CAN/CSA-C22.2 No.601.2.31-98 (R2006)

This National Standard of Canada is equivalent to International Standard CEI/IEC 601-2-31:1994. 1 Scope and object This clause of the General Standard applies, except as follows: 1.1 Scope Addition: This Particular International Standard specifies the particular safety requirements for EXTERNAL PACEMAKERS as defined in 2.1.101, hereinafter referred to as EQUIPMENT, powered by an INTERNAL ELECTRICAL POWER SOURCE. This Standard applies to PATIENT CABLES as defined in 2.1.104. This Standard does not apply to EQUIPMENT which can be directly or indirectly connected to a SUPPLY MAINS. This Standard does not apply to pacing LEADS, or other equipment for cardiac stimulation which either: 1) forms an integral part of equipment with other functions; or 2) applies the stimulus across the thorax externally or in the oesophagus; or 3) providees antitachycardia therapy beyond high rate burst pacing; or 4) provides pacing system analysis functions. Each of the two channels of DUAL CHAMBER EQUIPMENT is subject to the requirements of this Standard. 1.2 Object Replacement: The object of this Particular Standard is to establish particular requirements for the safety of EXTERNAL PACEMAKERS as defined in 2.1.101.