1.1 本规范涵盖了外科植入物应用的磷酸钙涂层的材料要求。 1.2 在颗粒和整体形式中，磷酸钙材料系统在生物反应方面已经得到了很好的表征 ( 1. ， 2. ) 2. 和实验室表征 ( 2个- 4. ) .若干出版物 ( 5个- 10 ) 已记录 体外 和 体内 所选磷酸钙涂层体系的性能。 1.3 本规范涵盖羟基磷灰石涂层、其他磷酸钙（例如八钙磷酸钙、无定形磷酸钙、二水磷酸二钙）涂层或含有两种或多种磷酸钙相组合的涂层，有或没有故意少量添加其他元素或化合物（例如氟、锰、镁、碳酸盐）， 3. 并通过包括但不限于以下的方法应用: ( 1. )等离子喷涂沉积( 2. )溶液沉淀( 3. )浸渍/烧结( 4. )电泳沉积，以及( 5. )溅射。 1.4 对于含有两个或更多磷酸钙相的涂层，其中一个或更多将是涂层中的一个或多个主相，而其他相可能作为第二相或次相出现，应分别针对每个相应的结晶相确定涂层的相组成。看见 X1.2 。 1.5 基底可以包括光滑的、多孔的、有纹理的和其他可植入的地形形式。 1.6 本规范不包括可能含有钙和磷酸盐离子物质的有机涂层。 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 the material requirements for calcium phosphate coatings for surgical implant applications. 1.2 In particulate and monolithic form, the calcium phosphate materials system has been well characterized regarding biological response ( 1 , 2 ) 2 and laboratory characterization ( 2- 4 ) . Several publications ( 5- 10 ) have documented the in vitro and in vivo properties of selected calcium phosphate coating systems. 1.3 This specification covers hydroxylapatite coatings, other calcium phosphate (for example, octacalcium calcium phosphate, amorphous calcium phosphate, dicalcium phosphate dihydrate) coatings, or a coating containing a combination of two or more calcium phosphate phases, with or without intentional minor additions of other elements or compounds (for example, fluorine, manganese, magnesium, carbonate), 3 and applied by methods including, but not limited to, the following: ( 1 ) plasma spray deposition, ( 2 ) solution precipitation, ( 3 ) dipping/sintering, ( 4 ) electrophoretic deposition, and ( 5 ) sputtering. 1.4 For a coating containing two or more calcium phosphate phases, one or more of which will be a major phase or major phases in the coating, while the other phase(s) may occur as a second or minor phases, the phase composition(s) of the coating should be determined against each corresponding crystalline phase, respectively. See X1.2 . 1.5 Substrates may include smooth, porous, textured, and other implantable topographical forms. 1.6 This specification excludes organic coatings that may contain calcium and phosphate ionic species. 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.