DS/EN ISO 13485:2001 ( Withdrawn )

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001


Status:
Withdrawn
Type:
Standard
Language:
English
Subject:
Replaced by:
Price from:
€ 56.85

Scope

The standard specifies, in conjunction with ISO 9001, the quality system requirements for the design/development, production, and when relevant, installation and servicing of medical devices. The standard, in conjunction with ISO 9001, is applicable when there is a need to assess a medical device supplier's quality system.


Number of pages: 24

Published: 2001-03-07

Date of approval: 2001-02-09

Date of withdrawal: 2006-08-06

International relationships : EN ISO 13485:2000 IDT ISO 13485:1996 IDT

ICS: 03.120.10 - Quality management and quality assurance 11.040.01 - Medical equipment in general 03.100.70 - Management systems

Item number: 42126


Committees

Committee

  • CEN/TC 205
  • CENCLC/CWG QS
  • ISO/TC 210

Danish committee

DS/S-093