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測試類別及依據(jù)

測試項目

安規(guī)
Safety

IEC/EN/UL 60601-1
IEC/EN 61010-1
etc.

輸入功率Power input

剩余電壓Voltage limitation

防除顫測試
Defibrillation-proof applied parts

接地阻抗
Earthing and potential equalization

漏電流測試Leakage current test

耐壓測試Dielectric voltage withstand

外殼機械強度測試
Enclosure mechanical strength

穩(wěn)定性測試Stability and transportability

溫升測試Temperature

溢流，潑灑，泄漏，清洗，消毒和滅菌
Overflow, spillage, leakage, cleaning,
sterilization and disinfection

單一故障測試
Abnormal operation and fault conditions

電源線拉力和扭力測試Cord anchorages

電源護(hù)套彎折測試Cord bending

變壓器過載和短路測試
Transformer overload and short-circuit tests

變壓器倍壓倍頻測試
Transformer dielectric voltage withstand

球壓測試Ball pressure

墜落沖擊測試Drop impact test

模壓測試Mold stress relief test

等etc.

電磁兼容
EMC
IEC/EN 61326-2-6,
IEC/EN 61000-3,
IEC/EN 61000-4,
EN 55011,
etc.

傳導(dǎo)干擾Conducted Emission

輻射干擾Radiated Emission

諧波干擾Harmonic Emission

電壓閃爍Flicker Emmission

靜電放電Electrostatic Discharge (ESD)

輻射抗擾度Radiated Immunity

快速脈沖群Electrical Fast Transients (EFT)

工頻磁場Power Frequency Magnetic Feld (PFMF)

電壓跌落和中斷Voltage Dips and Interruptions

浪涌Surge

射頻 RF

等etc.

生物相容性
Biocompatibility
ISO/EN 10993
etc.

熱源　Pyrogen

植入Implantation

基因毒性Genotoxicity

系統(tǒng)毒性Systemic Toxicity

血液相容性Hemolysis

皮膚刺激性Skin Irritation

皮內(nèi)刺激性Intracutaneous Irrtation

急性細(xì)胞毒性Acute Cytotoxicity

極大化過敏性Maximization Sensitization

兔子眼睛刺激性
The Irratation os Rabbit Eyes

可靠性
Reliability
IEC 60068, IEC 60529, IEC 60598,
EIA-364, MIL-STD-202,
ISO 4892, ISO 1431,
ASTM G 154, ASTM G 155, ASTM D4728,
etc.

高溫/低溫High / Low Temprature

恒溫恒濕
Constant Temprature and Humidity

振動Vibration

鹽霧Salt Spray

溫度濕度循環(huán)Temprature & Humidity Cycling

壽命分析

高加速壽命試驗& 高加速應(yīng)力篩選

臭氧老化 Ozone Aging

防水防塵Waterproof and Dustproof

震動&溫度&濕度
Vitration & Temprature & Humidity

高加速壽命試驗 HALT/HASS/HASA

失效分析與預(yù)防
Failure Analysis and Prevention

IPC/ECA-J-STD,
IPC-TM 650-2,
ISO16232-10,
etc.

PCB&PCBA失效分析和評估
PCB & PCBA Analysis and Evaluation

IC可靠性設(shè)計分析
Reliability Design and Analysis of IC

無損檢測
Non-destructive Testing

涂鍍層Coating and Palte Analysis

材料熱學(xué)Material Thermal

材料硬度Materal Hardness

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Diagnostic Ultrasonic 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)院電動床Hospital Electric Bed

IEC/EN 60601-2-38, IEC/EN 60601-2-52

流動心電圖機
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Sphygmomanometer

EN1060-1, EN 1060-3，SP10

輪椅/電動代步車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

電子肌動描記器及誘發(fā)反應(yīng)electromyographs and evoked
response equipment

IEC/EN 60601-2-40