0 Stavka
Moj nalog
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 18113-2:2022

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents 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) reagents, calibrators and controls intended for professional use.
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 self-testing.

Životni ciklus

PRETHODNO

POVUČEN
ISO 18113-2:2009

TRENUTNO

OBJAVLJEN
ISO 18113-2:2022
60.60 Standard objavljen
6. 10. 2022.

Nacionalna preuzimanja

SRPS EN ISO 18113-2:2024  
ISS

In vitro dijagnostička medicinska sredstva – Informacije izdate od strane proizvođača (obeležavanje) – Deo 2: In vitro dijagnostički reagensi za profesionalnu upotrebu

60.60   Standard objavljen

Z076 Saznaj više