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

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
Normative References(Required to achieve compliance to this standard)ISO 14971, ISO 15223-1, ISO 18113-1, IEC 61010-1, IEC 61010-2-101, IEC 61326-2-6, IEC 62366, EN 980
Informative References(Provided for Information)ISO 15197, ISO 17593, ISO 18113-4, ISO/IEC Directives Part 2, EN 592:2002, 98/79/EC
ReplacesBS EN ISO 18113-5:2009
International RelationshipsEN ISO 18113-5:2011,ISO 18113-5:2009
Amended ByCorrigendum, January 2012
DescriptorsDiagnosis (medical), Medical equipment, Product information, Instructions for use, Labels, Labelling (process), Clinical investigation instruments, Clinical laboratory equipment, Consumers
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 Size1.557 MB
Price£130.00


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