ISO13485:2012/AC 2012 and EN ISO13485:2012 - What is the difference?

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W

wrodnigg

#3
Since none of them is neither available at the austrian nor the german standards institute, I just can't tell.
 
C

cristhel.fernandez

#4
what does AC in the regulatory stands for?
should I declare EN ISO 13485:2012 only
or should I use EN ISO 13485:2012/AC:2012
 
W

wrodnigg

#6
The official harmonized version is:

EN ISO 13485:2012 + AC:2012

The AC:2012 contains a correction of the title of EN ISO 13485:2012:
"Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)"

and a modification to ZC.4, Relationship with Annex VII of Directive 98/79/EC (lines 2...4 of the table):
3.1 second paragraph 1st indent, reference to Annex IV, 3.1, 1st indent - Not covered
3.1 second paragraph 1st indent, reference to Annex IV, 3.1, 2nd indent - Not covered
3.1 second paragraph 1st indent, reference to Annex IV, 3.1, 3rd indent - Not covered

which were screwed up as three times "3.1 second paragraph 1st indent" in the 2012 version.

So no "relevant" changes for medical device manufacturers, a formal correction for IVD manuifacturers - and yes, a formally corrected title.

It should be sufficient to just cite "EN ISO 13485:2012" (as long as counting points and dashes is not important).

As an alternative, one could cite a national translation/version of the standard, since all known translations were published after AC:2012, so DIN EN ISO 13485:2012 would be pretty fine.
 

Jean_B

Trusted Information Resource
#7
Are the changes made by the AC as described by wrodnigg the only ones?

In table ZB.1, regarding relationships between Annex II of directive 93/42/EEC and EN ISO 13485 reference is made to section 5.1.1 of the standard covering 93/42/EE, Annex II, 3.2 third paragraph (b).
Yet I cannot find this clause in my copy of EN ISO 13485.
 

qu1nn

Involved In Discussions
#8
If I look at the current harmonized standard listing for the Medical Device Directive which at the time of this writing is OJ C 022 of 23/01/2013

http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/index_en.htm


and I scroll down to look at 13485 I see two distinct items for 13485:

First:

EN ISO 13485:2012
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)



Then underneath, Second:

EN ISO 13485:2012/AC:2012



Maybe I am confused, and I have certainly goofed up in the past on these topics....but I read it as:

The First line is stating that the ISO 13485:2003 is expired at the date of this publication.

the Second line is stating that the addendum corrigendum exists and can also be considered valid. However, It does not say that EN ISO 13485:2012 is expired.

Thus I would think that it is valid to state either EN ISO 13485:2012 is current as well as EN ISO 13485:2012 / AC:2012.


qu1nn
 

Ronen E

Problem Solver
Staff member
Moderator
#9
Hi,

What it's saying is that, as of 23.1.2013, to benefit the presumption of conformity EN ISO 13485:2012 must be complied with, either with or without AC:2012.

ISO 13485:2003 is not expired. Only EN ISO 13485:2003 is.

Cheers,
Ronen.
 
J

jinggu

#10
This is getting me more confused. The two line items both are EN version of ISO 13485 in the most recent list harmonized standards in OJ of EU.
 
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