IEC/AAMI/ANSI 60601-1:2005 Checklist

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F

freewind

#13
Hi there,

I recently started looking into electrical safety and the IEC 60601-1:2005 standard and managed to come across this thread.

Previously, my predecessor had an external testing body tested the same product in accordance to the IEC 60601-1:1988 standard. The test report has roughly the same main points as the checklist from MECA but with slightly more details for each main point.

My question is: Would completing this checklist be sufficient to claim the medical device is IEC60601 compliant? as opposed to going through an external testing body?

Thanks in advance!
 
M

MIREGMGR

#14
Would completing this checklist be sufficient to claim the medical device is IEC60601 compliant? as opposed to going through an external testing body?
What market and regulatory system are you aiming at, and what is the reason for compliance?

Some FDA classification codes define IEC 60601-1 as a relevant Recognized Consensus Standard. A 510(k) premarket notification for a product in one of those classes will be most easily accepted if it includes evidence of conformance. Third party testing is an easy path to that evidence, but depending on the class I believe in-house testing is viable as well. In-house testing will require much more documentation, though, since you'll have to establish your calibrations and other measurement equipment validations, your technique conformance to measurement method standards, your personnel competence, etc.

Another common reason for compliance in the US market is that a number of inspectional jurisdictions...primarily large cities...won't approve the installation of electrical equipment unless it's Listed, and the Listing must be obtained via determination of standard conformance by a major test lab.

We also have heard of hospitals that have been told by their insurors in regard to potential major imaging system purchases that only Listed systems would be eligible for inclusion in their insurance coverage. I've heard of another instance where end users felt that they had to buy Listed equipment in regard to their JCAHO compliance stance, though I don't fully understand that one.

If your goal is to be able to support a marketing claim, at least in the US market, I'd think that in-house testing, competently carried out with appropriate documentation of course, would be fully sufficient.
 

RSantos

Registered Visitor
#15
I would expect your registrar to want 60601-1 testing, especially the EMC testing, to be performed by an ISO 17025 accredited lab. Those labs are accredited to specific test methods (always check their scope of accreditation) plus the quality system requirements. It's a lot of work ($$) setting a 17025 system in place, plus continued competency must be proven by round-robin testing and witnessing of testing.
 
F

freewind

#16
Thank you both for your reply.

I am currently working towards gaining registration with TGA. I believe ultimately, the path will lead to registering with FDA. But till then, as a manufacturer in Australia, TGA comes first, and electrical safety compliance is a must.

I guess we will try to perform in-house testing for now and keep our fingers crossed.

By the way is anyone a consultant in Australia?
 

Stijloor

Staff member
Super Moderator
#17
Thank you both for your reply.

I am currently working towards gaining registration with TGA. I believe ultimately, the path will lead to registering with FDA. But till then, as a manufacturer in Australia, TGA comes first, and electrical safety compliance is a must.

I guess we will try to perform in-house testing for now and keep our fingers crossed.

By the way is anyone a consultant in Australia?
Freewind,

JaneB is. She is a very nice person!

Stijloor.
 
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