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ISO 18113-5:2022

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
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 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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 18113-5:2009

TRENUTNO

OBJAVLJEN
ISO 18113-5:2022
60.60 Standard objavljen
6. 10. 2022.

Nacionalna preuzimanja

SRPS EN ISO 18113-5:2024  
ISS

In vitro dijagnostička medicinska sredstva – Informacije izdate od strane proizvođača (obeležavanje) – Deo 5: In vitro dijagnostički instrumenti za samotestiranje

60.60   Standard objavljen

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