PD IEC/TR 62366-2 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices

PD IEC/TR 62366-2:2016

Medical devices. Guidance on the application of usability engineering to medical devices

Status : Current   Published : May 2016

Format
PDF

Format
HARDCOPY



What is this standard about?

Medical practice is increasingly using medical devices for observation and treatment of patients. Use errors caused by inadequate medical device usability have become an increasing cause for concern. Many of the medical devices developed without applying a usability engineering process are non-intuitive, difficult to learn and difficult to use. They can also include design shortcomings that can allow use errors and potentially lead to harm. This standard therefore provides medical devices manufacturers with guidance on how to integrate usability engineering principles and user interface design practices into their overall medical device processes.

Who is this standard for?

  • Medical devices manufacturers – this document provides them with guidance on how to integrate usability engineering principles and user interface design practices into their overall medical device development processes
  • Medical devices patients – particularly as healthcare evolves and less skilled users including the patients themselves are now using medical devices and those medical devices are becoming more complicated

Why should you use this standard? 

The guidance provided in it applies to all medical devices, including:

  • Those used by laypersons and/or healthcare professionals
  • Medical devices that perform one function or several 
  • User interfaces in the form of hardware, software, documentation and packaging
  • Medical devices of all shapes and sizes and that may or may not require training before use

The document recognizes that all medical devices involving human interaction present opportunities for optimization through the application of usability engineering.  

It covers the quality of user interactions with medical devices which can be very varied: attaching accessories to a medical device and interpreting warnings, as well as understanding relevant aspects for the proper use of the medical device by reading the accompanying documentation.

What’s changed since the last update?

When the revision of BS EN 62366:2008 started, a decision was made by the joint working group that the existing document would be broken into two parts. Therefore, together with BS EN 62366-1:2015, this document supersedes BS EN 62366:2008+A1:2015. 

BS EN 62366-1:2015 contains updated normative requirements for the application of usability engineering to medical devices.




Standard NumberPD IEC/TR 62366-2:2016
TitleMedical devices. Guidance on the application of usability engineering to medical devices
StatusCurrent
Publication Date31 May 2016
Normative References(Required to achieve compliance to this standard)IEC 62366-1:2015, ISO 14971:2007
Informative References(Provided for Information)IEC 60601-1-8:2006, IEC 62366:2007/A1:2014, IEC 60601-1-6:2010/A1:2013, ISO/TR 24971:2013, AAMI HE75:2009, ISO 19218-1:2011, ISO 9241-110:2006, IEC 60601-1-6:2010, ISO 16781:2013, ISO 14915-2:2003, IEC 60601-1-11, IEC 62366:2007, ISO 13485:2003, GHTF/SG2/N54/R6:2005, ISO 14915-3:2002, IEC 60601-1-8:2006/A1:2012, HFES 300:2003, IEC 60601-1:2005, HFES 100:2007, IEC 82079-1:2012, HFES 200, IEC 60601-1:2005/A1:2012, ISO 14915-1:2002, ISO 80369-1:2016, AAMI TIR49:2013, ISO 9241-5:1998, ISO 14155:2011, AAMI TIR50:2014
ReplacesBS EN 62366:2008+A1:2015
International RelationshipsIEC TR 62366-2:2016
DescriptorsMedical technology, Hazards, Medical instruments, Ergonomics, Equipment safety, Design, Medical equipment, Instructions for use
ICS11.040.01
CommitteeCH/62/1
ISBN978 0 580 85673 0
PublisherBSI
FormatA4
DeliveryYes
Pages108
File Size3.343 MB
Price£292.00


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