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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Withdrawn from 06.12.2016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
ICS Groups
03.120.10 Quality management and quality assurance 11.040.01 Medical equipment in general
Directives or regulations
None

Standard history

Status
Date
Type
Name
02.03.2016
Main + corrigendum
EVS-EN ISO 13485:2016
06.10.2006
Main
CEN ISO/TR 14969:2005
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.

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Standard monitoring
English (PDF 445 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English