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EVS-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)

General information

Valid from 01.07.2024
Base Documents
ISO 18113-2:2022; EN ISO 18113-2:2024
Directives or regulations
None

Standard history

Status
Date
Type
Name
01.07.2024
Main
02.11.2011
Main

ISO 18113-2 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators and controls intended for professional use. It can also be applied to accessories, to the labels for outer and immediate containers and to the instructions for use.

ISO 18113-2 is concerned solely with information supplied with IVD reagents, calibrators and control materials intended for professional use. It is intended to be used in conjunction with ISO 18113-1, which contains the general requirements for information supplied by the manufacturer and definitions of general labelling concepts.

ISO 18113-2:2022 text has been approved in Europe as EN ISO 18113-2:2024 without any changes.

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