Medical Device Electrical Safety Testing

Medical device electrical safety testing ensures the safety of clinicians, visitors or patients who may come in contact with any devices. It is always part of preventative maintenance procedures and is developed to prevent danger to anyone from electric shock. The safety testing for medical devices is subject to more rigorous standards than those for general electrical devices.

Two main international standards for medical electrical devices are IEC 60601 and IEC 61010. These standards ensure the safety and performance of devices, setting guidelines for their design, testing, and use in various medical and laboratory environments. Understanding the difference between the two standards are critical for manufacturers looking for various regulatory compliance like the EU, UK and FDA.

The IEC 60601 series of standards focuses on medical electrical devices with direct patient interaction. These devices often have applied parts in contact with the patient, facilitate energy transfer to or from the patient, or monitor such transfers. Examples include ventilators, x-ray machines, operating tables, and hearing aids. The standards ensure these devices meet safety and essential performance requirements to protect patients and healthcare providers.

The IEC 61010 series of standards focuses on laboratory and measurement equipment, covering devices outside the scope of IEC 60601. It primarily pertains to laboratory equipment used for measurement, analysis, and industrial control, including in vitro diagnostic devices. Unlike IEC 60601, devices under IEC 61010 generally do not make physical contact with patients. Both standards follow a similar structure, with a general standard supplemented by device-specific requirements. For IEC 60601, this includes additional focus areas like electrostatic discharge (ESD).

The IEC 60601 series of standards released by the International Electrotechnical Commission (IEC) for checking and qualifying the safety and performance of medical electrical devices for any type and device class. The IEC 60601 series is a widely recognized and adopted set of standards that provide guidelines for the design, testing, and operation of medical devices to ensure their safety and effectiveness. The IEC 60601 series is divided into several parts, each covering different aspects of medical electrical equipment are detailed in the below table