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ONORM EN ISO 18113-4:2024
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)
This document specifies requirements for the information provided by the manufacturer of in vitro diagnostic (IVD) reagents, calibration materials and control materials for home use studies. This document can also be applied to accessories. This document is applicable to labels for the external and primary containers as well as the instructions for use. This document is not applicable to: a) IVD devices or equipment; b) IVD reagents for professional use.
Austrian Standards Institute [on]