测试类别及依据

测试项目

安规
Safety

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

输入功率Power input

剩余电压Voltage limitation

防除颤测试
Defibrillation-proof applied parts

接地阻抗
Earthing and potential equalization

漏电流测试Leakage current test

耐压测试Dielectric voltage withstand

外壳机械强度测试
Enclosure mechanical strength

稳定性测试Stability and transportability

温升测试Temperature

溢流，泼洒，泄漏，清洗，消毒和灭菌
Overflow, spillage, leakage, cleaning,
sterilization and disinfection

单一故障测试
Abnormal operation and fault conditions

电源线拉力和扭力测试Cord anchorages

电源护套弯折测试Cord bending

变压器过载和短路测试
Transformer overload and short-circuit tests

变压器倍压倍频测试
Transformer dielectric voltage withstand

球压测试Ball pressure

坠落冲击测试Drop impact test

模压测试Mold stress relief test

等etc.

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

传导干扰Conducted Emission

辐射干扰Radiated Emission

谐波干扰Harmonic Emission

电压闪烁Flicker Emmission

静电放电Electrostatic Discharge (ESD)

辐射抗扰度Radiated Immunity

快速脉冲群Electrical Fast Transients (EFT)

工频磁场Power Frequency Magnetic Feld (PFMF)

电压跌落和中断Voltage Dips and Interruptions

浪涌Surge

射频 RF

等etc.

生物相容性
Biocompatibility
ISO/EN 10993
etc.

热源　Pyrogen

植入Implantation

基因毒性Genotoxicity

系统毒性Systemic Toxicity

血液相容性Hemolysis

皮肤刺激性Skin Irritation

皮内刺激性Intracutaneous Irrtation

急性细胞毒性Acute Cytotoxicity

极大化过敏性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.

高温/低温High / Low Temprature

恒温恒湿
Constant Temprature and Humidity

振动Vibration

盐雾Salt Spray

温度湿度循环Temprature & Humidity Cycling

寿命分析

高加速寿命试验& 高加速应力筛选

臭氧老化 Ozone Aging

防水防尘Waterproof and Dustproof

震动&温度&湿度
Vitration & Temprature & Humidity

高加速寿命试验 HALT/HASS/HASA

失效分析与预防
Failure Analysis and Prevention

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

PCB&PCBA失效分析和评估
PCB & PCBA Analysis and Evaluation

IC可靠性设计分析
Reliability Design and Analysis of IC

无损检测
Non-destructive Testing

涂镀层Coating and Palte Analysis

材料热学Material Thermal

材料硬度Materal Hardness

扫描电镜能谱分析SEM-EDS

医疗器械产品

测试标准

所有的医用电气设备
All the medical electrical equipment

IEC/EN 60601-1 2nd Ed & IEC/EN60601-1 3rd Ed

体外诊断设备In vitro diagnostic
(IVD) equipment

IEC/EN61010-1，IEC/EN61010-2-101

医用电气系统Medical electrical systems

IEC/EN 60601-1-1

警报系统alarm systems in medical electrical
equipment and medical electrical systems

IEC/EN 60601-1-8

高频手术设备High frequency surgical
equipment

IEC/EN 60601-2-2

神经和肌肉刺激器
Neuromuscular Stimulation Device

IEC/EN 60601-2-10

麻醉系统Anaesthetic systems

IEC/EN 60601-2-13

内窥镜Endoscopic equipment

IEC/EN 60601-2-18

心电图机Electrocardiographs

IEC/EN/UL  60601-1, IEC/EN 60601-2-25, IEC/EN 60601-2-51

无创血压监护Automated non-invasive sphygmomanometers

IEC/EN 60601-2-30

医用电热毯，褥和垫
Blankets, pads and mattresses, intended for heating in medical use

IEC/EN 60601-2-35

诊断超声设备Diagnostic Ultrasonic Device

IEC/EN  60601-1, IEC/EN 60601-2-37

治疗超声设备Therapeutic Ultrasonic Device

IEC/EN  60601-1, EN 60601-2-5

医院电动床Hospital Electric Bed

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

流动心电图机
Ambulatory electrocardiographic systems

IEC/EN 60601-2-47，EC38

多功能病人监护仪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

电子血压计Sphygmomanometer

EN1060-1, EN 1060-3，SP10

轮椅/电动代步车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

残疾人辅助器具
Technical Aids for Disabled Persons

BS EN 12182

医用温度计Clinical Termometer

IEC/EN 12470-3，IEC/EN 12470-5,ASTM E1965, ASTM_F1992

雾化器Nebulizer

IEC/EN/UL 60601-1, ISO 13544

牙科椅Dentist Chairs

ISO 6875

脑电图机Electroencephalograph

IEC/EN 60601-2-26

心电监护设备Diagnostic
electrocardiographic devices

EC11，EC13

诊断和治疗用激光设备Diagnostic and therapeutic laser equipment

IEC/EN 60601-2-22，IEC60825-1

电子肌动描记器及诱发反应electromyographs and evoked
response equipment

IEC/EN 60601-2-40