BS EN 60601-1-6:2010 specifies a process for a manufacturer to analyse, specify,
design, verify and validate usability, as it relates to basic safety and essential
performance of medical electrical equipment, hereafter referred to as ME equipment.
This usability engineering process assesses and mitigates risks caused by usability
problems associated with correct use and use errors, i.e., normal use. It can be used to
identify but does not assess or mitigate risks associated with abnormal use.
If the usability engineering process detailed in BS EN 60601-1-6:2010 has been complied
with and the acceptance criteria documented in the usability validation plan have been met
(see 5.9 of IEC 62366:2007), then the residual risks, as defined in ISO 14971, associated
with usability of ME equipment are presumed to be acceptable, unless there is objective
evidence to the contrary (see 4.1.2 of IEC 62366:2007).
Cross References:IEC 60601-1:2005
IEC 60601-1-8:2006
IEC 62366:2007
ISO 14971:2007
EN 60601-1:2006
EN 60601-1-8:2007
EN 62366:2008
EN ISO 14971:2009
ISO 9241-2:1992
ISO 9241-11:1998
ISO 9241-20:2008
ISO 9241-110:2006
ISO 9241-171:2008
ISO 9241-210
ISO 9241-300:2008
ISO 9241-302:2008
ISO 9241-303:2008
ISO 9241-304:2008
ISO 9241-305:2008
ISO 9241-307:2008
ISO 9241-400:2007
ISO 9241-410:2008
ISO 9241-920:2009
ISO 13407:1999
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
EN 29241:1993
EN ISO 9241-11:1998
EN ISO 9241-20:2009
EN ISO 9241-110:2006
EN ISO 9241-171:2008
EN ISO 9241-300:2008
EN ISO 9241-302:2008
EN ISO 9241-303:2008
EN ISO 9241-304:2008
EN ISO 9241-305:2008
EN ISO 9241-307:2008
EN ISO 9241-400:2007
EN ISO 9241-410:2008
EN ISO 13407:1999
Replaces BS EN 60601-1-6:2007 which remains current.
All current amendments available at time of purchase are included with the purchase of this document. | File Size : | 1
file
, 1.5 MB |
| ISBN(s) : | 9780580650376 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 26 |
| Product Code(s) : | 30191861, 30191861 |
| Published : | 05/31/2010 |
