What is BS EN 45517-2017?

BS EN 45517-2017 is a technical standard that provides guidelines and specifications for the design, testing, and performance of medical electrical equipment. It specifically focuses on active implantable medical devices (AIMDs) and their compatibility with external electronic devices.

Scope and Importance

The scope of BS EN 45517-2017 covers a wide range of AIMDs, including cardiac pacemakers, neurostimulators, cochlear implants, and drug pumps. These devices directly interact with the human body, making it crucial to ensure their safety and effectiveness. This standard plays a vital role in guaranteeing the reliability, stability, and quality of these devices.

BS EN 45517-2017 also addresses the potential risks associated with electromagnetic disturbances and outlines requirements for electromagnetic emissions and immunity. By establishing specific limits and test methods, it ensures that AIMDs can operate safely in various environments without interference from external electronic devices.

Key Requirements

The standard specifies several key requirements that manufacturers must adhere to when designing and manufacturing AIMDs:

1. Design Considerations: Manufacturers must consider factors such as device architecture, electrical safety, and risk management during the design phase. This involves analyzing potential hazards and implementing necessary safeguards to mitigate risks.

2. Software Risk Management: As AIMDs increasingly rely on software for functionality, the standard emphasizes the importance of robust software development processes and risk management strategies. It requires manufacturers to identify potential software failures and implement measures to prevent or minimize them.

3. Electromagnetic Compatibility: The standard outlines stringent requirements for electromagnetic compatibility, including both emissions and immunity. AIMDs should not emit excessive electromagnetic radiation and should be able to withstand external electromagnetic disturbances without compromising their performance.

Conclusion

BS EN 45517-2017 plays a critical role in ensuring the safety, reliability, and effectiveness of active implantable medical devices. By establishing guidelines for design, testing, and electromagnetic compatibility, it sets a standard that manufacturers must meet to bring these life-saving devices to market. Strict adherence to this standard helps protect patients and ensures the proper functioning of AIMDs in diverse environments.