Is formulative testing always required

david316

Involved In Discussions
Hello,

As I read IEC 62366-1 2015 it does not mandate that formative testing is required. In particular clauses 5.2-5.4 require you to identify use errors etc but as far as I can make out it does not mandate formative testing. Is this interpretation correct and if so when is formative testing required?

Thanks
 

Marcelo

Inactive Registered Visitor
Yes, there's no requirement that formative tests are performed, only summative tests are required to be performed as a way to "validate" the usability of the user interface at the end of the process.

Formative tests are important in a HFE/Usability engineering process as a way to identify as quickly as possible, before taking design and development some decisions, usability shortcomings.
 

Haresh

Involved In Discussions
Yes, there's no requirement that formative tests are performed, only summative tests are required to be performed as a way to "validate" the usability of the user interface at the end of the process.

Formative tests are important in a HFE/Usability engineering process as a way to identify as quickly as possible, before taking design and development some decisions, usability shortcomings.
Dear Marcelo,
Have you any formative usability evaluation protocol for non-active surgical device?
Awaiting your reply
 

Jim Wynne

Leader
Admin
Dear Marcelo,
Have you any formative usability evaluation protocol for non-active surgical device?
Awaiting your reply
It's unlikely that you'll get a response from Marcelo:

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We'll see if anyone else can answer your question.
 

yodon

Leader
Super Moderator
You don't need a protocol for formative studies. 62366-2 notes:

A FORMATIVE EVALUATION can be a simple activity, noting that the goal is to learn about design solutions’ strengths and opportunities for improvement. FORMATIVE EVALUATIONS usually takes the form of USABILITY TESTS (see 16.2.4), cognitive walkthroughs (see 16.2.3), expert reviews (see E.7), and other evaluation techniques.

We frequently use, for example, surveys, slide decks, wireframe GUIs, etc. presenting various design options.

The UI Evaluation Plan can be used to frame up the formative evaluations. Do be sure to capture the outputs (often design decisions) as part of the UE File.
 
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