As society ages and the outbreak of the COVID-19, the demand for medical devices accelerated increases. No matter the medical devices are used in the hospital or at home, they all play an important role to keep people healthy. In addition to ensuring the performance and safety protection of the medical device is comply with the standard, the patient and the medical personnel must be ensured utmost safety when in contact with these devices.
Therefore, every government has established strict laws and regulations on medical devices. Basically, they all follow the IEC 60601 series of standards to formulate relevant safety and performance requirements. This series includes general standards, collateral standards (defined certain safety and performance), and particular standards (defined individual products, such as high-frequency scalpels, blood pressure monitors, etc.) The IEC 60601 series standards require medical devices must pass Hipot test, GB test, and leakage current test. Some medical devices would use ultra-high voltage to carry out the Hipot test.
Ikonix offers complete testing solutions that enable manufacturers to ensure their product is safe, reliable, precise, and in compliance with regulations and standards, and help make the world a better place.
To learn more about medical device industry safety testing, please download our Medical Application Paper now.