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. |
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Intended Use
Hazard Identification
Risk Estimation
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- Options Analysis
- Implementation
- Residual risk evaluation & acceptance
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| POST PRODUCTION
INFORMATION |
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- Post-production Experience
- Review of Risk Man Experience
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All recorded in the |
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THE EN ISO 14971 PROCESS IS CONTINUOUS
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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