Software safety classification

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.[1]

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

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
  1. "Developing Medical Device Software to IEC 62304 | MDDI Medical Device and Diagnostic Industry News Products and Suppliers". www.mddionline.com. Retrieved 2017-06-15.
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