ISO 18113-5:2022
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ISO 18113-5:2022

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

Summary

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing. This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing. This document can also be applicable to accessories. This document does not apply to: a) instructions for instrument servicing or repair; b) IVD reagents, including calibrators and control materials for use in control of the reagent; c) IVD instruments 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 10
EAN ---
ISBN ---
Weight (in grams) ---

Replaces

Previous versions

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