ISO 18113-4:2022 ✓ Most Recent

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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing

standard by International Organization for Standardization , 09/30/2022

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Full Description

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

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 professional use.

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Document History

  1. ISO 18113-4:2022

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    In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing

    • Most Recent

  2. ISO 18113-4:2009


    In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing

    • Historical Version

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Product Details

Published:

09/30/2022

File Size:

1 file

Note:

This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus