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ISO 13485:2012 Published

Publication of latest version of ISO 13485


The latest version of the BS EN ISO 13485 Standard was published on 24/01/2012 replacing the previous version ISO 13485:2003.

The Standard was revised as a number of countries within the EU objected to the inference that if you were certified to ISO 13485, it was almost assumed you were in compliance with one of the three Directives (90/385/EEC AIMD, 93/42/EEC MDD and 98/79/EC IVDD).

In response the main changes to the 2012 Revision has been to expend the Annexes at the beginning of the Standard to link each clause of the Standard against the requirements of the Directives.

 The good news is there have been no actual changes in the text of the Standard so no significant changes will be required. This means as long as you conform to existing requirements you should receive an updated certificate from your Certification Body (expect them to request references to the standard to be amended from 2003 to 2012).

As it is only the European Standard that is changing, all other countries will still used the 2003 version at this moment.

It is expected this will start happening in August 2012.

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