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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use

ISO 18113-2:2022

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use

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

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 self-testing.

This document is available in electronic format only.

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Details

Date of Publication: October 1, 2022

Order Code PDF: ISO181132Ed2E

Order Code Print: print not available

Edition: Second

Pages: 11

ISO 18113-2:2022 Additional Details

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