Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
Clause 1 of the general standard2) applies, except as follows:201.1.1 *ScopeReplacement:This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HFSURGICAL EQUIPMENT as defined in 201.3.222.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 therequirements of this particular standard. These exemptions are indicated in the relevant requirements.