ISO 18113-4:2022
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ISO 18113-4:2022

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling)
Part 4: In vitro diagnostic reagents for self-testing

Summary

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.

Notes

60.60 : Norme internationale publiée

Technical characteristics

Publisher International Organization for Standardization (ISO)
Publication Date 10/06/2022
Edition 2
Page Count 11
EAN ---
ISBN ---
Weight (in grams) ---

Replaces

Previous versions

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