Full Description

This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT.

Cross References:
IEC 60601-1:2005
IEC 60601-1:2005/A1:2012
EN 60601-1:2006
EN 60601-1:2006/Corrigendum 1:2010
EN 60601-1:2006/A1:2013
EN 60601-1:2006/A1:2013/Corrigendum 1:2014
EN 60601-1:2006/A12:2014
IEC 60601-1-8:2006
IEC 60601-1-8:2006/A1:2012
EN 60601-1-8:2007
EN 60601-1-8:2007/A1:2013
EN 60601-1-8:2007/A1:2013/Corrigendum 1:2014
IEC 62366:2007
IEC 62366:2007/A1:2014
EN 62366:2008
EN 62366:2008/A1:2015
ISO 14971:2007
EN ISO 14971:2009
ISO 9241-2:1992
EN 29241:1993
ISO 9241-11:1998
EN ISO 9241-11:1998
ISO 9241-20:2008
EN ISO 9241-20:2009
ISO 9241-110:2006
EN ISO 9241-110:2006
ISO 9241-171:2008
EN ISO 9241-171:2008
ISO 9241-300:2008
EN ISO 9241-300:2008
ISO 9241-302:2008
EN ISO 9241-302:2008
ISO 9241-303:2008
EN ISO 9241-303:2008
ISO 9241-304:2008
EN ISO 9241-304:2008
ISO 9241-305:2008
EN ISO 9241-305:2008
ISO 9241-307:2008
EN ISO 9241-307:2008
ISO 9241-400:2007
EN ISO 9241-400:2007
ISO 9241-410:2008
EN ISO 9241-410:2008
ISO 13407:1999
EN ISO 13407:1999
90/385/EEC
ISO 9241-210
ISO 9241-920:2009
ISO/IEC 14598-1:1999
ISO/IEC 14598-2:2000
ISO/IEC 14598-3:2000
ISO/IEC 14598-4:1999
ISO/IEC 14598-5:1998
ISO/IEC 14598-6:2001
ISO/IEC 15910:1999
ISO/TR 16982:2002
ISO/IEC 18019:2004
ISO/IEC 25062:2006
ANSI/AAMI HE 74:2001


Replaces BS EN 60601-1-6:2010 which remains current

Incorporates the following:
Amendment, July 2021. Amends and replaces BS EN 60601-1-6:2010 which remains current