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.
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.