医疗电气设备 - 第2-16部分:血液透析 血液过滤和除血设备基本安全和基本性能的特殊要求

[中文适用范围]： 除以下情况外，通用标准 1 的第 1 条适用@： 替换：IEC 60601 的本部分适用于 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。本文件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或透析液中央输送系统的具体安全细节。但是，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。本文件规定了血液透析设备的最低安全要求。这些血液透析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监督下使用。本文件包括旨在向 PATIENT@ 提供 HAEMODIALYSIS@ HAEMODIAFILTRATION 和 HAEMOFILTRATION 治疗的所有 ME 设备，无论治疗持续时间和地点如何。如果适用@本文件适用于用于其他体外血液净化治疗的 ME 设备的相关部分。本文件中的特殊要求不适用于： ?C 体外电路（参见 ISO 8637-2@ [12]2）； ?CD 透析器（参见 ISO 8637-1@ [11]）； ?C 透析水供应系统（参见 ISO 23500-2@ [16]）； ?C 透析液浓缩液中央输送系统（参见 ISO 23500-4@ [18]）@ 描述为透析设施中批量混合浓缩液的系统； ?C 用于执行腹膜透析的设备（参见 IEC 60601-2-39@ [8]）。 1 通用标准为IEC 60601-1:2005和IEC 60601-1:2005/AMD1:2012@医疗电气设备?C第1部分：基本安全和基本性能的通用要求。 2 方括号中的数字指的是参考书目。 [外文原描述]： IEC 60601-2-16:2018 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2018 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 60601-2-16:2018 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 60601-2-16:2018 includes all electromedical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This fifth edition cancels and replaces the fourth edition of IEC 60601-2-16, published in 2012. This edition includes the following significant technical changes with respect to the previous edition: a) update of references to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, of references and requirements to IEC 60601-1-2:2014, of references to IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013, of references and requirements to IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, of references to IEC 60601-1-9:2007 and IEC 60601-1-9:2007/AMD1:2013, of references to IEC 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013 and of references to IEC 60601-1-11:2015; b) widening of the scope; c) editorial improvements; d) addition of requirements for anticoagulant delivery means; e) other few small technical changes.