CAN/CSA-C22.2 NO. 601.2.16-92 (R1997):1992 Edition

1 Scope

This Particular Standard specifies requirements for the safety of single PATIENT single pass HAEMODIALYSIS EQUIPMENT as defined in Sub-clause 2.1.26, hereinafter referred to as EQUIPMENT and designed to be installed and used in accordance with the Rules of the Canadian Electrical Code, Part I. These devices are intended for use either by medical staff or under the supervision of medical expertise, including HAEMODIALYSIS EQUIPMENT operated by the PATIENT. These Particular Requirements do not apply to blood lines, HAEMODIALYSERS, DIALYSING FLUID CONCENTRATE or water purification equipment.

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.