ASTM F3744 : 26 New ASTM DRM Policy

1.1 This guide outlines an appropriate experimental approach for evaluating the effects of physiologically relevant constant or cyclic loads (e.g. stresses, strains) on the performance characteristics of an absorbable metal implant or test specimen.

1.2 The intent of this guide is to encompass testing that ties together various potential corrosion modalities (e.g. general uniform corrosion, pitting corrosion, stress-induced corrosion cracking) and the effects of fatigue.

1.3 This type of testing is undertaken with loading that approximates or surpasses the expected in vivo application. This guide provides general considerations that may be taken into account when evaluating implants fabricated from absorbable metals and does not provide specific instructions for any particular implant type or variety.

1.4 This guide is considered applicable to all absorbable metals, including magnesium, iron, zinc, and molybdenum-based metals and alloys.

1.5 The obtained test results may be used to screen materials and/or constructs prior to evaluation of a more refined fabricated implant, or to simulate lifetime or failure mechanisms of fully manufactured implants.

1.6 While corrosion fatigue life can be affected by numerous factors, including microstructure, surface roughness, surface defects, residual stresses, coatings, and other surface treatments, as well as factors introduced through the corrosion environment, this evaluation approach does not address the underlying factors contributing to the identified failure mode.

1.7 The described tests are not considered to be representative of in vivo conditions and could potentially provide a more rapid or slower corrosion fatigue behavior than an absorbable metal specimen under in vivo conditions. Corrosion fatigue testing does not necessarily provide a comprehensive understanding of the performance characteristics of absorbable metals. Additional tests (e.g. in vitro degradation, in vivo testing, and clinical trials) and Finite Element Analysis (FEA) may be required to fully characterize an implant.

1.8 This 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.

1.9 This 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.