测试类别及依据 | 测试项目 |
安规 Safety | 输入功率Power input |
剩余电压Voltage limitation | |
防除颤测试 | |
接地阻抗 | |
漏电流测试 Leakage current test | |
耐压测试 Dielectric voltage withstand | |
外壳机械强度测试 | |
稳定性测试 Stability and transportability | |
温升测试 Temperature | |
溢流,泼洒,泄漏,清洗,消毒和灭菌 | |
单一故障测试 | |
电源线拉力和扭力测试 Cord anchorages | |
电源护套弯折测试 Cord bending | |
变压器过载和短路测试 | |
变压器倍压倍频测试 | |
球压测试 Ball pressure | |
坠落冲击测试 Drop impact test | |
模压测试 Mold stress relief test | |
等 etc. | |
电磁兼容 EMC | 传导干扰 Conducted Emission |
辐射干扰 Radiated Emission | |
谐波干扰 Harmonic Emission | |
电压闪烁 Flicker Emmission | |
静电放电 Electrostatic Discharge (ESD) | |
辐射抗扰度 Radiated Immunity | |
快速脉冲群 Electrical Fast Transients (EFT) | |
工频磁场 Power Frequency Magnetic Feld (PFMF) | |
电压跌落和中断 Voltage Dips and Interruptions | |
浪涌 Surge | |
射频 RF | |
等 etc. | |
生物相容性 Biocompatibility | 热源 Pyrogen |
植入 Implantation | |
基因毒性 Genotoxicity | |
系统毒性 Systemic Toxicity | |
血液相容性 Hemolysis | |
皮肤刺激性 Skin Irritation | |
皮内刺激性 Intracutaneous Irrtation | |
急性细胞毒性 Acute Cytotoxicity | |
极大化过敏性 Maximization Sensitization | |
兔子眼睛刺激性 | |
可靠性 Reliability ISO 1431, ASTM G 154, ASTM G 155, ASTM D 4728, etc. | 高温/低温 High / Low Temprature |
恒温恒湿 | |
振动 Vibration | |
盐雾 Salt Spray | |
温度湿度循环 Temprature & Humidity Cycling | |
寿命分析 | |
高加速寿命试验 & 高加速应力筛选 | |
臭氧老化 Ozone Aging | |
防水防尘 Waterproof and Dustproof | |
震动 & 温度 & 湿度 | |
高加速寿命试验 HALT / HASS / HASA | |
失效分析与预防 | PCB & PCBA 失效分析和评估 |
IC可靠性设计分析 | |
无损检测 | |
涂镀层 Coating and Palte Analysis | |
材料热学 Material Thermal | |
材料硬度 Materal Hardness | |
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 All the medical electrical equipment | IEC/EN 60601-1 2nd Ed, IEC/EN60601-1 3rd Ed |
体外诊断设备 In vitro diagnostic (IVD) equipment | 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 equipment and medical electrical systems | IEC/EN 60601-1-8 |
高频手术设备 High frequency surgical equipment | IEC/EN 60601-2-2 |
神经和肌肉刺激器 Neuromuscular Stimulation Device | 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 Blankets, pads and mattresses, intended for heating in medical use | IEC/EN 60601-2-35 |
诊断超声设备 DiagnosticUltrasonic 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 Ambulatory electrocardiographic systems | 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 Technical Aids for Disabled Persons | 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 electrocardiographic devices | 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 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
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