BS EN ISO 18113-3:2011 - In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for professional use

BS EN ISO 18113-3:2011

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for professional use

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

Format
PDF

Format
HARDCOPY



ISO 18113-3:2009 specifies requirements for information supplied by the manufacturer of in vitro dignostic (IVD) instruments for professional use. ISO 18113-3:2009 also applies to apparatus and equipment intended to be used with IVD instruments for professional use. ISO 18113-3:2009 can also be applied to accessories, where appropriate.




Standard NumberBS EN ISO 18113-3:2011
TitleIn vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for professional use
StatusCurrent
Publication Date30 November 2011
Conformity to regulationDesignated
Normative References(Required to achieve compliance to this standard)IEC 61326-2-6, IEC 61010-1, ISO 14971, IEC 61010-2-101, ISO 15223-1, IEC 62366, EN 980, ISO 18113-1
Informative References(Provided for Information)ISO/IEC Directives Part 2, EN 591, ISO 18113-2
ReplacesBS EN ISO 18113-3:2009
International RelationshipsEN ISO 18113-3:2011,ISO 18113-3:2009
DescriptorsDiagnosis (medical), Clinical investigation instruments, Labels, Labelling (process), Product information, Medical equipment, Clinical laboratory equipment, Instructions for use, Health service personnel
ICS11.100.10
Title in FrenchDispositifs médicaux de diagnostic in vitro. Informations fournies par le fabricant (étiquetage). Instruments de diagnostic in vitro à usage professionnel
Title in GermanIn-vitro-Diagnostika. Bereitstellung von Informationen durch den Hersteller. Geräte für in-vitro-diagnostische Untersuchungen zum Gebrauch durch Fachpersonal
CommitteeCH/212
ISBN978 0 580 76942 9
PublisherBSI
FormatA4
DeliveryYes
Pages22
File Size1.009 MB
Price£134.00


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