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EN 46001:1993

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

General information

99.60 Withdrawal effective   Aug 1, 1996

CEN/CENELEC

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

European Norm

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
more

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WITHDRAWN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WITHDRAWN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WITHDRAWN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