BS EN 60601-2-16:2015 PDF

201.1   Scope, object and related standards Clause 1 of the general standard1 applies, except as follows:

201.1.1   Scope

Addition : This International Standard applies to the basic safety and essential performance of haemodialysis , haemodiafiltration and haemofiltration equipment , hereafter referred to as haemodialysis equipment . This International Standard does not take into consideration the dialysis fluid control system of haemodialysis equipment using regeneration of dialysis 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. This International Standard specifies the minimum safety requirements for haemodialysis eq...