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SSH EN 592:2004

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

Jan 1, 2004
95.99 Withdrawal of Standard   May 13, 2015

General information

95.99     May 13, 2015

DPS

DPS/KT 140

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

Directives related to this standards.

98/79/EC

In vitro diagnostic medical devices

Harmonized

Life cycle

NOW

WITHDRAWN
SSH EN 592:2004
95.99 Withdrawal of Standard
May 13, 2015

REVISED BY

PUBLISHED
SSH EN ISO 18113-5:2011

Related project

Adopted from EN 592:2002