Types of the testing required by IEC 60601-1 and IEC 60601-1-2, which are the international standards that outline the general requirements for the basic safety, and electromagnetic compatibility, and essential performance of medical electrical equipment and systems. IEC 60601-1 provides guidelines to ensure that devices are designed and manufactured to operate safely, protect patients and operators, and reduce risks associated with electrical, mechanical, thermal, and radiation hazards. IEC 60601-1-2, a collateral standard within the 60601 series, focuses specifically on the electromagnetic compatibility (EMC) of medical devices. It defines testing and performance criteria to ensure that medical electrical equipment can function properly in the presence of electromagnetic disturbances while not interfering with other devices or systems in its environment. Together, these standards ensure medical devices are safe, reliable, and compliant with global regulatory requirements.
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