Medical Electrical Equipment Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment
|Publication Date:||1 September 1998|
|ICS Code (Surgical instruments and materials):||11.040.30|
This Particular Standard specifies requirements for the safety of HIGH FREQUENCY SURGICAL EQUIPMENT used in medical practice, as defined in 2.1.101 and hereinafter referred to as HF SURGICAL EQUIPMENT.
HF SURGICAL EQUIPMENT having a RATED OUTPUT POWER not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this Particular Standard. These exemptions are indicated in the relevant requirements.