Standard

NEN-EN-ISO 18113-5:2007 Ontw. en

Clinical laboratory testing and in vitro diagnostic medical systems - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing

  • This norm is withdrawn since 11-01-2010

23,85 28,86 Incl BTW

About norm

Status Withdrawn
Number of pages 15
Committee In vitro diagnostica
Published on 01-01-2007
Language English
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing. This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 does not apply to a) instructions for instrument servicing or repair, b) IVD reagents, including calibrators and control materials for use in control of the reagent, c) IVD instruments for professional use.

Details

ICS-code 11.100.10
Dutch title Klinische laboratoriumbeproeving en in-vitro-diagnostische medische systemen - Informatie te verstrekken door de fabrikant (merking) - Deel 5: In-vrito-diagnostische instrumenten voor zelf-testen
English title Clinical laboratory testing and in vitro diagnostic medical systems - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
Replaces
Replaced by

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