CEN - EN ISO 13485
Quality Systems - Medical Devices - Particular Requirements for the Application of EN ISO 9001
inactive
| Organization: | CEN |
| Publication Date: | 1 November 2000 |
| Status: | inactive |
| Page Count: | 72 |
| ICS Code (Quality management and quality assurance): | 03.120.10 |
| ICS Code (Medical equipment in general): | 11.040.01 |
Document History
March 1, 2016
Medical devices - Quality management systems - Requirements for regulatory purposes
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...
March 1, 2016
Medical devices - Quality management systems - Requirements for regulatory purposes
European foreword
This document (EN ISO 13485:2016) has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices” in collaboration...
February 1, 2012
Medical devices - Quality management systems - Requirements for regulatory purposes
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...
February 1, 2012
Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1
A description is not available for this item.
July 24, 2003
Medical devices Quality management systems Requirements for regulatory purposes
A description is not available for this item.
July 24, 2003
Medical devices - Quality management systems - Requirements for regulatory purposes
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...
EN ISO 13485
November 1, 2000
Quality Systems - Medical Devices - Particular Requirements for the Application of EN ISO 9001
A description is not available for this item.