BS EN 46001:1997 Historical

Document History

1. BS EN ISO 13485:2016+A11:2021

   September 2021
   Medical devices. Quality management systems. Requirements for regulatory purposes

   •  Most Recent

2. BS EN ISO 13485:2016

   January 2017
   Medical devices. Quality management systems. Requirements for regulatory purposes

   • Historical Version

3. BS EN ISO 13485:2012

   September 2012
   Medical devices. Quality management systems. Requirements for regulatory purposes

   • Historical Version

4. BS EN ISO 13485:2003

   January 2010
   Medical devices. Quality management systems. Requirements for regulatory purposes

   • Historical Version

5. BS EN ISO 13488:2001

   March 2001
   Quality systems. Medical devices. Particular requirements for the application of EN ISO 9002

   • Historical Version

6. BS EN ISO 13485:2001

   March 2001
   Quality systems. Medical devices. Particular requirements for the application of EN ISO 9001

   • Historical Version

7. BS EN 46003:1999

   October 1999
   Quality systems. Medical devices. Particular requirements for the application of EN ISO 9003

   • Historical Version

8. BS EN 46002:1997

   February 1997
   Specification for application of EN ISO 9002 to the manufacture of medical devices

   • Historical Version

9. BS EN 46001:1997

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   February 1997
   Specification for application of EN ISO 9001 to the manufacture of medical devices

   • Historical Version

10. BS EN 46002:1994

    January 1994
    Application of EN 29002 (BS 5750:Part 2) to the manufacture of medical devices

    • Historical Version

11. BS EN 46001:1994

    January 1994
    Application of EN 29001 (BS 5750:Part 1) to the manufacture of medical devices

    • Historical Version