Standard No.:	GB/T 19634-2021
English Name:	In vitro diagnostic test systems—General technical requirements for blood-glucose monitoring systems for self-testing
Chinese Name:	体外诊断检验系统 自测用血糖监测系统通用技术条件
Chinese Classification:	C44    Medical laboratory equipment
Professional Classification:	GB    National Standard
Source Content Issued by:	SAMR; SAC
Issued on:	2021-10-11
Implemented on:	2023-5-1
Status:	valid
Superseding:	GB/T 19634-2005 In vitro diagnostic test systems - General technical requirements for blood-glucose monitoring systems for self-testing GB/T 19634-2005/XG1-2006 In vitro diagnostic test systems-General technical requirements for blood-glucose monitoring systems for self-testing, includes Amendment 1
Target Language:	English
File Format:	PDF
Word Count:	7500 words
Translation Price(USD):	225.0
Delivery:	via email in 1~3 business day

本文件规定了自测用血糖监测系统的术语和定义、要求、试验方法、标签和使用说明书、包装、运输和贮存。?
本文件适用于体外监测人体毛细血管全血中葡萄糖浓度的自测用血糖监测系统（通常包括便携式血糖仪、一次性试条和质控物质)。
本文件不适用于：
——以诊断糖尿病为目的的血糖浓度测定；
——具有等级测定值的测定程序（如可视性半定量测定程序)、无创型血糖监测系统、连续血糖监测系统。