In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing.
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 professional use.
This document is available in electronic format only.
Date of Publication: October 1, 2022
Order Code PDF: ISO181134Ed2E
Order Code Print: print not available
ISO 18113-4:2022 Additional Details
Membership discounts cannot be applied to ISO documents because they are not published by CLSI. CLSI is able to offer ISO Technical Committee 212 approved and draft standards through an agreement with the American National Standards Institute.
Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.