BS EN ISO 18113-5:2009 - In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for self-testing

BS EN ISO 18113-5:2009

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

Status : Revised, Withdrawn   Published : February 2010 Replaced By : BS EN ISO 18113-5:2011

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Standard NumberBS EN ISO 18113-5:2009
TitleIn vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments 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StatusRevised, Withdrawn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Withdrawn Date30 November 2011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 14971, IEC 61010-1, ISO 18113-1, IEC 61326-2-6, EN 980, IEC 61010-2-101, IEC 62366, ISO 15223-1
Informative References(Provided for Information)98/79/EC, ISO 17593, ISO 18113-4, ISO/IEC Directives Part 2, ISO 15197, EN 592:2002
Replaced ByBS EN ISO 18113-5:2011
ReplacesBS EN 592:2002
International RelationshipsISO 18113-5:2009,EN ISO 18113-5:2009
Draft Superseded By06/30146526 DC
DescriptorsClinical investigation instruments, Labelling (process), Diagnosis (medical), Product information, Clinical laboratory equipment, Medical equipment, Consumers, Labels, Instructions for use
ICS11.100.10
Title in FrenchDispositifs médicaux de diagnostic in vitro. Informations fournies par le fabricant (étiquetage). Instruments de diagnostic in vitro pour auto-tests
Title in GermanIn-vitro-Diagnostika. Bereitstellung von Informationen durch den Hersteller. Geräte für in-vitrodiagnostische Untersuchungen zur Eigenanwendung
CommitteeCH/212
ISBN978 0 580 56593 9
PublisherBSI
FormatA4
DeliveryNo
Pages20
File Size412 KB
Price£130.00


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