This part of IEC 80601 applies to the general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ROBOTS that physically interact with a PATIENT with an IMPAIRMENT to support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the PATIENT?S MOVEMENT FUNCTIONS, as intended by the MANUFACTURER.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

Cross References:
IEC 60601-1-2:2014
IEC 60601-1-6:2010
IEC 60601-1-10:2007
EN 62366-1:2015/AC:2015
IEC 60601-1-11:2015
EN 60601-1-10:2008
ISO 22523:2006
ISO 14971:2007
EN 62366-1:2015
IEC 60601-1-8:2006
IEC 62366-1:2015
EN 60601-1-6:2010
EN 60601-1-2:2015
EN 60601-2-33
ISO 10535:2006
IEC 61924-2:2012
IEC TR 62366-2:2016
EN 60601-1-9:2008
IEC 60601-1-2:2007
EN ISO 10535:2006
ISO 13482:2014
ISO 9999:2016
IEC TR 60601-4-1:2017
EN ISO 9999 (ISO 9999:2016) AS
EN ISO 10218-1:2011
EN ISO 13482:2014
ISO 10218-1:2011
EN ISO 11064-7:2006
ISO 11064-7:2006
EN 61924-2:2013
IEC 60601-1-9:2007
ISO 8373:2012


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