BS EN ISO 18113-4:2009 - In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for self-testing

BS EN ISO 18113-4:2009

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for self-testing

Status : Revised, Withdrawn   Published : February 2010 Replaced By : BS EN ISO 18113-4:2011

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Standard NumberBS EN ISO 18113-4:2009
TitleIn vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for self-testing
StatusRevised, Withdrawn
Publication Date28 February 2010
Confirm Date05 August 2015
Withdrawn Date30 November 2011
Normative References(Required to achieve compliance to this standard)ISO 15223-1, EN 980, ISO 18113-1, ISO 14971
Informative References(Provided for Information)CLSI GP10-A:1995, ISO 18113-5, ISO 15197, 98/79/EC, CLSI C28-AMD 2:2000, ISO/IEC Directives Part 2, ISO 17593, EN 376:2002
Replaced ByBS EN ISO 18113-4:2011
ReplacesBS EN 376:2002
International RelationshipsISO 18113-4:2009,EN ISO 18113-4:2009
Draft Superseded By06/30146522 DC
DescriptorsReagent solutions, Diagnostic reagents, Consumers, Product information, Clinical laboratory equipment, Instructions for use, Diagnosis (medical), Medical equipment, Labelling (process), Labels, Containers
ICS11.100.10
Title in FrenchDispositifs médicaux de diagnostic in vitro. Informations fournies par le fabricant (étiquetage). Réactifs de diagnostic in vitro pour auto-tests
Title in GermanIn-vitro-Diagnostika. Bereitstellung von Informationen durch den Hersteller. Reagenzien für in-vitrodiagnostische Untersuchungen zur Eigenanwendung
CommitteeCH/212
ISBN978 0 580 56592 2
PublisherBSI
FormatA4
DeliveryNo
Pages22
File Size826 KB
Price£130.00


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