USABILITY  ENGINEERING / HUMAN  FACTORS  ENGINEERING -- THE NEW IEC 62366-1:2015, and IEC/TR 62366-2:2016

Some answers to some questions raised on my webinar on the above subject:

Ques: Examples of FDA HF guidance documents, etc?:

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HumanFactors/ucm119190.htm#guidancehf

As mentioned, use the search box in upper right on FDA web site, as well as links from the above link.

Ques:  HE75?

Ans:  The ANSI web site sells both HE75 and IEC 62366-1:2015 together, and states:

"The ANSI/AAMI HE75 and ANSI/AAMI/IEC 62366 Human Factor Set addresses a broad range of human factors engineering (HFE) topics in a structured format. The material emphasizes adoption of a user-centered focus throughout the product design and development process, with the goal of making medical devices easier to use and less prone to use error. By providing a structured approach to user interface design, this set documents can help manufacturers develop safe and usable medical devices.

• The ANSI/AAMI HE75 and ANSI/AAMI/IEC 62366 Human Factor Set includes
• ANSI/AAMI HE75:2009 (R2013) (ANSI/AAMI HE 75:2009 (R2013))
• ANSI/AAMI/IEC 62366-1:2015"

http://webstore.ansi.org/RecordDetail.aspx?sku=ANSI%2FAAMI+HE75+and+ANSI%2FAAMI%2FIEC+62366+Human+Factor+Set&source=google&adgroup=ansi-aami&gclid=CjwKEAiA0fnFBRC6g8rgmICvrw0SJADx1_zAwESZsbs9ED83LJflK_Qq0H773imIq4qMb-lGfKA12hoCrbnw_wcB

Not too helpful in my opinion.

The FDA allows you the manufacturer to determine how to address (and they allow plenty of leeway as long as the requirements are addressed by your procedures , and you follow your own procedures).  For CE-marking, work with the preferences of your Notified Body, following the general outline presented in the webinar / standard (the 9 stages, documented in a Usability Engineering File), and and  with consideration of the new EU MDR.

I still believe that the new IEC 62366-1:2015 is the documented process to follow with all current and further UE projects, following and documenting the 9 stages in the UE File as we discussed in the webinar.  The FDA and ANSI/AAMI HE 75 and others could be used in the actual HF/UE analysis where appropriate for ideas, but the documented process should follow IEE 62366-1:2015's 9 stages and the document deliverable in the UE File.

I suspect it will take awhile for some consensus in implementation to build (with the EU implementation).  But I believe that the "end" result will be similar to what I've outlined above. 

-- John E. Lincoln  --  jel@jelincoln.com 

For the basic UE / HF process to follow (and for the basic format of a UE / HF Product File), use the 9 stages defined in IEC 62366-1, worldwide; for the specific UE / HF techniques to employ, use the various other UE / HF standards and/or guidance documents, as applicable. - JEL 03/27/2024