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

Standard No.

DIN EN ISO 13485:2010

Release Date

2010

Published By

German Institute for Standardization

Status

Withdraw

Replace By

DIN EN ISO 13485:2012

Latest

DIN EN ISO 13485 Berichtigung 1:2017

DIN EN ISO 13485/A1:2019

DIN EN ISO 13485:2016

DIN EN ISO 13485:2021-12

DIN EN ISO 13485 E:2014-04

DIN EN ISO 13485:2012

Scope

This standard specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices that consistently meet customer requirements and regulatory requirements applicable to medical devices. Different from DIN EN ISO 13485:2001-02 and DIN EN ISO 13488:2001-02, the revised standard DIN ISO 13485 is a stand-alone standard. Organisations whose quality management systems conform to DIN ISO 13485 cannot claim conformity to ISO 9001:2000 unless their quality

DIN EN ISO 13485:2010 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
• 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