ISO-18113-5 › In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing

ISO-18113-5 - 2ND EDITION - CURRENT
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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.

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Document Number

ISO 18113-5:2022

Revision Level

2ND EDITION

Status

Current

Publication Date

Oct. 1, 2022

Committee Number

ISO/TC 212