BS PD IEC/TR 60601-4-1:2017 is intended to help a MANUFACTURER through the key decisions andsteps to be taken to perform a detailed RISK MANAGEMENT and USABILITY ENGINEERINGPROCESSES for MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM, hereafterreferred 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 alsoprovides guidance on:
- methodologies to perform the RISK MANAGEMENT PROCESS and USABILITY ENGINEERING for anMEE or MES with a DOA;
- considerations of BASIC SAFETY and ESSENTIAL PERFORMANCE for an MEE and MES with aDOA; and
- identifying the use of DOA, and similar concepts in existing ISO/IEC standards dealing withMEE or MES with the goal to facilitate alignment of standards by consistent use of theconcept 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 anMEE or MES that fulfils its INTENDED USE and does not have unacceptable RISK throughout itsLIFE-CYCLE.This document provides guidance to help the MANUFACTURER in complying with therequirements of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 for MEE and MES withDOA. 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 60601-2-43:2010 IEC 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 8 IEC 60601-2-54:2009 Ed 1ISO 10535:2006 Ed 2IEC 80601-2-59:2008 2007/47/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 ED3 IEC 80601-2-30:2009IEC 60601-2-18:2009 Ed 3IEC TR 61850-90-7:2013 IEC 60601-2-27:2011 Ed 3IEC 60601-2-68:2014 ED1ISO 80601-2-56:2017 IEC 60601-2-19:2009IEC 6
