DS/EN ISO 13488:2001 ( Withdrawn )

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002

Status:
Withdrawn
Type:
Standard
Language:
English
Subject:
Sundhed
Replaced by:
Price from:
€ 56.86

Scope

The standard specifies, in conjunction with ISO 9002, the quality system requirements for the production and, when relevant, installation of medical devices. This standard, in conjuntion with ISO 9002, is applicable when there is a need to assess a medical device supplier's quality system.

Replaces:

Number of pages: 24

Published: 2001-03-07

Date of approval: 2001-02-09

Date of withdrawal: 2003-09-15

International relationships : EN ISO 13488:2000 IDT ISO 13488:1996 IDT

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

Item number: 42127

Committees

Committee

  • CEN/TC 205
  • ISO/TC 210

Danish committee

DS/S-093