IEC TR 62653:2020 血液透析治疗用医疗设备安全操作指南

标准编号：IEC TR 62653:2020

中文名称：血液透析治疗用医疗设备安全操作指南

英文名称：Guideline for safe operation of medical equipment used for haemodialysis treatments

发布日期：2020-04-17

标准范围

IEC TR 62653:2020作为IEC TR 62653:2020 RLV提供，其中包含国际标准及其红线版本，显示了与上一版本相比技术内容的所有变化。IEC TR 62653:2020描述了在慢性血液透析、血液滤过和血液透析滤过中使用医疗设备的技术建议。遵守这些原则对于确保安全、允许和适当的应用非常重要。术语血液透析在本文中用作所有治疗方式的同义词。该范围可适用于家庭、急症和儿科环境中使用的医疗设备。该范围还可适用于吸附剂透析系统。医生负责治疗处方。然而，管理治疗的组织负责与治疗相关的所有资源、结构和过程。这些职责在此不再赘述。IEC 60601-2-16的要求确保用于体外肾脏替代治疗的医用电气设备以高水平的安全性运行。然而，尽管安全性很高，但仍然存在一些与医学-生物、物理-化学和技术危害有关的残余风险。管理治疗的组织负责管理剩余风险。本文件不打算用作监管检查或认证评估活动的基础。IEC TR 62653:2020取消并取代2012年发布的第一版。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ISO 23500系列新编号方案的相关参考；b)与IEC 60601-1:20 05和IEC 60601-1:20 5/AMD1:2012、IEC 62353:2014和60601-2-16:20 18一致；c)几个部分的技术补充。

IEC TR 62653:2020 is available as IEC TR 62653:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

IEC TR 62653:2020 describes the technical recommendations for use of medical equipment in chronic Haemodialysis, Haemofiltration and Haemodiafiltration. These principles are important to be complied with to ensure safe, permissible and appropriate application. The term Haemodialysis is used in this document as synonym for all therapy modalities.
The scope can be applicable to the use of the medical equipment in home, acute and pediatrics environment. The scope may also be applicable to Sorbent Dialysis Systems.
The physician is responsible for the treatment prescription. However, the Organization administering the treatment is responsible for all resources, structures and processes used in connection with the treatment. These responsibilities will not be described here. The requirements of IEC 60601-2-16 ensure that medical electrical equipment used for extracorporeal renal replacement therapy operates with a high level of safety. Despite that high level of safety, however, some residual risk remains, related to medical-biological, physical-chemical and technical Hazards. The Organization administering the treatment is responsible for managing the residual risk. This document is not intended to be used as the basis of regulatory inspection or certification assessment activities. IEC TR 62653:2020 cancels and replaces the first edition published in 2012. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) update the relevant references to the new numbering scheme of the ISO 23500 family;
b) alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, IEC 62353:2014 and 60601-2-16:2018;
c) technical additions in several sections.

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