Ensuring the Safety of Medical Devices
The purpose of safety testing medical electronic equipment is to be sure that a device is safe from electrical hazards to the patient and caregivers. There are a number of global standards that serve as the ruling body on how medical products will be tested. One in particular, IEC60601-1, has been accepted and implemented around the world. IEC60601-1 is mainly intended for product development where safety considerations must be taken into account early in the design phase of a product, however much of it applies to production line testing to ensure manufacturer are shipping safe products.
Vital areas of medical device electrical safety testing include hipot test or dielectric breakdown, leakage current, insulation resistance and ground bond testing. To better understand the differences in these tests and others, the papers below examine the purpose and techniques for each test then offers a detailed discussion on ensuring the safety of medical electronics.