As a minimum it needs to be a controlled change with records to show continued compliance with regulatory requirements. This could be based on engineering judgement rather than repeated tests, but someone still has review the applicable requirements, to sign off and take responsibility.
Requirements could include, for example, performance, EMC, electrical safety, based on standards and your own claims.
Engineering considerations could include compatibility of the medical device is to power supply regulation, noise (ripple), response to transient loads and so on; electrical isolation (why IEC 60950 is OK?), existing EMC tests on the power supply etc etc
The next issue is whether this is reportable change under a 510(k) which again someone will need to decide. Again, this is open to interpretation and judgement, and may depend on risk, but most important thing is to keep a record of the decision and rationale.
Finally, if yo do report the change or get audited, the technical reviewer may or may not agree with your judgements, but chances reduce if it is documented properly.
Finally (really finally), you may find it cheaper and quicker just to retest
Requirements could include, for example, performance, EMC, electrical safety, based on standards and your own claims.
Engineering considerations could include compatibility of the medical device is to power supply regulation, noise (ripple), response to transient loads and so on; electrical isolation (why IEC 60950 is OK?), existing EMC tests on the power supply etc etc
The next issue is whether this is reportable change under a 510(k) which again someone will need to decide. Again, this is open to interpretation and judgement, and may depend on risk, but most important thing is to keep a record of the decision and rationale.
Finally, if yo do report the change or get audited, the technical reviewer may or may not agree with your judgements, but chances reduce if it is documented properly.
Finally (really finally), you may find it cheaper and quicker just to retest
marmotte
Diapason Consulting
A "middle of road" solution can be to retest you device with both PSUs in a local --not necessarily fully certified-- EMC test house, without the whole 60601-1-2 paperwork/report. Such a test is generally one order of magnitude cheaper than a certified+report 60601-1-2 test.
The resulting report, assuming of course it shows that your device performs similarly with both PSUs, would be a very solid piece of justification to include in the Change Note, which will certainly confort an auditor (and yourself!) more than *only* engineering judgement.
Hope it helps
The resulting report, assuming of course it shows that your device performs similarly with both PSUs, would be a very solid piece of justification to include in the Change Note, which will certainly confort an auditor (and yourself!) more than *only* engineering judgement.
Hope it helps
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