DS/EN ISO 13485/AC:2009 ( Withdrawn )

Medical devices - Quality management systems - Requirements for regulatory purposes


Status:
Withdrawn
Type:
Correction sheet
Language:
English
Subject:
Replaced by:
Price from:
€ 0.00

Scope

This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.


Number of pages: 12

Published: 2009-10-24

Date of approval: 2009-09-30

Date of withdrawal: 2012-03-09

International relationships : EN ISO 13485:2003/AC:2009 IDT ISO 13485:2003/Cor 1:2009 IDT

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

Item number: M242809


Committees

Committee

  • CENCLC/JTC 3
  • ISO/TC 210/JWG 1

Danish committee

DS/S-257