IEC 62366 for medical device usability engineering has been replaced by two new publications. The first, IEC 62366-1, is available now. The second, IEC 62366-2, is still in preparation. You can get your copy of IEC 62366-1, “Medical devices – Part 1: Application of usability engineering to medical devices,” from Document Center Inc. It’s available in both paper and pdf formats and can be included in our Standards Online multi-user subscription service as well.
This change divides the IEC 62366 into two parts. Part 1, as noted above, is on the application of usability engineering to medical devices. Part 2 will be titled “Medical devices – Part 2: Guidance on the application of usability engineering to medical devices” when it is released.
Let’s take a look at the new IEC 62366-1 to see how the document has been revised.
Part 1 has been updated to include more up-to-date concepts of usability engineering and to streamline the process. The ties to ISO 14971 have also been strengthened for the application of risk management to the safety related aspects of medical device user interfaces.
What will you find in this standard? After the usual scope, referenced documents and definitions clauses, the IEC 62366-1 discusses the principles of usability engineering. This is an overview of the process, the usability engineering file, and how to tailor your efforts.
The next clause (clause 5) covers the concept of the usability engineering process in depth. It takes you all the way from preparing your user specification to the final evaluation of your user interface.
Five Annexes provide you with information that you’ll find to be very helpful. Annex A gives you general guidance and the rationale for usability engineering. Annex B is a set of hazardous situations related to usability. Annex C is a requirement, with information on the evaluation of a user interface “of unknown provenance.” Annex D gives you a list of the types of medical device usages, along with examples. And Annex E is a table that shows the relationship of the IEC 62366-1 clauses to the ISO/TR 16142‘s essential principles.
Lastly, a 46-item bibliography and an index of defined terms complete the standard.
FYI: The Part 2 will include tutorial information to assist manufacturers comply with Part 1. It will offer a more detailed description of the usability engineering methods you can use. And it will extend IEC 62366 principles beyond the safety-related aspects of medical device user interfaces.
Now to get your copy of this new update. You can order online at the Document Center webstore, www.document-center.com. Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (firstname.lastname@example.org). We’ve been an authorized distributor of IEC standards since the 1990’s and have been providing standards to our customers since 1982. You’ll rely on Document Center Inc. to assist you with all your requirements relating to this type of conformance information. Make us your Standards Experts!