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!

ISO 15223 Series on Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied

ISO 15223 has been around since 1998, but in 2007 it was split into 2 parts covering two distinct topics.  We often sell this set here at Document Center Inc. so I thought you might appreciate a brief synopsis of the two documents.

ISO 15223-1:2007 is titled “Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.”  Note the English spelling for labeling.  All ISO standards are published using the English spelling, not the American.  The standard is not complete without Amendment 1, ISO 15223-1:2007/Amd 1:2008.  So be sure to order both items when you purchase the standard.

ISO 15223-1:2007 identifies requirements for the development and use of symbols that may be used to convey information on the safe and effective use of medical devices. It also lists symbols that satisfy it’s requirements.

ISO 15223-1:2007 is limited to symbols applicable to a broad spectrum of devices that may be marketed globally. These symbols may be used on the device itself or its package or in the associated documentation.

ISO 15223-2:2010, titled “Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation,” specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1.

The purpose of ISO 15223-2 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group.

If the symbol validation process detailed in ISO 15223-2:2010 has been complied with, then the residual risks, as defined in ISO 14971 and IEC 62366, associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary.

ISO 15223-2:2010 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.

These standards, and all ISO and IEC documents, are available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re happy to answer any questions you may have about these publications.

Human Factors for Medical Devices – IEC 62366 and ANSI/AAMI HE75

Do you need help in finding the best practices guidance in medical device human factors engineering?  With the focus of good design being expanded to the entire product life cycle, the issue of insuring adequate medical device usability has taken on new importance.  Here at Document Center Inc. our customers have been relying on two standards for this – ANSI/AAMI 75 and IEC 62366.

Human Factors Engineering (HFE) is a new and separate discipline within the medical device industry. It has evolved due to the high concentration of medical device incident reports and recalls involving use error.  HFE includes all aspects of a device that users interact with when operating the product.  It considers the interaction with the device by operators, maintainers, cleaners, caregivers, and patients.  By providing adequate labeling, instruction, and ease of use, manufacturers can reduce use-associated risk.

IEC 62366 Edition 1.0 from 2007, “Medical devices – Application of usability engineering to medical devices,” focuses on the process of analysis, evaluation, and testing methods for developing safe and usable medical devices.  It aims to improve usability by reducing design-induced error.  Simply stated, IEC 62366 covers human factors design process — what needs to be done and when.

One important aspect in using the standard is the presumption of reduction of risk as defined in ISO 14971.  If the usability engineering process detailed in the standard and the acceptance criteria documented in the usability validation plan have both been met, then the residual risks associated with usability of a medical device are considered to be acceptable, unless there is objective evidence to the contrary.

It is my understanding that if you already meet the IEC 60601-1-6, you have most of the requirements of the IEC 62366 already achieved.  The document has been adopted for use in Europe as EN 62366: 2008.

ANSI/AAMI HE75-2009, “Human Factors Engineering—Design of Medical Devices,” covers the principles of HFE.  The standard provides detailed human factors engineering design guidance, examples, checklists, and case studies. With 445 pages, and extensive illustrations, it is considered an encyclopedia of HFE for specific situations.  It covers all aspect of design, from basic human skills and abilities to post-market issues.  The standard is a powerful tool in all stages of the design life cycle.

These standards can all be purchased from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  As always, questions and comments are welcome.