J
Hello!
I’m struggling with showing compliance to the usability standard IEC62366 and a major issue has become the paragraph:
5.3.2 * Identification of known or foreseeable HAZARDS and HAZARDOUS SITUATIONS
That states that ”During the identification of HAZARDS and HAZARDOUS SITUATIONS, the following shall be considered:” …
“– * if an incorrect mental model of the operation of the MEDICAL DEVICE can cause a USE ERROR resulting in a HAZARDOUS SITUATION; and” …
My question is, does this statement in the standard require us to define every possible mental model the users might have? I have my opinion about this, in my organization others have theirs… I would be very very grateful for any external opinions from this forum about this. Perhaps a concrete example of how you have or would have handled this.
Regards!
I’m struggling with showing compliance to the usability standard IEC62366 and a major issue has become the paragraph:
5.3.2 * Identification of known or foreseeable HAZARDS and HAZARDOUS SITUATIONS
That states that ”During the identification of HAZARDS and HAZARDOUS SITUATIONS, the following shall be considered:” …
“– * if an incorrect mental model of the operation of the MEDICAL DEVICE can cause a USE ERROR resulting in a HAZARDOUS SITUATION; and” …
My question is, does this statement in the standard require us to define every possible mental model the users might have? I have my opinion about this, in my organization others have theirs… I would be very very grateful for any external opinions from this forum about this. Perhaps a concrete example of how you have or would have handled this.
Regards!