ISO 18113-5:2022

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

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 18113-5:2009

NOW

PUBLISHED
ISO 18113-5:2022
60.60 Standard published
6 tet 2022

National adoptions

SSH ISO 18113-5:2022

DPS

Pajisje mjekësore për diagnostikimin in vitro - Informacioni i dorëzuar nga prodhuesi (etiketimi) - Pjesa 5: Instrumentet të diagnostikimit in vitro për vetë-testim

60.60 Standard published

DPS/KT 140 më tepër