It seems like the 2012 of BS EN ISO 13485,”Medical devices. Quality management systems. Requirements for regulatory purposes,” was just released. But a few corrections have been found so the consolidated BS EN ISO 13485:2012 with Corrigendum 1 is now available from Document Center Inc. A Corrigendum is a technical correction sheet and the EN standards are released as interfiled reprints of the original document.
The CENELEC corrigendum is from July 2012, but the integration into the BS Edition is dated 9/30/2012. There are two corrections: the title was altered and Table ZC.3 (Relationship with Annex IV of Directive 98/79/EC) was updated.
If you bought your copy of the BS EN ISO 13485:2012 from Document Center Inc., we’ll provide you with a corrected copy for a modest printing fee. If not, you’ll need to purchase the new copy in its entirety. You can order the document on our website, www.document-center.com. Otherwise, contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for more information.
