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; 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.


Cross References:
IEC 62304:2006/AMD1:2015
IEC 80001-1:2010
IEC 62304:2006
IEC 62366-1:2015
ISO 14971:2007 Ed 2 (R10) IEC TR 62390:2005
IEC 60050-151:2001 Ed 2
IEC 60601-2-49:2011 Ed 2
IEC 60601-2-24:2012 ED2
IEC 60730-1:2013/AMD1:2015
IEC 60601-2-37:2007 Ed 2
IEC 60601-2-54:2009/AMD1:2015
IEC 60601-2-5:2009
ISO 14155:2011
ISO 11135-1:2007 Ed 1
IEC 60601-2-1:2009 Ed 3
IEC 60601-2-16:2012
IEC 60601-2-2:2017
EN 12184:2009
ISO 80601-2-12:2011 Ed 1
IEC 60601-1-10:2007 Ed 1
ISO 17664:2004 Ed 1
IEC 80601-2-30:2009/AMD1:2013
IEC 60601-2-21:2009/AMD1:2016
ISO 22675:2016
IEC 60601-2-23:2011 Ed 3
IEC 60601-2-33:2010
ISO 8373:2012
ISO 13485:2003 Ed 2
IEC 60601-2-33:2010/AMD1:2013
ISO/IEC Guide 71:2014 ED2
IEC 60601-1-10:2007/AMD1:2013
ISO/TR 24971:2013 ED1
ISO 11137-1:2006 Ed 1
IEC 60601-2-31:2008 Ed 2
IEC 60947-2:2006 Cons Ed 4-1
IEC 60601-2-43:2010
IEC 60601-2-37:2007/AMD1:2015
ISO/IEC Guide 63:2012 Ed 2
IEC 60601-2-66:2015
IEC 60601-2-20:2009/AMD1:2016
ISO/IEC GUIDE 2:2004 Ed 8
IEC 60601-2-54:2009 Ed 1
ISO 10535:2006 Ed 2
IEC 80601-2-59:2008
2007/47/EC
IEC 60601
IEC 80001
ISO 80601-2-61:2011 Ed 1
IEC 60601-2-39:2007 Ed 2
IEC 62443-3-3:2013 ED1
ISO 80601-2-13:2011
ISO 22523:2006 Ed 1
IEC 60601-2-33:2010/AMD2:2015
IEC 60601-2-10:2012
IEC 60601-2-19:009/AMD1:2016
IEC 60601-2-45:2011 Ed 3
ISO 80601-2-55:2011 Ed 1
ISO 16201:2006 Ed 1
IEC 60601-2-4:2010 Ed 3
IEC 60601-2-25:2011 Ed 2
IEC 60601-2-41:2009 Ed 2
EN 1985:1998
IEC 60601-2-21:2009
IEC 60601-2-20:2009
ISO 13482:2014 ED1
IEC 60601-2-41:2009/AMD1:2013
ISO 11137-2:2013 ED3
IEC 60601-2-45:2011/AMD1:2015
IEC 60601-2-26:2012 ED3
IEC 80601-2-30:2009
IEC 60601-2-18:2009 Ed 3
IEC TR 61850-90-7:2013
IEC 60601-2-27:2011 Ed 3
IEC 60601-2-68:2014 ED1
ISO 80601-2-56:2017
IEC 60601-2-19:2009
IEC 6


All current amendments available at time of purchase are included with the purchase of this document.