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SSH EN 591:2006

Instructions for use for in vitro diagnostic instruments for professional use

Jan 1, 2006
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 user manuals for in vitro diagnostic instruments including apparatus and equipment for professional use, hereafter called instruments. Note 1: User manuals are essential to enable the safe and proper operation of instruments. 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
Directive 98/79/EC

Life cycle

NOW

WITHDRAWN
SSH EN 591:2006
95.99 Withdrawal of Standard
May 13, 2015

REVISED BY

PUBLISHED
SSH EN ISO 18113-3:2011

Related project

Adopted from EN 591:2001