KingPo recently completed the delivery, commissioning, and technical support of a medical electrical safety test equipment package for Sichuan Institute for Drug Control (Sichuan Medical Device Testing Center), a provincial-level testing institution in China.
Different from a single-instrument delivery, this project involved a coordinated configuration of multiple KingPo medical test systems, including a programmable leakage current tester, KP8850 electrosurgical unit analyzer, KP1230S dielectric strength tester, KP1240S high voltage current carrying test system, and NE contact impedance tester.
The delivered equipment package is designed to support the laboratory’s testing capability across IEC 60601-1, IEC 60601-2-2, IEC 60990, ISO 27186, and related medical electrical safety requirements.
Project Background
Medical device testing laboratories need reliable, repeatable, and standards-oriented test instruments to evaluate different safety risks across multiple product categories. For medical electrical equipment, these risks may include patient leakage current, protective conductor current, high-frequency leakage current, dielectric withstand performance, neutral electrode contact impedance, and high-voltage pulse endurance.
To support these testing requirements, Sichuan Medical Device Testing Center selected KingPo to provide an integrated medical electrical safety testing solution. The project focused not only on equipment delivery, but also on practical laboratory application, test setup guidance, and long-term workflow support.
This delivery further demonstrates KingPo’s capability to provide medical testing equipment for professional laboratories, certification-related institutions, and medical device manufacturers.
Delivered Medical Electrical Safety Test Equipment
The Sichuan project included several KingPo instruments covering both general medical electrical safety testing and specialized active medical device test applications.
IEC 60601-1 Programmable Leakage Current Tester
The programmable leakage current tester was supplied to support electrical safety testing of medical electrical equipment and other electrical products.
The instrument supports multiple leakage current measurement modes, including AC, AC+DC, PEAK, and DC, and is designed for standards such as IEC 60601-1, IEC 60990, IEC 61010-1, and other related safety requirements. It also supports programmable upper and lower limits, timing settings, and Excel data export via U-disk, helping laboratories improve test repeatability and data management efficiency.
For medical device testing laboratories, leakage current testing is one of the most routine but critical safety test items. A programmable leakage current tester helps reduce manual operation variation and provides a more consistent workflow for routine inspection, type testing, and technical verification.
KP8850 Electrosurgical Unit Analyzer
The KingPo KP8850 Electrosurgical Unit Analyzer was included to support high-frequency surgical equipment testing under IEC 60601-2-2.
Electrosurgical units require dedicated test instruments because their output involves high-frequency waveforms, output power stability, load response, high-frequency leakage current, and REM/CQM monitoring functions. These test items cannot be fully evaluated by general electrical safety testers.
The KP8850 supports output power measurement, voltage measurement, current measurement, high-frequency leakage current testing, and REM/CQM simulation. According to the product specification, it supports ESU testing up to 1 MHz, a power range of 0–500 W, a voltage range up to 5 kV peak, and HF leakage current testing from 2 mA to 500 mA.
For laboratories testing electrosurgical generators and related accessories, the KP8850 provides a dedicated platform for ESU performance verification and safety assessment.
KP1230S Dielectric Strength Tester for ISO 27186
The KP1230S Dielectric Strength Tester was supplied for high-voltage pulse testing of quadripolar connector systems used in active implantable medical devices.
This instrument is designed to generate a monophasic truncated exponential waveform for dielectric strength and defibrillation resistance evaluation. The product page specifies compliance with ISO 27186:2020 Annex C and YY/T 0972-2016 Appendix C, with a 1.53 kV peak voltage adjustable up to 2 kV.
The tester is suitable for applications involving pacemakers, ICDs, CRT devices, and related quadripolar connector systems, where insulation integrity and pulse withstand capability are important.
KP1240S High Voltage Current Carrying Test System
The KP1240S High Voltage Current Carrying Test System was provided to evaluate the high-voltage and high-current withstand capability of quadripolar connector systems.
This system supports high-current pulse testing for ISO 27186-related connector verification. The product page describes it as a high-current pulse generator for quadripolar connector systems, with ISO 27186:2020 Annex E compliance, 0–2 kV peak voltage, and ≥50 A peak current under a standard 100 Ω load.
Together with the KP1230S dielectric strength tester, the KP1240S provides a more complete solution for active implantable medical device connector evaluation.
NE Contact Impedance Tester
The NE Contact Impedance Tester was supplied to support neutral electrode contact impedance testing for high-frequency surgical equipment.
Neutral electrode contact impedance is an important safety-related parameter in electrosurgical applications. If the contact impedance is too high, the current dispersion path may become unstable, which may increase the risk of localized heating during surgical operation.
The KingPo NE Contact Impedance Tester is designed for IEC 60601-2-2 clause 201.15.101.6 testing. It supports testing from 50 kHz to 5 MHz and provides 200 mA RMS current output into 0–50 Ω loads, helping laboratories perform repeatable neutral electrode verification.
On-Site Commissioning and Technical Support
After delivery, KingPo engineers supported the customer with equipment setup, functional verification, wiring guidance, operation demonstration, and practical training.
The training covered test connection methods, safety precautions, parameter settings, test sequence planning, result interpretation, and routine maintenance. This was especially important because the delivered configuration included high-frequency, high-voltage, and pulse-output test instruments.
By combining equipment delivery with application support, KingPo helped the laboratory establish a more standardized workflow for future medical electrical safety testing.
Project Value
This Sichuan project demonstrates KingPo’s ability to provide an integrated medical electrical safety testing solution for professional laboratories.
Instead of focusing on a single test item, the delivered equipment package covers several important medical device testing areas:
- leakage current testing for medical electrical equipment;
- electrosurgical unit output and high-frequency leakage current testing;
- neutral electrode contact impedance testing;
- dielectric strength testing for quadripolar connector systems;
- high-voltage current carrying evaluation for active implantable medical device connectors.
This configuration helps the laboratory expand its test coverage and improve testing efficiency for medical device safety verification.
For testing laboratories, certification bodies, and medical device manufacturers, KingPo can provide customized medical test equipment configurations based on applicable standards, product categories, and test workflow requirements.
Explore more KingPo Medical Test Equipment for IEC 60601, IEC 60601-2-2, IEC 60990, ISO 27186, and other medical device testing applications.
