Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
医用电气设备第2-16部分:血液透析、血液透析过滤和血液过滤设备的基本安全和基本性能的特殊要求
This standard specifies the minimum safety requirements for single-patient hemodialysis, hemodiafiltration and hemofiltration equipment. These devices are intended for use either by medical staff or under the supervision of medical expertise, including hemodialysis, hemodiafiltration and hemofiltration equipment operated by the patient.