常见问题
血糖仪检测需要多长时间？
通常7-15个工作日。
血糖仪检测费用大概多少？
根据检测项目数量确定。
血糖仪检测报告有什么用途？
可用于质量评估、项目验收，北检研究院检测中心旗下实验室拥有CMA、CNAS、ISO等检验检测资质。
血糖仪试纸条需要单独检测吗？
需要，试纸条作为配套耗材其批间差和稳定性直接影响测量结果，必须纳入整体检测体系。
血糖仪检测方法
- T/ZZB 1217-2019 免调码便携式血糖仪
- JJF 1383-2012 便携式血糖分析仪校准规范
- KS C 1929-3-2017(2022) 유헬스케어 ─ 혈당측정기 ─ 기본 안전 및 성능 확보를 위한 요구사항
- KS C 1929-3(2022 Confirm)(2022) 유헬스케어 ─ 혈당측정기 ─ 기본 안전 및 성능 확보를 위한 요구사항
- T/CHIA 14.6-2018 医疗健康物联网 感知设备通讯数据命名表 第6部分：血糖仪
- CLSI POCT17-Ed1(R2023) Use of Glucose Meters for Critically Ill Patients, 1st Edition, POCT17Ed1E
- ГОСТ Р 57848-2017 Информатизация здоровья. Связь с медицинскими приборами индивидуального контроля состояния здоровья. Часть 10417. Специализация прибора. Глюкометр
- IEEE/ISO 11073-10417-2017 ISO/IEEE Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter
- DIN EN ISO 11073-10417:2018-03 Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter (ISO/IEEE 11073-10417:2017); English version EN ISO 11073-10417:2017
- DIN EN ISO/IEEE 11073-10417:2026-08 Health informatics - Device interoperability - Part 10417: Personal health device communication, device specialization, glucose meter (ISO/IEEE FDIS 11073-10417:2026); English version prEN ISO/IEEE 11073-10417:2026
- IEEE 11073-10417-2009 Health informatics--Personal health device communication Part 10417: Device specialization- Glucose meter
- IEEE 11073-10417-2011 IEEE Health informatics--Personal health device communication Part 10417: Device specialization--Glucose meter
- ISO/IEEE 11073-10425:2024 Health informatics — Device interoperability — Part 10425: Personal health device communication — Device specialization — Continuous Glucose Monitor (CGM)
- T/CASMES 104-2022 酶电极生物传感器血糖检测仪
- DIN EN ISO 11073-10417:2017-08 Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter (ISO/IEEE 11073-10417:2017); English version prEN ISO 11073-10417:2017
- DIN EN ISO 11073-10417:2014-06 Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter (ISO/IEEE 11073-10417:2014); English version EN ISO 11073-10417:2014
- DIN EN ISO 11073-10417:2011-07 Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter (ISO/IEEE 11073-10417:2010); English version EN ISO 11073-10417:2011
- DIN EN ISO 11073-10417:2013-07 Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter (ISO/IEEE FDIS 11073-10417:2013); English version FprEN ISO 11073-10417:2013
- DIN EN ISO 11073-10417:2009-12 Health Informatics - Personal Health Device Communication - Part 10417: Device Specialization - Glucose Meter (ISO/IEEE/FDIS 11073-10417:2009); English version FprEN ISO 11073-10417:2009
总结
血糖仪检测涵盖准确度、重复性、电气安全及电磁兼容等核心参数的验证。北检研究院检测中心旗下实验室拥有CMA、CNAS、ISO等检验检测资质。检测报告可用于产品注册、质量评估及验收，常规交付周期为7-15个工作日。
