ASTM F1839-08(2021)

5.1This specification describes the compositional requirements, physical requirements, mechanical requirements, and test methods for rigid unicellular polyurethane foam for use in testing orthopaedic devices or instruments.

5.2This foam described in this specification is not intended to replicate the mechanical properties of human or animal bone. The requirements of this specification are intended to provide a consistent and uniform material with properties on the order of human cancellous bone to use as a test medium when testing various orthopaedic devices, such as bone screws.

1.1This specification covers rigid unicellular polyurethane foam for use as a standard material for performing mechanical tests utilizing orthopaedic devices or instruments. The specification is applicable to sheets or blocks of foam, or foam that is made by the user using a two-part liquid mixture.

1.2This specification covers polyurethane foam material that is used in the laboratory for mechanical testing, as described in 1.1. These materials are not intended for implantation into the human body.

1.3The foam described herein possesses mechanical properties which are on the order of those reported for human cancellous bone. See Appendix X1, Rationale, for further information regarding the appropriateness of using the specified foam as a model for human cancellous bone.

1.4This specification covers compositional requirements, physical requirements, mechanical requirements, and test methods for rigid polyurethane foam in the solid final form.

1.5This specification provides qualification criteria for vendor or end user processes and acceptance criteria for individual material lots.

1.6This specification provides mechanical properties of five different grades of foam in the solid final form. A foam that does not meet the specified mechanical properties shall be identified as an ungraded foam.

1.7The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.8The following precautionary statement pertains to the test method portion only, Section 8, of this specification: 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.

1.9This 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.