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IEC 62366-1:2015 Usability Verification / Validation Plan example wanted

mvroops

Starting to get Involved
#1
Hi All,

I would like to prepare usability verification and validation plan for ISO 62336.

Anybody having sample template for the same?
if kindly share
 
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yodon

Staff member
Super Moderator
#3
Usability is so specific to the item being examined, I don't think a generic template would be possible.

The standard calls for (one or more) formative studies. Each formative study could be for a different aspect of the UI and they are intended as much for learning as anything. The basics would be to define what what you want to assess, define who you want to be involved, gather data regarding the use / usability of the aspect under the study, and then refine, as necessary, the UI (and update the Risk Analysis if appropriate). The data could be based on user feedback (i.e., usability scores) or from observation (was the user able to do the function).

The summative study is designed to confirm that the use / usability controls are in place to ensure the device is used safely. Depending on the actors involved, this could be multiple studies also. And, as you might guess, a summative study for a tongue depressor would be vastly different from a summative study involving an infusion pump.

If you don't have the standard, you should get it plus IEC TR 62366-2:2016 (the guidance on the application of the standard) plus ANSI/AAMI HE75. Good information in all those about usability / usability engineering (process).
 

tazer

Involved In Discussions
#4
I'm working on this document. I took as a starting point the Annex H of 62366. It gives a good template to begin with.
 
F

fayyaz NDT Level 3

#7
:thanx:
Hi All,

I would like to prepare usability verification and validation plan for ISO 62336.

Anybody having sample template for the same?
if kindly share
Dear Ajit,

I am from line pipe manufacturing organization (pipe mill as per API 5L).We have included design and development in our scope.
we manufacture a range of pipe diameters and these sizes are repeated time to time.does it need to repeat design validation every time or limited to once for any pipe size.
our manufacturing processes are well defined and all process inputs (machine,manpower,parameter range) is same under same product standard (API 5L).

We manufacture pipes under same product specification or even for same client.All the process (NDT,WELDING,HYDROTEST,BEVELING) are qualified and tested for all pipe sizes many times.
do we also need to repeat validation each time.
based on our previously qualified designs,can we continue our regular production after one or two initial pipes are manufactured and tested satisfactorily & we maintain and adjust all parameters for ongoing production.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
:thanx:
Dear Ajit,

I am from line pipe manufacturing organization (pipe mill as per API 5L).We have included design and development in our scope.
we manufacture a range of pipe diameters and these sizes are repeated time to time.does it need to repeat design validation every time or limited to once for any pipe size.
our manufacturing processes are well defined and all process inputs (machine,manpower,parameter range) is same under same product standard (API 5L).

We manufacture pipes under same product specification or even for same client.All the process (NDT,WELDING,HYDROTEST,BEVELING) are qualified and tested for all pipe sizes many times.
do we also need to repeat validation each time.
based on our previously qualified designs,can we continue our regular production after one or two initial pipes are manufactured and tested satisfactorily & we maintain and adjust all parameters for ongoing production.
This thread has a medical devices perspective. Are your products related to medical devices?
 

yodon

Staff member
Super Moderator
#10
Could anyone please give a copy of Annex K of the 62366-2?
Short answer: no; it's copyright material.

As I presume you're aware, it's a discussion on the number of participants ('sample size') in a usability test. The gist is that after 15 participants, likelihood of finding new issues drops significantly.

FDA has a guidance document (https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm259760.pdf), "Applying Human Factors and Usability Engineering to Medical Devices" that echoes (see Appendix B) much of what's in Annex K, including the recommendation of 15 study participants.
 
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