BS EN ISO 18113-4:2011 - In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for self-testing

BS EN ISO 18113-4:2011

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

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

Format
PDF

Format
HARDCOPY






Standard NumberBS EN ISO 18113-4:2011
TitleIn vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for self-testing
StatusCurrent
Publication Date30 November 2011
Conformity to regulationDesignated
Normative References(Required to achieve compliance to this standard)ISO 18113-1, EN 980, ISO 15223-1, ISO 14971
Informative References(Provided for Information)ISO 17593, CLSI C28-A2:2000, ISO 15197, 98/79/EC, ISO 18113-5, ISO/IEC Directives Part 2, CLSI GP10-A:1995, EN 376:2002
ReplacesBS EN ISO 18113-4:2009
International RelationshipsEN ISO 18113-4:2011,ISO 18113-4:2009
Amended ByCorrigendum, January 2012
DescriptorsMedical equipment, Diagnostic reagents, Clinical laboratory equipment, Containers, Instructions for use, Diagnosis (medical), Labels, Reagent solutions, Labelling (process), Product information, Consumers
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 77329 7
PublisherBSI
FormatA4
DeliveryYes
Pages24
File Size1.568 MB
Price£186.00


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