ASTM F116 - 12(2021): Standard Guide for Biological Evaluation

The ASTM F116 - 12(2021) is a critical standard guide developed by ASTM International, specifically designed for the healthcare technology sector. As a cornerstone document, it provides comprehensive guidelines for the biological evaluation of medical devices in accordance with ISO 10993 standards. This standard is essential for ensuring the safety and efficacy of medical devices, addressing the necessity for rigorous biological assessment before any clinical application.

Introduced in 2021, this updated version of ASTM F116 outlines the scope of biological assessment procedures, highlighting the importance of testing and validating materials that come into contact with the human body. It serves as an essential resource for manufacturers, regulatory bodies, and healthcare professionals who aim to comply with safety regulations while innovating in product development.

The document delineates a systematic approach to evaluating the potential biological risks posed by medical devices, including cytotoxicity, sensitization, and irritation studies. Utilizing the latest scientific research, ASTM F116 - 12(2021) incorporates methodologies that ensure comprehensive assessments are conducted for various medical applications. This ensures that products not only comply with regulatory demands but also meet the highest standards of patient safety.

Moreover, the standard emphasizes the significance of ongoing risk management practices in the lifecycle of a medical device—from conception through post-market surveillance. By supporting a more proactive approach, it advocates for continual assessment and responsivity to emerging biological data, thus ensuring that any potential risks are mitigated effectively.

This standard is available in both PDF and hardcopy formats, priced at just £68.00. It is an indispensable investment for entities seeking to navigate the complexities of the healthcare industry efficiently. Compliance with ASTM F116 - 12(2021) not only bolsters regulatory approval processes but also instills confidence in patients and healthcare providers alike, underpinning a culture of safety and innovation within the field.

For further information, or to acquire your copy of this essential standard, visit our website or contact our customer support team. Ensure that your products are developed with the highest standards of safety, efficacy, and quality.