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EN 540:1993

Clinical investigation of medical devices for human subjects EN 540:1993

Publication date:   Jun 4, 2001

General information

99.60 Withdrawal effective   Feb 15, 2003

CEN

CEN/TC 258 Clinical investigation of medical devices

European Norm

11.040.10   Anaesthetic, respiratory and reanimation equipment | 11.060.01   Dentistry in general | 11.140   Hospital equipment

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Scope

This European Standard pertains to the clinical investigation in human subjects of those medical devices whose clinical performance needs assessment before being placed on the market. This European Standard does not apply to in vitro diagnostic devices.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
more
93/42/EEC

Medical devices

Harmonized/Supporting
more

Life cycle

NOW

WITHDRAWN
EN 540:1993
99.60 Withdrawal effective
Feb 15, 2003

CORRIGENDA / AMENDMENTS

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EN 540:1993/AC:1998

REVISED BY

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EN ISO 14155-1:2003