BS EN 591:2001 - Instructions for use for in vitro diagnostic instruments for professional use – BSI British Standards

BS EN 591:2001

Instructions for use for in vitro diagnostic instruments for professional use

Status : Superseded, Withdrawn   Published : May 2001 Replaced By : BS EN ISO 18113-3:2009

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BS EN 591:2001 specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus, equipment, calibrators and control materials for professional use, hereafter called IVD instruments.

NOTE 1 Instructions for use are essential to enable the safe and proper operation of IVD instruments.

NOTE 2 This standard can also be applied to accessories.

This European standard is not applicable to field repair instructions.




Standard NumberBS EN 591:2001
TitleInstructions for use for in vitro diagnostic instruments for professional use
StatusSuperseded, Withdrawn
Publication Date15 May 2001
Withdrawn Date28 February 2010
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Replaced ByBS EN ISO 18113-3:2009
ReplacesBS EN 591:1995
International RelationshipsEN 591:2001
Draft Superseded By98/565576 DC
DescriptorsDiagnosis (medical), Clinical investigation instruments, Instructions for use, Medical equipment
ICS11.100.10
Title in FrenchNotices d'utilisation des instruments pour le diagnostic in vitro pour usage professionnel
Title in GermanGebrauchsanweisungen fuer Geraete fuer in-vitro-diagnostische Untersuchungen zum Gebrauch durch Fachpersonal
CommitteeCH/212
ISBN0 580 37232 4
PublisherBSI
FormatA4
DeliveryNo
Pages14
File Size243.8 KB
Price£110.00


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