测试类别及依据 |
测试项目 |
安规 |
输入功率Power input |
剩余电压Voltage limitation |
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防除颤测试 |
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接地阻抗 |
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漏电流测试Leakage current test |
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耐压测试Dielectric voltage withstand |
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外壳机械强度测试 |
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稳定性测试Stability and transportability |
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温升测试Temperature |
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溢流,泼洒,泄漏,清洗,消毒和灭菌 |
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单一故障测试 |
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电源线拉力和扭力测试Cord anchorages |
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电源护套弯折测试Cord bending |
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变压器过载和短路测试 |
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变压器倍压倍频测试 |
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球压测试Ball pressure |
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坠落冲击测试Drop impact test |
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模压测试Mold stress relief test |
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等etc. |
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电磁兼容 |
传导干扰Conducted Emission |
辐射干扰Radiated Emission |
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谐波干扰Harmonic Emission |
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电压闪烁Flicker Emmission |
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静电放电Electrostatic Discharge (ESD) |
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辐射抗扰度Radiated Immunity |
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快速脉冲群Electrical Fast Transients (EFT) |
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工频磁场Power Frequency Magnetic Feld (PFMF) |
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电压跌落和中断Voltage Dips and Interruptions |
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浪涌Surge |
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射频 RF |
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等etc. |
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生物相容性 |
热源 Pyrogen |
植入Implantation |
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基因毒性Genotoxicity |
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系统毒性Systemic Toxicity |
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血液相容性Hemolysis |
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皮肤刺激性Skin Irritation |
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皮内刺激性Intracutaneous Irrtation |
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急性细胞毒性Acute Cytotoxicity |
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极大化过敏性Maximization Sensitization |
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兔子眼睛刺激性 |
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可靠性 |
高温/低温High / Low Temprature |
恒温恒湿 |
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振动Vibration |
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盐雾Salt Spray |
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温度湿度循环Temprature & Humidity Cycling |
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寿命分析 |
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高加速寿命试验& 高加速应力筛选 |
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臭氧老化 Ozone Aging |
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防水防尘Waterproof and Dustproof |
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震动&温度&湿度 |
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高加速寿命试验 HALT/HASS/HASA |
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失效分析与预防 |
PCB&PCBA失效分析和评估 |
IC可靠性设计分析 |
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无损检测 |
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涂镀层Coating and Palte Analysis |
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材料热学Material Thermal |
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材料硬度Materal Hardness |
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扫描电镜能谱分析SEM-EDS |
医疗器械产品 |
测试标准 |
所有的医用电气设备 |
IEC/EN 60601-1 2nd Ed & IEC/EN60601-1 3rd Ed |
体外诊断设备In vitro diagnostic |
IEC/EN61010-1,IEC/EN61010-2-101 |
医用电气系统Medical electrical systems |
IEC/EN 60601-1-1 |
警报系统alarm systems in medical electrical |
IEC/EN 60601-1-8 |
高频手术设备High frequency surgical |
IEC/EN 60601-2-2 |
神经和肌肉刺激器 |
IEC/EN 60601-2-10 |
麻醉系统Anaesthetic systems |
IEC/EN 60601-2-13 |
内窥镜Endoscopic equipment |
IEC/EN 60601-2-18 |
心电图机Electrocardiographs |
IEC/EN/UL 60601-1, IEC/EN 60601-2-25, IEC/EN 60601-2-51 |
无创血压监护Automated non-invasive sphygmomanometers |
IEC/EN 60601-2-30 |
医用电热毯,褥和垫 |
IEC/EN 60601-2-35 |
诊断超声设备Diagnostic Ultrasonic Device |
IEC/EN 60601-1, IEC/EN 60601-2-37 |
治疗超声设备Therapeutic Ultrasonic Device |
IEC/EN 60601-1, EN 60601-2-5 |
医院电动床Hospital Electric Bed |
IEC/EN 60601-2-38, IEC/EN 60601-2-52 |
流动心电图机 |
IEC/EN 60601-2-47,EC38 |
多功能病人监护仪Multifunction Patient Monitor |
IEC/EN/UL 60601-1, IEC/EN 60601-2-27, IEC/EN 60601-2-30, IEC/EN 60601-2-34, IEC/EN 60601-2-49, ISO 9919, EN 12470-4 |
电子血压计Sphygmomanometer |
EN1060-1, EN 1060-3,SP10 |
轮椅/电动代步车Wheelchairs / Electric Scooters |
ISO 7176 Serial,EN 12183, EN 12184, GB 18029 serial |
拐杖/ 助行器Walking Sticks / Walking Aids |
ISO 11199 serial, ISO 11334 serial, EN 1985, BS 5205, BS 497, BS 5181, JIS T 9204 |
洗澡椅/ 便器椅Shower Chairs Sanitary Chairs |
BS EN 12182, AS 3973 |
残疾人辅助器具 |
BS EN 12182 |
医用温度计Clinical Termometer |
IEC/EN 12470-3,IEC/EN 12470-5,ASTM E1965, ASTM_F1992 |
雾化器Nebulizer |
IEC/EN/UL 60601-1, ISO 13544 |
牙科椅Dentist Chairs |
ISO 6875 |
脑电图机Electroencephalograph |
IEC/EN 60601-2-26 |
心电监护设备Diagnostic |
EC11,EC13 |
诊断和治疗用激光设备Diagnostic and therapeutic laser equipment |
IEC/EN 60601-2-22,IEC60825-1 |
电子肌动描记器及诱发反应electromyographs and evoked |
IEC/EN 60601-2-40 |
研讨会& 培训
医疗器械产品美国FDA最新要求及应对措施
医疗器械产品欧盟CE标识最新要求及应对措施
医疗器械指令93/42/EEC解读
IEC/EN 60601最新要求及应对措施
ISO 13485最新要求及应对措施
ISO 14971最新要求及应对措施
其它