Software safety classification

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

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.
  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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