ISO 18113-1:2022

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements

Publication date: 6 tet 2022

General information

Current stage: 60.60 Effective date: 6 tet 2022

Originator: ISO

Owner: ISO/TC 212

Type: International Standard

ICS: 11.100.10

Gjuha: anglisht frëngjisht

Buying

Statusi: Publikuar

PDF - 21 936 Lekë

Paper - 21 936 Lekë

CD - 21 936 Lekë

Language

Language in which you want to receive the document.

Scope

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).
.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 18113-1:2009

NOW

PUBLISHED
ISO 18113-1:2022
60.60 Standard published
6 tet 2022

National adoptions

SSH ISO 18113-1:2022

DPS

Pajisje mjekësore për diagnostikimin in vitro - Informacioni i dhënë nga prodhuesi (etiketimi) - Pjesa 1: Termat, përkufizimet dhe kërkesat e përgjithshme

60.60 Standard published

DPS/KT 140 më tepër