|Number of pages||15|
|Committee||In vitro diagnostica|
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.
|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|