ASTM F 3718 : 2024

1.1It is the intent of this standard practice to permit an investigator to maintain oxidative capacity of test solutions and provide a standardized approach for oxidative degradation screening of polymers as recommended in ISO 10993-13. The method described in this standard practice can be used for real-time monitoring and maintaining hydrogen peroxide (H₂O₂) concentrations in aqueous test solutions within a consistent range for oxidative degradation tests at ambient and elevated temperatures for prolonged periods. Due to the sensitivity of electrochemical components used in this method, the stability range of the H₂O₂ concentration in the test solutions may vary between test systems and shall be reported by the user of this practice.

1.2Although this standard practice can be used for in vitro oxidative degradation screening of non-absorbable polymers, this practice makes no clinical predictions, as it may not precisely simulate the in vivo degradation of a polymeric medical device after implantation. It is incumbent on the user to determine applicability of this standard practice to their specific device or material. This standard practice considers polymer degradation by hydrolytic and oxidative chemical pathways of the finished polymeric device. It is not applicable to degradation of the device induced during its intended use by mechanical stress, wear, electromagnetic radiation, or biological factors such as enzymes, other proteins, or cellular activity.

1.3The values presented in this standard practice adhere to SI units as the standard. Any conversion to alternative units is provided for informational purposes only. It is the responsibility of the user to ensure safety, health, and environmental practices in accordance with regulatory requirements.

1.4This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.5This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.