Knowing when an EN version modifies the base standard

rothlis · Dec 17, 2014

The question is very simple: what is the best way to know whether the EN version of a document modifies the base standard without actually purchasing a version of the harmonised standard (e.g., BS EN)? I see that in several cases the harmonised standard listing will say "Modified", or "Corrected Version" - as with 60601-1-2, 14971 and 16061 - but is it safe to assume that there aren't modifications if it does not say that? Thanks in advance.

planB · Dec 17, 2014

rothlis,

the standards you have listed can be found here:

http://ec.europa.eu/enterprise/poli...onised-standards/medical-devices/index_en.htm

For most of the EN version of the standards you will find a related ISO standard in brackets. This means that the normative part of the EN standard version is identical to the listed ISO version, respectively. For medical devices, the harmonized EN stndard version only differs from the ISO version in the Z annexes which explain how the EN standard fulfills the related MDD or AIMD requirements.

HTH,

Gerhard

rothlis · Dec 17, 2014

Gerhard,
I'm familiar with the scheme and I know that the harmonisation usually doesn't change application of the base standard. Sometimes, however, it does define changes (as in the examples I gave) so I'm wondering if those notes in the journal listing ("Modified" and "Corrected Version") are reliable guides to knowing whether the EN version requires something different than the base standard.

planB · Dec 17, 2014

rothlis,

I definitely know for EN ISO 14971:2012 and (corrected) ISO 14971:2007 that the normative text is the same between the two standards, and the only difference is in the Z annexes.

Likewise, the normative text of EN ISO 16061:2009 is identical to (ISO 16061:2008, Corrected version 2009-03-15). Similar for the IEC standard you listed as an example.

So the terms "corrected" and "modified" relate to corrections and modifications of the ISO / IEC standards, which of course have then also found their way into the identical (normative) text of the EN standard version.

HTH,

Gerhard

rothlis · Dec 17, 2014

OK, so it looks like the listing in the Official Journal doesn't tell us anything about how the EN adoption impacts the application of the standard. I realize that the body of the standard isn't being changed with these EN versions, but the annexes definitely do sometimes change the application of the standard. I recently updated our Risk Management SOP because of the EN version of 14971.

I'm trying to avoid spending thousands of dollars for documents that are effectively equivalent to documents that we already have. I would appreciate it if somebody can fill in the following blank with an answer that doesn't require purchase of an EN version of the document:

When a base standard has a harmonised version in the Official Journal, it is safe to assume that the base standard can be used for establishing compliance to the MDD if _______________.

Ronen E · Dec 17, 2014

rothlis said:
OK, so it looks like the listing in the Official Journal doesn't tell us anything about how the EN adoption impacts the application of the standard. I realize that the body of the standard isn't being changed with these EN versions, but the annexes definitely do sometimes change the application of the standard. I recently updated our Risk Management SOP because of the EN version of 14971.

I'm trying to avoid spending thousands of dollars for documents that are effectively equivalent to documents that we already have. I would appreciate it if somebody can fill in the following blank with an answer that doesn't require purchase of an EN version of the document:

When a base standard has a harmonised version in the Official Journal, it is safe to assume that the base standard can be used for establishing compliance to the MDD if _______________.

I am guessing that most (if not all) esteemed NBs would require you have the EN standard at hand if you claim conformity for the purpose of ERs presumption of conformity, because formally you can't make such a claim regarding a standard unless you have it. So I'm afraid you will have to purchase even if you know that the normative part is identical.

Cheers,
Ronen.

rothlis · Dec 17, 2014

I am guessing that most (if not all) esteemed NBs would require you have the EN standard at hand if you claim conformity for the purpose of ERs presumption of conformity, because formally you can't make such a claim regarding a standard unless you have it. So I'm afraid you will have to purchase even if you know that the normative part is identical.

I'm willing to argue that point with the NB if I have evidence that the EN version truly is effectively equivalent to the base standard. The problem is that I can't figure out how to obtain such evidence. Is purchasing the EN versions really the only way?

Ronen E · Dec 17, 2014

rothlis said:
I'm willing to argue that point with the NB if I have evidence that the EN version truly is effectively equivalent to the base standard. The problem is that I can't figure out how to obtain such evidence. Is purchasing the EN versions really the only way?

Good luck with that. You won't be the first.

rothlis · Dec 17, 2014

We've been through one submission and a few audits and the only time this has come up is with 14971, where the EN changes really do make a difference. They have never asked us to prove that we know that the base standards are effectively equivalent, I suspect because they already know which standards actually have relevant additions and none of the others we've referenced do. Even so, I would rather that we know these things before they have to point it out to us.

Ronen E · Dec 17, 2014

rothlis said:
We've been through one submission and a few audits and the only time this has come up is with 14971, where the EN changes really do make a difference. They have never asked us to prove that we know that the base standards are effectively equivalent, I suspect because they already know which standards actually have relevant additions and none of the others we've referenced do. Even so, I would rather that we know these things before they have to point it out to us.

Well, not all NBs are the same...

If you never had any issues surrounding that, and don't plan on changing your NB, I would let it go. If you do a risk-benefit analysis, I think that the risk of getting cited for a non-equivalent standard seems low enough to leave it alone.

Knowing when an EN version modifies the base standard

rothlis

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planB

rothlis

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planB

rothlis

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Ronen E

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rothlis

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Ronen E

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rothlis

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Ronen E

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