IEC 60601-2-16:20 25 RLV包含官方IEC国际标准及其红线版本。Redline版本仅提供英文版本，为您提供了一种快速简单的方法来比较IEC官方标准与其以前版本之间的所有变化。 IEC 60601-2-16:20 25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）的基本安全性和基本性能。它适用于供医务人员使用或在医学专家监督下使用的血液透析设备，包括由患者操作的血液透析设备，无论血液透析设备是在医院还是在家庭环境中使用。如果一个条款或子条款特别旨在仅适用于ME设备，或仅适用于ME系统，该条款或子条款的标题和内容将如此说明。如果不是这种情况，该条款或子条款适用于相关的ME设备和ME系统。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的透析液控制系统的具体安全细节。然而，它确实考虑了这种血液透析设备关于电气安全和患者安全的特定安全要求。本文件规定了血液透析设备的最低安全要求。这些血液透析设备旨在供医务人员使用，或供患者或其他受过培训的人员在医疗监督下使用。本文件包括旨在向患者提供血液透析、血液透析滤过和血液滤过治疗的所有ME设备，与治疗持续时间和位置无关。如果适用，本文件适用于用于其他体外血液净化治疗的ME设备的相关部件。 本文件中的特殊要求不适用于: -体外回路(参见ISO 8637-2)， -透析器(参见ISO 8637-1[2])， -透析液浓缩物(参见ISO 23500-4)， -预制透析液袋， -透析供水系统(参见ISO 23500-2)， -用于透析流体浓缩物的中央递送系统(参见ISO 23500-4)，描述为用于在透析设施中批量混合浓缩物的系统， -用于进行腹膜透析的设备（参见IEC 60601-2-39）。 IEC 60601-2-16:20 24取消并取代了2018年发布的第五版。本版构成技术修订版。 与上一版相比，此版本包括以下重大技术变更:a)更新IEC 60601的参考文献？1:20 05，IEC 60601？1:20 05/AMD1:2012和IEC 60601？1:20 05/AMD2:2020，参考IEC 60601？1？2:20 14和IEC 60601？1？2:20 14/AMD1:20 20，参考IEC 60601？1？8:20 06，IEC 60601？1？8:20 06/AMD1:2012和IEC 60601？1？8:20 06/AMD2:2020，参考IEC 60601？1？9:20 07，IEC 60601？1？9:20 07/AMD1:2013和IEC 60601？1？9:20 07/AMD2:2020，参考IEC 60601？1？10:20 07，IEC 60601？1？10:20 07/AMD1:2013和IEC 60601？1？10:20 07/AMD2:2020以及IEC 60601的参考文献？1？11:20 15和IEC 60601？1？11:20 5/AMD1:2020； b)关于IEC 60601的单故障条件下基本性能的考虑？1:05 5/AMD1:2012/ISH1:2021； c)包括文件62D/1771A/INF中提供的关于201.11.8的信息； d)包括已撤回的IEC PAS 63023作为附件CC；e)包括安全（网络安全）要求； f)考虑使用预制透析液袋的血液透析设备； g)标签的改进； h)其他小的技术改进； ㈠编辑方面的改进。

IEC 60601-2-16:2025 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition.

IEC 60601-2-16:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT. It applies to HAEMODIALYSIS EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including HAEMODIALYSIS EQUIPMENT operated by the PATIENT, regardless of whether the HAEMODIALYSIS EQUIPMENT is used in a hospital or domestic environment. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. 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),
– DIALYSERS (see ISO 8637-1 [2]),
– DIALYSIS FLUID CONCENTRATES (see ISO 23500-4),
– pre-manufactured DIALYSIS FLUID bags,
– DIALYSIS WATER supply systems (see ISO 23500-2),
– CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID CONCENTRATES (see ISO 23500-4), described as systems for bulk mixing concentrate at a dialysis facility,
– equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39).
IEC 60601-2-16:2024 cancels and replaces the fifth edition published in 2018. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) update of references to IEC 60601？1:2005, IEC 60601？1:2005/AMD1:2012 and IEC 60601？1:2005/AMD2:2020, of references to IEC 60601？1？2:2014 and IEC 60601？1？2:2014/AMD1:2020, of references to IEC 60601？1？8:2006, IEC 60601？1？8:2006/AMD1:2012 and IEC 60601？1？8:2006/AMD2:2020, of references to IEC 60601？1？9:2007, IEC 60601？1？9:2007/AMD1:2013 and IEC 60601？1？9:2007/AMD2:2020, of references to IEC 60601？1？10:2007, IEC 60601？1？10:2007/AMD1:2013 and IEC 60601？1？10:2007/AMD2:2020 and of references to IEC 60601？1？11:2015 and IEC 60601？1？11:2015/AMD1:2020;
b) consideration of ESSENTIAL PERFORMANCE in SINGLE FAULT CONDITION regarding IEC 60601？1:2005/AMD1:2012/ISH1:2021;
c) including the information given in the document 62D/1771A/INF regarding 201.11.8;
d) including withdrawn IEC PAS 63023 as Annex CC;
e) including SECURITY (CYBERSECURITY) requirements;
f) consideration of HAEMODIALYSIS EQUIPMENT using pre-manufactured DIALYSIS FLUID bags;
g) improvements for labelling;
h) other minor technical improvements;
i) editorial improvements.