At some point, we’ve all encountered medical instruments during hospital visits. Have you ever wondered why we feel so confident allowing these devices to come into contact with our bodies? In the medical industry, these devices are critical for safeguarding patients and healthcare professionals. However, if they fail, the consequences can include patient harm, equipment damage, and delays in treatment.
To prevent such outcomes, medical manufacturers must comply with rigorous safety standards, like IEC 60601—the global benchmark for medical device safety. At Associated Research, we provide dependable solutions to help manufacturers test their products effectively. In this article, we’ll explore the challenges manufacturers face and how our solutions address them.
Common Tests for Medical Devices
In previous e-newsletters and our medical application notes, we’ve shared valuable testing insights. To meet IEC 60601 standards, medical devices must undergo several critical tests. Here’s a summary of the most common ones:
- AC Hipot Tests: Evaluate insulation strength for input power and applied parts.
- Ground Bond Tests: Verify that grounding connections can handle fault currents ranging from 25 to 40 amps.
- Insulation Resistance Tests: Ensure that no unintended electrical flow occurs within the insulation.
- Leakage Current Tests: Measure unintended current flow in earth connections, applied parts, or between applied parts.
While these tests are essential, manufacturers often face additional hurdles to ensure compliance with standards.
3 Common Challenges in Medical Device Testing and Solution
1. Testing Takes Too Long
Challenge: Performing multiple tests can significantly slow production lines.
Solution: The OMNIA® II Series consolidates seven critical tests into one device, including withstand, insulation resistance, ground bond, and leakage current. With its built-in 500VA power source, it can handle high-power devices, reducing testing time and costs. For devices requiring more power, the eec 8500 series AC power source delivers stable performance with a capacity of up to 6kVA.
2. Operator Errors
Challenge: Complicated setups and frequent connection changes can lead to mistakes during testing.
Solution: The SC6540 Scanner simplifies multi-point and batch testing, streamlining the process and minimizing errors. It improves setup efficiency and ensures accurate results.
3. Data Management Challenges
Challenge: Capturing test results for device history can be tedious work.
Solution: WithStand® Software generates detailed, traceable reports, capturing key data such as pass/fail results, model numbers, and serial numbers for every device tested. This simplifies documentation and improves traceability.
Ready to Simplify Your Testing Process?
At Associated Research, we offer the MedTEST system, specifically designed to help you overcome testing challenges. If you're a manufacturer dealing with these obstacles, let us assist you. Reach out today for expert guidance and innovative tools to streamline your testing process!
