Looks good to me. Too often this sort of thing is not well documented,
but here is a welcome exception.
John Woodgate OOO-Own Opinions Only
J M Woodgate and Associates www.woodjohn.uk
Rayleigh, Essex UK
On 2017-12-30 16:26, Bart De Geeter wrote:
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 AnnexI)
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
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