The international standard for Medical Device risk analysis is ISO 14971.

  • Risk analysis,
  • Risk Evaluation
  • and Risk control

are the essential phases of the risk management process.
The possible hazards are identified and categorized according to the severity and probability of occurrence of harm caused by the particular risk. Risk criteria are an important term defined by the manufacturer in the risk management plan for the evaluation of the risk. Depending on the risk criteria the evaluated risk is categorized as accepted or unaccepted risk. Unaccepted risks are further reduced using the risk control measures to make it acceptable.
According to the ISO 14971 standard, the risk criteria set-up is completely on the discretion of the manufacturer INTENDED use and which should be based on following factors

  • Generally accepted state of art
  • Comparing levels of risk evident from medical devices already in use
  • Applicable national or regional regulations and relevant International Standards.
  • Stakeholders opinion
  • Technical and Clinical Experts opinion

Options available for the application of risk acceptability criteria are

  • Indicating the combination of probability and severity in a matrix form  as acceptable and unacceptable
  • further subdividing the matrix and that risks first be made “ALARP – as low as reasonably practicable” before determining that they are acceptable.
  • Depending on the Risk Priority number RPN= Severity x Occurrence with the acceptable value of RPN as acceptable risk and values above acceptable RPN is unacceptable risk.

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