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User Interface of Unknown Provenance (UOUP) applicability

#1
Looking to understand timing of when UOUP actually applies. This is my understanding of the timing of events.

IEC62366-1:2007 released- initial version
IEC62366-1:2007 Am1 released in 2014- includes UOUP
IEC62366-1:2015- updated for clarity

Can you confirm the timing of these events is correct. If correct does this imply that UOUP applies to any product development before the release of amendment # 1 in 2014. Also when a standard is released what is the time frame that companies have for compliance? e.g. do we have 3 years from release of standard or is it in effect immediately.
 

yodon

Staff member
Super Moderator
#2
It's my understanding (and that's not to say it's right) that, irrespective of the releases of the standards, if you didn't develop a UI in accordance with the standard (and gather the applicable records), you can adopt the standard moving forward, as you modify the UI.

The 3rd paragraph in Annex C seems to support this:

The PROCESS of this annex can be applied to UOUP for A USER INTERFACE or part of a USER INTERFACE for which adequate RECORDS of the development using the USABILITY ENGINEERING PROCESS of IEC 62366-1:— are not available. However, if any modifications are made to the USER INTERFACE or its parts, only the unchanged parts of the USER INTERFACE remain UOUP and the changed parts of the USER INTERFACE are subject to 5.1 to 5.8.

So, essentially, do the gap analysis and begin applying the standard for changes moving forward.
 

Tobias_HF

Starting to get Involved
#3
I always thought that the Annex C (formerly known as Annex K) is for medical devices that were brought to market before 2007.
Since 2007 there is the original standard. So everything released after that should follow the 2007 version. Then there was a lot of confusion about legacy devices, so the Annex K amendment described what to do with existing products (2014), that are on the market and did not follow the 2007 standard. I assume because they were on the market before 2007.
The Annex C (2015) describes this in a bit more detail.

In my understanding the critical date is 2007 - but I know that NB also think of 2014 as the relevant date. So when you developed between 2007 to 2014, you basically could just evade the standard - which I think is a bad thing to do.

Cheers
Tobias
 

yodon

Staff member
Super Moderator
#4
It's quite possible that the product was developed for a market that didn't 'require' compliance to 62366 and the UI was developed outside the UE process. They then decided that they wanted to enter a market where 62366 was recognized as a way to meet applicable regulatory requirements.

It's also quite possible that they got market clearance without demonstrating compliance and now it's more of a focus. Dates of when things did / didn't happen are mostly irrelevant.
 


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