IEC 62366 for Stand-Alone Medical Device Software and Usability Engineering

Marcelo

Inactive Registered Visitor
#11
testable requirements for
USABILITY of the PRIMARY OPERATING FUNCTIONS including criteria
for determining the adequacy of

RISK CONTROL achieved by the USABILITY ENGINEERING
PROCESS." in the usability specification. However in the annex H, those requirements are written without criterias. So I'm confused.
I told you that Annex H is not exhaustive. As mentioned in the notes, the testable requirements for primary operating functions can be usability goals, and examples can be foung in Table D.5, Table D.6, and Annex G. Not in Annex H.

Shouldn't criterias be included in the usability validation plan instead of the usability specification?
Test criteria to verify design (in this case, the user interface design) are related to verification. Validation is related to the evaluation if the implemented design fulfills user or intented use requirements. Validation can have it's own criterias.

Also note that the standard call verification activities "tests" and validation activities "methods" to clearly show the difference between them.
 
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Marcelo

Inactive Registered Visitor
#12
You test your requirements from usability spec and SRS in your software test plan. Doing that way, you verify both your SRS requirements and usability requirements during tests phases.
Take care when using the term "usability requirements". You do not verify usability requirements (which are the requirements related to a specification or intended use) with verification tests. Verification test only evaluate design requirements, meaning, the requirements for the user interface design in this case (as noted in the standard - The USER INTERFACE is subject to VERIFICATION to the USABILITY SPECIFICATION. The USABILITY SPECIFICATION is subject to VALIDATION, where the USABILITY VALIDATION plan incorporates the acceptance criteria).


The usability validation plan is a document with a broader view. It contains references to your qms procedures and to documents of your project, to show that you pass all the requirements of the 62366 standard.
Sorry, but where did this information come from? The usability validation plan does not evaluate that you pass all requirements of the standard (note that meeting the standard in principle does not means that validation is achieved). Validation verifies the device usability validation, which is related to the intended use of the device.

It does not need references to the QMS nor to project documentation. The usability validation plan only needs what is required by 5.6. For more info on this, please see 4.7.3.

With this in mind, please note that you example validation plan on your attached file is wrong.

A basic template usability validation plan per IEC 62366 would need at least the following information:

1 - Method(s) used for validation of the primary operating functions (which includes, for example, if the methods are quantitative or qualitative, which types of conditions are used - actual or simulated, what is the method process used, who is gonna be tested, remembering that it must be representative of the intended user population)

2 - Risk acceptability criteria per ISO 14971 (validation criteria)

3 - Frequent and reasonably foreseeable user scenarios (form the usability specification
 
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S

sparvhok

#13
Thanks for your extensive answers.

"The USER INTERFACE is subject to VERIFICATION to the USABILITY SPECIFICATION."

Does this mean that we should verify that the user interface lives up to the usability specification?
What way would be the best way to do this verification?

Best regards
Michael
 

Marcelo

Inactive Registered Visitor
#14
"The USER INTERFACE is subject to VERIFICATION to the USABILITY SPECIFICATION."
Does this mean that we should verify that the user interface lives up to the usability specification?
As the usability specification is intented to create verifiable requirements for the verification, yes.

What way would be the best way to do this verification?
Way to to this, as mentioned in the standard:

"USABILITY VERIFICATION can be done by inspection of the implemented USER INTERFACE or through a PROCESS of observing and collecting data from intended USERS while they interact with either the MEDICAL DEVICE or a (high fidelity) MEDICAL DEVICE prototype in the intended or simulated environment of use."
 

c.mitch

Quite Involved in Discussions
#15
Thank you Marcello for your informative answer.
The example I uploaded in the cove is what I did for several medical devices. And it passed the audits. But this is not a systematic proof that I do it right to implement the standard.
My "validation plan" (between brackets, I'll have to change the name) draws the links between the documents of the project and the sections of the standard, to ensure that the standard is fully implemented.

The usability validation is part of the series of tests of software when it is delivered for testing with end-users, what I call a end-user test report with end-user scenarios (the #3 of your basic template).
However, the #1 and #2 of your basic template raise a warning for me and I'll check that mine are ok.
 

Marcelo

Inactive Registered Visitor
#16
The example I uploaded in the cove is what I did for several medical devices. And it passed the audits. But this is not a systematic proof that I do it right to implement the standard.
I´s good that you acknowledge that, because this situation is happening a lot. For example, auditors auditing IEC 62366 have no idea what it is and then accept anything that seems more or less ok. Problem is, a lot of times they are being told it´s wrong, and then when they get back to the manufacturer, they say that what was accepted in the previous audit is not accepted anymore. CBs and NBs should have people trained in what they audit, but this is really a deep and ongoing problem (and IEC 62366 and other process standards do not help, cause they do not make it clear how to evaluate the conformity).

My "validation plan" (between brackets, I'll have to change the name) draws the links between the documents of the project and the sections of the standard, to ensure that the standard is fully implemented.
As I said, verifying that the standard has been implemented is verification, not validation.

The usability validation is part of the series of tests of software when it is delivered for testing with end-users, what I call a end-user test report with end-user scenarios (the #3 of your basic template).
Those can be either verification or validation, depending on what is "tested". If you only tests design implementation, then it´s verification. If you test user requirements, it´s validation.

Note that the general difference between verification and validation is:

Verification - test what I said I would design

Validation - test if what I designed is what the users needed.

A lot of people think that what I design is what the user wanted - the problem here might be that I didn't ´t understand what the user wanted and designed something which did not fulfill their needs. That´s exactly what validation wants to verify.
 
#17
Hi Marcelo,

kindly help.

I am bit confused,between Usability Verification , Usability validation & Validation. i would like to state my understanding,

Usability Verification : Like software verification, prepare the test plan considering usability specification as input document and test according to the plan.

Usability validation : Nothing to do with the Usability specification, the input document is the user needs / user requirement (in our case it is called as marketing input, it is user requirement consolidated by our marketing department). as i understand usability validation is checking whether the final product meets its indended use/user needs/user requirement (final product : prototype after all software testing iteration & finalysed to release is taken for validation activities).but earlier also i was doing the "Validation" activity as same as i mentioned about usability validation.

hence usability validation & validation is one and the same.

kindly reply if my understanding is right ?

thank you,
 
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