Hi Just had a brief scan of the standard and it doesn’t appear to cover immunity to DC Magnetic fields. I would have thought that many patients fitted with these devices would be having on going medical treatment such that they may require MRI scans, where they could be subject to magnetic fields of greater than 7T. Also wouldn't it be sensible to ensure that all devices met the ICNIRP exposure levels ?
Regards Andy -----Original Message----- From: Dürrer Bernd [mailto:bernd.duer...@wilo.com] Sent: 03 April 2017 08:37 To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] AW: [PSES] Active Implantable Medical Devices Dear Grace, you can check the status and scheduled publication date (incl. citation in the OJ) of ETSI standards at https://portal.etsi.org/webapp/WorkProgram/SimpleSearch/QueryForm.asp For the 301 489 series standards, click on "EN - European standard (Telecommunication series)" in the Type field and enter "301 489" (incl. the blank in the middle) as number. The search will return a table of work items: The "Status" column contains hyperlinks to the schedule of the standard, that includes the target date for citation in the OJ at the bottom of the table. Kind regards, Bernd Von: Grace Lin [mailto:graceli...@gmail.com] Gesendet: Montag, 3. April 2017 07:35 An: EMC-PSTC@LISTSERV.IEEE.ORG Betreff: [PSES] Active Implantable Medical Devices Dear Members, For active implantable medical devices to comply with the RED requirements: 1. Do all active implantable medical devices require Notified Body’s involvement per RED? From online search (https://ec.europa.eu/growth/single-market/ce-marking/manufacturers_en), it seems the answer is yes. Could you please confirm? 2. The 301 489 series EMC standards covering RED have not been published/harmonized. For those manufacturers that do not want to wait for the harmonized standards to be published, should the manufacturers proceed with the DRAFT version of the standards (and send to NB)? 3. Do you have any idea when 301 489 series standards covering RED will be published? The current status is “On Approval”. Thank you very much for your time and I look forward to hearing from you. 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