Essential Performance in IEC 3rd edition of the 60601-1

[aeropel]

Hello,

To the best of what I know - it is now in the 3rd edition of the 60601-1 that essential performance has become an important issue. I do not recall to have been asked for it ( by the NB) in the previous version of the standard though it exisetd also in the older particular standrads.
Is it true?

Thanks.

 

[Marcelo]

Re: Essential Performance

To the best of what I know - it is now in the 3rd edition of the 60601-1 that essential performance has become an important issue. I do not recall to have been asked for it ( by the NB) in the previous version of the standard though it exisetd also in the older particular standrads.
Is it true?

The third edition introduced formal requirements for essential performance.

Some second edition particulars used the term, but without a clear definition or requirement.

 

[Peter Selvey]

Re: Essential Performance

There are many old particulars with "performance" tests, for example IEC 60601-2-51 for diagnostic ECGs.

The difference is that term "essential performance" is now defined, and should be the output of the risk management process.

Since ISO 14971 states "... the policy for determining criteria for risk acceptability ... shall ensure that criteria are based upon ... relevant International Standards", when put together with the definition for essential performance, it effectively means that if an international standard includes performance criteria, it automatically becomes "essential performance".

 

[aeropel]

Re: Essential Performance

If I am not supposed to comply with the 3rd edition iof IEC 60601-1 (bcause of particulars that are not yet the OJ) I undertsatn that I continue to use the "old" 60601-1 2nd edition and the eseential performance is a non defined issue.
Am I right in this assumption?

Thanks

 

[Peter Selvey]

Re: Essential Performance

I forgot to mention, essential performance already exists under the EMC standard even with the 2nd edition.

In the context of the MDD, there is still an essential requirement which covers this issue (performance under the stresses of normal use, see essential requirement No. 4). But that is something previously handled under ISO 13485, ISO 14971 and others.

So, I guess your question really is, do you need to consider "essential performance" in the context of IEC 60601 2nd edition based reports. The answer there is, only for EMC.

 

[Marcelo]

Re: Essential Performance

If I am not supposed to comply with the 3rd edition iof IEC 60601-1 (bcause of particulars that are not yet the OJ) I undertsatn that I continue to use the "old" 60601-1 2nd edition and the eseential performance is a non defined issue.
Am I right in this assumption?

Well, you are not supposed to comply with any standard anyway, as they are voluntary

Anyway, if you use IEC 60601 to gain presumption of conformity with the essential requirements, yes, the idea is that the need to use the third edition is linked to the harmonization of the particular standard, so you will need to update to the third edition only after the particular has been harmonized.