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GB 9706.1-2020 安規(guī)摸底測(cè)試項(xiàng)目?jī)?nèi)容

YY9706.1-2020 安規(guī)測(cè)試項(xiàng)目?jī)?nèi)容
深圳市容創(chuàng)醫(yī)療技術(shù)有限公司

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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
元件功率或能量損耗除4.7, 8.1 b), 8.7.2, 和13.2.2中相關(guān)的火焰的噴射,可融金屬或者易燃物質(zhì)外的單一故障狀態(tài)的測(cè)量

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。


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