Software installed in medical devices is assessed for health and safety issues according to international standards.
Software classification is based on the potential for hazard(s) that could cause injury to the user or patient.
[1] Per [[IEC 62304|IEC 62304:2006] + A1:2015], the 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.