Minimum 60601 requirements for a clinical trial

shimonv

Trusted Information Resource
#1
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
 
Last edited:
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Mark Meer

Trusted Information Resource
#2
...I realise its product related but there should be some guiding principles on how to go about this...
I suspect, as you say, it all depends on device classification and the particular regulatory body (By "MOH" do you mean Singapore's Ministry of Health?).

My only experience, for what it's worth, was submitting an Investigational Testing Authorization (ITA) application to Health Canada for a Class II device, and no 60601 data was required at all.
 

shimonv

Trusted Information Resource
#3
Thanks Mark. For the record, it would most likely be a class II device and the MOH European or may perhaps US.
I suppose such things would be handled on a case by basis, with correlation to the risk profile. Still, if someone has an interesting experience to share that would be great.
 

yodon

Staff member
Super Moderator
#4
We've always relied on cooperation with the test lab (and the IRB if one's involved) to determine minimum requirements.
 
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