Peter - Regarding the US and Canadian approvals - 1. I assume that the GSM radio module in question includes operation at 1900MHz and is approved here - if it is a 900/1800 MHz version only, it is a no go. 2. The final device must meet be re-approved both in US and Canda as a new radio device (integration), and this includes SAR!! Not all of the original test for need to be repeated.******** 3. I believe there are other wireless monitoring devices, using various radio standards already sold in US and Canada. 4. Since you asked - we are not in Europe, but... :)) Kindest regards, Kate Kathy M. MacLean President, APREL Laboratories -EMC-RF Safety-Antenna design/test-SAR/MPE- SAR Tools-Acoustics-Wireless- 51 Spectrum Way, Nepean, Ontario K2R 1E6 (613) 820-2730 fax (613) 820-4161 cell (613) 791-3777 Web site: <http://www.aprel.com/> http://www.aprel.com - watch for our new web site coming soon! See you at the IEEE EMC Symposium, Montreal August 13-17, 2001 Booth 1330
-----Original Message----- From: Paolo Gemma [mailto:[email protected]] Sent: August 10, 2001 5:00 AM To: Peter Merguerian; [email protected] Subject: Re: Wrist Medical Device with a GSM Link 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 ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ <http://www.ewh.ieee.org/soc/emcs/pstc/> To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson: [email protected] Dave Heald [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.rcic.com/ <http://www.rcic.com/%A0%A0%A0%A0> click on "Virtual Conference Hall," _____ 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 [email protected] _____
