I've been out of doing EMC Compliance for Laboratory Equipment for some years, but is this a general protocol statement in the IEC standard or an FDA requirement? I would hope there is an FDA Guidance Document that clarifies this?
Best regards, Ron Wellman From: Ruth Shapira <rshap...@tauex.tau.ac.il> Sent: Monday, May 4, 2020 10:06 AM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] EMC testing for IVD equipment Hi Josh, If the IVD equipment is used in a medical environment (hospital, clinic, etc.) the applied standard is IEC 60601-1-2 ed.4 (in which are specified the environments for use a medical electrical equipment). If the IVD equipment is located in a laboratory area out of medical env, the IEC 62368-2-6 (IVD Lab Equip) standard apply. I hope that the above help. Best Regards and lot of health, Steli Steli Loznen, M.Sc., SM-IEEE VP for Technical Activities and Member of BoG IEEE-PSES Convener IEC 62A/MT29+MT 62354 17-3 Shaul HaMelech Blvd. Tel Aviv 6436719 Israel Tel:+972-3-6912668 Fax:+972-3-6913988 Mobile:+972-54-4818816 e-mail: sloz...@ieee.org <mailto:sloz...@ieee.org> From: Wiseman, Joshua <joshua.wise...@orthoclinicaldiagnostics.com <mailto:joshua.wise...@orthoclinicaldiagnostics.com> > Sent: Monday, May 4, 2020 6:05 PM To: EMC-PSTC@LISTSERV.IEEE.ORG <mailto:EMC-PSTC@LISTSERV.IEEE.ORG> Subject: [PSES] EMC testing for IVD equipment Recently there has been reports of the FDA requiring in vitro diagnostic equipment to be tested according to IEC 60601-1-2 (Medical Equip) instead of IEC 62368-2-6 (IVD Lab Equip). Does anyone have any information about this? 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