Risk Management ISO 14971

🔴 Risk Management ISO 14971

It is an international standard for medical device risk management that identifies potential hazards, calculates and evaluates risks, controls them, and monitors their effects throughout the entire lifecycle of medical devices, including design, manufacturing, and use.

This standard applies throughout the lifecycle of the medical device and does not apply to clinical judgments related to the use of the medical device.

♦️ Terms and Definitions

The key terms and definitions used in ISO 14971 are as follows.

  1. Benefit
    • Positive impact on individual health, desired outcomes, or positive impact on patient care or public health when using a medical device
  2. Harm
    • Injury or damage to human health or damage to property or the environment
  3. Hazard
    • Potential causes of harm
  4. Hazardous Situation
    • A state in which people, property, or the environment are exposed to one or more harmful factors.
  5. Intended Use / Intended Purpose
    • Using a product, process, or service as intended in accordance with the specifications, instructions, and information provided by the manufacturer
  6. Risk
    • A combination of risk probability and risk severity
  7. Risk Analysis
    • Systematically using available information to identify risk factors and estimate risks
  8. Risk Assessment
    • The overall process including risk analysis and risk assessment
  9. Risk Control
    • A process in which decisions are made and measures are implemented to reduce or maintain risk below a defined level.
  10. Risk Estimation
    • A process used to assign values ​​to the probability of harm occurring and the severity of that harm
  11. Risk Evaluation
    • A process of comparing an estimated risk with a given risk tolerance standard to determine the acceptableness of the risk.
  12. Risk Management File
    • A set of records and other documents generated by risk management
    • All risk management activities are documented in the risk management file.

♦️ Application of risk management

  • Applicable To
    • Patient
    • Medical staff
    • Medical Device Operator
    • Peripheral Equipment and Environment

  • Applied Area
    • 위험관리 요구사항은 설계 개발 단계부터 제품 폐기까지 의료기기 수명 전 주기
    • 의료기기 위해 요인을 식별, 위험을 산정.평가.통제함으로써 통제의 효율성을 감시하고 새로운 위험을 식별하기 위한 프로세스

♦️ RMF (Risk Management File)

The Risk Management File (RMF) must include the following:

  • Comprehensive risk management plan
  • Risk Identification and Risk Analysis Document
  • Risk assessment records
  • Failure Mode and Effects Analysis (FMEDA)
    • FMEDA on Electromechanical Hazards
    • FMEDA for electromagnetic hazards
    • FMEDA on software risks
    • FMEDA on the risk of usability
    • FMEDA regarding manufacturing process risks
  • Documentation and verified effectiveness of risk control measures
  • Residual Risk Acceptability and Overall Benefit-Risk Analysis
  • Post-marketing surveillance data and continuous risk communication

♦️ Risk Management Process

  1. Risk Management Plan
    • Defines the scope of risk, liability, and risk tolerance standards for the device
    • Documents that must be updated periodically throughout the device lifecycle to guide all safety activities
  2. Risk Analysis
    • The process of identifying potential risk factors (causes of damage) and analyzing a predictable series of events that could lead to dangerous situations.
    • Predict user errors and potential failures in both normal and faulty states
  3. Risk Evaluation
    • In risk assessment, values ​​are assigned to the probability of occurrence and the severity of damage.
    • Determine whether risk reduction is necessary by comparing the estimated risk with the acceptance criteria defined in the risk management plan.
  4. Risk Control
    • For unacceptable risks, the manufacturer implements risk controls.
    • Risk Control Methods
      • Safe design
      • Supplementary (protective) measures
      • Safety Information (Labels and Manuals)
  5. Evaluation of overall residual risk
    • Residual risk: Risk remaining after applying control measures
    • If the total residual risk is determined to be unacceptable, a formal benefit-risk analysis is performed to demonstrate that the clinical benefits of the device outweigh the remaining risks.
  6. Risk Management Report
  7. Production and post-production information

♦️ The ultimate goal of risk management

The goal is to continuously launch highly beneficial, safe, and effective medical products by improving the efficiency of the risk management process.

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