IEC 62366 for medical device usability engineering has been replaced by two new publications.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 (info@document-center.com). 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!
Just to point out that actually the “essential prinicples” are rather derived from 93/42/EEC than from ISO/TR 16142.
Quote “And Annex E is a table that shows the relationship of the IEC 62366-1 clauses to the ISO/TR 16142‘s essential principles.”
Thanks so much for the clarification, Florian!
Cheers,
Claudia
Do you know when the effective date is for this standard?
Hi Crystal:
Thanks so much for asking.
I assume that you are talking about when the European EN edition of the standard will be accepted. There are a number of dates for the release of the EN 62366-1.
EN 62366-1 has been ratified. It will be available for access by each European country at the end of this month (the standard publishing delay). All countries must announce that it is available by July and will be available in all national editions by the end of the year. The previous EN 62366 document will be valid 3/31/2018 as the transition period for moving from the older document (now obsolete) to the new one.
With regards to the adoption of the IEC 62366-1 in other jurisdictions, it is (as always) on a case-by-case basis.
I do hope that this answers your question. Thanks for your interest, and do let us know if we can be of any additional assistance.
Regards,
Claudia
Thank you so much for the information! That answers my question for now.
Good Afternoon,
I have a couple of questions regarding the new release of IEC 62366.
With the changes what is/are the industry norms for capturing usability risk? Are companies starting to do a usability risk analysis along with the product/process risk?
When is -2 anticipated to be released?
Thanks for asking, Ryan:
There is a new IEC/TR 62366-2 Ed. 1.0 “Medical devices – Part 2: Guidance on the application of usability engineering to medical devices” in the works. The forecasted publication date is 9/2015. However, these dates are always subject to change.
Now with regards to the usability risk… As you probably know, the new Annex Z’s that are starting to appear in various EN publications have upped the bar when it comes to assessing and mitigating risks associated with medical devices. With this new emphasis on reducing risk as far as possible rather than as far as is reasonably practical, companies must take a look at all areas where something could go wrong. And believe me, when we talk about quality issues, many times we are talking about the mistakes that ordinary people make.
So, with this need to recalibrate the concept of risk due to the requirements of the EU, comes an increased focus on usability and minimizing usability risk. Thus, the IEC 62366-1 and it’s companion IEC 62366-2 due out soon have a far greater role to play moving forward.
I hope this is helpful.
Regards,
Claudia
By the way, if you use the AAMI adoption of the IEC 62366, the transition to the new IEC 62366-1 has been made. Check in with the Document Center staff for your copy, or order online at http://www.document-center.com. Thanks!
Claudia
The transition date info of 3/31/2018 is very helpful. In general, where can one find these transition dates when a revised standard is being introduced? And is there a source to find out when regulatory bodies such as the FDA no longer recognize the old standard?
Thank you,
Vic
Hi Vic:
Boy, this is a question that’s on everyone’s mind these days.
I asked our IEC contact and she stated that transition dates are included in the IEC standards themselves. However, recommendations by authorizing committees are just that, recommendations…
For Harmonized EN standards, it’s a bit simpler. You look on the harmonized list and in the “presumption of conformity” column you’ll see when the old edition will be invalid. So that gives you your transition period.
I don’t know of a similar scheme for other regulatory bodies like the FDA. I’ll check it out and if I get some good information, you’ll see a new blog on the topic for sure!
Great question!
Regards,
Claudia
Hello,
If a medical device has complied with the previous 2007 version of IEC 62366, and no design changes have occurred, is the device required to now show compliance to the 62366-1:2015 version?
Hi Stephanie:
Thanks so much for asking.
The answer to your question depends on the jurisdiction where the device will be sold. So you will need to check on a location-by-location basis to see which edition is currently in force. I will say that usually you are given a 3-year transition period to move from one edition of a standard to the next.
You’ll also want to do a gap analysis of the old edition and its replacements. If the new edition changes do not affect your product, you can make the upgrade easily. However, if the new edition has requirements that apply to your product, you’ll probably want to do further research on the regulations in the areas where the product is being marketed.
Let us know if you require further assistance.
Hope this is helpful.
Best regards,
Claudia