CAN/CSA-C22.2 NO. 601.2.4-M90 (R2001)

Scope

This Particular Standard specifies requirements for the safety of CARDIAC DEFIBRILLATORS and CARDIAC DEFIBRILLATOR-MONITORS as defined in Sub-clauses 2.1.101 and 2.1.102, hereinafter referred to as EQUIPMENT, incorporating a capacitive energy storage device and which are designed to be installed and used in ac cordance with the Rules of the Canadian Electrical Code, Part I.

This Standard does not apply to a CARDIAC MONITOR which is not part of a DEFIBRILLATOR-MONITOR.

In combined EQUIPMENT in which the ECG monitoring signal cannot be derived via the DEFIBRILLATOR ELECTRODES, this Standard applies to the DEFIBRILLATOR part only.

The requirements of this Particular Standard are in addition to those of CSA Standard CAN/CSA-C22.2 No. 601.1, Medical Electri cal 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 first meet all the requirements of C22.2 No. 601.1, as applicable, and then meet the additional requirements stated in this Particular Standard.

Special devices such as automatic implantable DEFIBRILLATORS, automatic or advisory external DEFIBRILLATORS, or telephone remote-controlled DEFIBRILLATORS, are not covered in this Particular Standard as they have special features and modes of operatio n which are beyond the Scope of this Particular 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.