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SRPS EN 591:2008

Instructions for use for in vitro diagnostic instruments for professional use

Dec 29, 2008
95.99   Withdrawal of Standard   Feb 28, 2018

General information

95.99     Feb 28, 2018

ISS

Z076

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

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WITHDRAWN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 591:2008
95.99 Withdrawal of Standard
Feb 28, 2018

REVISED BY

WITHDRAWN
SRPS EN ISO 18113-3:2011

Related project

Adopted from EN 591:2001