标准摘要
[中文适用范围]： 补充：本标准规定了单个患者血液透析、血液透析滤过和血液滤过设备（如 2.101 中定义）的最低安全要求。这些设备供医务人员使用或在医疗专业知识的监督下使用，包括由患者操作的血液透析、血液透析滤过和血液滤过设备。这些特殊要求不适用于 - 体外回路， - 透析器， - 透析浓缩液， - 水净化设备， - 用于进行腹膜透析的设备（参见 IEC 60601-2-39）。 [外文原描述]： Specifies the minimum safety requirements for single patient haemodialysis, haemodiafiltration and haemofiltration equipment. These devices are intended for use either by medical staff or under the supervision of medical expertise, including haemodialysis, haemodiafiltration and haemofiltration equipment operated by the patient.
英文名称Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment