血液透析治疗用医疗设备安全操作指南

[中文适用范围]： 本文档描述了在慢性血液透析、血液过滤和血液透析过滤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。 本文档中使用术语“血液透析”作为所有治疗方式的同义词。 本范围可适用于家庭、急症和儿科环境中医疗设备的使用。本范围也可能适用于吸附透析系统。 医生负责治疗处方。然而，负责治疗的机构负责与治疗相关的所有资源、结构和流程。这些责任将不在此处描述。 IEC 60601-2-16的要求确保用于体外肾脏替代治疗的医疗电气设备以高水平的安全性运行。尽管有这种高水平的安全性，但仍存在一些与医学生物、物理化学和技术危害相关的残余风险。负责治疗的机构负责管理残余风险。 本文档不打算用作监管检查或认证评估活动的基础。 [外文原描述]： 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.