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EN 592:2002

Instructions for use for in vitro diagnostic instruments for self-testing EN 592:2002

Publication date:   Jan 22, 2004

General information

99.60 Withdrawal effective   Dec 15, 2009

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

11.100   Laboratory medicine

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Scope

This standard specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus and equipment for self-testing which hereafter are called IVD instruments.

NOTE 1 Instructions for use are essential to enable the safe and proper operation of IVD instruments by lay persons.

NOTE 2 This standard can also be applied to accessories.

This standard is not applicable to field repair instructions.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
Legislation 98/79/EC

Life cycle

PREVIOUSLY

WITHDRAWN
EN 592:1994

NOW

WITHDRAWN
EN 592:2002
99.60 Withdrawal effective
Dec 15, 2009

REVISED BY

WITHDRAWN
EN ISO 18113-5:2009