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About This Item

 

Full Description

Abstract

This standard is identical to ISO 13485:2003
 

Document History

  1. UNE-EN ISO 13485:2004

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

    • Most Recent
  2. UNE-EN ISO 13485:2001


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

    • Historical Version
  3. UNE-EN ISO 13488:2001


    Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002. (ISO 13488:1996)

    • Historical Version
  4. UNE-EN 46003:2000


    QUALITY SYSTEMS. MEDICAL DEVICES. PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9003

    • Historical Version
 

Amendments & Errata

  1. UNE-EN ISO 13485:2004 ERRATUM


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

  2. UNE-EN ISO 13485:2004 ERRATUM:2007


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

  3. UNE-EN ISO 13485:2004 ERRATUM:2009


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