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EN ISO 13485:2003/AC:2009

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)

General information

99.60 Withdrawal effective   Feb 15, 2012

CEN/CENELEC

CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices

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
93/42/EEC

Medical devices

Harmonized/Supporting
Legislation 93/42/EEC
90/385/EEC

Active implantable medical devices

Harmonized/Supporting
Legislation 90/385/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 13485:2003/AC:2007

WITHDRAWN
EN ISO 13485:2003

NOW

WITHDRAWN
EN ISO 13485:2003/AC:2009
99.60 Withdrawal effective
Feb 15, 2012

REVISED BY

WITHDRAWN
EN ISO 13485:2012