GB/T 19634-2005体外诊断检验系统自测用血糖监测系统通用技术条件.pdf

ICS 11.100 C 44 召昌 中 华 人 民 共 和 国 国 家 标 准 GB/T 19634-2005 体外诊断检验系统 自测用血糖监测系统通用技术条件 Invitrodiagnostictestsystems- Generaltechnicalrequirementsforblood-glucosemonitoring systemsforself-testing (ISO 15197:2003，NEQ) 2005-01-24发布 2005-05-01实施 中华人民共和国国家质量监督检验检疫总局 发 布 中 国 国家 标 准 化 管 理 委 员会 GB/T19634-2005 目 次 前言 一 弓I言 一 . 1 范围 ， J 规范性引用文件 .·1 术语和定义 ·········，······················‘··························································。··········…… 1 要求 ········，············‘·········· ·········，，·4··‘···， ········甲，，···‘···，·····‘······，···…… 3 亡 J 试验方法 ········································································································…… 4 内 卜 U 标签和使用说明 参考文献 ···························，···········，·································································…… 10 表1血糖仪和血搪试条测量重复性 ··‘···。······“·····，，························…·…，，.，.……。.… 。.…3 表2 准确度要求 ······························，······················，·············································…… 4 表3 重复性试验用血糖浓度范围 ········。···················································…·…，..…·… ..‘…5 表4 系统准确度试验用血糖样品要求 5 GB/T19634-2005 .JJ 山 口 日 ‘种 月四 吕 GB/T19634体《外诊断检验系统 自测用血糖监测系统通用技术条件》与ISO 15197的一致性程 度为非等效。 本标准由国家食品药品监督管理局提出。 本标准由全国医用临床检验实验室和体外诊断系统标准化技术委员会归口。 本标准起草单位:北京市医疗器械检验所、美国强生公司。 本标准主要起草人:胡冬梅、续勇、JohnMahoney. GB/T19634-2005 引