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 information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing.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 professional use.
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