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SSH EN ISO 18113-2:2024

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022)

Jun 25, 2025

General information

60.60     Jun 25, 2025

95.99   

DPS

DPS/KT 140

European Norm

11.100.10  

English  

Buying

Published

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 professional use.
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 self-testing.

Related directives

Directives related to this standards.

2017/746

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 18113-2:2011

NOW

PUBLISHED
SSH EN ISO 18113-2:2024
60.60 Standard published
Jun 25, 2025

Related project

Adopted from EN ISO 18113-2:2024 IDENTICAL

Adopted from ISO 18113-2:2022 IDENTICAL