BS EN ISO 18113-2:2009 - In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for professional use

BS EN ISO 18113-2:2009

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for professional use

Status : Revised, Withdrawn   Published : February 2010 Replaced By : BS EN ISO 18113-2:2011

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Standard NumberBS EN ISO 18113-2:2009
TitleIn vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for professional use
StatusRevised, Withdrawn
Publication Date28 February 2010
Confirm Date05 August 2015
Withdrawn Date30 November 2011
Normative References(Required to achieve compliance to this standard)EN 980, ISO 14971, ISO 18113-1, ISO 8601, ISO 15223-1
Informative References(Provided for Information)ISO/IEC Directives Part 2, ISO 18153, ISO 17511, CLSI C28-AMD 2:2000, 98/79/EC, ISO 18113-3, CLSI GP10-A:1995, EN 375:2001
Replaced ByBS EN ISO 18113-2:2011
ReplacesBS EN 375:2001
International RelationshipsISO 18113-2:2009,EN ISO 18113-2:2009
Draft Superseded By06/30146515 DC
DescriptorsInstructions for use, Labelling (process), Labels, Health service personnel, Diagnosis (medical), Clinical laboratory equipment, Reagent solutions, Medical equipment, Containers, Diagnostic reagents, Product information
ICS11.100.10
Title in FrenchDispositifs médicaux de diagnostic in vitro. Informations fournies par le fabricant (étiquetage). Réactifs de diagnostic in vitro à usage professionnel
Title in GermanIn-vitro-Diagnostika. Bereitstellung von Informationen durch den Hersteller. In-vitro-diagnostische Reagenzien für den Gebrauch durch Fachpersonal
CommitteeCH/212
ISBN978 0 580 56590 8
PublisherBSI
FormatA4
DeliveryNo
Pages22
File Size434 KB
Price£130.00


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