Journal of Applied Reliability (한국신뢰성학회지:신뢰성응용연구)

The Korean Reliability Society (한국신뢰성학회)
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Study on Reliability Assessment for the Medical Device Software from the Viewpoint of Functional Safety

기능 안전 관점에서의 의료기기 소프트웨어 신뢰성 평가 방법에 관한 연구

  • Received : 2016.08.16
  • Accepted : 2016.09.23
  • Published : 2016.09.25
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Abstract

Purpose: This paper suggests the procedure to enhance the reliability of the software of the medical device that is to cure, treat, diagnose, and prevent a disease or an abnormal health conditions. Methods: After test requirements are classified by the software requirements specification for safety and backgrounds, reliability assessment methods are suggested. Results: Verification and validation for function and safety can be performed whether the medical device software are implemented as intended. Conclusion: Procedure on the static analysis, unit test, integration test, and system test are provided for the medical device software.

Keywords

References

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