DIN EN ISO 13485:2016
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016

Standard No.

DIN EN ISO 13485:2016

Release Date

2016

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN ISO 13485 Berichtigung 1:2017

Latest

DIN EN ISO 13485:2021

DIN EN ISO 13485/A1:2019

DIN EN ISO 13485:2016

DIN EN ISO 13485:2021-12

Replace

DIN EN ISO 13485:2012 DIN EN ISO 13485:2015

DIN EN ISO 13485:2016 Referenced Document

• DIN EN ISO 10012:2004 Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003); Trilingual version EN ISO 10012:2003
• DIN EN ISO 11607-1:2014 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006 + Amd 1:2014); German version EN ISO 11607-1:2009 + A1:2014
• DIN EN ISO 11607-2:2014 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006 + Amd 1:2014); German version EN ISO 11607-2:2006 + A1:2014
• DIN EN ISO 11644:2009 Leather - Test for adhesion of finish (ISO 11644:2009); English version of DIN EN ISO 11644:2009-09
• DIN EN ISO 14698-1:2004 Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003); German version EN ISO 14698-1:2003
• DIN EN ISO 14698-2:2004 Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (ISO 14698-2:2003); German version EN ISO 14698-2:2003
• DIN EN ISO 19011:2011 Guidelines for auditing management systems (ISO 19011:2011); German and English version EN ISO 19011:2011
• DIN EN ISO 9000:2015 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015); German and English version EN ISO 9000:2015
• DIN EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015); German and English version EN ISO 9001:2015

DIN EN ISO 13485:2016 history

• 2021 DIN EN ISO 13485:2021 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021
• 2019 DIN EN ISO 13485/A1:2019 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019
• 2017 DIN EN ISO 13485 Berichtigung 1:2017 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016, Corrigendum to DIN EN ISO 13485:2016-08; German version EN ISO 13485:2016/AC:2016
• 2016 DIN EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016
• 1970 DIN EN ISO 13485 E:2015-05
• 0000 DIN EN ISO 13485:2015
• 2012 DIN EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2012 + AC:2012
• 2010 DIN EN ISO 13485:2010 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2003 + AC:2009
• 2007 DIN EN ISO 13485:2007 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003+AC:2007
• 2003 DIN EN ISO 13485:2003 Medical devices quality management systems requirements for regulatory purposes
• 2001 DIN EN ISO 13485:2001 Quality assurance systems for medical devices