[National standard of blood glucose analyzers and common problems found during registration tests].
This article elucidates the understanding of National Standard GB/T19634-2005 "In Vitro Diagnostic Test Systems-General Technical Requirements for Blood-Glucose Monitoring Systems for Self-Testing" from the perspective of registration tests of blood glucose analyzers, and summarizes some of the common problems existing in sending the blood glucose analyzers for inspection in registration tests according to the relevant regulations.
Fang
Qing
Q
Shanghai Testing & Inspection Institute for Medical Devices.
D001786:Blood Glucose / Q000032:analysis; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000592:standards*; D006282:Health Personnel
D001786:Blood Glucose