BS EN ISO 10993-4:2017+A1:2025 - Biological Evaluation of Medical Devices: Selection of Tests for Interactions with Blood

In the ever-evolving world of medical technology, ensuring the safety and efficacy of medical devices is paramount. The BS EN ISO 10993-4:2017+A1:2025 standard is a critical document that provides comprehensive guidelines for the biological evaluation of medical devices, specifically focusing on the selection of tests for interactions with blood. This standard is an essential resource for manufacturers, researchers, and regulatory bodies involved in the development and approval of medical devices.

Key Features of the Standard

• Standard Number: BS EN ISO 10993-4:2017+A1:2025
• Pages: 88
• Release Date: March 7, 2025
• ISBN: 978 0 539 27371 7
• Status: Standard

Comprehensive Guidance for Medical Device Evaluation

The BS EN ISO 10993-4:2017+A1:2025 standard is meticulously designed to address the complex interactions between medical devices and blood. It provides a structured approach to selecting appropriate tests that assess the potential biological risks associated with these interactions. This ensures that medical devices are not only effective but also safe for use in clinical settings.

With 88 pages of detailed information, this standard covers a wide range of topics, including the principles of biological evaluation, the selection of test methods, and the interpretation of test results. It serves as a vital tool for ensuring that medical devices meet the highest standards of safety and performance.

Why This Standard is Essential

Medical devices that come into contact with blood, such as catheters, stents, and dialysis equipment, must undergo rigorous testing to ensure they do not cause adverse reactions. The BS EN ISO 10993-4:2017+A1:2025 standard provides the necessary framework for conducting these evaluations, helping to identify potential risks and mitigate them before the devices reach the market.

By adhering to this standard, manufacturers can demonstrate their commitment to patient safety and regulatory compliance. It also facilitates the approval process by providing clear guidelines that align with international regulatory requirements.

Who Should Use This Standard?

This standard is indispensable for a wide range of professionals in the medical device industry, including:

• Medical Device Manufacturers: To ensure their products meet safety and performance standards.
• Regulatory Bodies: To evaluate the compliance of medical devices with international safety standards.
• Researchers and Scientists: To develop and refine testing methods for medical device evaluation.
• Quality Assurance Professionals: To implement and maintain quality control processes in line with the standard.

Stay Ahead with the Latest Amendments

The inclusion of the amendment A1:2025 ensures that this standard reflects the latest advancements and insights in the field of medical device evaluation. By staying up-to-date with these changes, stakeholders can maintain a competitive edge and continue to deliver safe, effective medical devices to the market.

Conclusion

The BS EN ISO 10993-4:2017+A1:2025 standard is an invaluable resource for anyone involved in the development, testing, and regulation of medical devices. Its comprehensive guidelines for the selection of tests for interactions with blood are crucial for ensuring the safety and efficacy of these devices. By integrating this standard into their processes, organizations can enhance their product offerings, ensure regulatory compliance, and ultimately improve patient outcomes.

Invest in the future of medical device safety and performance with the BS EN ISO 10993-4:2017+A1:2025 standard, and be part of a global effort to advance healthcare technology.

BS EN ISO 10993-4:2017+A1:2025

• 11.100.20 Biological evaluation of medical devices