1.1 本规范涵盖了硬质单孔聚氨酯泡沫塑料，该泡沫塑料用作利用矫形装置或仪器进行机械试验的标准材料。本规范适用于泡沫片或泡沫块，或用户使用两部分液体混合物制成的泡沫。 1.2 本规范涵盖实验室用于机械测试的聚氨酯泡沫材料，如中所述 1.1 . 这些材料不用于植入人体。 1.3 本文所述的泡沫具有与人类松质骨相同的力学性能。 看见 附录X1 ，基本原理，以获取有关使用指定泡沫作为人类松质骨模型的适当性的进一步信息。 1.4 本规范涵盖固体最终形式的硬质聚氨酯泡沫的成分要求、物理要求、机械要求和试验方法。 1.5 本规范提供了供应商或最终用户工艺的资格标准以及单个材料批次的验收标准。 1.6 本规范提供了五种不同等级的固体最终形状泡沫的机械性能。不符合规定机械性能的泡沫应被视为未分级泡沫。 1.7 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.8 以下预防说明仅适用于试验方法部分，第 8. ，本规范 :本标准无意解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.9 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 5.1 本规范描述了用于测试矫形装置或仪器的硬质单孔聚氨酯泡沫的成分要求、物理要求、机械要求和测试方法。 5.2 本规范中所述的泡沫无意复制人类或动物骨骼的机械性能。本规范的要求旨在提供一致、均匀的材料，其性能与人体松质骨相当，在测试各种矫形设备（如骨螺钉）时用作测试介质。

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 specification 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 implantation into the human body. 1.3 The 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. 1.4 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 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. 1.7 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 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. ====== Significance And Use ====== 5.1 This 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. 5.2 This 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.