Software safety classification
 | This article needs additional citations for verification. (July 2017) |
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|IEC 62304:2006] + A1:2015], the software can be divided into three separate classes:
- 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.