EN 591:2001

Name: EN 591:2001
Brand: CEN
SKU: EN 591:2001
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Instructions for use for in vitro diagnostic instruments for professional use EN 591:2001

Publication date: Jan 22, 2004

General information

Current stage: 99.60 Withdrawal effective Dec 15, 2009

Originator: CEN

Owner: CEN/TC 140 In vitro diagnostic medical devices

Type: European Norm

ICS: 11.100 Laboratory medicine

Buying

Status: Withdrawn

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 legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting

PREVIOUSLY

WITHDRAWN
EN 591:1994

NOW

WITHDRAWN
EN 591:2001
99.60 Withdrawal effective
Dec 15, 2009

REVISED BY

WITHDRAWN
EN ISO 18113-3:2009