Definition of 'Harm' in ISO 14971

A

Agent J

#1
Cove,

I read an article the other day that started me wondering if the definition of harm is limited to a person's physical health or if mental health should also be included in the risk assessment.

For convenience:
[FONT=Arial,Bold][FONT=Arial,Bold]2.2
harm​
[/FONT]
[/FONT]
physical injury or damage to the health of people, or damage to property or the environment​
[ISO/IEC Guide 51:1999, definition 3.3]
On the one hand, in a world where mental health is given more and more consideration in insurance coverage, I can see where it would be included in "health of people". On the other hand, I don't want to take on the added work if this is something that is usually limited to just physical harm.
 
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M

MIREGMGR

#2
I think that mental health, i.e. stress level, of regulatory managers should be considered. :D

***

More seriously, the company for which I work considers only injury or health damage that is readily understood to be physical, i.e. not including molecular mechanisms by which "mental health" issues occur.

We do however consider health damage at the societal level in our approach to risk, particularly in regard to the role of cost in determining the total provision of health care in the context of a limited societal health care expenditure level.

The cited section of the standard is very badly designed. It should have included a discussion of these very points, which should have been foreseen by the drafters.
 
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