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About This Item

 

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Cross References: BS EN ISO 8402*BS EN ISO 9001*EN 724*EN 928*EN 50103*90/385/EEC*93/42/EEC

Replaced by BS EN ISO 13485:2001 but remains current.
 

Document History

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


    Medical devices. Quality management systems. Requirements for regulatory purposes

    • Most Recent
  2. BS EN ISO 13485:2016


    Medical devices. Quality management systems. Requirements for regulatory purposes

    • Historical Version
  3. BS EN ISO 13485:2012


    Medical devices. Quality management systems. Requirements for regulatory purposes

    • Historical Version
  4. BS EN ISO 13485:2003


    Medical devices. Quality management systems. Requirements for regulatory purposes

    • Historical Version
  5. BS EN ISO 13488:2001


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

    • Historical Version
  6. BS EN ISO 13485:2001


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

    • Historical Version
  7. BS EN 46003:1999


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

    • Historical Version
  8. BS EN 46002:1997


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

    • Historical Version
  9. BS EN 46001:1997

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

    • Historical Version
  10. BS EN 46002:1994


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

    • Historical Version
  11. BS EN 46001:1994


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

    • Historical Version