Sistemi ispitivanja za dijagnostiku in vitro – Zahtevi za sisteme praćenja glukoze u krvi za samotestiranje u kontrolisanju dijabetes melitusa

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)

Ovaj međunarodni standard utvrđuje zahteve za in vitro sisteme praćenja glukoze u krvi koji mere koncentraciju glukoze u uzorcima iz krvnih kapilara za specifičnu verifikaciju projekta procedura i za validaciju performansi koju vrši predviđeni korisnik. Ovi sistemi su predviđeni za samomerenje koje izvode laici da bi upravljali dijabetes mellitusom.

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.

SRPS EN ISO 15197:2017 zamenjuje SRPS EN ISO 15197:2014 - 31.01.2017

instrumenti za klinička ispitivanja, glukoza, krv, merenja