CAN/CSA-C22.2 No. 60601-2-16-01 (R2005)

This National Standard of Canada is equivalent to International Standard IEC 60601-2-16:1998, (second edition, 1998-02). 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 single PATIENT HAEMODIALYSIS, HAEMODIAFILTRATION EQUIPMENT (as defined in 2.101). These devices are intended for use either by medical staff or under the supervision of medical expertise, including HAEMODIALYSIS, HAEMODIAFILTRATION EQUIPMENT operated by the PATIENT. These particular requirements do not apply to - EXTRACORPOREAL CIRCUITS, - DIALYSERS, - DIALYSING FLUID CONCENTRATES, - water purification EQUIPMENT, - EQUIPMENT used to perform peritoneal dialysis (see IEC 60601- 2-39).