IEC 60601-2-16:1998

Haemodialysis is a highly specialized treatment to correct the electrolytes and imbalances in a patient's blood by means of diffusion and/or ultrafiltration. It necessitates delicate haemodialysis equipment for which this publication provides specific requirements for safety and performance.

IEC 60601-2-16:2008 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2008 does not take into consideration the dialysing fluid control system of Haemodialysis equipment using regeneration of dialysing fluid and central delivery systems. It does however take into consideration the specific safety requirements of such Haemodialysis equipment concerning electrical safety and patient safety. IEC 60601-2-16:2008 specifies the minimum safety requirements for haemodialysis equipment. These devices are intended for use either by medical staff or for use by the patient or other trained personnel under the supervision of medical expertise. IEC 60601-2-16:2008 includes all medical electrical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This third edition cancels and replaces the second edition of IEC 60601-2-16, published in 1998. This edition constitutes a technical revision. Changes since the previous edition include, among others, a summary of additional essential performance requirements, revision of terms and definitions, classification of applied parts and limits as numbers for protection against hazardous outputs, in the annex. The contents of the corrigendum of October 2008 have been included in this copy.