60.60 Standard published Jun 10, 2015
CEN
CEN/TC 140 In vitro diagnostic medical devices
European Norm
11.100.10 In vitro diagnostic test systems
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.
Legislation related to this standard
WITHDRAWN
EN ISO 15197:2013
PUBLISHED
EN ISO 15197:2015
60.60
Standard published
Jun 10, 2015
IN_DEVELOPMENT
EN ISO 15197:2015/prA11