ISO 17327-1:2018规定了非活性外科植入物涂层的一般要求，包括表面涂层和表面改性。本文件规定了与通用涂层性能有关的要求，包括化学和相组成、表面纹理、涂层覆盖完整性、溶解性、涂层厚度、粘附强度、耐磨性、孔隙率和孔径以及表面润湿性。 ISO 17327-1:2018适用于表面涂层，表面涂层是指有意添加到基材上的具有与基材自然表面不同性质的材料层。 ISO 17327-1:2018适用于表面改性，其定义为有意转换或重建原始基板的表面，以形成新的表面材料，该表面材料由基板自身材料和可能的异物组成，并形成具有不同性质的表面层。 由于涂层的相关特性及其所需的表征水平高度依赖于植入物的预期应用，因此本文件中一般要求的一般性质不打算覆盖或取代应用规定- 具体性能标准。 ISO 17327-1:2018不适用于仅为了改变表面粗糙度或原材料强度而通过纹理改性的表面。 ISO 17327-1:2018不适用于本机钝化金属表面。虽然本文件适用于有意钝化的金属表面，但通过常规技术（如硝酸浸泡）钝化的成熟材料通常是无害的，可以用非常基本的方式进行描述。 ISO 17327-1:2018不适用于使用活组织的植入涂层。 ISO 17327-1:2018不适用于层压板，即由多层制成的复合材料，例如由不同膨胀聚四氟乙烯层构成的人造血管，但层压板的暴露表面除外，其可以是植入物涂层（见3.1，条目注2）。 ISO 17327-1:2018不适用于覆盖物，例如覆盖支架。 注1 ISO 17327-1:2018不包含生物相容性要求。然而，这是设备和涂层的一个关键特性，需要在风险评估期间加以解决。 注2 ISO 17327-1:2018补充了不适用的- 主动外科植入物标准和ISO 14630。 注3 ISO 17327-1:2018不要求制造商建立质量管理体系。然而，应用质量管理体系，如ISO 13485中所述，可能有助于确保植入物达到预期性能。 注4:尽管全多孔植入物不是涂层，但本文件中的一些注意事项也适用于它们。

ISO 17327-1:2018 specifies general requirements for implant coatings, comprising both surface coatings and surface modifications, applied to non-active surgical implants. This document specifies requirements concerned with generic coating properties including chemical and phase compositions, surface texture, coating coverage integrity, dissolvability, coating thickness, adhesion strength, abrasion resistance, porosity and pore size, and surface wettability. ISO 17327-1:2018 is applicable to surface coatings, which are defined as layers of material with any different property than the natural surface of the substrate which are intentionally added to the substrate. ISO 17327-1:2018 is applicable to surface modifications, which are defined as intentional conversion or reconstruction of the surface of the original substrate to form a new surface material consisting of components of the substrate's own material and possibly foreign material and forming a surface layer with different properties. Since the pertinent properties of a coating and their needed level of characterization are highly dependent on the intended application of the implant, the generic nature of the general requirements in this document is not intended to either override or replace the provisions of application-specific performance standards. ISO 17327-1:2018 is not applicable to surfaces modified by texturing with the exclusive intention to change the roughness of the surface or the strength of the raw material. ISO 17327-1:2018 is not applicable to natively passivated metal surfaces. While this document is applicable to intentionally passivated metal surfaces, well-established materials passivated by conventional techniques, such as nitric acid immersion, are usually non-hazardous and can be described in a very basic manner. ISO 17327-1:2018 is not applicable to implant coatings utilizing viable tissue. ISO 17327-1:2018 is not applicable to laminates, i.e. composite materials made of multiple layers, e.g. vascular prosthesis constructed of different expanded polytetrafluoroethylene layers, except the exposed surface of the laminate, which can be an implant coating (see 3.1, note 2 to entry). ISO 17327-1:2018 is not applicable to coverings, e.g. covered stents. NOTE 1 ISO 17327-1:2018 does not contain requirements on biocompatibility. Nevertheless, this is a critical property of the device and coating and needs to be addressed during risk assessment. NOTE 2 ISO 17327-1:2018 supplements applicable non-active surgical implant standards and ISO 14630. NOTE 3 ISO 17327-1:2018 does not require that manufacturers have a quality management system in place. However, the application of a quality management system, such as that described in ISO 13485, could be appropriate to help ensure that the implant achieves its intended performance. NOTE 4 Although fully porous implants are not coatings, some of the considerations in this document can also be applied to them.