Telefon: (011) 7541-421, 3409-301, 3409-335, 6547-293, 3409-310
E-mail: Prodaja standarda: prodaja@iss.rs Seminari, obuke: iss-edukacija@iss.rs Informacije o standardima: infocentar@iss.rs
Stevana Brakusa 2, 11030 Beograd
Glavni meni

ISO 18113-3:2022

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
6. 10. 2022.

Опште информације

60.60     6. 10. 2022.

ISO

ISO/TC 212

Međunarodni standard

11.100.10  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 18113-3:2009

TRENUTNO

OBJAVLJEN
ISO 18113-3:2022
60.60 Standard objavljen
6. 10. 2022.

Nacionalna preuzimanja

In vitro dijagnostička medicinska sredstva – Informacije izdate od strane proizvođača (obeležavanje) – Deo 3: In vitro dijagnostički instrumenti za profesionalnu upotrebu

60.60   Standard objavljen