ASTM F3860-26

1.1 This test method provides mechanical performance considerations and standard test methods for measuring basic properties of interference screws that are implanted into bone. The interference screws that may be evaluated by this test standard can have varying designs such as solid, fenestrated, cannulated, or multi-component interference screws, such as those which have an attached or separated sheath.

1.2 This standard does not address testing methods for absorbable or degradable devices, as representative testing is already found in Guide F2902. This standard does not address testing methods for device removal or evaluation of device removal risks.

The insertion verification testing presented in this standard does not address end user validation testing or usability testing/human factors testing which may need to replicate the operating environment (e.g., visualization).

Multiple test methods are included in this standard. However, the test types in this standard may not address all end-user/customer needs that are important for development of your interference screw. The user is not obligated to use only the tests identified in this standard, nor are they obligated to test their device using all of the methods described.

The user should only select, with justification, test methods that are appropriate for a particular device design and this may only be a subset of the herein described test methods. This test method does not address the evaluation of other soft tissue fixation devices, including but not limited to suture anchors or cortical buttons.

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

1.4 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.

1.5 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.

5.1 Please see Annex A1 and Annex A2 for the significance of use descriptions for the insertion torque and pull-out testing methods, respectively.