BS PD IEC/TR 60601-4-1:2017旨在帮助制造商完成关键决策和 执行详细的风险管理和可用性工程需要采取的步骤 医用电气设备或医用电气系统的工艺，以下简称 称为MEE或MES，采用一定程度的自主权（DOA）。本文档提供MEE或MES和医疗机器人的DOA定义，以及 提供以下方面的指导:执行风险管理流程和可用性工程的方法 有DOA的MEE或MES；MEE和MES的基本安全和基本性能考虑 DOA；确定DOA的使用，以及现有ISO/IEC标准中处理DOA的类似概念 MEE或MES的目标是通过一致使用 DOA概念；区分医疗机器人和其他MEE和MES。 除非另有规定，本文件将MEE和MES一并考虑。具有DOA的MEE或MES的制造商应设计和制造 MEE或MES满足其预期用途，且在整个使用过程中没有不可接受的风险 生命周期。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对带有 多阿。本文件还旨在为未来的标准编写者提供指导。本文档没有任何先决条件。交叉引用:IEC 62304:2006/AMD1:2015IEC 80001-1:2010IEC 62304:2006IEC 62366-1:2015ISO 14971:2007第2版（R10）IEC TR 62390: 2.2.2.2.2 2.2.2 2.2.2.2.2.2 2.2 2.2 2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-1-2-2-2-2-2-1-1-1-1-1-1-1-1-1-1-1-1-1-1-1-1-1-1-1-1-1-1-1-1-1-1-1-1-1-1-1-2004:Ed 1IEC 80601-2-30:2009/AMD1:2013IEC60601-2-21:2009/AMD1:2016ISO 22675:2016IEC 60601-2-23:2011 Ed 3IEC 60601-2-33:2010ISO 8373:2012ISO 13485:2003 Ed 2IEC 60601- 3.1.1:1:1:1:1:1:1:3:3:3:3:3:3:3:3:3:3:3:3:3:3:1:1:1:1:1:1:3:3:3:3:3:3:1:1:1:1:1:1:1:1:3:1:3:3:3:3:3:3:3:3:3:3:3:3:3:3:3 ISO/3）ISO/3/3:3:3:3:3:3:3:3:1:3:3:3:3:3:3:3:3:3:3:3:3:3:3:3:3:3:3:3:3:3:3:3:3:3:3:3:3:3:3:3:3:3:3 ISO/3:3:3:3:3 ISO（ISO（3）ISO/3:3:3:3:3 3时间:20082007/47/ECIEC 60601IEC80001ISO 80601-2-61:2011版1IEC 60601-2-39:2007版2IEC 62443-3-2013版1ISO 80601-2-13:2011ISO 22523: 2.10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 2 2 2 2 2 2 2 2 2 2 2 2 2 2-2 2 2 2 2 2 2 2-2 2 2-2 2 2 2-2 2 2-2 2-2 2-2 2-2-2-2-2-2-2-2 2-2 2 2-2-1 1 1 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 45:2011/AMD1:2015IEC 60601-2-26:2012 ED3IEC80601-2-30:2009IEC 60601-2-18:2009版3IEC TR 61850-90-7:2013IEC 60601-2-27:2011版3IEC 60601- 2-68:2014 ED1ISO 80601-2-56:2017IEC 60601-2-19:2009IEC 6购买时可用的所有现行修订版均包含在本文件的购买中。

BS PD IEC/TR 60601-4-1:2017 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; andidentifying 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; anddistinguishing 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.Cross References:IEC 62304:2006/AMD1:2015IEC 80001-1:2010IEC 62304:2006IEC 62366-1:2015ISO 14971:2007 Ed 2 (R10) IEC TR 62390:2005IEC 60050-151:2001 Ed 2IEC 60601-2-49:2011 Ed 2IEC 60601-2-24:2012 ED2IEC 60730-1:2013/AMD1:2015IEC 60601-2-37:2007 Ed 2IEC 60601-2-54:2009/AMD1:2015IEC 60601-2-5:2009ISO 14155:2011ISO 11135-1:2007 Ed 1IEC 60601-2-1:2009 Ed 3IEC 60601-2-16:2012IEC 60601-2-2:2017EN 12184:2009ISO 80601-2-12:2011 Ed 1IEC 60601-1-10:2007 Ed 1ISO 17664:2004 Ed 1IEC 80601-2-30:2009/AMD1:2013IEC 60601-2-21:2009/AMD1:2016ISO 22675:2016IEC 60601-2-23:2011 Ed 3IEC 60601-2-33:2010ISO 8373:2012ISO 13485:2003 Ed 2IEC 60601-2-33:2010/AMD1:2013ISO/IEC Guide 71:2014 ED2IEC 60601-1-10:2007/AMD1:2013ISO/TR 24971:2013 ED1ISO 11137-1:2006 Ed 1IEC 60601-2-31:2008 Ed 2IEC 60947-2:2006 Cons Ed 4-1IEC 60601-2-43:2010IEC 60601-2-37:2007/AMD1:2015ISO/IEC Guide 63:2012 Ed 2IEC 60601-2-66:2015IEC 60601-2-20:2009/AMD1:2016ISO/IEC GUIDE 2:2004 Ed 8IEC 60601-2-54:2009 Ed 1ISO 10535:2006 Ed 2IEC 80601-2-59:20082007/47/ECIEC 60601IEC 80001ISO 80601-2-61:2011 Ed 1IEC 60601-2-39:2007 Ed 2IEC 62443-3-3:2013 ED1ISO 80601-2-13:2011ISO 22523:2006 Ed 1IEC 60601-2-33:2010/AMD2:2015IEC 60601-2-10:2012IEC 60601-2-19:009/AMD1:2016IEC 60601-2-45:2011 Ed 3ISO 80601-2-55:2011 Ed 1ISO 16201:2006 Ed 1IEC 60601-2-4:2010 Ed 3IEC 60601-2-25:2011 Ed 2IEC 60601-2-41:2009 Ed 2EN 1985:1998IEC 60601-2-21:2009IEC 60601-2-20:2009ISO 13482:2014 ED1IEC 60601-2-41:2009/AMD1:2013ISO 11137-2:2013 ED3IEC 60601-2-45:2011/AMD1:2015IEC 60601-2-26:2012 ED3IEC 80601-2-30:2009IEC 60601-2-18:2009 Ed 3IEC TR 61850-90-7:2013IEC 60601-2-27:2011 Ed 3IEC 60601-2-68:2014 ED1ISO 80601-2-56:2017IEC 60601-2-19:2009IEC 6All current amendments available at time of purchase are included with the purchase of this document.