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EN ISO 14971:2000/A1:2003

Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements (ISO 14971:2000/AM1:2003) EN ISO 14971:2000/A1:2003

Publication date:   Jun 30, 2004

General information

99.60   Withdrawal effective   Mar 15, 2007

CEN/CENELEC

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

European Norm

11.040.01   Medical equipment in general | 11.120.01   Pharmaceutics in general

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Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonised Standard / Cited in the Official Journal
Legislation 98/79/EC
90/385/EEC

Active implantable medical devices

Harmonised Standard / Cited in the Official Journal
Legislation 90/385/EEC
93/42/EEC

Medical devices

Legislation 93/42/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 14971:2000

NOW

WITHDRAWN
EN ISO 14971:2000/A1:2003
99.60 Withdrawal effective
Mar 15, 2007

REVISED BY

WITHDRAWN
EN ISO 14971:2007




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