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各种测试类目及法律规定 |
检测该项目 |
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安规 Safety |
键入电功率Power input |
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所剩电压电流Voltage limitation |
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防除颤測試 |
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的接地抗阻 |
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漏电流测试英文 Leakage current test |
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耐压试验自测 Dielectric voltage withstand |
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硬壳机械性程度测评 |
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不稳性检验 Stability and transportability |
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温度软件测试 Temperature |
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进水口 ，泼洒 ，渗漏 ，擦拭 ，紫外线灯消毒和杀菌 |
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单调常见故障自测 |
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外接电源线拉力和推力公测 Cord anchorages |
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电绝缘护套弯曲测验 Cord bending |
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低压变压器超负荷和短路故障测试仪 |
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箱式变压器倍压倍频测量 |
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球压检查 Ball pressure |
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坠机波动测试英文 Drop impact test |
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模压检验 Mold stress relief test |
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等 etc. |
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电磁炉兼容 EMC |
减弱要素 Conducted Emission |
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电磁辐射打扰 Radiated Emission |
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谐波串扰 Harmonic Emission |
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端电压闪亮 Flicker Emmission |
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除静电尖端放电 Electrostatic Discharge (ESD) |
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福射抗扰度 Radiated Immunity |
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飞速脉冲造成的群 Electrical Fast Transients (EFT) |
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工频交变电场 Power Frequency Magnetic Feld (PFMF) |
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电流电压跌入和经常中断 Voltage Dips and Interruptions |
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浪涌 Surge |
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微波射频 RF |
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等 etc. |
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微生物混溶性 Biocompatibility |
热力 Pyrogen |
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值入 Implantation |
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染色体致毒 Genotoxicity |
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系统致癌性 Systemic Toxicity |
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鲜血混溶性 Hemolysis |
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白色皮肤刺激作用性 Skin Irritation |
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皮内激励性 Intracutaneous Irrtation |
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亚急性細胞渗透性 Acute Cytotoxicity |
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极大值化过敏症状性 Maximization Sensitization |
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小兔子眼部刺击性 |
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牢靠性 Reliability ISO 1431, ASTM G 154, ASTM G 155, ASTM D 4728, etc. |
低温/超高温 High / Low Temprature |
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恒湿恒湿 |
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激振 Vibration |
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盐雾 Salt Spray |
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体温湿球温度循坏 Temprature & Humidity Cycling |
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耐用度浅析 |
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高t加速使用时间实验室检测 & 高变快地应力需求 |
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老化试验老化试验 Ozone Aging |
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耐磨防尘耐磨防尘 Waterproof and Dustproof |
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颤动 & 温度表 & 室内湿度 |
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高减速生命检验 HALT / HASS / HASA |
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无效概述与防冶 |
PCB & PCBA 报废概述和评估方法 |
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IC可信性设计的概念研究分析 |
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高质量检测工具 |
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涂涂层 Coating and Palte Analysis |
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装修材料热学 Material Thermal |
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的原材料光洁度 Materal Hardness |
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扫锚电镜能谱具体分析 SEM-EDS |
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医治器戒食品 |
试验标准规定 |
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所以的医疗电气机械机械 ;All the medical electrical equipment |
IEC/EN 60601-1 2nd Ed, IEC/EN60601-1 3rd Ed |
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休外评估机 ;In vitro diagnostic (IVD) equipment |
IEC/EN61010-1, IEC/EN61010-2-101 |
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医用品电力电气软件 Medical electrical systems |
IEC/EN 60601-1-1 |
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警笛系统的 alarm systems in medical electrical equipment and medical electrical systems |
IEC/EN 60601-1-8 |
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中频术产品 High frequency surgical equipment |
IEC/EN 60601-2-2 |
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神经末梢和腿部肌肉敏感器 Neuromuscular Stimulation Device |
IEC/EN 60601-2-10 |
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麻醉师系统软件 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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窦性心律机 Electrocardiographs |
IEC/EN/UL 60601-1, IEC/EN 60601-2-25, IEC/EN 60601-2-51 |
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微创血脂监护人 Automated non-invasive sphygmomanometers |
IEC/EN 60601-2-30 |
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医疗器具电加热毯 ，褥和垫 Blankets, pads and mattresses, intended for heating in medical use |
IEC/EN 60601-2-35 |
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判断多普勒彩超机械设备 DiagnosticUltrasonic Device |
IEC/EN 60601-1, IEC/EN 60601-2-37 |
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进行治疗超声心动图机械设备 Therapeutic Ultrasonic Device |
IEC/EN 60601-1, EN 60601-2-5 |
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卫生院电动三轮床 Hospital Electric Bed |
IEC/EN 60601-2-38, IEC/EN 60601-2-52 |
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还是流动性脑电图机 Ambulatory electrocardiographic systems |
IEC/EN 60601-2-47, EC38 |
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多实用功能缺乏监护人仪 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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网络血压偏高计 Sphygmomanometer |
EN1060-1, EN 1060-3, SP10 |
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残疾轮椅/电动式代步车 Wheelchairs / Electric Scooters |
ISO 7176 Serial, EN 12183, EN 12184, GB 18029 serial |
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拐棍/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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洗个澡椅/便器椅 Shower Chairs / Sanitary Chairs |
BS EN 12182, AS 3973 |
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残障人助手用具 Technical Aids for Disabled Persons |
BS EN 12182 |
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医用品的体温计 Clinical Termometer |
IEC/EN 12470-3, IEC/EN 12470-5, ASTM E1965, ASTM_F1992 |
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做雾化器 Nebulizer |
IEC/EN/UL 60601-1, ISO 13544 |
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牙医门诊椅 Dentist Chairs |
ISO 6875 |
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脑电图机 Electroencephalograph |
IEC/EN 60601-2-26 |
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心电看护机械设备 Diagnostic electrocardiographic devices |
EC11, EC13 |
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的诊断和控制用脉冲光系统 Diagnostic and therapeutic laser equipment |
IEC/EN 60601-2-22, IEC60825-1 |
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电子为了满足电子时代发展的需求 ，肌动描记器及引起体现 electromyographs and evoked response equipment |
IEC/EN 60601-2-40 |
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