Back

CEN ISO/TR 14969:2005

Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003

General information
Withdrawn from 06.12.2016
Base Documents
ISO/TR 14969:2004; CEN ISO/TR 14969:2005
Directives or regulations
None
Standard history
Status
Date
Type
Name
02.03.2016
Main + corrigendum
06.10.2006
Main
This Technical Report provides guidance for the application of the requirements for quality management systems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 13485. This Technical Report does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.
*
*
*
PDF
26.58 € incl tax
Paper
26.58 € incl tax
Price: 2.40 € incl tax
Standard monitoring
Customers who bought this item also bought
Main

EVS-EN ISO 14971:2012

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
Withdrawn from 02.01.2020
Main

EVS-EN ISO 25539-2:2012

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
Withdrawn from 15.10.2020
Main + corrigendum

EVS-EN ISO 13485:2012

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
Withdrawn from 02.03.2016
Main

EVS-EN ISO 10993-16:2010

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Withdrawn from 18.12.2017