EU Harmonized Standards to which a company has declared compliance

DCONN1

Starting to get Involved
#1
I'm in the process of reviewing a list of standards to which a company has declared compliance for their product. I am unsure if some standards noted as harmonized on this list are currently harmonized in the EU as they are not listed on the relevant page on the EC website (which contains a disclaimer stating that the list may not be complete or fully up to date anyway).

Medical devices - European Commission

As examples, EN ISO 11135:2014, EN ISO 11138-1:2006, and EN ISO 15223-1:2012 are absent from the European harmonized standards list published on the EC website. Are these standards currently harmonized? Is the EC page with standards listing the best source for determining which standards are currently harmonized in the EU?
 
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shimonv

Trusted Information Resource
#2
Hi DCONN1,
This is the official source for harmonized standards. I can tell specifically that ISO 15223-1:2012 became harmonized at one point but later on was withdrawn and EN 980 was reinstate. So, in effect it is up to date.

Shimon
 

Mark Meer

Trusted Information Resource
#3
Yes, this is the list I reference...

If a standard has been updated but is not yet on the list, it is a pretty simple matter to justify applying the updated one as a better reflection of "state-of-the-art" in your technical file... This approach has worked fine for us (and accepted by our NB) in the past...

Also, some standards are simply referenced from ones on the list (even though they do not appear themselves on the list). For example, EN ISO 10993-10 is not on the list, but is referenced by 10993-1 (which is on the list).
 
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Ronen E

Problem Solver
Staff member
Moderator
#4
I'm in the process of reviewing a list of standards to which a company has declared compliance for their product. I am unsure if some standards noted as harmonized on this list are currently harmonized in the EU as they are not listed on the relevant page on the EC website (which contains a disclaimer stating that the list may not be complete or fully up to date anyway).

Medical devices - European Commission

As examples, EN ISO 11135:2014, EN ISO 11138-1:2006, and EN ISO 15223-1:2012 are absent from the European harmonized standards list published on the EC website. Are these standards currently harmonized? Is the EC page with standards listing the best source for determining which standards are currently harmonized in the EU?
The website disclaimer is mostly a formality, but if you want to be 100% sure you can check the actual OJEU record. Whatever is in the latest OJEU record is what’s harmonized.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
EN ISO 10993-10 is not on the list, but is referenced by 10993-1 (which is on the list).
ISO 10993-1 suggests considering tests specified in ISO 10993-10, so that reference does not confer any “implied harmonized status” on the latter.

Let’s not forget what harmonizing standards is all about in the MDD context. It is about equating a published standard compliance with some (specified) MDD requirements compliance, via the “presumption of conformity”. Complying with ISO 10993-1 (and this can sometimes be done without any testing) grants presumption of conformity with some ER; complying with ISO 10993-10, in itself, doesn’t grant any such presumption.
 

Mark Meer

Trusted Information Resource
#6
ISO 10993-1 suggests considering tests specified in ISO 10993-10, so that reference does not confer any “implied harmonized status” on the latter.
It is true that ISO 10993-1 suggests tests, but if assessed as necessary, the standard then points to an associated 10993-x standard.

If, for example, you've assessed that a cytotoxicity test is necessary, and then did NOT do the cytotoxicity test as per 10993-5, then presumably you can't claim compliance to 10993-1, no?

Also, to use another example, IEC 62133 (Safety requirement for secondary cells) is not a harmonized standard, but is referenced by EN 60601-1. Therefore, wouldn't it be safe to assume that compliance to IEC 62133, even though it is not on the list of harmonized standards, bears some evidence of conformity with respect to electrical safety vis-a-vis its relationship to EN 60601-1?

Let’s not forget what harmonizing standards is all about in the MDD context. It is about equating a published standard compliance with some (specified) MDD requirements compliance, via the “presumption of conformity”. Complying with ISO 10993-1 (and this can sometimes be done without any testing) grants presumption of conformity with some ER; complying with ISO 10993-10, in itself, doesn’t grant any such presumption.
I've mentioned this in another thread already, but I have to admit to being still confused in this case. EN ISO 10993-10:2013, although not presently on the list of harmonised standards, does have an Annex ZA listing the presumptions of conformity with ERs. Granted, the annex does state "Once this Standard is cited in the Official Journal of the European Union...", so I presume that the Z-Annex is not "official" until officially harmonized.

That being said, I think that it is very unlikely that an NB would reject or question the use of such a standard to evidence ER conformity as (a) it is tied to (harmonized) 10993-1; (b) it has a Z annex.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
If, for example, you've assessed that a cytotoxicity test is necessary, and then did NOT do the cytotoxicity test as per 10993-5, then presumably you can't claim compliance to 10993-1, no?
No. ISO 10993-1:2009 refers to parts like -10 and -5 in a rather neutral way (“see ISO 10993-X”). I was never in a situation where an alternative test method was used so I can’t say what would have been the outcome, but I wouldn’t be surprised if the NB would have insisted that it’s a NC because the ISO 10993 part method wasn’t used, despite no such clear requirement in part 1. As mentioned in some threads here, ISO 10993-1 is routinely misread and misapplied. :(

Also, to use another example, IEC 62133 (Safety requirement for secondary cells) is not a harmonized standard, but is referenced by EN 60601-1. Therefore, wouldn't it be safe to assume that compliance to IEC 62133, even though it is not on the list of harmonized standards, bears some evidence of conformity with respect to electrical safety vis-a-vis its relationship to EN 60601-1?
I don’t know these standards well enough to comment. The formal relationship should be determined based on the actual language in the standards. Again, I wouldn’t be surprised if this is practiced (by NB) in contrast with the actual language or intent, though...

I've mentioned this in another thread already, but I have to admit to being still confused in this case. EN ISO 10993-10:2013, although not presently on the list of harmonised standards, does have an Annex ZA listing the presumptions of conformity with ERs. Granted, the annex does state "Once this Standard is cited in the Official Journal of the European Union...", so I presume that the Z-Annex is not "official" until officially harmonized.
If I’m not mistaken, this standard was once harmonized, then taken off the list. I can’t remember the reason (not sure I ever even fully knew it); there might have been some discussion about it in Elsmar.

That being said, I think that it is very unlikely that an NB would reject or question the use of such a standard to evidence ER conformity as (a) it is tied to (harmonized) 10993-1; (b) it has a Z annex.
The NB would probably not reject because it can be conveniently considered “state of the art” (unless proved otherwise). As I stated above, part 10 is not “tied” to part 1, only loosely associated. The existence of an annex Z in a standard has no binding meaning, it’s just a guidance (and a hypothetical one if the standard is not officially harmonized).
 

Ronen E

Problem Solver
Staff member
Moderator
#9
You can find/follow harmonised standards from only following link; CEN - Advanced search - Publications and Work in Progress


Journal is not updated. EN 980 is withdrawn ages ago they forget to remove from journal.
These statements are strange to me.
CEN prepare European standards but I don’t think they have the authority to actually harmonize them.
The OJEU publication is what gives force to the harmonisation. It is regrettable if OJEU publications lag behind or are erroneous (as sometimes happens), but they are legally binding nevertheless, at least as far as I know.

The EN 980 / ISO 15223 ordeal has been discussed here when it happened, and again later. Apparently it was a collection of mistakes, some of which have been rectified since.
 

Remus

Involved In Discussions
#10
CEN is preparing the Annex ZA/ZB of standards then send to EC, if they accept it is harmonised and updated on CEN site. However, EC guys are too lazy to update journal...

So don't bother journal...
 
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