EN
SR EN ISO 18113-4:2024
Dispozitive medicale pentru diagnostic in vitro. Informaţii furnizate de producător (etichetare). Partea 4: Reactivi pentru diagnostic in vitro pentru autotestare
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing. This document can also be applicable to accessories. This document is applicable to the labels for outer and immediate containers and to the instructions for use. This document does not apply to: a) IVD instruments or equipment; b) IVD reagents for professional use.
Status :
In vigoare
Data aprobării : 31.12.2024
Număr de pagini : 26
ICS : 11.100.10 Sisteme pentru încercari de diagnostic in vitro
Comitet tehnic : 377 - Medicale
- Inlocuieste SR EN ISO 18113-4:2012