深圳容創(chuàng)醫(yī)療
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GB 9706.1-2020/IEC 60601-1: 2012測(cè)試項(xiàng)目信息表
4.11 | Power Input 輸入功率 |
5.7 | Humidity 潮濕預(yù)處理 |
5.9.2 | Accessibie parts可觸及部分 |
7.1.2 | Legibility of markings 標(biāo)記可讀性 |
7.1.3 | Durability of Marking 標(biāo)記耐久性測(cè)試 |
7.2.6 | Voltage mismatch 電壓失配 |
8.4.2 | Working Voltage / Power Measurement 工作電壓/能量測(cè)試 |
8.4.3a | Voltage Limitation 電壓極限 |
8.4.3b | Stored Charge Limitation 儲(chǔ)存能量極限 |
8.4.4 | Residual Voltage or Energy in Capacitors 電容剩余電壓或能量測(cè)試 |
8.5.2.3 | Patient leads and patient cables 患者導(dǎo)聯(lián)和患者電纜 |
8.5.4 | Working Voltage Measurement 工作電壓測(cè)量 |
8.5.5.1 | Defibrillation-proof applied parts – measurement of hazardous electrical energies 防除顫應(yīng)用部分-危害電能的測(cè)量 |
8.5.5.2 | Defibrillation-Proof Applied Parts - Energy reduction 防除顫應(yīng)用部分-能量衰減 |
8.6.4 | Earthing and Potential Equalization 接地和等電位 |
8.7 | Leakage Current 漏電流 |
8.7.3e | Leakage Current 漏電流 |
8.8.3 | Dielectric Strength Test 電介質(zhì)強(qiáng)度測(cè)試 |
8.8.4.1 | Ball pressure test 球壓測(cè)試 |
8.8.4.2 | Resistance to environmental stress--Natural latex rubber 環(huán)境的壓力阻抗-天然橡膠 |
8.9.3.2a | Thermal cycling tests - solid insulation 熱循環(huán)測(cè)試-固體絕緣 |
8.9.3.2b | Humidity preconditioning after the thermal cycling test 熱循環(huán)試驗(yàn)后的潮濕處理 |
8.9.3.2c | Dielectric Strength Test after thermal cycling test 熱循環(huán)試驗(yàn)后的電介質(zhì)強(qiáng)度測(cè)試 |
8.9.3.3a | Thermal cycling tests - solid insulation 熱循環(huán)測(cè)試-固體絕緣 |
8.9.3.3b | Humidity preconditioning after the thermal cycling test 熱循環(huán)試驗(yàn)后的潮濕處理 |
8.9.3.3c | Dielectric Strength Test after thermal cycling test 熱循環(huán)試驗(yàn)后的電介質(zhì)強(qiáng)度測(cè)試 |
8.10.4.1 | Limitation of operating voltages 操作電壓限值 |
8.11.3.5 | Cord anchorages 軟線的固定 |
8.11.3.6 | Cord Bending 軟電線彎曲 |
9.2.2.2 | Measurement of Gaps(Trapping Zones) 縫隙測(cè)試(設(shè)陷區(qū)域) |
9.2.3.2 | Over-travel End Stop 超程限位 |
9.4.2 | Stability 穩(wěn)定性 |
9.4.2.4.2 | Mobile Equipment Force for Propulsion Test 移動(dòng)式設(shè)備的推力測(cè)試 |
9.4.2.4.3 | Castors and wheels – Movement over a threshold 腳輪和輪子-過(guò)門檻 |
9.4.3.1 | Instability from unwanted lateral movement (including sliding) in transport position 運(yùn)輸狀態(tài)中不必要側(cè)向移動(dòng)(包括滑行)的穩(wěn)定性 |
9.4.3.2a | Instability from unwanted lateral movement (including sliding) excluding transport position 運(yùn)輸狀態(tài)外不必要側(cè)向移動(dòng)(包括滑行)的穩(wěn)定性 |
9.4.3 .2b | Lateral force test 側(cè)力測(cè)試 |
9.4.4 | Handle loading test 提手載荷測(cè)試 |
9.6.2.1 | Audible acoustic energy Measurement 可聽(tīng)見(jiàn)的聲能測(cè)試 |
9.6.3 | Hand Transmitted Vibration 傳向手腕的振動(dòng) |
9.7 | Hydrostatic Pressure and Pressure-Relief Device Cycling Test靜態(tài)壓力和壓力釋放裝置循環(huán)測(cè)試 |
9.8.2 | Tensile safety factor 張力安全系數(shù) |
9.8.3.2a | Supporting load for a foot rest 腳架的支撐負(fù)荷 |
9.8.3.2b | Supporting load for area of support/suspension where a patient or operator can sit 支撐/懸掛的患者或操作者能坐區(qū)域的支撐負(fù)荷 |
9.8.3.3 | Supporting load for area where dynamic forces can be exerted on 能施加動(dòng)力的區(qū)域的支撐負(fù)荷 |
9.8.4.3 | MECHANICAL PROTECTIVE DEVICE intended for single activation 一次性機(jī)械防護(hù)裝置 |
11.1 | Excessive temperatures in ME equipment 醫(yī)療電氣設(shè)備的超溫 |
11.6 | Humidity, Harmful Ingress of Liquids, Overflow, Spillage, Leakage, Cleaning, Sterilization, Disinfecting 潮濕,溢流,液體潑灑,泄露,進(jìn)液,清洗,消毒,滅菌 |
11.8 | Interruption of power supply 電源中斷 |
13.1.2 | measurement of power or energy dissipation in parts & components to waive SINGLE FAULT CONDITIONS in 4.7, 8.1 b), 8.7.2, and 13.2.2 relative to emission of flames, molten metal, or ignitable substances |
13.2 | Abnormal Operation and Single Fault Conditions 故障操作和單一故障狀態(tài)測(cè)試 |
15.3.2 | Push tests 按壓測(cè)試 |
15.3.3 | Impact tests 沖擊測(cè)試 |
15.3.4 | Drop tests 跌落測(cè)試 |
15.3.5 | Rough handling tests 粗魯搬運(yùn)測(cè)試 |
15.3.6 | Mold stress relief tests 模壓應(yīng)力消除測(cè)試 |
15.4.3 | Reversed Battery Connection/Overcharging 電池反接/過(guò)充 |
15.4.6a | Actuating parts of controls of ME EQUIPMENT – torque tests扭力測(cè)試 |
15.4.6b | Actuating parts of controls of ME EQUIPMENT – axial pull tests 軸壓測(cè)試 |
15.4.7.1b | Foot Operated Control Devices-Loading 腳踏操作控制裝置-帶載 |
15.5.1.2 | Transformer Short Circuit 變壓器短路 |
15.5.1.3 | Transformer Overload 變壓器過(guò)載 |
15.5.2 | Transformer dielectric strength after humidity preconditioning of 5.7 5.7潮濕預(yù)處理后的變壓器電介質(zhì)強(qiáng)度 |
16.6.1 | leakage currents in me system _ touch current measurements 醫(yī)療電氣系統(tǒng)漏電流_接觸電流測(cè)量 |
Additional or special tests conducted 增加或特定測(cè)試 |
以上是GB 9706.1-2020 安南所有的摸底測(cè)試項(xiàng)目?jī)?nèi)容。