CAN/CSA-C22.2 No. 60601-2-39:02 (R2007)

This National Standard of Canada is equivalent to International Standard IEC 60601-2-39:1999 (first edition, 1999-06). 1 Scope and object This clause of the General Standard applies except as follows: 1.1 Scope Addition: This Particular Standard specifies the minimum safety requirements for PERITONEAL DIALYSIS EQUIPMENT as defined in 2.1.102, hereinafter referred to as EQUIPMENT. It applies to EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including EQUIPMENT operated by the PATIENT, regardless of whether the equipment is used in a hospital or domestic environment. These particular requirements do not apply to the DIALYSING SOLUTION, the DIALYSING SOLUTION circuit, or to EQUIPMENT solely intended for use as continuous ambulatory PERITONEAL DIALYSIS EQUIPMENT. 1.2 Object Replacement: The object of this Particular Standard is to establish particular requirements for the safety of EQUIPMENT as defined in 2.1.102.