ISO 18113-5:2022 ✓ Most Recent

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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments 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) 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 History

  1. ISO 18113-5:2022

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

    • Most Recent

  2. ISO 18113-5:2009


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

    • Historical Version

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Published:

09/30/2022

File Size:

1 file

Note:

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