What is IEC 60601-1?
IEC 60601-1 is a series of technical standards for the safety and effectiveness of medical electrical equipment that has become a de facto requirement for bringing new medical devices to market in many countries. Deviations from the standard do exist that relate to country-specific requirements, but those standards such as Europe's (EN 60601-1) and Canada's (CSA 60601-1) are harmonized to the IEC standards. Within IEC 60601-1, there are also "collateral" standards that are denoted as IEC 60601-1-x. For example, IEC 60601-1-2 is the EMC collateral standard that forms the basis of the latest 4th edition EMC requirements.