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EN ISO 14971:2009 RISK MANAGEMENT FOR MEDICAL DEVICES

EN ISO 14971:2009 – risk management for medical devices is the standard that should be applied to all medical devices.

During development, hazards and the likelihood of those hazards arising should be assessed. The design should then aim to eliminate or reduce such risks to an acceptable level throughout the expected life of the device.

Thereafter risks should be monitored to correct the risk assessment and, if necessary, introduce new risk reduction methods. This should continue throughout the life of the device, taking into account changes in design, specifications and manufacturing processes, changes in recommended use, changes in the packaging or the environment or changes in legislation, standards, or advances in technology. The aim should always be to keep the risk as low as reasonably practicable, and always acceptable when compared with the benefits offered by the device.

Definitions used in Risk Assessment

Refer to EN ISO 14971 for full and complete definitions

Harm Physical injury or damage to the health of people, or damage to property or the environment.
Hazard Potential source of harm.
Hazardous Situation Circumstance in which people, property, or the environment are exposed to one or more hazard(s)
Risk Combination of the probability of occurrence of harm and the severity of that harm.
Risk Analysis Systematic use of available information to identify hazards and estimate the risk.
Risk Estimation Process used to assign values to the probability of occurrence of harm and the severity of that harm.
Risk Evaluation Process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk.
Risk Control Process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels.
Safety Measure Freedom from unacceptable risk.

 

Risk
Assessment


RISK ANALYSIS
  • Intended Use
  • Hazard Identification
  • Risk Estimation
    		•

     














    		Risk
    Management
    RISK EVALUATION
    Acceptability Decisions

     
     
    RISK CONTROL
    • Options Analysis
    • Implementation
    • Residual risk evaluation & acceptance

     
     
    POST PRODUCTION INFORMATION
    • Post-production Experience
    • Review of Risk Man Experience

      All recorded in the
      
     
    RISK MANAGEMENT
    FILE
    		 

    THE EN ISO 14971 PROCESS IS CONTINUOUS

     
    Risk Analysis
    		 
     





    		 
    Risk
    Evaluation
    		 
    Post
    Production
     





    		 
     
    Risk Control
    		 

     

    Risk Management File. EN14971 requires specific records are kept in the Risk Management File. This, in turn, forms part of the Technical Documentation required to be retained under the Medical Devices Directive. Refer to the standard for more details.

    For more information – read the standard and should you still require assistance contact David Baker

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