BS EN ISO 18113-5:2011 - In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for self-testing

BS EN ISO 18113-5:2011

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

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

Format
PDF

Format
HARDCOPY






Standard NumberBS EN ISO 18113-5:2011
TitleIn vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for self-testing
StatusCurrent
Publication Date30 November 2011
Conformity to regulationDesignated
Normative References(Required to achieve compliance to this standard)IEC 62366, EN 980, ISO 15223-1, IEC 61010-2-101, IEC 61326-2-6, IEC 61010-1, ISO 14971, ISO 18113-1
Informative References(Provided for Information)98/79/EC, ISO/IEC Directives Part 2, ISO 17593, ISO 18113-4, ISO 15197, EN 592:2002
ReplacesBS EN ISO 18113-5:2009
International RelationshipsEN ISO 18113-5:2011,ISO 18113-5:2009
Amended ByCorrigendum, January 2012
DescriptorsConsumers, Diagnosis (medical), Clinical investigation instruments, Instructions for use, Product information, Medical equipment, Labels, Clinical laboratory equipment, Labelling (process)
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 77330 3
PublisherBSI
FormatA4
DeliveryYes
Pages22
File Size1.527 MB
Price£134.00


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