List of Harmonized Standards for the MDD, IVD and IMDD - June 2006

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Sidney Vianna

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#2
Re: Harmonized Standards

Al Rosen said:
Note: If you don't know what the abbreviations mean you don't need the list of standards.
Good point, Al. These documents are NOT for the non-initiated...:rolleyes:
PS you must be the most thanked Cover so far....:agree1:
 
W

wrodnigg

#3
I am still curious about these lists of harmonized standards, because there are still errors in these lists after years (e.g. EN ISO 4135:2001 in the IVD list ot EN 375:2001 EN 376 in the MDD list)…

And ISO/IEC 17050 (declaration of conformity) is still not harmonized, but it should…
 
W

wrodnigg

#4
Update: List of Harmonized Standards for the MDD, IVD and IMDD - June 2006

Btw, there is a recent update for the MDD standards:
http://eur-lex.europa.eu/LexUriServ/site/en/oj/2006/c_173/c_17320060726en00020009.pdf

Be aware of the fact, that many of the OJ do not list all of the harmonized standards, so you have to do a tinker job to get a comprehensive list.

I am reviewing our CE compendium at the moment – when I have done the harmonized standards, I will post an actual list.

I have also a list of all European standards dealing with medical devices, after updating this list, I will also post it here (with german titles, but it might be of some help).
 
R

Rezzi

#5
Hi
I missed the EN 61010-2-101 in the IVD list of harmonized standards. Any explanations for this?
 
W

wrodnigg

#6
Hi
I missed the EN 61010-2-101 in the IVD list of harmonized standards. Any explanations for this?
This standard was harmonized by OJ C 8 of 2006-01-13.

The listings in the OJ often do not list all of the harmonized standards. Especially there are often listings from the lower (up to 30000) numbers or the higher ones (60000 and above). There is also no official list with all of them. It is a known "problem" and in the OJ there are some errors in the listings...

So the OJ C 129 of 2006-06-02 does not contain a full list of all standards, but some of them...

Thats the inofficial explanation - HTH :notme:
 
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