ISO 18113-3:2022

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling)
Part 3: In vitro diagnostic instruments for professional use

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Description

Features

Life cycle

Historical

Summary

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use. This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use. 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 self-testing.

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)	---