// Workers AI · dad joke modeWhat did software safety classification say to its date? You're classified as a match.
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Software installed in medical devices is assessed for health and safety issues according to international standards.
Safety classes
[edit]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“
Serious injury
[edit]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
[edit]- ↑ "Developing Medical Device Software to IEC 62304 | MDDI Medical Device and Diagnostic Industry News Products and Suppliers". www.mddionline.com. June 2010. Retrieved 2017-06-15.