British Standards Document
BS EN ISO 13485
Medical devices. Quality management systems. Requirements for regulatory purposes
https://doi.org/10.3403/30257645U
BS EN ISO 13485 is maintained by CH/210. The current release of this standard is:
BS EN ISO 13485:2016+A11:2021 Medical devices. Quality management systems. Requirements for regulatory purposes
https://doi.org/10.3403/30257645 (published 29/02/2016)
This standard is available from the following sources:
Other historical versions of this standard document also exist:
- BS EN ISO 13485:2016 [current until 08/09/2021]
- BS EN ISO 13485:2012 [current until 29/02/2016]
- BS EN ISO 13485:2003 [current until 24/08/2012]
- BS EN ISO 13485:2001 [current until 01/07/2006]