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

Standard No.

ISO 13485:1996

Release Date

1996

Published By

International Organization for Standardization (ISO)

Status

Withdraw

Replace By

ISO 13485:2003

Latest

ISO 13485:2016

ISO 13485:1996 history

• 2016 ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
• 2009 ISO 13485:2003/Cor 1:2009 Medical devices - Quality management systems - Requirements for regulatory purposes; Technical Corrigendum 1
• 2003 ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
• 1996 ISO 13485:1996 Quality systems - Medical devices - Particular requirements for the application of ISO 9001