Standard No.:	GB/T 19634-2005
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
Issued by:	AQSIQ;SAC
Issued on:	2005-1-24
Implemented on:	2005-5-1
Status:	abolished
Superseded by:	GB/T 19634-2021 In vitro diagnostic test systems—General technical requirements for blood-glucose monitoring systems for self-testing
Superseded on:	2023-5-1
Abolished on:	2023-05-01
Language:	English
File Format:	PDF
Word Count:	4500 words
Price(USD):	120.00
Delivery:	via email in 1~3 business day

本标准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、包装、运输和贮存。本标准适用于体外监测人体毛细血管全血和/或静脉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)。