GB/T 19634-2021
ActiveIn vitro diagnostic test systems—General technical requirements for blood-glucose monitoring systems for self-testing
体外诊断检验系统 自测用血糖监测系统通用技术条件
Application Summary AI generated
This standard specifies the general technical requirements for blood-glucose monitoring systems intended for self-testing by laypersons outside of clinical settings. It covers aspects such as system accuracy, precision, interference resistance, and user interface design to ensure reliable and safe home management of diabetes. The standard applies to manufacturers and regulatory bodies evaluating handheld glucose meters and test strips for personal use.
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Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.