Final draft of IEC 60601-1 Amendment 1 available - May 2012

M

Mondo 22

Hi Marcelo,

What is the benefit of buying this standard?

Are the amendments 'major'?

Thanks
 
M

Marcelo

Inactive Registered Visitor
What is the benefit of buying this standard?

Are the amendments 'major'?
Click to expand...

Hi

Yes, they are. In fact, the amendment has over 100 pages, which is quite a lot, and changes the fundamental principles of the new edition, meaning, how to use the standard together with a risk management process according to ISo 14971, among a lot of other changes.
 
M

Mondo 22

Thanks Marcelo,

What will need to be referenced in the ER checklist?

Regards,
Ray
 
M

Marcelo

Inactive Registered Visitor
Hi

What will need to be referenced in the ER checklist?
Click to expand...

Sorry, not sure what you mean. This in principle has nothing to with the the ER checklist (just to make sure, you meant the essential requirements checklist right?)

IEC 60601 requires that you use the standard together with a risk management process in conformance with ISO 14971. The oroginal third edition did not make it clear how to use them together. There were also a lot of incorrect references to risk management. One of the things that the amendment does is to clarify how to use them together.
 
Last edited:
M

Mondo 22

Marcelo,

I have purchased the first amendment, it is very intereseting,.

Thanks for shgaring this on the Cove

Regards,
Ray
 
I

IECcsc

The final draft was only available during the 2 months voting period, that's why the link in the first post doesn't work anymore.

The amendment has now been published and very shortly a consolidated edition will be available.
 
I

IECcsc

Further to my previous post I am glad to let you know that the consolidated edition is now available !

You can buy it from the IEC Webstore or any appointed sales outlet.
 
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