ANSI/AAMI HF18-1993
电手术装置已作废

Electrosurgical Devices

标准号

ANSI/AAMI HF18-1993

发布日期

1993年09月17日

实施日期

废止日期

无

中国标准分类号

C39

国际标准分类号

11.040.30

发布单位

美国国家标准学会

代替标准

ANSI/AAMI HF18-2001

适用范围

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 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 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.NOTE-When it is necessary to create product stanards for specialty devices(e.g., neurological lesion generators,depilation units,endoscopic devices combining a fiber-optic light source or gas insufflator with the electrosurgical generator), appropriate,applicable requirements for the electrosurgical portion of the unit and its accessories may be necessary.

ANSI/AAMI HF18-1993相似标准

推荐