范围:IEC 60601的本部分适用于血液透析、血液透析滤过和血液滤过设备（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或透析液中央输送系统的血液透析设备透析液控制系统的具体安全细节。然而，它确实考虑了此类血液透析设备在电气安全和患者安全方面的具体安全要求。本文件规定了血液透析设备的最低安全要求。 这些血液透析设备可供医务人员使用，也可供患者或在医疗监督下接受过培训的其他人员使用。本文件包括旨在为患者提供血液透析、血液透析滤过和血液滤过治疗的所有医用电气设备，与治疗持续时间和地点无关。如果适用，本文件适用于其他体外血液净化治疗用医用电气设备的相关部分。本文件中的特殊要求不适用于:体外电路（见ISO 8637-2，[12]2）；透析器（见ISO 8637-1[11]）； 透析液浓缩物（见ISO 23500-4[18]）；透析供水系统（见ISO 23500-2[16]）；透析液浓缩液的中央输送系统（见ISO 23500-4[18]），描述为透析设施中的散装混合浓缩液系统；用于进行腹膜透析的设备（见IEC 60601-2-39[8]）。目的:本特殊标准的目的是建立血液透析设备的基本安全和基本性能要求。

Scope:This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT.This document does not take into consideration specific safety details of the DIALYSIS FLUID control system of HAEMODIALYSIS EQUIPMENT using regeneration of DIALYSIS FLUID or CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID. It does, however, take into consideration the specific safety requirements of such HAEMODIALYSIS EQUIPMENT concerning electrical safety and PATIENT safety.This document specifies the minimum safety requirements for HAEMODIALYSIS EQUIPMENT. These HAEMODIALYSIS EQUIPMENT are intended for use either by medical staff or for use by the PATIENT or other trained personnel under medical supervision.This document includes all ME EQUIPMENT that is intended to deliver a HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION treatment to a PATIENT, independent of the treatment duration and location.If applicable, this document applies to the relevant parts of ME EQUIPMENT intended for other extracorporeal blood purification treatments.The particular requirements in this document do not apply to:EXTRACORPOREAL CIRCUITS (see ISO 8637-2, [12]2);DIALYSERS (see ISO 8637-1, [11]);DIALYSIS FLUID CONCENTRATES (see ISO 23500-4, [18]);DIALYSIS WATER supply systems (see ISO 23500-2, [16]);CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID CONCENTRATES (see ISO 23500-4, [18]), described as systems for bulk mixing concentrate at a dialysis facility;equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39, [8]).Object: The object of this particular standard is to establish BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for HAEMODIALYSIS EQUIPMENT.