CAN/CSA C22.2 NO. 601.2.25-94(R2007)

This Particular Standard applies to ELECTROCARDIOGRAPHS, vector-cardiographs, and EQUIPMENT for stress testing, hereinafter referred to as EQUIPMENT, designed to be installed and used in accordance with the rules of the Canadian Electrical Code, Part I.
This Particular Standard covers minimum safety requirements.
Special requirements concerning use in ambulances, phono-cardiographs, cardiographic monitors, polygraphs, telemetering, special tests (for example, His bundle electrocardiographs), etc. are not covered by this Particular Standard.
EQUIPMENT with microelectrodes used directly in the fibres of the heart muscle is also excluded.
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, and its supplement C22.2 No. 601.1S1 (adopted amendment 1 to IEC 601-1), 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.