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Transformer Double Voltage/ Double Frequency Testing

The linear transformer winding of medical electrical equipment needs to have sufficient insulation to prevent dangerous situations that may arise from overheating in internal short circuits. The transformer voltage and frequency doubling test, which evaluates quality and electrical safety characteristics, is one of the most important tests for safety of medical electrical products.

? Service Background

Transformer Voltage and Frequency Doubling：The linear transformer winding of medical electrical equipment needs to have sufficient insulation to prevent dangerous situations that may arise from overheating in internal short circuits. For transformer’s winding with rated voltage less than or equal to 500V, or rated frequency less than or equal to 60Hz, 5 times the rated voltage or maximum rated frequency will be will be used, applying a frequency not less than 5 times the rated frequency at both ends of the winding. During the testing process, the insulation should not be broken. The transformer voltage and frequency doubling test, which evaluates quality and electrical safety characteristics, is one of the most important tests for safety of medical electrical products

Medical device testing is the basis for medical devices to enter the global market. If a product is to be exported to the European Union or the United States, then corresponding tests will need to be done to meet the EU or US standards.

? Other Services of Medical Devices

Testing of active medical device
EMC testing and debugging service
Reliability Testing
NMPA registration testing service
Validation of product life
Failure mode analysis
biocompatibility test
Software evaluation
Global marketing access
US agent service
EU representative service
Training Service

? Medical Device Testing Standards

In Vitro Diagnostic Medical Devices

SN	Title	International Standard	National Standard
1	Electrical Equipment For Measurement, Control, and Laboratory Use	IEC/EN 61010-1	GB4793.1
2	Safety requirements for electrical equipment for measurement, control and laboratory use –Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment	IEC/EN 61010-2-101	YY 0648
3	Safety requirements for electrical equipment for measurement, control and laboratory use – Part 081: Particular requirements for automatic and semiautomatic laboratory equipment for analysis and other purposes	IEC/EN 61010-2-081	GB4793.9
4	Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 1: General requirements	IEC/EN 61326-1	GB/T 18268.1
5	Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment	IEC/EN 61326-2-6	GB/T18268.26

