At 04:54 PM 8/8/01 +0200, Peter Merguerian wrote:
Dear All,
I am looking into step by step procedure for approving a medical device -
worn by patients with heart problems on the wrist on a daily basis. Device
includes non-invasive sensors for diagnosis of body temperature, blood
pressure, ECG and oximeter. The device includes a GSM modem by Siemens TC35,
an antenna like on a cellphone, a lithium battery pack, a microcontroller
unit, flash memory and a data link controller, all on printed boards
within this high density packaged medical device. My questions are as
follows:
1. What is the procedure to obtain GSM radio approvals in 1) Europe 2)
Canada 3) US?
2. What are the applicable GSM radio standards in Europe only RTTE
directive, Canada and US?
3. What are some well known labs in Europe which can give radio approvals
quickly and efficiently.
4. Assuming the TC35 GSM modem module within the device has CE for Europe
under the RTTE, is there a requirement to obtain radio approvals on the
complete device in Europe?
In Europe You shall to apply the RTTE directive for this directive If you
use the module without any modification on antenna and so on you have only
to test the EMC and the safety characteries of the products all is on self
certification. The equipment, I think, is also under the medical directive
that I don't know well .
Ciao
Paolo
5.. Assuming the TC35 GSM modem module within the device has US and Canada
radio approvals, is there a requirement to obtain radio approvals on the
complete device in North America?
6. Does Canada have a similar approval procedure like the FDA in the States
regarding medical devices?
7. Can this product be FDA approved under the 510K program (ie is there a
similar product out there)?
8. What would be the environmental requirements for this type of device?
PETER S. MERGUERIAN
Technical Director
I.T.L. (Product Testing) Ltd.
26 Hacharoshet St., POB 211
Or Yehuda 60251, Israel
Tel: + 972-(0)3-5339022 Fax: + 972-(0)3-5339019
Mobile: + 972-(0)54-838175
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Paolo Gemma
Siemens Information and Communication Network spa
Microwave Networks MW R&D NSA EMC
SS Padana sup. KM 158 20060 Cassina de'Pecchi (MI) Italy
phone +39 02 9526 6587 fax +39 02 9526 6203
mobile +39 348 3690185
e-mail paolo.ge...@icn.siemens.it
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