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ONORM EN ISO 18113-5:2024

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)

This document specifies requirements for the information provided by the manufacturer of in vitro diagnostic (IVD) devices for self-use studies. This document is also applicable to devices and equipment intended for use in conjunction with IVD devices for self-use studies. This document can also be applied to accessories. This document is not applicable to: a) instructions for equipment maintenance or repair; b) IVD reagents, including calibration materials and control materials to control the reagent; c) IVD devices for use by professionals.

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Austrian Standards Institute [on]

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