CAN/CSA-ISO 15197:15 (ISO 15197:2013, IDT)
1 Scope
This International Standard 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.
This International Standard 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.
This International Standard does not:
— provide a comprehensive evaluation of all possible factors that could affect the performance of
these systems,
— pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus,
— address the medical aspects of diabetes mellitus management,
— apply to measurement procedures with measured values on an ordinal scale (e.g. visual,
semiquantitative measurement procedures), or to continuous glucose monitoring systems,
— apply to glucose meters intended for use in medical applications other than self-testing for the
management of diabetes mellitus
OEN:
CSA
Langue:
English
Code(s) de l'ICS:
11.100.10
Statut:
Norme
Date de Publication:
2015-07-31
Numéro Standard:
CAN/CSA-ISO 15197:15 (ISO 15197:2013, IDT)