IEC TR 60601-4-1:2017 医用电气设备第4-1部分:指南和解释采用一定自治度的医用电气设备和医用电气系统

标准编号：IEC TR 60601-4-1:2017

中文名称：医用电气设备第4-1部分:指南和解释采用一定自治度的医用电气设备和医用电气系统

英文名称：Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy

发布日期：2017-05-22

标准范围

IEC TR 60601-4-1:20 17（E）旨在帮助制造商完成关键决策和步骤，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，采用自主程度（DOA）。本文件提供了MEE或MES和医疗机器人的DOA的定义，还提供了以下方面的指导:-为具有DOA的MEE或MES执行风险管理过程和可用性工程的方法；-具有DOA的MEE和MES的基本安全和基本性能的考虑；和-确定DOA的使用以及处理MEE或MES的现有ISO/IEC标准中的类似概念，目标是通过一致使用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，本文件将MEE和MES一起考虑。具有DOA的MEE或MES的制造商应设计和制造满足其预期用途且在其整个生命周期内不存在不可接受风险的MEE或MES。本文件提供了指导，以帮助制造商遵守IEC 60601-1:20 05和IEC 60601-1:20 05/AMD1:2012对MEE和MES的DOA要求。该文档也旨在为未来的标准编写者提供指导。本文件没有先决条件。

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.

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