Software safety classification


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 that could cause injury to the user or patient.
Per IEC 62304:2006, software can be divided into three separate classes:
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.