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EN ISO 18113-2:2024 Standard

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  Keywords:

#information #ivd #calibrators #intended #diagnostic

  Directive

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

  Last Official Journal reference

Wednesday 28th of January 2026

  Description:

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

  Purpose

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.

  Publication

Wednesday 28th of January 2026

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