EN
SR EN ISO 18113-3:2024
Dispozitive medicale pentru diagnostic in vitro. Informaţii furnizate de producător (etichetare). Partea 3: Instrumente pentru diagnostic in vitro pentru uz profesional
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use. This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use. 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 self-testing.
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 18113-3:2012