60.60 Standard published Oct 6, 2022
ISO
ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
International Standard
11.100.10 In vitro diagnostic test systems
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.
WITHDRAWN
ISO 18113-5:2009
PUBLISHED
ISO 18113-5:2022
60.60
Standard published
Oct 6, 2022