ISO 18113-2

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ISO 18113-2:2022

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ISO 18113-2:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use

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USD 69.00

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators and controls intended for professional use.

This document can also be applicable to accessories.

This document is applicable to the labels for outer and immediate containers and to the instructions for use.

This document does not apply to:

a) IVD instruments or equipment;

b) IVD reagents for self-testing.

Standard Number ISO 18113-2:2022
Title ISO 18113-2:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents 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 11
Price USD 69.00
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