医疗电气设备. 第4-1部分: 指南和说明. 高度自治的医疗电气设备和医疗电气系统

[中文适用范围]： IEC 60601 的本部分旨在帮助制造商做出关键决策和采取的步骤，以执行医疗电气设备或医疗电气系统（以下简称 MEE 或 MES）的详细风险管理和可用性工程流程，采用自主度 (DOA)。本文件提供了 MEE 或 MES 和医疗机器人的 DOA 定义，并提供了以下方面的指导： 针对具有 DOA 的 MEE 或 MES 执行风险管理流程和可用性工程的方法；对具有 DOA 的 MEE 和 MES 的基本安全和基本性能的考虑；和;确定 DOA 以及涉及 MEE 或 MES 的现有 ISO/IEC 标准中类似概念的使用，目的是通过一致使用 DOA 概念来促进标准的一致性；和;区分医疗机器人和其他 MEE 和 MES。除非另有说明，本文档将 MEE 和 MES 一起考虑。具有 DOA 的 MEE 或 MES 制造商应设计和制造满足其预期用途且在整个生命周期中不存在不可接受的风险的 MEE 或 MES。本文件提供指导，帮助制造商遵守 IEC 60601-1:2005 和 IEC 60601-1:2005/AMD1:2012 对于带有 DOA 的 MEE 和 MES 的要求。该文件还旨在为未来的标准制定者提供指导。本文档没有任何先决条件。 [外文原描述]： IEC TR 60601-4-1:2017(E) is intended to help a manufacturer through the key decisions and steps to be taken to perform a detailed risk management and usability engineering processes for medical electrical equipment or a medical electrical system, hereafter referred to as MEE or MES, employing a degree of autonomy (DOA). This document provides a definition of DOA of MEE or MES and a medical robot, and also provides guidance on: - methodologies to perform the risk management process and usability engineering for an MEE or MES with a DOA; - considerations of basic safety and essential performance for an MEE and MES with a DOA; and - identifying the use of DOA, and similar concepts in existing ISO/IEC standards dealing with MEE or MES with the goal to facilitate alignment of standards by consistent use of the concept of DOA; and - distinguishing between medical robots, and other MEE and MES. Unless specified otherwise, this document considers MEE and MES together. The manufacturer of an MEE or MES with a DOA is expected to design and manufacture an MEE or MES that fulfils its intended use and does not have unacceptable risk throughout its life-cycle. This document provides guidance to help the manufacturer in complying with the requirements of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 for MEE and MES with DOA. The document is also intended as guidance for future standard writers. There are no prerequisites to this document.