In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
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.
This document is available in electronic format only.
Date of Publication: October 1, 2022
Order Code PDF: ISO181135Ed2E
Order Code Print: print not available
ISO 18113-5:2022 Additional Details
Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.