DIN EN ISO 13485 PDF

Published Date: 12/01/2021

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) (includes Corrigendum :2018)

Published Date: 11/01/2019

Draft Document - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019

Published Date: 07/01/2017

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) , Corrigendum to DIN EN ISO 13485:2016-08

Published Date: 04/01/2014

Draft Document - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/DIS 13485:2014); German version prEN ISO 13485:2014

Published Date: 11/01/2012

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009) (includes Corrigendum :2012)

Published Date: 01/01/2010

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009) (includes Corrigendum AC:2009)

Published Date: 10/01/2007

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) (includes Corrigendum AC:2007)

Published Date: 01/01/2009

Draft Document - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard - Usability (IEC 62A/630/CD:2008)

Published Date: 07/01/2018

Draft Document - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 62A/1204/CD:2017); Text in German and English

Published Date: 03/01/1992