采用IEC 60601-2-16第4.0版规定血液透析、血液透析滤过和血液滤过设备的基本安全和基本性能要求。它没有考虑使用透析液再生和中央输送系统的血液透析设备的透析液控制系统。它确实考虑了此类血液透析设备在电气安全和患者安全方面的具体安全要求。结合AS/NZSIEC60601阅读。1:2015.

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.