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AS/NZS IEC 60601.2.16:2015
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AS/NZS IEC 60601.2.16:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
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Adopts IEC 60601-2-16, Ed.4.0 to specify basic safety and essential performance requirements for haemodialysis, haemodiafiltration and haemofiltration equipment. It does not take into consideration the dialysis fluid control system of haemodialysis equipment using regeneration of dialysis fluid and central delivery systems. It does take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety. To be read in conjunction with AS/NZSIEC60601.1:2015.
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AS/NZS IEC 60601.2.16:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment