply with directives and standards listed below.
1999/05/EC
2002/95/EC
CFR title 47
UL 60 950-1
NAPRD .03.V5.6
3GPP TS 51.010.1

ETSI EN 301 511 V9.0.2
ETSI EN 301 489-1 V1.8.1
ETSI EN 301 489-7 V1.3.1
EN 60950-1 : 2006

The manufacturer advise us to test it with EN 50360 standard for evaluation human exposure.
Is it the 60601-1-2 the right standard to test the device for EMC test or there are more?
Best regards.
 
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#2
Re: GPRS and EMC

60601-1-2 is the EMC standard for medical electrical equipment.
Itself it calls many other standards, for details of test technique. These are the CISPR standards for emissions and the IEC61000 series for immunity.

Where you have an intentional transmitter and receiver you are allowed dispensation at the operating frequencies of the Tx/Rx. You are also required to state the output power of your transmitter in the Operators Manual.

EN 50360 is titled
"Product standard to demonstrate the compliance of mobile phones with the basic restrictions related to human exposure to electromagnetic fields (300 MHz - 3 GHz)"
As 60601-1-2 does not directly address the human exposure aspect then it would seem to be a good idea to use the requirements and tests in EN50360 to provide the input to your risk management process.
 
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