What do you think the revision of IEC 62366 should bring?

Marcelo

Inactive Registered Visitor
What do you think the revision of IEC 62366 should bring?

For example, one of the things I always thought about it (and 60601-1-6) is that it´s written as a kind of "separate" process from design and development.

A more clear linkage to the main design and development process might help.

This is also a problem, in my opinion, because the standard is also written as if to be used by a human factors professional - which does not exist in a lot of countries, and even in countries where they do exist, such as the US, a lot of companies cannot afford one person just to that. So, in practice people using 62366 are design and development, risk management or quality people - with little or no background in HF. So the standard would need to be written with these possible users in mind.
 

Pads38

Moderator
I am the company member who, by default, has been stuck with the implications of 62366. I do not have any previous background in the subject but will have to pick it up along the way.

The existing standard, at clause 4.3, clearly states that the usability effort should be scaled to be appropriate to the device in question. But the example specification given in annex H manages to run to 10 pages just for a thermometer. That is longer than the requirements section of the standard itself! If this is a starter I would not like to see what is needed for something complicated.

Part of our present difficulty is that we do not have anything as a starting point for knowing what is expected. We have been in contact with our notified body to ask for guidance but I get the impression that they don't really know either. As SteveK noted on another thread his auditor was impressed just by having something in the file. I suspect that, just as smaller manufacturers will have to "just get on with it" using whatever staff are available, so to will notified bodies have to use existing auditors with the review of the usability process being added to the Tech File review.

The best guidance that I have seen, so far, is the template produced by SteveK on the other thread. Perhaps we could have, in a new standard, full examples of both a low usability risk device and a higher risk device (annex G might be seen as that already).

As highlighted elsewhere the difficulty of applying the standard to existing products could be addressed.
 

Marcelo

Inactive Registered Visitor
Hello, Pads

Yes, you case is a perfect example of my impression of the standards.

One important point you mentioned and I didn't is, it's not very clear what the standard expects, meaning it's does not facility assessment. I was thniking that maybe defining some more target documents or actions might help (instead of the general - verify the risk management file), or even creating a template for an assessment procedure as an Annex.

In relation to the average user, I would think that an Annex pinpointing how to integrate the usability process with the design and development process would help also.

The legacy products problem is lready being addressed by the revision.

I'm not sure if separate examples would help, simply because the example nowalready uses a low risk device! An example for more complex device would be even bigger and more complicated. Maybe a step-by-step example would be better, and even make it clear the links with design and development.

Regarding the auditor, I would say that he, as a lot of auditors I know, does not have a clue of what the usability engineering process is.
 

Marcelo

Inactive Registered Visitor
Also, although SteveK's template is interesting, it's in reality not a template of the usability engineering file, ony a rework (using his product) of the usability specification which is one of the documents required by the usability process. A template of the usability engineering process needs to contemplate all parts of the process, as examplified in in Figure A.1 of IEC 62366 and in the requirements subclause (I'm creating an usability engineering template that addresses all aspects required by the standard and will share here in the conve when finished).
 
P

phloQS

Hi all,

I think one of the big problems with this standard is, that it is still focused on devices with electrical components like touchscreens or whatever. our company produces endoprothesis and many of the points are really hard to adapt on our products, e.g. 5.4 main operating function, it is really hard to define main operating functions on implants as there are nearly no operating functions as interfaces between surgeon and implant or even better patient and implant. So a more general applicable standard would be better, or specialized standars for devices categories like 60601-1-6 for electricla equipement.

Regards phloQS
 

Marcelo

Inactive Registered Visitor
Hello phioQS

You are totally right, as 62366 was based on 60601-1-6 (for medical electrical equipment), the ideas and exemples are still influenced by electrical equipment.

The idea of main operating functions (which might be efined using any kind of ****ional analysis techniques) is in reality applicable to all devices, however, to some tou would really need to adapt some things. I would say, in the case of prothesis, that functions are really more related to clinical performance, instead of being related just to the interface. However, the standard does not make it clear that for different types of devices some of the required stuff has to be taken from a slightly different approach.

Not sure if ther's any way to modify a srandard to make it even more generic, but maybe some guidance for some knows types of devices might help.
 

Pads38

Moderator
I'm struggling through 62366 now.

I think the difficulties that I am having can be highlighted with this quote (annex A 5.7)
The design of the USER INTERFACE should be focused on the USER'S needs and requirements. A multidisciplinary team approach to USER INTERFACE design is required. This team can include actual USERS, engineers, USER-interface specialists, cognitive psychologists, multimedia programmers, USABILITY engineers, marketing and training personnel.

The problem is that we do not have (nor is it in any way feasible that we could get) a "multidisciplinary team". We have me and one other person.

If we were creating anything with significant risk (such as the infusion pump that is used as an example in some of the annexes) that could be a problem. But the device we are creating has a simple function and is intended to be used by expert clinicians in outpatient clinic settings. (Most of our products are used in research settings). The user interface (including labeling) does not influence safety.

So I think we are justified in scaling the usability effort to a minimum. But the process outlined in 62366 is anything but minimum. We have approached our Notified Body to try and get an idea of what they will consider to be adequate but their answer was very non-committal.

So in answer to the question of what we would like to see in a revised standard I can think of 2 clear things.

Firstly, (as mentioned elsewhere) a process to be used with legacy devices.

Secondly, a process suited to low-risk devices.

These might be better addressed outside of an ISO/IEC standard; perhaps a Technical Report? or it could be guidance documents of the MedDev / NB-Med sort.
 

Marcelo

Inactive Registered Visitor
Secondly, a process suited to low-risk devices.

These might be better addressed outside of an ISO/IEC standard; perhaps a Technical Report? or it could be guidance documents of the MedDev / NB-Med sort.

The problem with doing a TR or guidance document is that they are not standards and thus do not have requirements. It makes it difficult for it to be adopted by regulations.
 
S

scotsman

can you supply a link to the thread of SteveK's for the template, can't sweem to find it.
 
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