医用电气设备 第2-16部分：血液透析 血液透析滤过和血液滤过设备基本安全和基本性能的特殊要求（3.0版）

[中文适用范围]： 本国际标准适用于医疗电气设备和医疗电气系统@以下简称ME设备和ME系统的基本安全和基本性能。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 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 4.2。本标准也适用于用于补偿或减轻疾病、伤害或残疾的设备。 IEC 61010 系列 2) 涵盖了不属于 ME 设备定义范围的体外诊断设备。本标准不适用于 ISO 14708-13 涵盖的有源植入式医疗器械的植入部分。该特定标准规定了单个患者血液透析@血液过滤和血液过滤设备（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HAEMODIALYSIS@HAEMODIAFILTRATION 和HAEMOFILTRATION 设备。这些特殊要求不适用于??C 体外回路@??C 透析器@??C 透析液浓缩物@??C 水净化设备@??C 用于进行腹膜透析的设备（参见IEC 60601-2-39） .2) IEC 61010（所有部分）@ 用于测量@控制@和实验室使用的电气设备的安全要求 3) ISO 14708-1@ 手术植入物 ?C 有源植入式医疗设备 ?C 第 1 部分：安全的一般要求@ 标记以及制造商提供的信息 [外文原描述]： IEC 60601-2-16:2008 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2008 does not take into consideration the dialysing fluid control system of Haemodialysis equipment using regeneration of dialysing 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 60601-2-16:2008 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 60601-2-16:2008 includes all medical electrical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This third edition cancels and replaces the second edition of IEC 60601-2-16, published in 1998. This edition constitutes a technical revision. Changes since the previous edition include, among others, a summary of additional essential performance requirements, revision of terms and definitions, classification of applied parts and limits as numbers for protection against hazardous outputs, in the annex. The contents of the corrigendum of October 2008 have been included in this copy.