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

ISO 18113-5:2022

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.

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Details

Date of Publication: October 1, 2022

Order Code PDF: ISO181135Ed2E

Order Code Print: print not available

Edition: Second

Pages: 10

ISO 18113-5:2022 Additional Details

Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.