Strict requirements outlined in medical testing standards have always been a challenge for medical manufacturers and end users alike. The IEC/UL 60601-1 3rd edition standard requires a series of electrical safety tests to ensure that the medical product being tested is safe for use in the field and will not pose a shock hazard to the end user or patient. The required electrical safety tests include the protective bonding or ground bond test, dielectric withstand test and the line leakage test. While this series of tests isn’t technically required for 100% production line testing of a product, not all end users find this excuse sufficient.
Medical Device Testing, IEC/UL 60601-1 3rd edition