UNE-EN ISO 13485:2016

Superseded

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Amended by

UNE-EN ISO 13485:2016/AC:2017

Available format(s)

Hardcopy , PDF

Superseded date

25-07-2018

Published date

25-05-2016

Publisher

Asociacion Espanola de Normalizacion

Committee	CTN 111
DevelopmentNote	Supersedes UNE EN 46001. (08/2003) Supersedes UNE EN ISO 13488 (03/2004) Supersedes UNE EN 46003. (08/2009)
DocumentType	Standard
Pages	68
PublisherName	Asociacion Espanola de Normalizacion
Status	Superseded
SupersededBy	UNE-EN ISO 13485:2018
Supersedes	UNE-EN ISO 13488:2001 UNE-EN ISO 13485:2013 UNE-CEN ISO/TR 14969:2006 IN UNE-EN 46003:2000 UNE-EN 46001:1996

ISO 19011:2011	Guidelines for auditing management systems
ISO 11607-2:2006	Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ISO 10012:2003	Measurement management systems — Requirements for measurement processes and measuring equipment
ISO 9001:2015	Quality management systems — Requirements
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 11607-1:2006	Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
EN ISO 9000:2015	Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)