EN
SR EN ISO 18113-5:2024
Dispozitive medicale pentru diagnostic in vitro. Informaţii furnizate de producător (etichetare). Partea 5: Instrumente pentru diagnostic in vitro pentru autotestare
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing. This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing. This document can also be applicable to accessories. This document 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.
Status :
In vigoare
Data aprobării : 31.12.2024
Număr de pagini : 24
ICS : 11.100.10 Sisteme pentru încercari de diagnostic in vitro
Comitet tehnic : 377 - Medicale
- Inlocuieste SR EN ISO 18113-5:2012