EN 46001:1993

Quality systems - Medical devices - Particular requirements for the application of EN 29001 EN 46001:1993

General information

Current stage: 99.60 Withdrawal effective Aug 1, 1996

Originator: CEN/CENELEC

Owner: CEN/CLC/WG QS CEN/CENELEC Coordinating working group on quality supplements

Type: European Norm

ICS: 11.040.01 Medical equipment in general

Scope

This European Standard specifies, in conjunction with EN 29 001, the quality system requirements for the design/development, production, and where relevant, installation and servicing of medical devices.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting

Legislation 90/385/EEC

Life cycle

NOW

WITHDRAWN
EN 46001:1993
99.60 Withdrawal effective
Aug 1, 1996

CORRIGENDA / AMENDMENTS

WITHDRAWN
EN 46001:1993/AC:1994

REVISED BY

WITHDRAWN
EN 46001:1996