Before revision: Per IEC 62304:2006, software can be divided into three separate classes: Class A: No injury or damage to health is possible Class B: Nonserious injury is possible Class C: Death or serious injury is possible Serious injury Injury or illnes 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 structur
After revision: Per IEC 62304:2006, software can be divided into three separate classes: Class A: No injury or damage to health is possible Class B: Nonserious injury is possible Class C: Death or serious injury is possible 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 structur