ASTM F 1635 : 2024

1.1This test method covers in vitro degradation of hydrolytically degradable polymers (HDP) intended for use in surgical implants. It provides a detailed methodology for conditioning samples and suggests quantitative techniques for evaluating changes in properties (for example, mass, molar mass, and mechanical strength) over time.

1.2The requirements of this test method apply to HDPs in various forms:

1.3This standard provides guidance for mechanical loading or fluid flow, or both, when relevant to the device being evaluated. The specifics of loading type, magnitude, and frequency for a given application are beyond the scope of this test method.

1.4This standard is not applicable to conditioning of polymers that degrade primarily through mechanisms other than hydrolysis (for example, enzymatic or oxidative degradation). See X1.1.1 for more information.

1.5The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6This 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.

1.7This 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.