IEC 60601-1 Testing Laboratories — Medical Electrical Equipment
IEC 60601-1 is the general standard for basic safety and essential performance of medical electrical equipment, and it is applied together with any collateral standards and the particular standards for the device type.
When is it used?
- Design verification and submission preparation for medical electrical equipment
- Changes to enclosure, isolation, power supply, applied parts or protective software
- Re-assessment after a standard edition or particular-standard change
Sample considerations
- Provide production-representative units with the shipping accessories and power supply.
- The assessment relies on documentation as well as measurement, including risk management output.
- Identify applicable particular standards early — adding one late usually adds testing.