測試類別及依據(jù) |
測試項(xiàng)目 |
安規(guī) Safety |
輸入功率Power input |
剩余電壓Voltage limitation |
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防除顫測試 |
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接地阻抗 |
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漏電流測試 Leakage current test |
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耐壓測試 Dielectric voltage withstand |
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外殼機(jī)械強(qiáng)度測試 |
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穩(wěn)定性測試 Stability and transportability |
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溫升測試 Temperature |
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溢流,潑灑,泄漏,清洗,消毒和滅菌 |
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單一故障測試 |
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電源線拉力和扭力測試 Cord anchorages |
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電源護(hù)套彎折測試 Cord bending |
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變壓器過載和短路測試 |
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變壓器倍壓倍頻測試 |
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球壓測試 Ball pressure |
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墜落沖擊測試 Drop impact test |
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模壓測試 Mold stress relief test |
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等 etc. |
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電磁兼容 EMC |
傳導(dǎo)干擾 Conducted Emission |
輻射干擾 Radiated Emission |
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諧波干擾 Harmonic Emission |
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電壓閃爍 Flicker Emmission |
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靜電放電 Electrostatic Discharge (ESD) |
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輻射抗擾度 Radiated Immunity |
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快速脈沖群 Electrical Fast Transients (EFT) |
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工頻磁場 Power Frequency Magnetic Feld (PFMF) |
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電壓跌落和中斷 Voltage Dips and Interruptions |
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浪涌 Surge |
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射頻 RF |
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等 etc. |
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生物相容性 Biocompatibility |
熱源 Pyrogen |
植入 Implantation |
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基因毒性 Genotoxicity |
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系統(tǒng)毒性 Systemic Toxicity |
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血液相容性 Hemolysis |
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皮膚刺激性 Skin Irritation |
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皮內(nèi)刺激性 Intracutaneous Irrtation |
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急性細(xì)胞毒性 Acute Cytotoxicity |
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極大化過敏性 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. |
高溫/低溫 High / Low Temprature |
恒溫恒濕 |
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振動(dòng) Vibration |
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鹽霧 Salt Spray |
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溫度濕度循環(huán) Temprature & Humidity Cycling |
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壽命分析 |
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高加速壽命試驗(yàn) & 高加速應(yīng)力篩選 |
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臭氧老化 Ozone Aging |
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防水防塵 Waterproof and Dustproof |
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震動(dòng) & 溫度 & 濕度 |
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高加速壽命試驗(yàn) HALT / HASS / HASA |
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失效分析與預(yù)防 |
PCB & PCBA 失效分析和評估 |
IC可靠性設(shè)計(jì)分析 |
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無損檢測 |
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涂鍍層 Coating and Palte Analysis |
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材料熱學(xué) Material Thermal |
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材料硬度 Materal Hardness |
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掃描電鏡能譜分析 SEM-EDS |
醫(yī)療器械產(chǎn)品 |
測試標(biāo)準(zhǔn) |
所有的醫(yī)用電氣設(shè)備 All the medical electrical equipment |
IEC/EN 60601-1 2nd Ed, IEC/EN60601-1 3rd Ed |
體外診斷設(shè)備 In vitro diagnostic (IVD) equipment |
IEC/EN61010-1, IEC/EN61010-2-101 |
醫(yī)用電氣系統(tǒng) Medical electrical systems |
IEC/EN 60601-1-1 |
警報(bào)系統(tǒng) alarm systems in medical electrical equipment and medical electrical systems |
IEC/EN 60601-1-8 |
高頻手術(shù)設(shè)備 High frequency surgical equipment |
IEC/EN 60601-2-2 |
神經(jīng)和肌肉刺激器 Neuromuscular Stimulation Device |
IEC/EN 60601-2-10 |
麻醉系統(tǒng) Anaesthetic systems |
IEC/EN 60601-2-13 |
內(nèi)窺鏡 Endoscopic equipment |
IEC/EN 60601-2-18 |
心電圖機(jī) Electrocardiographs |
IEC/EN/UL 60601-1, IEC/EN 60601-2-25, IEC/EN 60601-2-51 |
無創(chuàng)血壓監(jiān)護(hù) Automated non-invasive sphygmomanometers |
IEC/EN 60601-2-30 |
醫(yī)用電熱毯,褥和墊 Blankets, pads and mattresses, intended for heating in medical use |
IEC/EN 60601-2-35 |
診斷超聲設(shè)備 DiagnosticUltrasonic Device |
IEC/EN 60601-1, IEC/EN 60601-2-37 |
治療超聲設(shè)備 Therapeutic Ultrasonic Device |
IEC/EN 60601-1, EN 60601-2-5 |
醫(yī)院電動(dòng)床 Hospital Electric Bed |
IEC/EN 60601-2-38, IEC/EN 60601-2-52 |
流動(dòng)心電圖機(jī) Ambulatory electrocardiographic systems |
IEC/EN 60601-2-47, EC38 |
多功能病人監(jiān)護(hù)儀 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 |
電子血壓計(jì) Sphygmomanometer |
EN1060-1, EN 1060-3, SP10 |
輪椅/電動(dòng)代步車 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 |
殘疾人輔助器具 Technical Aids for Disabled Persons |
BS EN 12182 |
醫(yī)用溫度計(jì) Clinical Termometer |
IEC/EN 12470-3, IEC/EN 12470-5, ASTM E1965, ASTM_F1992 |
霧化器 Nebulizer |
IEC/EN/UL 60601-1, ISO 13544 |
牙科椅 Dentist Chairs |
ISO 6875 |
腦電圖機(jī) Electroencephalograph |
IEC/EN 60601-2-26 |
心電監(jiān)護(hù)設(shè)備 Diagnostic electrocardiographic devices |
EC11, EC13 |
診斷和治療用激光設(shè)備 Diagnostic and therapeutic laser equipment |
IEC/EN 60601-2-22, IEC60825-1 |
電子肌動(dòng)描記器及誘發(fā)反應(yīng) electromyographs and evoked response equipment |
IEC/EN 60601-2-40 |
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