GeezerVison

This article needs more citations. Please help improve this article by adding citations to reliable sources. Unsourced material may be challenged and removed. Find sources: "Software safety classification" – news · newspapers · books · scholar · JSTOR (July 2017) (Learn how and when to remove this message)

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 62304:2006 + A1:2015, the software can be divided into three separate classes: class A, B, and C.

• The SOFTWARE SYSTEM is software safety class A if:
  • the SOFTWARE SYSTEM cannot contribute to a HAZARDOUS SITUATION; or
  • the SOFTWARE SYSTEM can contribute to a HAZARDOUS SITUATION which does not result in unacceptable RISK after consideration of RISK CONTROL measures external to the SOFTWARE SYSTEM.
• The SOFTWARE SYSTEM is software safety class B if:
  • the SOFTWARE SYSTEM can contribute to a HAZARDOUS SITUATION which results in unacceptable RISK after consideration of RISK CONTROL measures external to the SOFTWARE SYSTEM and the resulting possible HARM is non-SERIOUS INJURY.
• The SOFTWARE SYSTEM is software safety class C if:
  • the SOFTWARE SYSTEM can contribute to a HAZARDOUS SITUATION which results in unacceptable RISK after consideration of RISK CONTROL measures external to the SOFTWARE SYSTEM and the resulting possible HARM is death or SERIOUS INJURY“