OK. Neither CISPR or IEC TC77 regard the DC magnetic field as a significant EMI issue. In fact, it's really outside the scope of CISPR, although CISPR/B doesn't take much notice of that. The subject might be within the scope of IEC 60601-1-2, but there is no indication that it is planned to introduce requirements.
With best wishes DESIGN IT IN! OOO – Own Opinions Only www.jmwa.demon.co.uk J M Woodgate and Associates Rayleigh England Sylvae in aeternum manent. -----Original Message----- From: McCallum, Andy [mailto:andy.mccal...@mottmac.com] Sent: Monday, April 3, 2017 10:00 AM To: John Woodgate <jmw1...@btinternet.com>; EMC-PSTC@LISTSERV.IEEE.ORG Subject: RE: [PSES] Active Implantable Medical Devices John TC 106 is for human exposure I was thinking of EMC issues - seems a gap here. Andy -----Original Message----- From: John Woodgate [mailto:jmw1...@btinternet.com] Sent: 03 April 2017 09:45 To: McCallum, Andy <andy.mccal...@mottmac.com>; EMC-PSTC@LISTSERV.IEEE.ORG Subject: RE: [PSES] Active Implantable Medical Devices DC magnetic fields are outside the scope of ETSI, and fall within that of IEC TC106. Remember that the question was about the RED, and no-one as far as I know, uses DC magnetic fields for radio communication. I might except Gaia, because a very broad definition of radio might include communication between the geomagnetic field and compass needles. (;-) But that's not strictly DC, as it is well-known to vary, albeit rather slowly. With best wishes DESIGN IT IN! OOO – Own Opinions Only www.jmwa.demon.co.uk J M Woodgate and Associates Rayleigh England Sylvae in aeternum manent. -----Original Message----- From: McCallum, Andy [mailto:andy.mccal...@mottmac.com] Sent: Monday, April 3, 2017 9:23 AM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] Active Implantable Medical Devices 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. Best regards, Grace Lin - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. 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