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