AAMI HF18-93

This standard establishes minimum safety and performance requirements for electrosurgical systems. An electrosurgical system consists of a high-frequency electrical-current generator, cables, electrodes, and safety devices for delivering this high-frequency electrical energy to the patient in order to accomplish electrosurgery. The system includes the circuitry and devices needed to control the duration, mode of operation, and intensity of the application. Included within the scope of this standard are electrosurgical devices and the electrosurgical portion of multifunction devices. Examples of devices within the scope of this standard are electrosurgical high-frequency generators and directly related accessories, including active electrodes and cables, dispersive electrodes and cables, and footswitches or other operator-controlled mechanisms for activating the generator output.