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.
Date of Publication: October 1, 2022
Order Code PDF: ISO181132Ed2E
Order Code Print: print not available
ISO 18113-2:2022 Additional Details
Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.