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Full Description

ADOPTED_FROM:EN ISO 13485:2003/AC:2007
 

Document History

  1. NS-EN ISO 13485:2016


    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

    • Most Recent
  2. NS-EN ISO 13485:2012/AC:2012


    Medical devices — Quality management systems — Requirements for regulatory purposes — Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)

    • Historical Version
  3. NS-EN ISO 13485:2012


    Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)

    • Historical Version
  4. NS-EN ISO 13485:2003/AC:2009


    Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)

    • Historical Version
  5. NS-EN ISO 13485:2003/AC:2007

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    Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)

    • Historical Version
  6. SN-CEN ISO/TR 14969:2005


    Medical devices — Quality management systems — Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)

    • Historical Version
  7. NS-EN ISO 13485:2003


    Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)

    • Historical Version
  8. NS-EN ISO 13485:2000


    Quality systems — Medical devices — Particular requirements for the application of EN ISO 9001 (ISO 13485:1996)

    • Historical Version
  9. NS-EN ISO 13488:2000


    Quality systems — Medical devices — Particular requirements for the application of EN ISO 9002 (revision of EN 46002:1996) (identical to ISO 13488:1996)

    • Historical Version
  10. NS-EN 46003:1999


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

    • Historical Version
  11. NS-EN 46001:1996


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

    • Historical Version
  12. NS-EN 46002:1996


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

    • Historical Version
  13. NS-EN 46001:1993


    Quality systems — Medical devices — Particular requirements for the application of EN 29001

    • Historical Version