Best place for buying standards

[evan_kim90]

Estonian Standards are a full member of CENELEC and their standards are just as good as everyone else's, but just cost less.
As stated above, buy a multi-user license and then there's no restriction on opening on more than one machine.

HI, Thanks @CharlieUK
Then when you declare standards in DOC or medical device file which is applied in medical device, should we mention, EVS one? ex)

EN 60601-1-11:2015+A1:2021​

 

[CharlieUK]

You only list the EN standard, without EVS, or other country, prefix - as your example

 

[evan_kim90]

You only list the EN standard, without EVS, or other country, prefix - as your example

I see. so with A1:2021 right? The reason I am asking the version is bit different in official site. So confusing which version i have to put.

 

[CharlieUK]

EN 60601-1-11:2015+A1:2021 is the CENELEC version of "IEC 60601-1-11:2015 + IEC 60601-1-11:2015/A1:2020"

 

[evan_kim90]

SO we can say
Harmonized version applied " EN 60601-1-11:2015+A1:2021"
Applied standard "IEC 60601-1-11:2015 + IEC 60601-1-11:2015/A1:2020"

 

[CharlieUK]

I'm not quite sure what differentiation you are trying to make.

Some CENELEC "EN" standards contain EU variations to IEC standards, but some don't - where they don't, the standards are the same.
For Europe you would generally declare compliance with the EN version

 

[evan_kim90]

I'm not quite sure what differentiation you are trying to make.

Some CENELEC "EN" standards contain EU variations to IEC standards, but some don't - where they don't, the standards are the same.
For Europe you would generally declare compliance with the EN version

Okay. Sorry for unclear explanation. I am kind of new in this field and audit is coming so I am so busiy to catching it up.
I have other questions. So, if i purchase that standard and do gap analysis with current one. And if there is no gap, can we declare new version in our technical file or DOC?

 

[Hi_Its_Matt]

Okay. Sorry for unclear explanation. I am kind of new in this field and audit is coming so I am so busiy to catching it up.
I have other questions. So, if i purchase that standard and do gap analysis with current one. And if there is no gap, can we declare new version in our technical file or DOC?

I am confused by your question.

For IEC 60601-1-11 specifically, the 2015 standard plus the 2020 amendment is the current version. The European standard (EN 60601-1-11) is identical to the International standard. The endorsement notices tell us so. You don't need to do a 2020 vs 2021 change analysis. The 2020 vs 2021 discrepancy is simply due to how quickly the standards were published by IEC and CENELEC.

What would your gap analysis be against?

If you currently conform to the 2015 standard (without the 2020 amendment), then you will need to review the 2020 amendment and do your gap analysis based on the amendment only.

If you conform to the 2010 version of the standard, then you will need to review the current standard (2015 version plus 2020 amendment) in its totality, and do your gap analysis based on that.

In either case, if the result of your analysis is that you have no gaps against the current standard, then yes, you can declare conformity to it.

 

[evan_kim90]

I am confused by your question.

For IEC 60601-1-11 specifically, the 2015 standard plus the 2020 amendment is the current version. The European standard (EN 60601-1-11) is identical to the International standard. The endorsement notices tell us so. You don't need to do a 2020 vs 2021 change analysis. The 2020 vs 2021 discrepancy is simply due to how quickly the standards were published by IEC and CENELEC.

What would your gap analysis be against?

If you currently conform to the 2015 standard (without the 2020 amendment), then you will need to review the 2020 amendment and do your gap analysis based on the amendment only.

If you conform to the 2010 version of the standard, then you will need to review the current standard (2015 version plus 2020 amendment) in its totality, and do your gap analysis based on that.

In either case, if the result of your analysis is that you have no gaps against the current standard, then yes, you can declare conformity to it.

It is now a bit clear to me. Thanks for the explanation. Is there any special form for gap analysis or way to do it? I am doing gap analysis first time so I want to gather information as possible as I can so I can prepare more properly.

 

[Hi_Its_Matt]

There is not a standard form or template for comparing your current design/process against the requirements of 60601-1-11.
You may be able to find some generalized / rudimentary template online, although it will probably be of limited value.
Here is a very basic starting point.
You could fill in the first column with every clause in the entire standard if that is what you are comparing against, or you could fill it in with only the changes introduced by the 2020 amendment.

Clause / Requirement	Is Current Design/Process Conforming? (Yes/No)	If conforming, what is the evidence? (Provide document number and revision.)	If not conforming, what is the gap? (Provide detailed description.)	Actions needed to close gap	Responsible party
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