راهنمای مدیریت ریسک در تجهیزات پزشکی ISO14971

بندهایی از استاندارد ISO14971

ISO 14971 is the international standard for risk management in the design and production of medical devices. It provides a framework for identifying, evaluating, controlling, and monitoring risks associated with medical devices throughout their lifecycle. Here are some of the key clauses (or sections) of ISO 14971:

1. Scope (Clause 1)

• Defines the scope of the standard, which covers the application of risk management to all phases of the life cycle of medical devices.

2. Terms and Definitions (Clause 3)

• Provides the key terms and definitions used throughout the standard to ensure clarity in the application of risk management concepts.

3. Risk Management Process (Clause 4)

• Introduces the overall process and the structured approach to managing risks, including responsibilities and documentation requirements.

4. Risk Analysis (Clause 5)

• Identification of hazards: Focuses on identifying potential hazards related to the medical device.
• Risk estimation: Defines how to estimate the risk associated with each identified hazard by considering the probability of occurrence and the severity of harm.

5. Risk Evaluation (Clause 6)

• Requires the manufacturer to evaluate if the estimated risks are acceptable according to predefined criteria.

6. Risk Control (Clause 7)

• Risk control options: Specifies how to reduce risks to acceptable levels through the application of protective measures or by redesigning the device.
• Residual risk evaluation: Ensures that any remaining risks after control measures are applied are acceptable.
• Benefit-risk analysis: If the residual risks are not acceptable, the benefit of the device’s intended use must outweigh the residual risks.
• Risk control verification: Verifies that the applied risk controls are effective.

7. Evaluation of Overall Residual Risk (Clause 8)

• Assesses the overall residual risk of the device and determines whether it is acceptable when considering the combination of all risks.

8. Risk Management Review (Clause 9)

• Requires periodic reviews of the risk management process to ensure effectiveness and to identify areas for improvement.

9. Production and Post-Production Activities (Clause 10)

• Focuses on monitoring and feedback systems during production and post-production phases to capture new risks or failures and evaluate them continuously.

These key sections ensure that medical device manufacturers systematically assess risks throughout the device’s lifecycle, ensuring patient safety and compliance with regulatory requirements.

Key Clauses of ISO 14971 (Continued):

10. Risk Management File (Clause 4.5)

• Requires the manufacturer to maintain a risk management file that documents all the risk management activities throughout the product lifecycle. This file should be continuously updated as new risks are identified, and any changes or updates to risk controls are implemented.

11. Post-market Surveillance and Feedback (Clause 10.2)

• Ensures that once the device is on the market, there is ongoing monitoring and collection of information from the use of the device in real-world scenarios. This feedback is vital for detecting potential risks that were not evident during the initial risk analysis phase.

12. Risk Communication (Clause 5.5)

• Stipulates that manufacturers must communicate risks and residual risks to relevant stakeholders, such as end-users, patients, or healthcare professionals. Instructions for use, warnings, and other communication tools are part of this risk communication process.

13. Review of Risk Management Process (Clause 9.1)

• The standard mandates that regular reviews of the risk management process are essential to ensure its ongoing effectiveness. This review should consider new information from production, post-production monitoring, or changes in technology.

14. Risk-benefit Analysis (Clause 7.4)

• In cases where the residual risk cannot be reduced to an acceptable level, manufacturers must conduct a risk-benefit analysis to justify the device’s benefits in relation to the remaining risk. This analysis ensures that the benefits to the patient outweigh the potential risks.

15. Risk Controls (Clause 7.1 – 7.5)

• Manufacturers must apply risk control measures in a prioritized manner: eliminating risks through design first, followed by protection measures, and lastly, providing warnings and instructions for users. Verification of the effectiveness of these controls is also required.

By focusing on the lifecycle approach, ISO 14971 ensures that all possible risks associated with a medical device are identified, evaluated, and mitigated as much as possible to protect patient safety.

The standard is pivotal in demonstrating regulatory compliance and ensuring that a thorough risk management process is in place, supporting the approval of medical devices in global markets.