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About This Item
Full Description
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.
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.