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医疗器械产品测试认证全面解决方案
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测试类别及依据 |
测试项目 |
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安规 Safety etc. |
输入功率Power input |
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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 EMC |
传导干扰 Conducted Emission |
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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 Biocompatibility |
热源 Pyrogen |
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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 Reliability ISO 1431, ASTM G 154, ASTM G 155, ASTM D 4728, etc. |
高温/低温 High / Low Temprature |
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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 |
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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 |
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医疗器械产品 |
测试标准 |
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所有的医用电气设备 All the medical electrical equipment |
IEC/EN 60601-1 2nd Ed, IEC/EN60601-1 3rd Ed |
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体外诊断设备 In vitro diagnostic (IVD) equipment |
IEC/EN61010-1, IEC/EN61010-2-101 |
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医用电气系统 Medical electrical systems |
IEC/EN 60601-1-1 |
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警报系统 alarm systems in medical electrical equipment and medical electrical systems |
IEC/EN 60601-1-8 |
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高频手术设备 High frequency surgical equipment |
IEC/EN 60601-2-2 |
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神经和肌肉刺激器 Neuromuscular Stimulation Device |
IEC/EN 60601-2-10 |
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麻醉系统 Anaesthetic systems |
IEC/EN 60601-2-13 |
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内窥镜 Endoscopic equipment |
IEC/EN 60601-2-18 |
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心电图机 Electrocardiographs |
IEC/EN/UL 60601-1, IEC/EN 60601-2-25, IEC/EN 60601-2-51 |
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无创血压监护 Automated non-invasive sphygmomanometers |
IEC/EN 60601-2-30 |
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医用电热毯，褥和垫 Blankets, pads and mattresses, intended for heating in medical use |
IEC/EN 60601-2-35 |
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诊断超声设备 DiagnosticUltrasonic Device |
IEC/EN 60601-1, IEC/EN 60601-2-37 |
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治疗超声设备 Therapeutic Ultrasonic Device |
IEC/EN 60601-1, EN 60601-2-5 |
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医院电动床 Hospital Electric Bed |
IEC/EN 60601-2-38, IEC/EN 60601-2-52 |
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流动心电图机 Ambulatory electrocardiographic systems |
IEC/EN 60601-2-47, EC38 |
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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 |
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电子血压计 Sphygmomanometer |
EN1060-1, EN 1060-3, SP10 |
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轮椅/电动代步车 Wheelchairs / Electric Scooters |
ISO 7176 Serial, EN 12183, EN 12184, GB 18029 serial |
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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 |
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洗澡椅/便器椅 Shower Chairs / Sanitary Chairs |
BS EN 12182, AS 3973 |
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残疾人辅助器具 Technical Aids for Disabled Persons |
BS EN 12182 |
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医用温度计 Clinical Termometer |
IEC/EN 12470-3, IEC/EN 12470-5, ASTM E1965, ASTM_F1992 |
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雾化器 Nebulizer |
IEC/EN/UL 60601-1, ISO 13544 |
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牙科椅 Dentist Chairs |
ISO 6875 |
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脑电图机 Electroencephalograph |
IEC/EN 60601-2-26 |
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心电监护设备 Diagnostic electrocardiographic devices |
EC11, EC13 |
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诊断和治疗用激光设备 Diagnostic and therapeutic laser equipment |
IEC/EN 60601-2-22, IEC60825-1 |
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电子肌动描记器及诱发反应 electromyographs and evoked response equipment |
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
