外科植入物.羟基磷灰石.第2部分:羟基磷灰石热喷涂涂层

[中文适用范围]： 本文件规定了应用于金属手术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属性并在组织之间传达这些属性。 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，尽管它们可以这样使用。 注 1：对于厚度小于 50 µm 的薄涂层，本文件中描述的一些测试方法可能难以在不进行修改的情况下应用。 注2:双层涂层(由下层金属涂层和上层羟基磷灰石涂层组成)的羟基磷灰石层的要求可参照本文件;然而，本文件中提到的测试方法不能应用于双层涂层。 如果参考本文件对双层涂层的羟基磷灰石层的要求，则可能认为有必要了解单层测试的试样如何代表双层涂层植入物的基本原理。 本文件不涵盖由玻璃、玻璃陶瓷、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羟基磷灰石热喷涂涂层的规范，但可能有必要建立常规控制程序，规定控制测试及其时间间隔，以确保涂层的特性保持在规定范围内。 限制。 注 4：本文件的制定重点是羟基磷灰石等离子喷涂涂层。 它还可用于表征其他羟基磷灰石热喷涂涂层。 然而，没有临床使用历史的热喷涂涂层可能会带来不同的风险，并且可能需要超出本文件中确定的其他特征。 [外文原描述]： 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.