Best place for buying standards

[evan_kim90]

Hi,

I have a question regarding buying standards like EN60601 series.
Where are you guys buying standards? Which store is most trustable and affordable?
Please recommend me!

 

[Hi_Its_Matt]

Estonian National Standards organization. EVS.ee

Buy a multi-user license for at least two users for each standard you want. A two person license for 60601-1 is something like 75 USD.

 

[evan_kim90]

Estonian National Standards organization. EVS.ee

Buy a multi-user license for at least two users for each standard you want. A two person license for 60601-1 is something like 75 USD.

Thanks for good information. Are EVS standards reliable (Issue with auditors)? the reason i am asking is that EVS has most recent standards than other stores, so I am so confused. Some people recommended EVS so i was looking but I want to confirm first. Also, is license belongs in account or laptop?

 

[Ron Rompen]

We use an online service (Techstreet Enterprise). No, it isn't free, but they carry pretty much ALL standards, and if there is one you need that they don't have, then they will get it.
One stop shopping for all my standards, and they maintain the most current standard available.

 

[Hi_Its_Matt]

The Estonian national standards organization and the standards themselves are totally legitimate. I don’t see any reason why you would have a problem with them with an auditor.

And a multi-user license allows you to download a PDF that can be opened by anyone that can access the file. The terms of service say it can be used by up to X number of users simultaneously. To my knowledge, this is enforced via the honor system, and not any technical system.

Here is what the National foreword says:

This Estonian standard EVS-EN 60601-1:2006+A1
+A12+A2:2021 consists of the English text of the
European standard EN 60601-1:2006 and its
amendments A1:2013, A12:2014 and A2:2021, and
its corrigenda AC:2010 and AC:2016.

This is telling you that the Estonian standard is just the English version of the European standard.

Then the European forward says

Endorsement notice
The text of the International Standard IEC 60601-1:2005 was approved by CENELEC as a European
Standard without any modification.

This tells you that the European version is the same as the International.


I will say things can be a bit confusing at times if the dates (years) of a European Standard and its International equivalent do not align. For example EN 60601-1 says 2006, while IEC 60601-1 says 2005. But the body of the standard is identical.

And sometimes the EU will add annexes or Amendments that aren’t in the International standard (ex: Annexes ZZA and ZZB, which describe how the standard relates to European regulations). But these can be easily explained/understood.

 

[AllTheThings]

I haven't had any issues with using Estonian standards for ISO or IEC standards. But then again, I haven't had an auditor chase down my standards sourcing approach...

For standards from other agencies or standards bodies, that route doesn't work, but for harmonized standards, I don't see a reason to waste money by going directly to ISO.

 

[MorganC]

We use Accuris Tec Store, I can't post a link because im too new , I looked up the spec that you noted and its on there. We are US based and do Aerospace, Automotive, Military and industrials, so no medical however i imagine the level of care and auditing is similar.

 

[evan_kim90]

We use an online service (Techstreet Enterprise). No, it isn't free, but they carry pretty much ALL standards, and if there is one you need that they don't have, then they will get it.

The Estonian national standards organization and the standards themselves are totally legitimate. I don’t see any reason why you would have a problem with them with an auditor.

And a multi-user license allows you to download a PDF that can be opened by anyone that can access the file. The terms of service say it can be used by up to X number of users simultaneously. To my knowledge, this is enforced via the honor system, and not any technical system.

Here is what the National foreword says:

This is telling you that the Estonian standard is just the English version of the European standard.

Then the European forward says


This tells you that the European version is the same as the International.


I will say things can be a bit confusing at times if the dates (years) of a European Standard and its International equivalent do not align. For example EN 60601-1 says 2006, while IEC 60601-1 says 2005. But the body of the standard is identical.

And sometimes the EU will add annexes or Amendments that aren’t in the International standard (ex: Annexes ZZA and ZZB, which describe how the standard relates to European regulations). But these can be easily explained/understood.

Hi, @Hi_Its_Matt Thanks for explanation. Then when you declare standards which is applied in medical device, should we mention, EVS one? ex)

EN 60601-1-11:2015+A1:2021​

 

[CharlieUK]

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.

 

[CharlieUK]

You don't need to quote an country prefix for any of the standards