ISO 18113-5

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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

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USD 69.00

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.

Standard Number ISO 18113-5:2022
Title ISO 18113-5:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
Status Published
Publication Date 06 Oct 2022
Committee ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
Publisher PECB Store
Format PDF
Pages 10
Price USD 69.00
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