ISO 18113-3

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ISO 18113-3:2022

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ISO 18113-3:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use

$ 69.00

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.

Standard Number ISO 18113-3:2022
Title ISO 18113-3:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
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 $ 69.00
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