检测信息
无创血压测量系统是一种通过袖带充放气或脉搏波传感等非侵入方式获取人体动脉血压数值的医疗设备，主要应用于监护、家庭健康监测、运动医学评估及急救转运等场景。
检测目的在于验证设备测量准确性、电气安全性和电磁兼容性，涉及示波法波形分析、压力传感器校准、气路密封性测试及漏电流测量等技术手段。
检测流程涵盖外观与结构检查、血压模拟器对比测量、重复性误差分析、过压保护触发验证及环境适应性试验等核心环节，关键参数包括收缩压/舒张压测量误差、脉率偏差及泄气速率。
常见问题
无创血压测量系统检测需要多长时间？
通常7-15个工作日，具体周期视检测项目数量及样品数量而定，涉及电磁兼容全项测试时可能需要适当延长。
无创血压测量系统检测费用大概多少？
根据检测项目数量确定，基础性能测试费用相对较低，涉及电气安全和电磁兼容全项检测费用较高，可依据实际需求提供具体报价单。
无创血压测量系统检测报告有什么用途？
可用于质量评估、项目验收、医疗器械注册申报及采购准入，北检(北京)检测技术研究院检测中心旗下实验室拥有CMA、CNAS、ISO等检验检测资质，报告具备法定效力。
无创血压测量系统检测需要提供什么样品？
需提供完整成品设备及配套袖带、电源适配器等附件，样品数量通常为2-3台，并附带产品技术说明书及电气原理图等技术资料。
无创血压测量系统检测项目
- JJG 692-2010 无创自动测量血压计
- DIN EN 1060-3:2006-11 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
- DIN EN 1060-3:1997-09 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
- BS EN 1060-3:1997 Non-invasive sphygmomanometers. Supplementary requirements for electro-mechanical blood pressure measuring systems
- AS EN 1060.3-2004 Non-invasive sphygmomanometers, Part 3: Supplementary requirements for electromechanical blood pressure measuring systems
- UNE-EN 1060-3:1997 NON-INVASIVE SPHYGMOMANOMETERS. PART 3: SUPPLEMENTARY REQUIREMENTS FOR ELECTRO-MECHANICAL BLOOD PRESSURE MEASURING SYSTEMS.
- YY 0670-2008 无创自动测量血压计
- DIN EN ISO 81060-3:2023-06 Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type (ISO 81060-3:2022)
- ISO 81060-3:2022 Non-invasive sphygmomanometers — Part 3: Clinical investigation of continuous automated measurement type
- ISO 81060-2:2018 Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type
- ISO 81060-2:2018/Amd 2:2024 Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type — Amendment 2
- ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type — Amendment 1
- ISO 81060-3:2022 Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous non-invasive automated measurement type
- JJG(皖) 67-2019 脉搏波法无创电子自动血压计检定规程
- ISO 81060-1:2007 Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type
- UNE-EN 1060-4:2005 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall accuracy of automated non-invasive sphygmomanometers
- EN ISO 81060-3:2023 Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type (ISO 81060-3:2022)
- AAMI/ISO 81060-2:2019 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
- BS ISO 81060-1:2007 Non-invasive sphygmomanometers. Requirements and test methods for non-automated measurement type
总结
无创血压测量系统检测涵盖测量误差、电气安全、电磁兼容及环境适应性等核心技术指标评估。北检(北京)检测技术研究院检测中心旗下实验室拥有CMA、CNAS、ISO等检验检测资质。检测周期一般为7-15个工作日，报告可用于医疗器械注册及质量验收。
