90.92 Standard to be revised Dec 19, 2024
ISO
ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
International Standard
11.100.10 In vitro diagnostic test systems
Published
ISO 15197:2013 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users. These systems are intended for self-measurement by lay persons for management of diabetes mellitus.
ISO 15197:2013 is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems.
WITHDRAWN
ISO 15197:2003
PUBLISHED
ISO 15197:2013
90.92
Standard to be revised
Dec 19, 2024
ABANDON
ISO/NP 15197