DS/EN ISO 13485/AC:2009 ( Withdrawn )

Medical devices - Quality management systems - Requirements for regulatory purposes

Status:
Withdrawn
Type:
Correction sheet
Language:
English
Subject:
Sundhed
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.

Replaces:

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

Item number: M242809

Committees

Committee

  • CENCLC/JTC 3
  • ISO/TC 210/JWG 1

Danish committee

DS/S-257