PD IEC/TR 60601-4-1:2017 - Medical electrical equipment. Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy

PD IEC/TR 60601-4-1:2017

Medical electrical equipment. Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy

Status : Current   Published : June 2017

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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.




Standard NumberPD IEC/TR 60601-4-1:2017
TitleMedical electrical equipment. Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy
StatusCurrent
Publication Date23 June 2017
Normative References(Required to achieve compliance to this standard)IEC 62304:2006/AMD1:2015, IEC 80001-1:2010, IEC 62304:2006, IEC 62366-1:2015, ISO 14971:2007
Informative References(Provided for Information)IEC TR 62390:2005, IEC 60050-151:2001, IEC 60601-2-49:2011, IEC 60601-2-24:2012, IEC 60730-1:2013/AMD1:2015, IEC 60601-2-37:2007, IEC 60601-2-54:2009/AMD1:2015, IEC 60601-2-5:2009, ISO 14155:2011, ISO 11135-1:2007, IEC 60601-2-1:2009, IEC 60601-2-16:2012, IEC 60601-2-2:2017, EN 12184:2009, ISO 80601-2-12:2011, IEC 60601-1-10:2007, ISO 17664:2004, IEC 80601-2-30:2009/AMD1:2013, IEC 60601-2-21:2009/AMD1:2016, ISO 22675:2016, IEC 60601-2-23:2011, IEC 60601-2-33:2010, ISO 8373:2012, ISO 13485:2003, IEC 60601-2-33:2010/AMD1:2013, ISO/IEC Guide 71:2014, IEC 60601-1-10:2007/AMD1:2013, ISO/TR 24971:2013, ISO 11137-1:2006, IEC 60601-2-31:2008, IEC 60947-2:2006, IEC 60601-2-43:2010, IEC 60601-2-37:2007/AMD1:2015, ISO/IEC Guide 63:2012, IEC 60601-2-66:2015, IEC 60601-2-20:2009/AMD1:2016, ISO/IEC GUIDE 2:2004, IEC 60601-2-54:2009, ISO 10535:2006, IEC 80601-2-59:2008, 2007/47/EC, IEC 60601, IEC 80001, ISO 80601-2-61:2011, IEC 60601-2-39:2007, IEC 62443-3-3:2013, ISO 80601-2-13:2011, ISO 22523:2006, IEC 60601-2-33:2010/AMD2:2015, IEC 60601-2-10:2012, IEC 60601-2-19:2009/A
International RelationshipsIEC TR 60601-4-1:2017
DescriptorsElectronic engineering, Medical electronics, Robots, Manufacturers, Medical electrical equipment
ICS11.040.01
33.160.30
CommitteeCH/62/1
ISBN978 0 580 84736 3
PublisherBSI
FormatA4
DeliveryYes
Pages84
File Size1.785 MB
Price£280.00


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