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EN ISO 13485:2000

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001 (revision of EN 46001:1996) (identical to ISO 13485:1996)

General information

99.60 Withdrawal effective   Jul 15, 2003

CEN/CENELEC

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

European Norm

03.100.70   Management systems | 11.040.01   Medical equipment in general

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
Legislation 98/79/EC
90/385/EEC

Active implantable medical devices

Legislation 90/385/EEC
93/42/EEC

Medical devices

Harmonized/Supporting
Legislation 93/42/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN 46001:1996

NOW

WITHDRAWN
EN ISO 13485:2000
99.60 Withdrawal effective
Jul 15, 2003

REVISED BY

WITHDRAWN
EN ISO 13485:2003

Relations

Adopted from ISO 13485:1996 IDENTICAL