MEDICAL DEVICE INDUSTRY

Compliance with medical testing standards is a challenge for all medical device manufacturers. We can help you find the right solution to ensure you are performing electrical safety compliance testing as efficiently and effectively as possible.

Complete Solution

To meet the requirements of IEC/UL 60601-1, 3rd edition, we recommend performing Ground Bond, Dielectric Withstand and Leakage Current tests on your medical devices. For a complete test solution customize an Associated Research MedTEST system to your specific compliance needs.

MedTEST gives you the ability to perform Hipot, Ground Bond, Insulation Resistance, Functional Run and Leakage Current testing for your B, BF or CF type applied parts, including Mains on Applied Parts (MOAP) tests. MedTEST handles loads that require up to 40 Amps of continuous current, includes ActiveLink® technology to reduces overall test time, and is compatible with our SC6540 modular scanning matrix for multi-point sequential testing. Utilize MedTEST with our Autoware 3 automation software to maximize productivity and store your test data.

Introductory Solution

As an introductory solution for your medical device testing we recommend performing a Leakage Current test as a 100% production test for your medical device. However, if your application does not require Leakage Current testing our HypotULTRA® model 7804 is the most efficient way to meet the Hipot and Ground Bond/Continuity test requirements of IEC 60601-1, 3rd Edition. Model 7804 is a 4-in-1 electrical safety compliance analyzer that includes AC Hipot, DC Hipot, Insulation Resistance, and Ground Bond tests. If your application requires multi-point testing the 7804 can be used with our SC6540 scanning matrix. To automate your solution, add our WithStand® software to perform remote tests and store test data.

Safe Workstation

Setting up a safe and secure workstation is one of the best ways to protect your test operators. You can setup test stations with or without direct protection depending on your requirements.

Educational Resources


Associated Research understands that there is a lot to know when it comes to our High Voltage Test Equipment and medical device safety testing. Here are some educational materials that may help you with your testing.

 

Electrical Safety Testing for Medical Devices Webinar >
3 Ways to Simplify Medical Device Testing >
Automation leads to Efficiency >
Basics of Leakage Current Testing Video >
Touch Current Testing Video >
Medical Device Case Study >