IEC60601-1-2 points to the IEC61000-4-X and -6 stuff for immunity, and IEC60601-1-11 extends EMC stuff for home healthcare equipment. The latest edition of -1-2 has some interesting stuff about test levels in annex E, and all medical EMC is based on intended end-use environment with no allowance for construction. Otherwise, you need to write a very pretty engineering rationale to satisfy risk manglement (management?) requirements.
Also, the test lab needs to specifically state why tests not done and provide a 'judgment' statement. Brian From: MARINA PEYZNER [mailto:epeyz...@sbcglobal.net] Sent: Monday, November 30, 2015 12:27 PM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] EN 61000-4-8 test for medical equipment per EN 60601-1-2 Dear members. Does anybody can point me out the mandatory of request for Power Frequency Magnetic Field testing for medical equipment even if none magnetic sensitive elements are in the EUT ? If this test is a must regardless of existence or not these elements. Thanks, Eugene - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <emc-p...@ieee.org> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <sdoug...@ieee.org> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org> David Heald: <dhe...@gmail.com>
