BS EN ISO 13485:2012
Medical devices. Quality management systems. Requirements for regulatory purposes

Standard No.

BS EN ISO 13485:2012

Release Date

2012

Published By

British Standards Institution (BSI)

Status

Be replaced

Replace By

BS EN ISO 13485:2016+A11:2021

Latest

BS EN ISO 13485:2016+A11:2021

Replace

BS EN ISO 13485:2003

BS EN ISO 13485:2012 history

• 1970 BS EN ISO 13485:2016+A11:2021 Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001
• 2012 BS EN ISO 13485:2012 Medical devices. Quality management systems. Requirements for regulatory purposes
• 2003 BS EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
• 2001 BS EN ISO 13485:2001 Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001
• 1997 BS EN 46001:1997 Specification for application of EN ISO 9001 to the manufacture of medical devices