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

S

sparvhok

#1
Hi!

I'm new to this forum and I'm glad to find such a rich information source related to IEC 62366. Since I am software risk manager I am interested in the software aspects of IEC 62366. But the examples in the standard itself are not so related to medical device software, especially regarding documentation and the usability engineering file annex.

Does anybody know where I can get more information about implementing IEC 62366 for Medical device software? After all Usability is very central to software development, so it should be easy to adapt to the process for software. But I haven't seen any examples of that yet. Is it even mandatory to implement a usability engineering process for medical device stand-alone software?

Best regards
Michael
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Re: IEC 62366 for Stand-Alone Software

A quick "Bump". My Thanks in advance to anyone who can help with this one.
 

Marcelo

Inactive Registered Visitor
#3
Re: IEC 62366 for Stand-Alone Software

Hello Michael and welcome to the Cove!

Standards are usually voluntary, but in fact the need to use them depend on which regulatory system (US, EU, Canada, etc) you need to address. For example, in the EU, if you do not use harmonized standards, you need to justify that your solution to the essential requirements has the same level of safety compared with using the harmonized standards.

There's alot os threads dealing with using standards on medical devices regulations in the Cove, plese browse some if you need more info on that.

Regarding the case of stand-alone software - this is really a new issue from the standpoint of the regulations. From the standpoint of standards, standards such as IEC 62366 are applicable to all medical devices, including stand-alone, but when they are created, they often ignore this case (they are too generic to enter into details of a specific type of device).

Some guidance related to usability and software (in the case, software user interfaces) can be found in ANSI/AAMI HE75, 2009 Edition - Human factors engineering—Design of medical devices - but again, this document is more focused on the most common, physical medical devices, so just a small part is clearly related to software.

Another thinng to keep in mind - from the standpoint of safety, the real usability issue with software is related to the user interface, which is the focs of IEC 62366.

(just a curiosity, your software is to used in conkunction with another medical device?)
 

c.mitch

Quite Involved in Discussions
#4
Re: IEC 62366 for Stand-Alone Software

Hi sparvhok,

As Marcelo says, there's not a lot about ergonomics in standalone soft Medical devices.

A simple implementation may be :
Doing mockup/model of your software and showing them during ergonomic meetings with selected end-users.
-a powerpoint during early stages of design (architecture, specifications)
-a V0.1 version during late stage of design (detailed design)
-a V0.x during coding

In these meetings, you collect remarks of your end-users and split them in two categories :
-risks linked to ergonomics --> inject them in risk management
-other remarks --> inject them in specifications requirements

You may use the structure of the usability engineering file in annex of the standard to organise the content of meetings : frequently used functions, functions related to safety, things that may go wrong ...

You may have an end-of-design review, where it is verified that all remarks were treated, which validates the ergonomics design of your software.

Ditto during verification tests phases,
You have tests cases which verify the specifications and risk mitigation actions about ergonomics.
early tests phases (alpha tests) may not require the presence of users
late tests phases (final beta tests) should require some users (the size of users sample matters, if they are patients).
At the end of test phase, you've verified the ergonomics, along with the rest of software.

This is for the process. For the content, it depends on your software.
Some examples:
-surface ergonomics : visibility of widgets, size of fonts, general layout, superimposition of colors, recognition of alarms, number of mouse clicks ...
-deep ergonomics : critical paths, multiple paths to do a task, saturation of information, lack of information ...

Regards,

Mitch.

PS: see my blog (link on my profile) on what I wrote about ergonomic requirements and traceability.
 
Last edited by a moderator:

Marcelo

Inactive Registered Visitor
#5
Re: IEC 62366 for Stand-Alone Software

You may use the structure of the usability engineering file in annex of the standard to organise the content of meetings
Just for clarification, IEC 62366 does not provide a structure to the usability engineering file. This is in fact one of the problem of the standard which will be addressed on the revision work.

If you mean Annex H, it only shows an example of a usability specification (H.3, with H.2 being the information used to create the usability specification of H.3) of an example device. This example is not even exhaustive.
 
#6
Re: IEC 62366 for Stand-Alone Software

If you mean Annex H, it only shows an example of a usability specification
I get the impression that Annex H more closely shows the requirements of 60601-1-6:2006, and indeed it is nearly identical to that standards Annex E.

My guess would be that it was not fully updated when 62366 was created.
 

Marcelo

Inactive Registered Visitor
#7
I get the impression that Annex H more closely shows the requirements of 60601-1-6:2006, and indeed it is nearly identical to that standards Annex E.

My guess would be that it was not fully updated when 62366 was created.
Sorry, not sure what you wanted to say.

IEC 62366 has basically the same requirements of IEC 60601-1-6:2006 - it only corrects some of the requirements and updates them to a general medical device.

Annex E of 60601-1-6:2006 is the "same" as Annex H of 62366. They both show an example of the usability specification (6.2.3 of 60601-1-6 and 46.202.3 0f 62366 - it´s even the same clause number and they use the same example).
 

c.mitch

Quite Involved in Discussions
#8
Re: IEC 62366 for Stand-Alone Software

Just for clarification, IEC 62366 does not provide a structure to the usability engineering file. This is in fact one of the problem of the standard which will be addressed on the revision work.

If you mean Annex H, it only shows an example of a usability specification (H.3, with H.2 being the information used to create the usability specification of H.3) of an example device. This example is not even exhaustive.
Agree with you. I was surprised to see what can be called a "cooking recipe" in a standard. As we, all users of standards, are very fond of cooking recipes because we have the feeling to save time, we fixed our choice on it.
I've even seen the example lying around on the cove (Probably a copyright issue, but this is another subject).

To come back to my post, I used the expression "you may":
-You may use the annex H of 62366
-You may use the section 21 of HE75
-You may not follow my example! :D

Regards,

Mitch.
 
S

sparvhok

#9
Thank you for your very informative answers!

Marcelo: The software is connected to a medical device. The medical device do a variety of tests from blood samples. The medical device has embedded software for the assay process. But the Software that I'm preparing a usability engineering file for right now is the stand-alone software. That software recieves results from the instrument and let's the user interpret and work with those results. But the stand-alone software is also involved in some steps for during the instrument assay process.

Right now I'm working not he usability specification and realise that the standard asks for "

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.

Shouldn't criterias be included in the usability validation plan instead of the usability specification?

 

c.mitch

Quite Involved in Discussions
#10
Hello,

One possibility is to write usability requirements like software requirements, with objective pass/fail criteria. Your usability specification is a kind of extension of your Software requirement specification (SRS)

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.

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.

I attached a dummy sample of usability requirmements and a sample of validation plan.

regards.

Mitch.
 

Attachments

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