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ISO 18113-1:2022

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements
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 defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.
This document does not address language requirements since that is the domain of national laws and regulations.
This document does not apply to:
a) IVD medical devices for performance evaluation (e.g. for investigational use only);
b) shipping documents;
c) material safety data sheets / Safety Data Sheets;
d) marketing information (consistent with applicable legal requirements).
.

Životni ciklus

PRETHODNO

POVUČEN
ISO 18113-1:2009

TRENUTNO

OBJAVLJEN
ISO 18113-1:2022
60.60 Standard objavljen
6. 10. 2022.

Nacionalna preuzimanja

SRPS EN ISO 18113-1:2024  
ISS

In vitro dijagnostička medicinska sredstva – Informacije izdate od strane proizvođača (obeležavanje) – Deo 1: Termini, definicije i opšti zahtevi

60.60   Standard objavljen

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