BS EN IEC 62366-1:2015+A1:2020

BS EN 62366-1:2015+A1:2020

Medical devices. Application of usability engineering to medical devices

Status : Current   Published : June 2015



What is this standard about?

Medical devices are increasingly used to observe and treat patients, and are becoming more complicated. Yet at the same time, they’re now often used by less-skilled individuals, including by patients themselves. To eliminate user error devices need to be intuitive and easy to use. These qualities can be developed efficiently by the use of a usability engineering process during the device’s development. This standard helps manufacturers improve usability by setting out an appropriate usability engineering process.  

Who is this standard for?

Manufacturers of medical equipment and systems.

Why should you use this standard?

It specifies a process with which manufacturers can analyse, specify, develop and evaluate the usability of a medical device as it relates to safety in normal use. The process is intended to identify and minimize use errors and thereby reduce use-associated risks.

What’s changed since the last update?

This amended standard replaces BS EN 62366-1:2015. Since that document’s publication experts have identified several inaccuracies which warranted correction, although note that the amendment makes no fundamental changes to the usability engineering process as set out in the 2015 standard.

Standard NumberBS EN 62366-1:2015+A1:2020
TitleMedical devices. Application of usability engineering to medical devices
Publication Date30 June 2015
Normative References(Required to achieve compliance to this standard)EN ISO 14971:2019, ISO 14971:2019, EN ISO 14971:2012, ISO 14971:2007
Informative References(Provided for Information)IEC TR 61258:2008, EN ISO 9001:2008, ISO 9001:2008, ISO 7010:2011, A1:2013, EN 60601-1-6:2010, A1:2012, AAMI HE 74:2001, GHTF SG2N31R8:2003, AAMI HE 75:2009, IEC 60601-1-8:2006, EN ISO 7010:2012, EN ISO 13485:2012, IEC 60601-1-11, IEC 60601-1:2005, EN 60601-1:2006, AAMI HE 48:1993, IEC 60601-1-6:2010, EN 60601-1-11, EN 60601-1-8:2007, EN ISO 9000:2005, EN ISO 9241-11:1998, TR 16142:2006, IEC Guide 63:2012, EN 60601-1-11:2015, EN 1041:2008, ISO 9241-11:1998, EN 1041:2008+A1:2013, EN ISO 13485:2016, EN ISO 9000:2015, ISO 9000:2015, EN ISO 9001:2015, ISO 13485:2016, IEC 60601-1-11:2015, ISO 9001:2015, ISO 13485:2003, ISO 9000:2005
ReplacesBS EN 62366:2008+A1:2015
International RelationshipsEN 62366-1:2015/A1:2020,IEC 62366-1:2015/AMD1:2020
Amended ByAmendment, August 2020; Corrigendum, January 2016
Draft Superseded By18/30359002 DC
DescriptorsHazards, Medical technology, Ergonomics, Instructions for use, Equipment safety, Design, Medical equipment, Medical instruments
Title in FrenchDispositifs médicaux Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux
Title in GermanMedizinprodukte Anwendung der Gebrauchstauglichkeit auf Medizinprodukte
ISBN978 0 580 98164 7
File Size2.763 MB

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