医用电气设备 第2-16部分：血液透析、血液透析滤过和血滤器的基本安全和主要性能特殊要求

[中文适用范围]： IEC 60601-1 的此部分适用于血液透析、血液透析滤过和血液过滤设备的基本安全和基本性能，后文简称为血液透析设备。它适用于旨在由医疗人员使用或在医疗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，无论该设备是在医院还是家庭环境中使用。如果某个条款或子条款专门适用于仅医疗设备或仅医疗系统，则该条款或子条款的标题和内容会明确说明。如果并非如此，则该条款或子条款适用于相关医疗设备或相关医疗系统。本文档不考虑使用再生透析液或透析液中央输送系统的血液透析设备中透析液控制系统的具体安全细节。然而，本文档确实考虑了此类血液透析设备关于电气安全和患者安全的具体安全要求。本文档规定了血液透析设备的最小安全要求。这些血液透析设备旨在由医疗人员使用，或由患者或其他经培训的人员在医疗监督下使用。本文档包括所有旨在向患者提供血液透析、血液透析滤过和血液过滤治疗的医疗设备，无论治疗持续时间或地点如何。如适用，本文档适用于旨在用于其他体外血液净化治疗的相关部分的医疗设备。本文档中的特定要求不适用于：体外循环回路（见 ISO 8637-2）；透析器（见 ISO 8637-1）；透析液浓缩液（见 ISO 23500-4）；预制的透析液袋；透析水供应系统（见 ISO 23500-2）；用于透析液浓缩液的中央输送系统（见 ISO 23500-4），即透析中心批量混合浓缩液的系统；用于腹膜透析的设备（见 IEC 60601-2-39）。 [外文原描述]： 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.