23-06-2012, 10:35 AM
ISO 14971, 2nd Ed., 2007 Medical devices: Application of risk management to medical devices
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Introduction to ISO 14971
The requirements contained in this International Standard provide manufacturers with a framework within which experience, insight and judgment are applied systematically to manage the risks associated with the use of medical devices.
This International Standard was developed specifically for medical device and medical system manufacturers using established principles of risk management.
1. Scope of ISO 14971
The requirements of this International Standard are applicable to all stages of the life-cycle of a medical device.
This International Standard does not apply to clinical decision making.
This International Standard does not specify acceptable risk levels.
2. Key Terms and Definitions
2.2 harm physical injury or damage to the health of people, or damage to property or the environment
2.3 hazard potential source of harm
2.4 hazardous situation circumstance in which people, property, or the environment are exposed to one or more hazard(s)
3. General Requirements
3.1 Risk management process
The manufacturer shall establish, document and maintain throughout the life-cycle an ongoing process for identifying hazards associated with a medical device, estimating and evaluating the associated risks, controlling these risks, and monitoring the effectiveness of the controls.
4. Risk Analysis
4.1 Risk analysis process
Risk analysis shall be performed for the particular medical device.
The implementation of the planned risk analysis activities and the results of the risk analysis shall be recorded in the risk management file.
5. Risk Evaluation
For each identified hazardous situation, the manufacturer shall decide, using the criteria defined in the risk management plan, if risk reduction is required.
If risk reduction is not required, completeness of risk control applies.
The results of this risk evaluation shall be recorded in the risk management file.
[attachment=25171]
Introduction to ISO 14971
The requirements contained in this International Standard provide manufacturers with a framework within which experience, insight and judgment are applied systematically to manage the risks associated with the use of medical devices.
This International Standard was developed specifically for medical device and medical system manufacturers using established principles of risk management.
1. Scope of ISO 14971
The requirements of this International Standard are applicable to all stages of the life-cycle of a medical device.
This International Standard does not apply to clinical decision making.
This International Standard does not specify acceptable risk levels.
2. Key Terms and Definitions
2.2 harm physical injury or damage to the health of people, or damage to property or the environment
2.3 hazard potential source of harm
2.4 hazardous situation circumstance in which people, property, or the environment are exposed to one or more hazard(s)
3. General Requirements
3.1 Risk management process
The manufacturer shall establish, document and maintain throughout the life-cycle an ongoing process for identifying hazards associated with a medical device, estimating and evaluating the associated risks, controlling these risks, and monitoring the effectiveness of the controls.
4. Risk Analysis
4.1 Risk analysis process
Risk analysis shall be performed for the particular medical device.
The implementation of the planned risk analysis activities and the results of the risk analysis shall be recorded in the risk management file.
5. Risk Evaluation
For each identified hazardous situation, the manufacturer shall decide, using the criteria defined in the risk management plan, if risk reduction is required.
If risk reduction is not required, completeness of risk control applies.
The results of this risk evaluation shall be recorded in the risk management file.