1.1 本规范涵盖了用于外科植入物的羟基磷灰石的化学和晶体学要求。对于一种被称为医用级羟基磷灰石的材料，它必须符合本规范。（参见 附录X1 .) 1.2 羟基磷灰石在软组织和骨骼中的生物反应具有临床使用史的特征 ( 1- 3. ) 2. 以及通过实验室研究 ( 4- 6. ) . 1.3 本规范包括拟用作外科植入物、外科植入物部件或用作制造工艺（如热喷涂、电泳沉积、物理气相沉积等）的原材料的粉末、颗粒和形式。 1.4 本规范特别不包括羟基磷灰石涂层、无定形磷酸钙、陶瓷玻璃、三盐基磷酸钙、白榴石以及α-和β- 磷酸三钙（见规范 2008年1月 ). 1.5 以国际单位制表示的数值应视为标准。本标准不包括其他计量单位。 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）。本标准的使用者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》中确立的国际公认的标准化原则制定的。

1.1 This specification covers chemical and crystallographic requirements for hydroxylapatite intended for surgical implants. For a material to be called medical-grade hydroxylapatite, it must conform to this specification. (See Appendix X1 .) 1.2 The biological response to hydroxylapatite in soft tissue and bone has been characterized by a history of clinical use ( 1- 3 ) 2 and by laboratory studies ( 4- 6 ) . 1.3 This specification includes powder, particulate, and forms intended for use as surgical implants, components of surgical implants, or as raw materials for manufacturing processes such as thermal spray coating, electrophoretic deposition, physical vapor deposition, and so forth. 1.4 This specification specifically excludes hydroxylapatite coatings, amorphous calcium phosphate, ceramic-glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate (see Specification F1088 ). 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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.