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SRPS EN 592:2008

Instructions for use for in vitro diagnostic instruments for self-testing

Dec 29, 2008
95.99   Withdrawal of Standard   Jun 28, 2011

General information

95.99     Jun 28, 2011

ISS

Z076

European Norm

11.100  

English  

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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 directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

98/79/EC

In vitro diagnostic medical devices

Harmonized

Life cycle

NOW

WITHDRAWN
SRPS EN 592:2008
95.99 Withdrawal of Standard
Jun 28, 2011

REVISED BY

WITHDRAWN
SRPS EN ISO 18113-5:2011

Related project

Adopted from EN 592:2002