magnifying icon Basket
1 item ^

Basket is empty
Login

Login

LOGGED AS

Help

Satisfaction enquiry

SATISFACTION ENQUIRY

Newsletter

Free of charge lifelong learning "Standardization"

FREE OF CHARGE LIFELONG LEARNING "STANDARDIZATION"

Standardisation

Draft standards in public enquiry

DRAFT STANDARDS IN PUBLIC ENQUIRY

Standards organizations

STANDARDS ORGANIZATIONS

  • National standards

  • European standards

  • International standards


Deliverable

 
Free preview
Price
Language
 
CEN ISO/TR 14969:2005 Edition 06/2005
Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
  •   
  •  
  • 83.8 / copy
  •  
 

Abstract

ISO/TR 14969:2004 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. It does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. This guidance can be used to better understand the requirements of ISO 13485 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 13485.

Status

Standard - Withdrawn

Origin

Technical Committee :
CEN/CLC/TC 3 : Quality management and corresponding general aspects for medical devices

Implementation

start of the vote on the project      date of ratification (dor)    03/03/2005
end of the vote on the project      date of anouncement (doa)   
start of the vote on the final project    09/12/2004   date of publication (dop)   
end of the vote on the final project    03/02/2005   date of withdrawal (dow)   


Publication Official Journal
of the Grand-Duchy of Luxembourg
10/01/2006
Reference

Relations

Evolutions
ILNAS-EN ISO 13485:2016

International Classification for Standards (ICS codes) :

03.120.10 : Quality management and quality assurance
11.040.01 : Medical equipment in general

magnifying icon Basket
1 item ^

Basket is empty


Warning:
DIN standards can be downloaded only once! After downloading, they are no longer available in the eLibrary.
Begin download?