National standard of blood glucose analyzers and common problems found during registration tests.
- Author:
Qing FANG
1
Author Information
1. Shanghai Testing & Inspection Institute for Medical Devices.
- Publication Type:Journal Article
- MeSH:
Blood Glucose;
analysis;
Blood Glucose Self-Monitoring;
instrumentation;
standards;
Health Personnel
- From:
Chinese Journal of Medical Instrumentation
2008;32(5):377-379
- CountryChina
- Language:Chinese
-
Abstract:
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.
