DS/EN 46001:1999 ( Withdrawn )

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

Status:
Withdrawn
Type:
Standard
Language:
Danish/English
Subject:
Sundhed
Replaced by:
Price from:
€ 61.03

Scope

The standard specifies, in conjunction with EN ISO 9001, the quality system requirements for the design/development, production, and where relevant, installation of medical devices.

Replaces:

Number of pages: 28

Published: 1999-07-01

Date of approval: 1999-05-20

Date of withdrawal: 2001-03-07

International relationships : EN 46001:1996 IDT

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

Item number: 39116

Committees

Committee

  • CEN/TC 205

Danish committee

DS/S-093