Safety-critical functions

Whether an operating function is critical to safety, results from the risk analysis. If the patient, a user, or a third party may suffer a defect, it is critical to safety: In general for each function or each UI element as part of risk management, you can, and must, review what happens when the user

1. Enters something wrong (or enters nothing) or
2. Selects something wrong (or selects nothing) or
3. Does not recognise something or recognises it wrongly.

In the recognition one distinguishes between the false reading (perception) and the wrong understanding (cognition).

Users can only enter, select and perform cognitive performances such as recognising, understanding and distinguishing. Precisely these requirements, to input, choose or recognise something on a system, which are the usage requirements .

Frequently used functions

You can deduce whether an operating function should be classified as frequently, if it is used as part of a core task. If so, the assumption that it is frequently used, should be true.

This requires, however, that you not only identify the usage requirements, but also the core task.

In the seminar " Usability, Requirements & IEC 62366", you will learn both. This seminar will provide you with all the knowledge and skills to

• create an IEC 62366 compliant to the serviceability act,
• identify the real needs of your users and thus develop (medical) products that deserve the title “innovative” and thus have the potential to "shake up " the market and
• avoid unnecessary, time-consuming and cost-incurring iterations and consistent reworks of seemingly constantly changing requirements 

As stated above, it is important to check the following:

1. That the specified requirements for the main operating functions are implemented
2. That the user requirements are met (i.e. the user can enter, select and recognise something as planned ) and
3. That (hence) users can obtain the best user objectives.

The test of 1. is equivalent to a usability verification, the 2nd and 3rd to the usability validation. Read more for the validation of medical devices (also the usability validation).

Functions, tasks and goals

The IEC 62366 uses the term "function" diligently, for example in the context of the main operating function, without having the concept of the term function defined at all. On the contrary, the way it is written above it confuses functions, tasks and objectives.

Thomas Geis helped me gather additional definitions:

• Target: an intended working result (Source: ISO 9241-11)
• Work task: The necessary measures for goal achievement activities (Source: ISO 9241-11). The activities required to achieve a desired working result (insertion of the first two terms)
• Function: The user objects and tools that can be used from a user perspective to accomplish a work task.

The previous sentence is not an official definition of "function", one can deduce this definition from the Usability Guide of the DAkkS. It does not lack real definitions of the term function. Thomas Geis has found no less than 10 (!) definitions of the term function that I have summarised for you in the glossary.