标准摘要
[中文适用范围]： 补充：本国际标准适用于HAEMODIALYSIS@HAEMODIAFILTRATION 和HAEMOFILTRATION EQUIPMENT@（以下简称血液透析设备）的基本安全和基本性能。本国际标准未考虑使用透析液再生的血液透析设备的透析液控制系统和中央输送系统。然而，它确实考虑了此类血液透析设备有关电气安全和患者安全的具体安全要求。本国际标准规定了血液透析设备的最低安全要求。这些设备供医务人员使用，或供患者或其他经过培训的人员在医疗专家的监督下使用。本国际标准包括旨在为患有肾衰竭的患者提供血液透析@血液透析和血液过滤治疗的所有 ME 设备。本国际标准中的特殊要求不适用于： ?C 体外电路； ?C 透析器； ?C 透析液浓缩液； ?C水处理设备； ?C 用于执行腹膜透析的设备（参见 IEC 60601-2-39）。如果某条款或子条款专门旨在仅适用于 ME 设备@或仅适用于 ME 系统@，则该条款或子条款的标题和内容将如此说明。如果情况并非如此@，则该条款或子条款同时适用于 ME 设备和相关的 ME 系统@。除 IEC 60601-1 的 7.2.13 和 8.4.1 之外，本标准中的具体要求不涵盖本标准范围内 ME 设备或 ME 系统的预期生理功能所固有的危险。注：另见 IEC 60601-1:2005 的 4.2。 [外文原描述]： IEC 60601-2-16:2012 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2012 does not take into consideration the dialysis fluid control system of Haemodialysis equipment using regeneration of dialysis fluid and central delivery systems. It does however take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety. IEC 60601-2-16:2012 specifies the minimum safety requirements for haemodialysis equipment. These devices are intended for use either by medical staff or for use by the patient or other trained personnel under the supervision of medical expertise. IEC 60601-2-16:2012 includes all electromedical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This fourth edition cancels and replaces the third edition of IEC 60601-2-16, published in 2008. This edition constitutes a technical revision. Changes since the previous edition include, among others, better adaptation of IEC 60601-1-8 and improvement of subclause 201.8.3.
英文名称Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment