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 defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.
This document does not address language requirements since that is the domain of national laws and regulations.
This document does not apply to:
a) IVD medical devices for performance evaluation (e.g. for investigational use only);
b) shipping documents;
c) material safety data sheets / Safety Data Sheets;
d) marketing information (consistent with applicable legal requirements).
.
WITHDRAWN
ISO 18113-1:2009
PUBLISHED
ISO 18113-1:2022
60.60
Standard published
Oct 6, 2022