Hello David,
I would refer to the following part of the EN60601-1-2: 6.1 General The documentation of the tests shall contain all the information necessary to facilitate adequate planning (test plan) and execution (test report) of the tests so that they can be readily reproduced. Compliance is checked by inspection of the test report. 6.2 Test plan Prior to the start of formal testing, a detailed test plan shall be provided to the test laboratory. Deviations from the test plan shall be documented in the test report. See Annex G for guidance on the recommended content of a test plan. Annex G states (although informative) that following information should be present as suggested minimum test plan content) 3 Description of the BASIC SAFETY and ESSENTIALPERFORMANCE including a description how the BASIC SAFETY and ESSENTIAL PERFORMANCE will be monitored against the pass/fail criteria during each test 13 IMMUNITY pass/fail criteria: Specific IMMUNITY pass/fail criteria for BASIC SAFETY and ESSENTIAL PERFORMANCE as per the RISK ANALYSIS (see Annex I) Hence, for your ESD case. You should ask the supplier for his EMC risk assesment study. (and his PASS/FAIL criteria for the ESD test). If out of his study, the conclusion is that if the EUT Stops after a 15kV discharge, that this behaviour is acceptable and poses no risk for the patient then the test has PASSED. In the EMC report the observed behaviour should be noted and your conclusion should be based on the provided pass/fail criteria, which is a result of the suppliers risk assessment. At least, this is my interpretation of the standard. To all people on copy of the reflector, feel free to comment on this. Greetings, Bart Van: itl-emc user group [mailto:itl...@itl.co.il] Verzonden: donderdag 28 december 2017 7:38 Aan: EMC-PSTC@LISTSERV.IEEE.ORG Onderwerp: [PSES] IEC 60601-1-2: 2014 Basic Safety and Essential Performance Pass/Fail Criteria Hello A manufacturer of medical equipment has declared that his device has no basic safety or essential requirements. During ESD testing, the device stopped working after Air Discharges of ±15 kV were applied. Is this regarded as a failure according to the standard? No Part 2 particular Safety standards are involved. Thanks in advance for any responses. Regards, David Shidlowsky | Technical Reviewer Address 1 Bat-Sheva St. LOD 7120101 Israel Tel 972-8-9186113 Fax 972-8-9153101 Mail : <mailto:dav...@itlglobal.org> dav...@itlglobal.org/ <mailto:dav...@itl.co.il> dav...@itl.co.il/e...@itl.co.il Web <http://www.itlglobal.orh> www.itlglobal.orh <http://app.sqm.co.il/SitePages/Questionnaire.aspx> Fill out Customer Satisfaction Survey Global Certifications You Can Trust This e-mail message may contain privileged or confidential information. If you are not the intended recipient, you may not disclose, use, disseminate, distribute, copy or rely upon this message or attachment in any way. If you received this e-mail message in error, please return by forwarding the message and its attachments to the sender. - ---------------------------------------------------------------- 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 <mailto: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) <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 <sdoug...@ieee.org <mailto:sdoug...@ieee.org> > Mike Cantwell <mcantw...@ieee.org <mailto:mcantw...@ieee.org> > For policy questions, send mail to: Jim Bacher <j.bac...@ieee.org <mailto:j.bac...@ieee.org> > David Heald <dhe...@gmail.com <mailto:dhe...@gmail.com> > - ---------------------------------------------------------------- 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>
