Introducing MedTEST Solutions: Maximizing Efficiency in Medical Device Testing

The medical device industry has continued to flourish, driven in part by the rescheduling and prioritization of non-essential surgeries, testing, and treatment that were postponed during the pandemic. According to Fortune Business Insight, the industry is projected to achieve an impressive Compound Annual Growth Rate (CAGR) of 5.5% by 2029¹. To ensure the utmost safety for both patients and operators, medical devices adhere to stringent standards, such as the IEC 60601, which surpass the requirements for other electronic devices. One critical aspect of IEC 60601 is the leakage current test, which adds complexity to the testing process. Consequently, many medical device manufacturers are seeking solutions to optimize testing efficiency while maintaining unwavering quality, safety, and compliance. In this article, we will explore the challenges associated with medical device testing and present solutions to overcome these issues.

Various Types of Leakage Current Tests for Medical Devices

In contrast to common leakage current tests for electronic devices, medical devices necessitate distinct types of leakage current tests to ensure patient and operator safety under to simulate different conditions. These include earth leakage current, enclosure leakage current (touch current), patient leakage current, patient auxiliary leakage current, and mains on applied parts leakage current. Each test requires specific test points to be examined meticulously. For instance, earth leakage current is measured between the protective earth terminal and ground, while enclosure leakage current is assessed between the enclosure and ground. Patient leakage current is measured between the applied part and the earth, while patient auxiliary leakage current is evaluated between different applied parts. Test points for mains on applied parts leakage current are situated between the applied part and the secondary transformer. Additionally, it is crucial to conduct each leakage current test under normal conditions as well as varying single-fault conditions such as open neutral, reverse polarity, and open ground.

Simplifying Testing Complexity with MedTEST

The complexity introduced by these testing requirements poses challenges for even the most experienced operators. The need to change cables at each step prolongs testing time and hampers efficiency. Additionally, errors in connecting the test points can significantly impact test accuracy, resulting in additional retesting. To tackle these challenges head-on, Ikonix has work closely with leading medical device companies to develop MedTEST—an all-in-one system solution.

MedTEST offers a comprehensive solution by addressing operators' concerns regarding complex cable connections through its fully automated multipoint sequential testing. The system comprises the Associated Research OMNIA®II Multi-Function Electrical Safety Tester, SC6540 Multiplexers, and an eec 8500 Series Programmable AC Power Source, providing a robust testing setup. The OMNIA®II integrates AC/DC Hipot (ACW/DCW), insulation resistance (IR), AC ground bond (AC GB), ground continuity (GC), touch current (TC), and run testing (RT) features in a single tester. The SC6540 enables automated up to 80 multi-point testing. Additionally, the system can be enhanced with the LINECHEK® II Leakage Current Tester 620L to accommodate continuous currents of up to 40A, making it ideal for applications that require currents exceeding 16A. The 8500 Series Programmable AC Power Source provides the necessary power to the Device Under Test (DUT), with available power ratings ranging from 500 VA to 6 kVA. By leveraging MedTEST, operators can streamline their testing process, enhancing efficiency and ensuring accurate and reliable results.

Ikonix is the leading provider of medical device electrical safety testing solutions. With our extensive expertise, we offer comprehensive support, including MedTEST and Application Consulting services. If you're interested in learning more about MedTEST, we invite you to watch our webinar video, which covers the required electrical safety tests for medical devices and demonstrates how the MedTEST system provides a complete testing solution that aligns with the IEC 60601-1 3rd Edition Standard. For any inquiries or to gain further insights into our medical solutions, please contact our sales representative today.



https://youtu.be/OxL2hiZV8tc