1.1 本试验方法涵盖用于外科植入应用的磷酸钙材料。 1.2 材料应代表为销售而生产的材料。应在标准制造条件下生产和加工。 1.3 材料可以是粉末、颗粒、层裂材料、预制形式或涂层；并且可以是代表最终用途产品的多孔、无孔、纹理和其他可植入地形基质形式。 1.4 磷酸钙材料可以是基质中的唯一材料，也可以是多种材料中的一种，只要存在的所有其他材料在本试验方法所述的试验条件下不溶解。 1.5 以国际单位制或英寸-磅单位表示的数值应单独视为标准值。每个系统中规定的值可能不是精确的等效值；因此，每个系统应相互独立使用。 将两个系统的值合并可能会导致不符合标准。 1.6 本标准并非旨在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。 1.7 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====== 4.1 实验室研究和临床应用已经报告了软组织和骨中磷酸钙材料的生物学反应方面 ( 1- 11 ) . 3. 4.2 本试验方法的要求适用于磷酸钙材料，如羟基磷灰石钙（见规范 F1185 )，β-磷酸三钙（见规范 F1088 )，以及含有或不含有其他次要成分（<10%）的两相混合物。 4.3 本试验方法仅限于磷酸钙材料溶解速率的实验室评估。结果与体内表现没有相关性。因此，建议在评估中包括控制材料。控制材料可以是标准材料，如NIST SRM 2910或历史控制材料。

1.1 This test method covers calcium phosphate materials intended for use in surgical implant applications. 1.2 The material(s) shall be representative of that produced for sale. It shall have been produced and processed under standard manufacturing conditions. 1.3 The materials may be in the form of powders, granules, spall material, fabricated forms, or coatings; and may be porous, nonporous, textured, and other implantable topographical substrate form representative of the end-use product. 1.4 The calcium phosphate material may constitute the only material in a substrate or it may be one of multiple materials so long as all other materials present do not dissolve under the test conditions described in this test method. 1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard. 1.6 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. 1.7 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 ====== 4.1 Aspects of the biological response to calcium phosphate materials in soft tissue and bone have been reported from laboratory studies and clinical use ( 1- 11 ) . 3 4.2 The requirements of this test method apply to calcium phosphate materials such as calcium hydroxyapatite (see Specification F1185 ), beta-tricalcium phosphate (see Specification F1088 ), and biphasic mixtures thereof with or without intentional addition of other minor (<10 %) components. 4.3 This test method is limited to the laboratory evaluation of the dissolution rate of a calcium phosphate material. No correlation of the results to in-vivo performance is implied. Therefore, it is recommended that a control material be included in the evaluation. The control material can be a standardized material such as NIST SRM 2910 or a historical control.