Active medical devices Testing Items

Publish time 2025-07-14 18:28

active medical device testing capabilities include, but are not limited to the Active devices such as following：

Multi-parameter monitors, cardiac pacemaker, cardiac defibrillator, ultrasonic diagnostic equipment, infusion pumps and infusion controllers, clinical thermometers, sphygmomanometer, non-invasive blood pressure monitoring equipment, pulse photo oximeter equipment, anesthesia respirator, high frequency electrosurgery equipment, nerve and muscle stimulators, endoscopes, ECG electrodes, surgery, cosmetics, diagnosis and treatment laser equipment, electrocardiograph, electrocardiographic monitoring equipment, infant incubator, infant radiant warmer, infant phototherapy equipment, operating shadowless lamp, operating table, medical bed, dental equipment, etc.

Product information

Our active medical device testing capabilities include, but are not limited to the Active devices such as following：

Multi-parameter monitors, cardiac pacemaker, cardiac defibrillator, ultrasonic diagnostic equipment, infusion pumps and infusion controllers, clinical thermometers, sphygmomanometer, non-invasive blood pressure monitoring equipment, pulse photo oximeter equipment, anesthesia respirator, high frequency electrosurgery equipment, nerve and muscle stimulators, endoscopes, ECG electrodes, surgery, cosmetics, diagnosis and treatment laser equipment, electrocardiograph, electrocardiographic monitoring equipment, infant incubator, infant radiant warmer, infant phototherapy equipment, operating shadowless lamp, operating table, medical bed, dental equipment, etc.

Standards

1. Safety, performance test standard:

NO.	Product/Product Category	Test standard and number
NO.	Product/Product Category	GB/YY	EN	IEC/ISO	ANSI/AAMI
1	Safety requirements for medical electrical equipment	GB 9706.1	EN 60601-1	IEC 60601-1	ANSI/AAMI ES 60601-1
2	Radiation protection in diagnostic X-ray equipment	GB 9706.12	EN 60601-1-3	IEC 60601-1-3
3	Usability	YY/T 9706.106	EN 60601-1-6	IEC 60601-1-6
4	Alarm systems in medical electrical equipment and medical electrical systems	YY 0709 YY 9706.108	EN 60601-1-8	IEC 60601-1-8
5	Medical electrical equipment or systems used in home healthcare environments	YY 9706.111	EN 60601-1-11	IEC 60601-1-11	ANSI/AAMI HA60601-1-11
6	High frequency electrosurgical equipment and its accessories	GB 9706.4	EN IEC 60601-2-2	IEC 60601-2-2	AAMI 60601-2-2
7	Short-wave therapy equipment	GB 9706.203	EN 60601-2-3	IEC 60601-2-3
8	Nerve and muscle stimulators	YY 0607; YY 9706.210	EN 60601-2-10	IEC 60601-2-10
9	Haemodialysis, haemodiafiltration and haemodiafiltration equipment	GB 9706.2	EN 60601-2-16	IEC 60601-2-16
10	Endoscopic equipment	GB 9706.19	EN 60601-2-18	IEC 60601-2-18
11	Infant incubators	GB 11243	EN 60601-2-19	IEC 60601-2-19
12	Infant transport incubators	YY 0827	EN 60601-2-20	IEC 60601-2-20
13	Infant radiant warmers	YY 0455	EN 60601-2-21	IEC 60601-2-21
14	Medical laser equipment	GB 9706.20	EN IEC 60601-2-22	IEC 60601-2-22
15	Injection pump and controller	GB 9706.27	EN 60601-2-24	IEC 60601-2-24
16	Electrocardiograph	GB 10793	EN 60601-2-25	IEC 60601-2-25	ANSI/AAMI/IEC 60601-2-25
17	Cardiac defibrillators	GB 9706.8	EN 60601-2-4	IEC 60601-2-4
18	Electrocardiographic monitoring equipment	GB 9706.25; YY 1079	EN 60601-2-27	IEC 60601-2-27	ANSI/AAMI/IEC 60601-2-27
19	Electroencephalographs	GB 9706.26	EN 60601-2-26	IEC 60601-2-26
20	Respiratory therapy equipment-Nebulizing systems and their components		EN ISO 27427:2019	ISO 27427:2013
21	Electrically powered wheelchairs, scooters and their chargers	GB/T 12996; GB/T 18029	EN 12184	ISO 7176
22	Ultrasound medical diagnosis and monitoring equipment	GB 9706.9	EN 60601-2-37	IEC 60601-2-37
23	Surgical luminaires and luminaires for diagnosis	YY 9706.241	EN 60601-2-41	IEC 60601-2-41
24	Operating table	YY 0570	EN IEC 60601-2-46	IEC 60601-2-46
25	Infant phototherapy equipment	YY 9706.250	EN 60601-2-50	IEC 60601-2-50
26	Medical bed	YY 0571	EN 60601-2-52	IEC 60601-2-52
27	Non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use	YY 9706.257	EN 60601-2-57	IEC 60601-2-57
28	Automated non-invasive sphygmomanometers	YY 0670	EN IEC 80601-2-30	IEC 80601-2-30
29	Dental equipment	GB 9706.260	EN IEC 80601-2-60	IEC 80601-2-60
30	Pulse oximeter equipment	YY 0784	EN ISO 80601-2-61	ISO 80601-2-61
31	Hearing aids and hearing systems		EN IEC 60601-2-66	IEC 60601-2-66
32	Safety of laser products	GB 7247	EN 60825-1	IEC 60825-1
33	X-ray equipment for interventional procedures	GB 9706.243	EN 60601-2-43	IEC 60601-2-43
34	X-ray equipment for computed tomography	GB 9706.244	EN 60601-2-44	IEC 60601-2-44
35	X-ray equipment for radiography and radioscopy	GB 9706.254	EN 60601-2-54	IEC 60601-2-54
36	Mammographie X-ray equipment and mammographie stereotactic devices	GB 9706.245	EN 60601-2-45	IEC 60601-2-45
37	X-ray tube assemblies for medical diagnosis	GB 9706.228	EN 60601-2-28	IEC 60601-2-28
38	Dental extra-oral X-ray equipment	GB 9706.263	EN 60601-2-63	IEC 60601-2-63
39	Dental intra-oral X-ray equipment	GB 9706.265; YY/T 0010	EN 60601-2-65	IEC 60601-2-65
40	Disposable ECG electrodes	YY/T 0196			ANSI/AAMI EC12
41	Medical foot switch	YY 1057
	…	…	…	…	…

2. Testing instruments：

AC source, Oscilloscope, multimeter, clamp meter, isolated transformers, electric energy meters, digital power meter, leakage tester, grounding tester, electronic load, dc power supply, induction withstand voltage tester, electrical safety analyzer, illuminance meter, LCR meter, vital signs simulator, infusion device analyzer, ECG electrode performance tester, electrosurgery analyzer, high frequency insulation tester, defibrillation effect tester, spectrometer, Band Radiometer, blue light irradiance meter, laser power meter, X-ray image evaluation system, high precision wireless infant incubator automatic calibration system, etc.

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