Leakage Current Testing for Medical Devices: WithStand® Adds OMNIA® II & 8500 Series Support

Leakage current testing for medical devices now supports higher-power configurations through an update to Ikonix’s WithStand® software platform, which can control leakage current testing performed by the OMNIA® II 8206 or 8256 paired with the EEC 8500 Series AC power source. This expands testing capacity up to 6kVA — supporting medical device manufacturers working toward IEC 60601-1 third edition compliance.

Medical device manufacturers running leakage current testing for medical devices under IEC 60601-1 often need more power than a standalone tester provides, especially for high-demand devices. WithStand®, Ikonix’s SaaS testing platform, has expanded to address this by adding support for the OMNIA® II 8206 or 8256 paired directly with the EEC 8500 Series AC power source.

8500 series

OMNIA-II

Why Power Matters During Leakage Current Testing for Medical Devices

Leakage current testing measures unintended current flow in a device’s earth connections, applied parts, or between applied parts — a core requirement under IEC 60601-1 third edition. High-powered or sensitive medical devices can require more testing capacity than a base instrument’s built-in power source supports. Pairing OMNIA® II with the EEC 8500 Series extends usable testing capacity up to 6kVA, enabling reliable, higher-power leakage current testing for medical devices without switching to an entirely separate test setup.

What’s New in WithStand®

withstand software

WithStand® records, tracks, and securely stores testing data, and its desktop configuration (WithStand® Desk) can operate even in limited internet or intranet environments. With this update, three specific benefits apply to combined OMNIA® II and 8500 Series configurations:

Key Benefits:

  • Easy Setup: Connect the OMNIA® II 8206 or 8256 to any EEC 8500 Series power source, and WithStand® promptly sets everything up. Start testing in just a few clicks!
  • Seamless Data Management: Capture and organize essential testing data quickly, ensuring your quality records stay complete and compliant.
  • Enhanced Power for Critical Testing: With the EEC 8500 Series, your testing capacity expands up to 6kVA, which is especially crucial for high-powered and sensitive medical devices.

Who This Update Is For

This expanded functionality is particularly relevant for manufacturers working toward IEC 60601-1 3rd Edition compliance, where leakage current testing for medical devices must produce both accurate results and audit-ready documentation for regulatory submissions. Combining higher power capacity with automated data capture reduces both testing time and manual documentation effort — two of the most common bottlenecks manufacturers face when scaling leakage current testing for medical devices across a full production line.

Ready to Get Started?

Try for Free: Sign up and begin your free trial today and see firsthand how simple testing can be with WithStand®’s updated features.

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FAQ

What is leakage current testing for medical devices?
It’s a required electrical safety test under IEC 60601-1 that measures unintended current flow in a device’s earth connections, applied parts, or between applied parts.

Why would a medical device need higher-power leakage current testing?
High-powered or sensitive medical devices can exceed the testing capacity of a standalone instrument’s built-in power source, requiring an external AC power source for reliable results.

How much power does the eec 8500 Series add to leakage current testing?
Pairing the OMNIA® II with the eec 8500 Series expands testing capacity up to 6kVA.

Does WithStand® work without a stable internet connection?
Yes — WithStand® Desk can operate in limited internet or intranet settings, which supports testing environments where connectivity isn’t guaranteed.

Learn More:

WithStand® now offers the flexibility, efficiency, and power for all your testing needs.