This Particular Standard specifies requirements for the safety of HIGH FREQUENCY SURGICAL EQUIPMENT as defined in Sub-clause 2.1.101, hereinafter referred to as EQUIPMENT. This equipment shall be designed to be installed and used in accordance with the rules of the Canadian Electrical Code, Part I.
EQUIPMENT having a rated output power not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exempted from certain of the requirements of this Standard. These exemptions are indicated in the relevant requirements.
The requirements of this Particular Standard are in addition to those of CSA Standard C22.2 No. 601.1, Medical Electrical Equipment - Part 1: General Requirements for Safety, hereinafter referred to as the General Standard. For the purposes of testing and approving EQUIPMENT covered within the scope of this Particular Standard, the EQUIPMENT must meet the combined requirements as applicable, of both this Particular Standard and the General Standard.
In this Particular Standard, shall indicates a mandatory requirement; should indicates a recommendation, or that which is advised but not mandatory.
Canadian Deviations and Editorial Changes are included in this Standard.