ČSN EN IEC 60601-2-16 ed. 4

This part of IEC 60601 applies to the basic safety and essential performance of haemodialysis, haemodiafil-tration and haemofiltration equipment, hereafter referred to as haemodialysis equipment. it applies to hae-modialysis equipment intended for use either by medical staff or under the supervision of medical experts, including haemodialysis equipment operated by the patient, regardless of whether the haemodialysis equip-ment is used in a hospital or domestic environment.