ASTM F1839-08(R2021) pdf free download

ASTM F1839-08(R2021) pdf free download.Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
1. Scope
1.1 This specification covers rigid unicellular polyurethane foam for use as a standard material for performing mechanical tests utilizing orthopaedic devices or instruments. The specifi- cation is applicable to sheets or blocks of foam, or foam that is made by the user using a two-part liquid mixture. 1.2 This 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 implan- tation into the human body. 1.3 The foam described herein possesses mechanical prop- erties 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 speci- fied foam as a model for human cancellous bone. 1.4 This specification covers compositional requirements, physical requirements, mechanical requirements, and test methods for rigid polyurethane foam in the solid final form. 1.5 This specification provides qualification criteria for vendor or end user processes and acceptance criteria for individual material lots. 1.6 This specification provides mechanical properties offive 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. 1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.8 The following precautionary statement pertains to the test method portion only, Section 8, of this specification: This standard does not purport to address all ofthe safety concerns, ifany, associated with its use. It is the responsibility ofthe 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 accor- dance with internationally recognized principles on standard- ization established in the Decision on Principles for the Development of International Standards, Guides and Recom- mendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
3. Terminology
3.1 Definitions: 3.1.1 final form—the condition of the foam product when used by the end user to perform tests of orthopaedic devices or instruments. 3.1.1.1 Discussion—This is the condition of the foam prod- uct of which all physical and mechanical tests required by this specification are performed. In the final form the foam is in a uniform solid such as a slab, plate, or block. 3.1.2 foam rise direction—the nominal direction that the foam rises during the polymerization (“foaming”) process, either at the supplier’s production facilities for the solid supplied foam, or at the end user’s facilities for foam produced from the liquid supplied form. The foam rise direction shall be marked on the foam block or indicated in the shipping documentation for foam that is supplied in the solid form.
4. Physical and Mechanical Requirements
4.1 Composition—The material shall be supplied either in solid or liquid form. The solid or combined liquid parts shall produce a foam consisting of polyether polyurethane. 4.2 Appearance: 4.2.1 Solid Supplied Form—The solid supplied form shall be free ofobvious extraneous matter, and appear to the unaided eye to be uniform throughout the slab in color and porosity. 4.2.2 Liquid Supplied Form—The two liquid components shall appear to the unaided eye throughout their volumes to be uniform and free from obvious extraneous matter or particulate debris. 4.2.3 SolidFinal Form—The solid final form shall be free of obvious extraneous matter, and appear to the unaided eye to be uniform throughout the slab in color and porosity. 4.3 Void Content—The material in the solid final form shall meet the requirements of Table 1 for voids, cracks, and nonuniform areas, when examined using the procedures de- scribed in 8.1. All specimens shall meet this requirement. 4.4 Density—The material in the solid final form shall have a density within the ranges specified in Table 2, according to the foam’s grade specification. The density shall be determined using the method described in 8.2. All specimens shall meet this requirement. 4.5 Dimensional Stability—The material in the solid final form shall have an average percentage thickness change less than 5.0 %, when tested according to the method described in 8.3. 4.6 Compressive Strength—The material in the solid final form shall meet the compressive strength requirements given in Table 3, when tested according to the method described in 8.4. All specimens shall meet this requirement.