本文件规定了应用于金属外科植入物的单层热喷涂羟基磷灰石涂层的要求。 这些要求旨在描述材料的特性，并在组织之间进行沟通。这些要求并不是为了取代公司的内部运营和评估要求而编写的，尽管它们可以作为内部运营和评估要求使用。 注1:对于厚度小于50μm的薄涂层，本文件中描述的一些试验方法在未经修改的情况下可能难以应用。 注2:双层涂层的羟基磷灰石层（包括下层金属涂层和上层羟基磷灰石涂层）的要求可遵循本文件； 然而，本文件中提到的测试方法不能应用于双层涂层。如果将本文件作为双层涂层羟基磷灰石层要求的参考，可能认为有必要说明单层测试试片如何代表双层涂层植入物。 本文件不包括由玻璃、微晶玻璃、α-和β-磷酸三钙、双相磷酸钙或其他形式的磷酸钙制成的涂层。 注3:虽然本文件中的要求旨在用作热喷涂羟基磷灰石涂层的规范，但可能有必要制定常规控制程序，规定控制试验及其时间间隔，以确保涂层的特性保持在规定的范围内。 注4:本文件的编制重点是羟基磷灰石的等离子喷涂涂层。它还可用于表征其他热喷涂羟基磷灰石涂层。然而，没有临床使用历史的热喷涂涂层可能存在不同的风险，并且可能需要本文件中确定的特征之外的其他特征。

This document specifies requirements for single layer thermally sprayed hydroxyapatite coatings applied to metallic surgical implants. These requirements are intended to describe properties of the materials and to communicate these between organizations. These requirements are not written with the objective of replacing a company's internal operational and assessment requirements although they could be used as such. NOTE 1 For thin coatings with a thickness of less than 50 μm, some of the test methods described in this document might be difficult to apply without modification. NOTE 2 The requirements of the hydroxyapatite layer of dual-layer coatings (consisting of a lower layer of metallic coating and an upper layer of hydroxyapatite coating) can follow this document; however, testing methods referred to in this document cannot be applied to dual layer coatings. If this document is taken in reference for the requirements of the hydroxyapatite layer of dual layer coatings, a rationale on how the single-layer tested coupons are representative of the dual-layer coated implant might be considered necessary. This document does not cover coatings made from glasses, glass ceramics, alpha- and beta-tricalcium phosphate, biphasic calcium phosphate or other forms of calcium phosphate. NOTE 3 While the requirements in this document are intended to be used as specifications of a thermally sprayed coating of hydroxyapatite, it might be necessary to establish routine control procedures specifying control tests and their time intervals to make sure the characteristics of the coating stay within specified limits. NOTE 4 This document was developed with a focus on plasma sprayed coating of hydroxyapatite. It might also be used to characterize other thermally sprayed coatings of hydroxyapatite. However, thermally sprayed coatings that do not have a history of clinical use might present different risks and might need additional characterizations beyond those identified in this document.