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Scope

This Particular Standard specifies requirements for the safety of ULTRASONIC THERAPY EQUIPMENT as defined in Sub-clause 2.1.101, hereinafter referred to as EQUIPMENT and designed to be installed and used in accordance with the Rules of the Canadian Electrical Code, Part I.

This Particular Standard does not apply to EQUIPMENT in which a tool is driven by ULTRASOUND (for example EQUIPMENT used in surgery or dentistry) or in which focused ULTRASOUND pulse waves are used to destroy conglomerates such as stones in the kidneys or the bladder (lithotrites).

The requirements of this Particular Standard are in addition to those of CSA Standard CAN/CSA-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.