I don’t like “risk assessment.”  It is highly subjective and not scientific.  
Read ISO 14971 or any treatise on risk assessment. 


I use the “energy transfer model.”   This is not subjective and highly 


It was first proposed by James J. Gibson in 1961: 


“Injuries to a living organism can be produced only by some energy interchange.”


The first step is to identify the energy sources within a product.  The second 
step is to class the energy sources as capable of causing injury or not.  The 
third step is to provide the energy sources capable of causing injury with one 
or more safeguards to prevent the transfer of energy to a body part.  The 
fourth step is to test the adequacy of the safeguards.


Easy and straight-forward.  Not subjective.  







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