In the medical device context, no this is not correct because the failure of 
the device to provide the claimed medical benefit can be a cause of ‘injury’.

Nick. 


> On 17 Apr 2018, at 20:17, Richard Nute <ri...@ieee.org> wrote:
> 
>  


>  
> Do you agree or disagree with James Gibson’s assertion that
>  
> “Injuries to a living organism can be produced only by some energy 
> interchange”?
>  
> (ISO 14971, C.2.5 recognizes energy transfer can result in injury.)   
>  


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