BS EN ISO 18113-2:2011 - In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for professional use

BS EN ISO 18113-2:2011

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

Status : Current   Published : November 2011
Conformity to regulation : Designated

Format
PDF

Format
HARDCOPY






Standard NumberBS EN ISO 18113-2:2011
TitleIn vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for professional use
StatusCurrent
Publication Date30 November 2011
Conformity to regulationDesignated
Normative References(Required to achieve compliance to this standard)ISO 8601, ISO 18113-1, ISO 15223-1, ISO 14971, EN 980
Informative References(Provided for Information)CLSI C28-A2:2000, CLSI GP10-A:1995, ISO 18153, ISO 18113-3, 98/79/EC, ISO 17511, ISO/IEC Directives Part 2, EN 375:2001
ReplacesBS EN ISO 18113-2:2009
International RelationshipsEN ISO 18113-2:2011,ISO 18113-2:2009
Amended ByCorrigendum, January 2012
DescriptorsProduct information, Reagent solutions, Clinical laboratory equipment, Health service personnel, Medical equipment, Labels, Containers, Labelling (process), Diagnosis (medical), Instructions for use, Diagnostic reagents
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 77328 0
PublisherBSI
FormatA4
DeliveryYes
Pages24
File Size1.548 MB
Price£186.00


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