When is ISO 13485:2003 Scheduled for Revision?

[Ajit Basrur]

According to the Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices

EN 46003:1999 is superceded by EN ISO 13485:2003/AC:2007. I do not know what does AC stand for but it seems doesnot refer to the year of publication as in ISO documents.

 

[Mr Niceguy]

So, do we have to get the latest ISO 13485 : 2007 version. Is itthe latest?

If the ISO website says 2003 is the latest version that's final. No need for rumours or argument

 

[Mr Niceguy]

The designation AC: yyyy seems to refer to a corrigendum in one of the European Standard versions of ISO13485. Presumably it is a corrigendum to the German language version. Many things can happen when an ISO standard gets adopted as a EN standard by parallel voting. For example a translation can never be 100% exact. A first official translation from English into German or French might survive a few years before some problem of interpretation is noticed and a corrigendum is issued. I don't know whether that happened here. Just a possibility.

 

[Stijloor]

The designation AC: yyyy seems to refer to a corrigendum in one of the European Standard versions of ISO13485. Presumably it is a corrigendum to the German language version. Many things can happen when an ISO standard gets adopted as a EN standard by parallel voting. For example a translation can never be 100% exact. A first official translation from English into German or French might survive a few years before some problem of interpretation is noticed and a corrigendum is issued. I don't know whether that happened here. Just a possibility.

Mr. Niceguy,

You are absolutely correct!

I found: Corrigendum AC - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

Stijloor.