EN 46001:1996

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

General information

99.60 Withdrawal effective   Nov 9, 2000

CEN/CENELEC

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

European Norm

03.120.10   Quality management and quality assurance | 11.040.01   Medical equipment in general

Scope

This European Standard specifies, in conjunction with EN ISO 9001, the quality system requirements for the design/development, production, and where relevant, installation and servicing of medical devices. The field of application of EN ISO 9001 applies. In addition, this European Standard, in conjunction with EN ISO 9001, is applicable when a medical device supplier's quality system is assessed in accordance with regulatory requirements. As part of an assessment by a third party for the purpose of regulatory requirements, the supplier may be required to provide access to confidential data in order to demonstrate compliance with this standard. The supplier may be required to exhibit these data but is not obliged to provide copies for retention.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

PREVIOUSLY

WITHDRAWN
EN 46001:1993

WITHDRAWN
EN 46001:1993/AC:1994

NOW

WITHDRAWN
EN 46001:1996
99.60 Withdrawal effective
Nov 9, 2000

REVISED BY

WITHDRAWN
EN ISO 13485:2000