DS/EN 46003:1999 ( Withdrawn )

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003

Status:
Withdrawn
Type:
Standard
Language:
English
Subject:
Sundhed
Replaced by:
Price from:
€ 34.55

Scope

This standard specifies, in conjunction with EN ISO 9003:1994, the quality system requirements for the final inspection and test of medical devices excluding in vitro diagnostic medical devices and active implantable medical devices, and is applicable when a medical devices supplier's quality system is assessed in accordance with regulatory requirements.

Number of pages: 12

Published: 1999-12-08

Date of approval: 1999-09-13

Date of withdrawal: 2007-07-02

International relationships : EN 46003:1999 IDT

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

Item number: 29283

Committees

Committee

  • CEN/TC 205

Danish committee

DS/S-093