IEC 62366 vs. IEC 60601-1-6 - Has IEC 62366 now replaced IEC 60601-1-6?

I have two questions.

1. Has IEC 62366 now replaced IEC 60601?
2. Has the FDA (and other regulatory organizations) endorsed IEC 62366, and will they include it in their audits?

In replying, if you could point me to any references supporting your reply that would be most helpful.

Re: IEC 62366 vs. IEC 60601

pip007 said:

2. Has the FDA (and other regulatory organizations) endorsed IEC 62366, and will they include it in their audits?

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The FDA does recognize IEC 62366 as a Recognized Consensus Standard, with a complex qualification of its extent and applicability. See here.

The FDA's QSIT level 1 and 2 audits have never included product-oriented-standards conformance. FDA reviews of pre-market submissions, on the other hand, do include examination of such conformance claims.

Re: IEC 62366 vs. IEC 60601 - Has IEC 62366 now replaced IEC 60601?

Which IEC 60601 standard are you talking about? IEC 60601-1-6?

IEC 62366 is a standard detailing a usability engineering process for medical devices.

IEC 60601-1-6, the usability collateral standard for medical electrical equipment, was the base for IEC 62366.

In the future, IEC 62366 will completely replace IEC 60601-1-6.

Re: IEC 62366 vs. IEC 60601 - Has IEC 62366 now replaced IEC 60601?

Thanks for your answer. Yes I was referring to 60601-1-6.

Re: IEC 62366 vs. IEC 60601 - Has IEC 62366 now replaced IEC 60601?

Thanks for your answer. Yes I was referring to 60601-1-6.

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Thought so. Anyway, IEC 60601-1-6 will still be around, because there are certain references to it which need to be updated. After amendment 1 of IEC 60601-1 is published, it´s ecpected that IEC 60601-1-6 will be withdrawn. The new version of IEC 60601-1-6 (in FDIS stage right now) willhave few requirements (only the few ones different from IEC 62366) and a comparison table.

Re: IEC 62366 vs. IEC 60601 - Has IEC 62366 now replaced IEC 60601?

Many thanks for the clarification.

Agree with all that "mmantunes" mentioined. Good job!

Thanks for confirming. Very helpful replies from all.

IEC 60601-1-6 in now obsolete? And, 62366 will be the replacement? When did this take effect?

IEC 60601-1-6 in now obsolete? And, 62366 will be the replacement? When did this take effect?

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??????? I´m not sure where you read this info on this thread.

IEC 60601-1 will still be around for a while. It´s expected that in the future it will be replaced by IEC 62366.