shimonv
Trusted Information Resource
Hi everyone,
We want to do a feasibility trial for a product intended to comply with IEC 60601-1, 60601-1-2, 60601-2-2.
It is possible that the the product would not be fully compliant with all the applicable requirements of the IEC standards by the time the trial begins.
What is your experience with MOH in regards to 60601 test reports. Is there a 'minimum' requirements that they would expect to see?
I mean, we could submit preliminary lab reports, but which sections are a must?
I realise its product related but there should be some guiding principles on how to go about this.
I'd appreciate hearing your experience in this matter.
Thanks,
Shimon
We want to do a feasibility trial for a product intended to comply with IEC 60601-1, 60601-1-2, 60601-2-2.
It is possible that the the product would not be fully compliant with all the applicable requirements of the IEC standards by the time the trial begins.
What is your experience with MOH in regards to 60601 test reports. Is there a 'minimum' requirements that they would expect to see?
I mean, we could submit preliminary lab reports, but which sections are a must?
I realise its product related but there should be some guiding principles on how to go about this.
I'd appreciate hearing your experience in this matter.
Thanks,
Shimon
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