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Part-1 : Risk Managment Definition

Part-1 : Risk Managment Definition

Reference: ISO 14971:2019

Part-1 : Risk Managment Definition
  1. Risk is the combination of the probability of occurrence of harm and the severity of the harm.

  2. Harm: Injury or damage to the health of people, or damage to property or the environment.

  3. Hazard: Potential source of harm.

  4. Severity: Measure of the possible consequences of a hazard.

  5. Hazardous situation: Circumstances in which people, property or environment is/are exposed to one or more hazards.

  1. Risk Analysis: Systematic use of available information to identify hazards and estimate the risk.

  2. Risk Assessment: Overall process containing risk analysis and a risk evaluation.

  3. Risk Control: Process in which decisions are made and measures implemented by which risks are reduced to, or maintained within specified levels.

  4. Risk Estimation: Process used to assign value to the probability of occurrence of harm and severity of the harm.

  5. Risk Evaluation: Process of comparing the estimated risk against the risk criteria to determine the acceptability of risk.

  6. Residual Risk: risk remaining after risk control measures have been implemented.

  7. Benefit: positive impact or desirable outcome of the use of the medical device on the health of an individual, or a positive impact on patient management or public health.

  8. Life cycle: Series of all phases of the medical device from initial conception to the final decommissioning and disposal.

  9. Objective Evidence: Date supporting to existence or variety of something.

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