DIN EN ISO 13485
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001 (Revision of EN 46001:1996) (ISO 13485:1996); English version of DIN EN ISO 13485
inactive
| Organization: | DIN |
| Publication Date: | 1 February 2001 |
| Status: | inactive |
| ICS Code (Quality management and quality assurance): | 03.120.10 |
| ICS Code (Medical equipment in general): | 11.040.01 |
Document History
December 1, 2021
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) (includes Corrigendum :2018)
A description is not available for this item.
November 1, 2019
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019
A description is not available for this item.
July 1, 2017
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) , Corrigendum to DIN EN ISO 13485:2016-08
A description is not available for this item.
August 1, 2016
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that...
May 1, 2015
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/DIS 13485:2015); German and English version prEN ISO 13485:2015
A description is not available for this item.
November 1, 2012
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009) (includes Corrigendum :2012)
General
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that...
January 1, 2010
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009) (includes Corrigendum AC:2009)
A description is not available for this item.
October 1, 2007
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) (includes Corrigendum AC:2007)
A description is not available for this item.
November 1, 2003
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
A description is not available for this item.
DIN EN ISO 13485
February 1, 2001
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001 (Revision of EN 46001:1996) (ISO 13485:1996); English version of DIN EN ISO 13485
A description is not available for this item.
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