Medical Device Testing Standards List

SN	Title	International Standard	National Standard
1	Medical safety and electrical essential equipment performance - Part 2-25: of electrocardiographs Particular requirements	IEC/EN 60601-2-25	GB 10793
2	Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type	EN ISO /ISO 81060-1
3	Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems	EN 1060-3
4	Medical electrical equipment -- Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems	IEC/EN 60601-1-1	GB 9706.15
5	Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment	IEC/EN 60601-2-27	GB 9706.25
7	Medical electrical equipment-Part 2-26: Particular requirements for the safety of electroencephalographs	IEC/EN 60601-2-26:2012 IEC 80601-2-26：2019	GB 9706.26
8	Medical safety and electrical essential equipment-Part performance2-56: of clinical Particular thermometers requirements for basic body temperature measurement	ISO/ EN ISO 80601-2-56
9	Non-invasive automated sphygmomanometers	ANSI/AAMI SP10	YY 0670
10	Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use	IEC/EN 60601-2-57
11	Basic Safety Electrical And Equipment Essential -Performance Part 2-2: Particular Of High Requirements Frequency For Surgical Equipment And High Frequency Surgical Accessories	IEC/EN/EN IEC 60601-2-2	GB 9706.4
12	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance	ANSI/AAMI ES60601-1 EN /IEC60601-1	GB9706.1
13	Medical electrical equipment - Part 2-10 : particular requirements for the safety of nerve and muscle stimulators	IECC/EN 60601-2-10	YY 0607
14	Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers	IEC/EN 80601-2-30	YY 0667
15	Medical electrical equipment-Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment	IEC/EN 60601-2-49/IEC 80601-2-49	YY 0668
16	Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment	EN ISO 9919 ISO / EN ISO 80601-2-61	YY 0784
18	Medical electrical equipment - Part 2: Particular requirements for the safety of electrically operated hospital beds	IEC/EN 60601-2-52	YY 0571
19	Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs	IEC/EN 60601-2-51	YY 0782-2010
20	Diagnostic electrocardiographic devices	ANSI/AAMI EC11	YY 1139
21	Electrocardiographic	ANSI/AAMI EC13	YY1079
22	Part 1-11: General requirements for basic safety and essential performance –Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment	IEC/EN 60601-1-11
23	Performance of compact electrical thermometers (non-predictive and predictive) with maximum device	EN 12470-3 ASTM E1112
24	Performance of electrical thermometers	EN 12470-4	YY 0785
25	infrared ear thermometers (with maximum device)	EN 12470-5 ASTM E1965-98	GB/T 21417.1
26	Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems	IEC/EN 60601-2-47 ANSI/AAMI EC38:2007 AAMI/ANSI/ISO 60601-2-47:2012	YY 0885
27	Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment	IEC/EN 60601-2-22	GB 9706.20
28	Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis	IEC/EN 60601-2-41	YY 0627
29	Part 2-46: Particular requirements for the basic safety and essential performance of operating tables	IEC/EN 60601-2-46	YY 0570
30	ECG trunk cables and patient leadwires	AAMI ANSI EC53	YY 0828
31	Part performance 2-18: Particular of endoscopic requirements equipment	IEC/EN 60601-2-18	GB9706.19
32	Medical electrical equipment-Part 1-2:General requirements for safety Collateral standard: Electromagnetic compatibility-Requirements and tests	IEC/EN 60601-1-2	YY 0505
37	Medical electrical equipment- Part 1-8: General requirements for safety Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems	IEC/EN 60601-1-8	YY0709
38	Safety of laser products —Part 1: Equipment classification and requirements	IEC/EN 60825-1 AS/NZS 2211.1	GB 7247.1
39	Photobiological safety of lamps and lamp systems	IEC /EN62471 AS/NZS IEC 62471 IEC IEC/TR 62778 IEC/TR 62471-2	GB/T 20145
40	RESPIRATORY THERAPY EQUIPMENT –Part 1: Nebulizing systems and their components	EN13544-1	YY 0109
41	Medical electrical equipment –Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers	IEC/EN 60601-2-24	GB 9706.27
42	Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment	IEC/EN 60601-2-34	YY0783
43	Medical electrical equipment –Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment	IEC/EN 80601-2-60
44	Medical devices IEC devices 62366-1: - Part 2015 1: IEC Application 62366: 2007+A1:2014 of usability engineering	IEC/EN 62366-1	YY/T 1474
45	Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability	IEC/EN 60601-1-6
46	Medical electrical equipment -Part 2:Particular requirements for safety of baby incubators	IEC/EN 60601-2-19	GB 11243
47	Medical electrical equipment Part 1-9: General requirements for basic safety and essential performance– Collateral Standard: Requirements for environmentally conscious design	IEC/EN 60601-1-9
48	Clinical electronic thermometer		GB/T21416
49	Medical device software — Software life cycle processes	IEC62304	YY/T 0664
50	Medical suction equipment Part 1: Electrically powered suction equipment — Safety requirements	ISO10079-1
51	Medical electrical equipment — Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment	EN 60601-2-37	GB 9706.9-2008 GB10152-2009
52	Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment	IEC 61157	GB/T16846 UD2 UD3
53	Ultrasonics dental descaler systems; measurement and declaration of the output characteristics	IEC 61205	YY/T 0751
54	ultrasonic Doppler fetal heartbeat detector		YY 0448
55	ultrasonic Doppler fetal monitor		YY/T0449
56	Medical electrical equipment — Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment	IEC/EN 60601-2-5	YY/T1090 GB9706.7
57	ultrasonic-Hydrophone Part 1: Measurement and characterization of medical ultrasonic fields to 40MHZ	IEC62127-1	YY/T 0865.1

? Applicable Products

Medical devices (including: thermometers, oximeters, sphygmomanometers, fetal heartbeat detector, electrocardiographs Color ultrasound system, X-ray machines, etc.)

? Sample Requirements

Complete and fully-functional samples. For more specific details, please contact CTI online customer service.

? Our Edge

CTI has qualified and experienced teams, ready to provide you professional consulting and services.

CTI has advanced laboratory equipment, ensuring accuracy and reliability of the test data.

CTI is a third-party testing and certification organization, trusted by customers globally and your endorsement of quality

We rely on our worldwide laboratory networks to provide you a comprehensive one-stop testing and certification solution.

? FAQ

How long is the lead-time for medical device testing?

Actual lead-times are based on the product and standards, please contact CTI customer service for more details.

What test method does CTI use for medical device testing?

The applied test and standards are carried out according to the export requirements or to the clients’ needs.

What is CTI’s retention period of samples?

Sample Return

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