ISO 18113-4:2022

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing

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 - 7 123 Lekë

Paper - 7 123 Lekë

CD - 7 123 Lekë

Language

Language in which you want to receive the document.

Scope

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing.
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 professional use.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 18113-4:2009

NOW

PUBLISHED
ISO 18113-4:2022
60.60 Standard published
6 tet 2022

National adoptions

SSH ISO 18113-4:2022

DPS

Pajisje mjekësore për diagnostikimin in vitro - Informacioni i dorëzuar nga prodhuesi (etiketimi) - Pjesa 4: Reagentët diagnostike për pajisjet in vitro për vetë - testim

60.60 Standard published

DPS/KT 140 më tepër