BS EN 592:2002 - Instructions for use for in vitro diagnostic instruments for self-testing – BSI British Standards

BS EN 592:2002

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

Status : Superseded, Withdrawn   Published : May 2002 Replaced By : BS EN ISO 18113-5:2009

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BS EN 592:2002 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 European standard is not applicable to field repair instructions.




Standard NumberBS EN 592:2002
TitleInstructions for use for in vitro diagnostic instruments for self-testing
StatusSuperseded, Withdrawn
Publication Date03 May 2002
Withdrawn Date28 February 2010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 18113-5:2009
ReplacesBS EN 592:1995
International RelationshipsEN 592:2002
Draft Superseded By99/565689 DC
DescriptorsMedical instruments, Medical equipment, Clinical investigation instruments, Diagnosis (medical), Instructions for use
ICS11.100.10
Title in FrenchInstructions d'utilisation d'instruments pour le diagnostic in vitro pour usage comme auto-test
Title in GermanGebrauchsanweisungen fuer Geraete fuer in-vitro-diagnostische Untersuchungen zur Eigenanwendung
CommitteeCH/212
ISBN0 580 39652 5
PublisherBSI
FormatA4
DeliveryNo
Pages14
File Size272.3 KB
Price£110.00


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