David My understanding is this:
* ME equipment is defined in EN 60601-1 clause 3.63 and includes those ACCESSORIES as defined by the MANUFACTURER that are necessary to enable the NORMAL USE of the ME EQUIPMENT. * 7.1.3 is for multimedia and ITE equipment "connected to", not "part of", ME equipment * The manufacturer should know what is what and should be defining the system and the test plan Best regards Charlie Charlie Blackham Sulis Consultants Ltd Tel: +44 (0)7946 624317 Web: https://sulisconsultants.com/ Registered in England and Wales, number 05466247 From: David Shidlovsky <[email protected]> Sent: 08 February 2021 17:06 To: [email protected] Subject: [PSES] Testing to IEC 60601-1-2 Hello IEC 60601-1-2 allows testing of conducted and radiated emissions to CISPR 11; CISPR 14-11; CISPR 32. Concerning the use of CISPR 32: According to Clause 7.1.1 General: "Unless otherwise specified herein, ME EQUIPMENT and ME SYSTEMS shall comply with CISPR 11" According to Clause 7.1.3 Multimedia equipment: "Multimedia equipment connected to ME EQUIPMENT and ME SYSTEMS shall comply with CISPR 32. If CISPR 32 class A equipment is supplied as part of an ME SYSTEM, the ME SYSTEM shall be classified class A." A number of modern medical equipment includes devices that are clearly multimedia equipment. Are there any published guidelines for indicating when testing medical equipment that includes multimedia devices to CISPR 32 instead of CISPR 11? Best Regards, David Shidlowsky Technical Reviewer [cid:[email protected]] Address 1 Bat-Sheva St. POB 6117, LOD7120101 Israel Tel: 972-8-9186100 Ext. 213 Direct: 972-8-9186113 Fax: 972-8-9153101 Mail: [email protected]<mailto:[email protected]> Web www.itlglobal.org<http://www.itlglobal.org/> [cid:[email protected]]Waze ITL: https://waze.com/ul/hsv8vccn2j - ---------------------------------------------------------------- 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 <[email protected]<mailto:[email protected]>> 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)<http://www.ieee-pses.org/list.html> List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]<mailto:[email protected]>> Mike Cantwell <[email protected]<mailto:[email protected]>> For policy questions, send mail to: Jim Bacher <[email protected]<mailto:[email protected]>> David Heald <[email protected]<mailto:[email protected]>> - ---------------------------------------------------------------- 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 <[email protected]> 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 <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]>
