ISO 18113-5:2022

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

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

PUBLISH DATE 2022

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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