This International Standard specifies requirements for in vitro glucose monitoring systems that measure
glucose concentrations in capillary blood samples and procedures for the verification and the validation of
performance by the intended users. These systems are intended for self-testing by laypersons 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, or
apply to measurement procedures with results on an ordinal scale (e.g. visual, semiquantitative test
methods).
Diese ÖNORM beschreibt Leistungsanforderungen für Systeme zur quantitativen Blutzuckerbestimmung in der laufenden Kontrolle durch den Patienten selbst. Systeme zur Diagnose einer Zuckerkrankheit oder zur Anwendung durch den Arzt sind nicht behandelt. Damit mit Systemen gemäß dieser Norm annehmbarere Ergebnisse erhalten werden, ist es notwendig, dass der Anwender sorgfälitg geschult wird und dass die Anleitungen des Herstellers exakt eingehalten werden.