ISO 13485

Medical devices - Quality management systems - Requirements for regulatory purposes
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Current edition

ISO 13485:2016 en
NEN-EN-ISO 13485:2016 en
Amendments and Corrections (3)
  • amendment
    NEN-EN-ISO 13485:2016/A11:2021 en
  • correction
    NEN-EN-ISO 13485:2016/C12:2018 en
  • correction
    NEN-EN-ISO 13485:2016/C11:2017 en
NEN-EN-ISO 13485:2016 nl
Amendments and Corrections (2)
  • amendment
    NEN-EN-ISO 13485:2016/A11:2021 nl
  • correction
    NEN-EN-ISO 13485:2016/C11:2017 nl

Other editions

Show All

ISO 13485:2003

standard
NEN-EN-ISO 13485:2012 en
Amendments and Corrections (1)
  • correction
    NEN-EN-ISO 13485:2012/C11:2012 en
standard
NEN-EN-ISO 13485:2003 en
Amendments and Corrections (2)
  • correction
    NEN-EN-ISO 13485:2003/C1:2009 en
  • correction
    NEN-EN-ISO 13485:2003/C11:2007 en
standard
NEN-EN-ISO 13485:2003 nl
Amendments and Corrections (3)
  • correction
    NEN-EN-ISO 13485:2003/C1:2009 nl
  • correction
    NEN-EN-ISO 13485:2003/C11:2007 nl
  • correction
    NEN-EN-ISO 13485:2003/C1:2006 nl
standard
ISO 13485:2003 en
Amendments and Corrections (1)
  • correction
    ISO 13485:2003/Cor 1:2009 en

ISO 13485:1996

standard
NEN-EN-ISO 13485:2000 en
standard
ISO 13485:1996 en