Revised List of Harmonized Standards for Medical Device Directives (MDD) in the EU

xcanals_tecno-med.es

Involved In Discussions
#1
Hi all
See the new list of harmonized standards for the medical devices directives published in the Official Journal of the European Union on 18 jan 2011




Regards

Xavier Canals
 
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Peter Selvey

Staff member
Super Moderator
#2
Re: Revised list of harmonized standards for medical device directives in the EU

This new list include a large number of ..../AC documents, for example EN 60601-1:2006/AC:2010.

This appears to be an "administrative circular" which I guess has no meaning. But we should really have hard evidence.

I have been unable to find these on CENELEC, CENELEC members sites (such as BSI) or IEC.

Does anyone know what these mean for sure?
 
A

Andre

#3
Re: Revised List of Harmonized Standards for Medical Device Directives (MDD) in the E

Does anyone know if there are any product standards for a Laparoscopic device?
 

xcanals_tecno-med.es

Involved In Discussions
#4
Re: Revised list of harmonized standards for medical device directives in the EU

This new list include a large number of ..../AC documents, for example EN 60601-1:2006/AC:2010.

This appears to be an "administrative circular" which I guess has no meaning. But we should really have hard evidence.

I have been unable to find these on CENELEC, CENELEC members sites (such as BSI) or IEC.

Does anyone know what these mean for sure?

Dear Peter

AC is the acronym for Amendment Corrigendum

The 2 types of madifications in the standards are (the following are the definitions by CEN CENELEC which provides the standards for the harminized standards list) :

2.11
amendment
ratified supplementary document to an EN (and HD for CENELEC) already circulated to CEN/CENELEC national members for national implementation, to be read in conjunction with that EN (and HD for CENELEC) and which alters and/or adds to previously agreed technical provisions in that EN (and HD for CENELEC)

2.12
corrigendum
supplementary document to one, two or all three versions of a CEN/CENELEC publication, which corrects one or more errors or ambiguities inadvertently introduced in either drafting or printing and which could lead to incorrect or unsafe application of those versions

see http://www.cenelec.eu/NR/rdonlyres/582F91CF-2087-4C24-924D-3705BC52ECCF/0/IR2_E.pdf

The standards are published by the CEN national members, so for example in spain the standards are published by AENOR www.aenor.es, in France by AFNOR, in UK by BSI, ....

Regards

Xavier
 

xcanals_tecno-med.es

Involved In Discussions
#5
Re: Revised List of Harmonized Standards for Medical Device Directives (MDD) in the E

Does anyone know if there are any product standards for a Laparoscopic device?
I think that the laparoscopic devices are covered by the harmonised standard: IEC 60601-2-18:2009
Medical electrical equipment –
Part 2-18: Particular requirements for the basic safety and essential
performance of endoscopic equipment

http://webstore.iec.ch/preview/info_iec60601-2-18{ed3.0}b.pdf

Regards

Xavier
 

Peter Selvey

Staff member
Super Moderator
#6
Re: Revised List of Harmonized Standards for Medical Device Directives (MDD) in the E

Thanks Xavier for the information on "AC". One problem has been finding concrete information as to whether "AC" means "Amendment", "Corrigendum" or both. BSI confused the issue further (in an email) saying "AC" stands for "Amendment by Corrigendum".

Fortunately, I finally found a clear reference on the CENELEC site that "AC" means only "Corrigendum":

http://www.cen.eu/boss/supporting/Guidance documents/GD040 - Updating/Pages/default.aspx

The upshot is that "AC" means editorial only, not new technical requirements.

I would still be nice to get hold of these documents. BSI have indicated that they are not available (somewhat odd for harmonised standards), and referenced back to CENELEC. I'm asking CENELEC for details where to obtain.
 
R

recruit

#7
Re: Revised List of Harmonized Standards for Medical Device Directives (MDD) in the E

Thanks Xavier for the information on "AC". One problem has been finding concrete information as to whether "AC" means "Amendment", "Corrigendum" or both. BSI confused the issue further (in an email) saying "AC" stands for "Amendment by Corrigendum".

Fortunately, I finally found a clear reference on the CENELEC site that "AC" means only "Corrigendum":

http://www.cen.eu/boss/supporting/Guidance documents/GD040 - Updating/Pages/default.aspx

The upshot is that "AC" means editorial only, not new technical requirements.

I would still be nice to get hold of these documents. BSI have indicated that they are not available (somewhat odd for harmonised standards), and referenced back to CENELEC. I'm asking CENELEC for details where to obtain.
Do you get answer from CENELEC?
 

Peter Selvey

Staff member
Super Moderator
#8
Re: Revised List of Harmonized Standards for Medical Device Directives (MDD) in the E

No answer from CENELEC. I might go back to BSI again. I'm sure there is a law somewhere that says these documents must be available to the public!

If anyone else has had any luck getting these documents, let us know.
 

xcanals_tecno-med.es

Involved In Discussions
#9
Re: Revised List of Harmonized Standards for Medical Device Directives (MDD) in the E

Dear Peter
the documents published as AC in the Official Journal are already available to the public as they are published by the national standards body of every country.
For example the new reference:
EN ISO 10993-1:2009/AC:2010
was published by AENOR un Spain as:
UNE EN ISO 10993-1:2010/AC
and corriges the figure 1 of the original standard and can be obtained from the AENOR website free of charge. (see attached file)

Best regards

Xavier
 

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