IEC/UL 60601-1 Test Sequence
From our experience, the common IEC 60601-1 test sequence starts from the ground bond test to measure the resistance between the medical device’s protective ground and chassis. Then, conducting the Hipot test. The testing points include DUT mains and patient leads to the chassis. Last, according to the product features, carrying out the relevant leakage current test:
- Earth leakage current
- Enclosure leakage current (touch current)
- Patient leakage current
- Patient auxiliary leakage current
- Mains on applied parts leakage current
Leakage current is measured using a measuring device (MD) which simulates the impedance of the human body, and the test points vary depending upon the leakage current type. For instance, the earth leakage current test points are protective earth terminal and ground. The enclosure and the ground are the enclosure leakage current test points. The patient leakage current measures the current between the applied part and the earth. Patient auxiliary leakage current measures the leakage current between applied parts. The test points of mains on the applied parts leakage currents are between the applied part and the secondary transformer.
In addition to conducting multiple leakage current tests, each test has to run under normal and varying single-fault conditions (open neutral, reverse polarity, and open ground), which increases the difficulty and complexity of the medical devices’ electrical safety test setups. Especially if the operator misses one of the abovementioned testing steps or connects the testing points in error, it could affect the testing accuracy and take more time to redo the test. Overall, the production line capacity would decrease.
A Complete Solution Simplify the Setup Process
Ikonix has more than 85 years of industry experience and already successfully helps many medical partners solve their testing challenges. Over the years of collaboration with medical partner experience, we have built a one-stop complete medical device testing solution – MedTest. It includes the ESA series electrical safety compliance analyzer, 7006 matrix scanners, and EAC series programmable 1 phase/3 phase AC power source to help to ensure the medical devices are safe and increase the testing efficiency. (Ikonix is in the progress of brand consolidation, the eec safety tester will be consolidated to the Associated Research brand, for more information, please read our press release or speak with our sales representative for further details.)
- The ESA series (will be known as OMNIA® II) is an all-in-one safety tester with ground bond/continuity, AC/DC Hipot, insulation resistance, and leakage current test. The built in IEC 60601-1 required human-body-simulation measuring devices (MD) replicating real-world conditions. Also, the optional built-in 500VA AC source which allows for conducting leakage current tests without an external supply make automated testing easier.
- 7006 matrix scanners (will be known as Multiplexers) can provide easily and quickly expand testing while optimizing efficiency by connecting up to 80 channels (one master with four slaves). The test can be run in sequence without repeat manual connection and reduce human errors.
- The medical products use electricity differently. The EAC series (will be known as 400XAC Series) is a single workstation capable of independently outputting single-phase, tri-phase, and DC power to simulate any operational circumstances.
This MedTest medical device testing solution can simplify the IEC 60601-1 testing setup and mitigate operator error by automatically switching connection points for each test to improve the production line test more efficient. If you want to learn more about MedTest or you have questions about carrying out IEC 60601-1 electrical safety tests, please get in touch with our sales representative now.
