IEC/TR 62366-2 is here!

IEC/TR 62366-2, “Medical devices – Part 2: Guidance on the application of usability engineering to medical devices,” has just been released and is available now from Document Center Inc.  You can order this new Edition 1.0 in either paper format or for pdf download, and enterprise solutions are also available.  Along with the IEC 62366-1, this new technical report replaces the now obsolete IEC 62366 from 2007 and the Amendment 1 from 2014.

What does the new IEC/TR 62366-2 cover?  The report is guidance on a general usability engineering process meant to help make medical devices safer when being used by both professionals and by lay persons.  This is accomplished by providing you with information on efficient ways to implement the IEC 62366-1.  Additionally, it covers task efficiency and user information intended on enhancing a medical device’s commercial success and safe implementation.

Who should be using this IEC/TR 62366-2?  Because the report discusses both the technical and business sides of usability evaluation, it is appropriate for the following:

  • Managers, including company, department, and product management
  • Design and engineering professionals
  • Medical researchers and clinicians
  • Marketers and medical device professionals
  • Quality and regulatory staff members
  • Product information authors

The standard includes the usual basic information in the first clauses of the publication, scope, terms, referenced documents plus a mapping of the technical report to IEC 62366-1.  Then it covers the background and justification rationale for a usability engineering program.  A review of the implementation process is next.  Clause 7 is an overview of the process itself, while Clause 8 shows you how to prepare your user instructions or specification.

The balance of the document reviews the types of errors that can occur when using medical devices, how to identify hazards and hazardous situations and communicate this to users.  It also walks you through the processes involved in user evaluation and training programs, including hardware user interface design issues.  And of course, this means that there is information on data collection, analysis, and documentation.

Annexes cover the following areas:

  • Recommended reading list
  • Jurisdictional resources to identify known problems
  • Developing usability goals for commercial purposes
  • End products of usability engineering projects
  • Methods used in usability engineering
  • Usability engineering studies in the clinical setting
  • User profiles
  • Use environment descriptions
  • User interface requirements
  • Modelling
  • Usability test sample size
  • Identifying distinct user groups

A 45-item bibliography and an index of defined terms complete this 106-page report.

As noted on the cover, you’ll want to make sure you use an authorized distributor like Document Center Inc. for all your standards purchases.  Use our web store, www.document-center.com, to search for an order the standards you need.  Here’s a direct link to the order page for IEC/TR 62366-2 for your convenience.  You may also want to order the IEC 62366-1 if you haven’t already purchased it yet.

As I mentioned, the IEC/TR 62366-2 can be delivered as part of our Standards Online enterprise solution.  If you’d like more information about that, or any of the many compliance services we offer, please get in touch with our staff by phone (650-591-7600) or email (info@document-center.com).  We’ve been providing folks like you with standards since 1982.  Make us your Standards Experts!