Safety Classes  Software classification is based on potential for hazard(s) that could cause injury to the user or patient. Serious injury Injury or illness that directly or indirectly is life threatening  results in permanent impairment of a body function or permanent damage to a body structure , or necessitates medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure. 
Software installed in medical devices is assessed for health and safety issues according to international standards. Safety classes Software classification is based on potential for hazard(s) that could cause injury to the user or patient. Serious injury For the purpose of this classification, serious injury is defined as injury or illness that directly or indirectly is life threatening ; results in permanent impairment of a body function or permanent damage to a body structure ; or necessitates medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure. References
R
Safety Classes
Software installed in medical devices is assessed for health and safety issues according to international standards.
A
Safety classes
R
Injury
For the purpose of this classification, serious injury is defined as injury
A
;
R
,
;
A
References