BS EN 62366-1:2015 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY.

This USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess and mitigate RISKS 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.

NOTE 1 SAFETY is freedom from unacceptable RISK. Unacceptable RISK can arise from USE ERROR, which can lead to exposure to direct physical HAZARDS or loss or degradation of clinical functionality.

NOTE 2 Guidance on the application of USABILITY ENGINEERING to MEDICAL DEVICES is available in IEC 62366-22, which addresses not only SAFETY but also aspects of USABILITY not related to SAFETY.

If the USABILITY ENGINEERING PROCESS detailed in this International Standard has been complied with, then the USABILITY of a MEDICAL DEVICE as it relates to SAFETY is presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary.

NOTE 3 Such OBJECTIVE EVIDENCE can subsequently originate from POST-PRODUCTION surveillance.


Cross References:
ISO 14971:2007
EN ISO 14971:2012
IEC 60601-1:2005
IEC 60601-1:2005/AMD1:2012
IEC 60601-1-6:2010
IEC 60601-1-6:2010/Amd1:2013
IEC 60601-1-8:2006
IEC 60601-1-8:2006/AMD1:2012
IEC 60601-1-11
IEC TR 61258:2008
ISO/IEC Guide 63:2012
ISO 7010:2011
ISO 9000:2005
ISO 9001:2008
ISO 9241-11:1998
ISO 13485:2003
ISO/TR 16142:2006
ANSI/AAMI HE 48:1993
ANSI/AAMI HE 74:2001
ANSI/AAMI HE 75:2009
EN 1041:2008
EN 1041:2008+A1:2013
GHTF SG2N31R8:2003


Together with PD IEC/TR 62366-2 (not yet published) it supersedes BS EN 62366:2008+A1:2015, which will be withdrawn on 31 March 2018

All current amendments available at time of purchase are included with the purchase of this document.