Testing of electrosurgical (monopolar and bipolar) active accessories and cables by DDL, Minneapolis, is used to support 510(k) submissions and to justify CE marking. Until a few years ago, ANSI/AAMI HF18 was the most widely used standard for electrosurgical accessories in the United States. Its requirements evolved since its first edition in 1986, and it had long been recognized by the FDA.  The international standard, IEC 60601-2-2, was developed more recently, but its third edition (1998) suffered from a number of shortcomings when compared with HF18, and it was largely ignored, especially in the US. Shown below are a few of the standards that are applicable to electrosurgical accessory testing:
• IEC 60601-2-2:  Particular Requirements for the Safety of High Frequency Surgical Equipment
• ANSI/AAMI HF18:2001: Electrosurgical Devices