BS 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。本文件适用于表面涂层，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。本文件适用于表面改性，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，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。 由于涂层的相关性能及其所需的表征水平在很大程度上取决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特定应用性能标准的规定。本文件不适用于仅为了改变表面粗糙度或原材料强度而进行纹理处理的表面。本文件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。本文件不适用于使用活组织的植入涂层。 本文件不适用于层压板，即多层复合材料，例如由不同膨胀聚四氟乙烯层构成的人造血管，但层压板的外露表面除外，该表面可以是植入物涂层（见3.1，条目注释2）。本文件不适用于覆盖物，例如覆盖支架。交叉引用:ISO 14630ISO 10993-18ISO 25539-1ISO 13179-1ASTM F1580ASTM F1926/F1926ISO 4288ASTM F1377ASTM F1854ASTM F2024ISO 13485ISO 14243-2ISO 12417-1ISO 14242-2ASTM F1978ASTM F1044ISO/TR 14283ASTM F1147ISO 14577-4ISO 25539-2ISO 14155ISO/IEC 17025ASTM C633ASTM F1160JIS H 8666ISO 4287ASTM F1609ISO 25539-3购买时可提供的所有最新修订均包含在购买时这份文件。

BS 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.This document 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.This document 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.This document 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.This document 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.This document is not applicable to implant coatings utilizing viable tissue.This document 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).This document is not applicable to coverings, e.g. covered stents.Cross References:ISO 14630ISO 10993-18ISO 25539-1ISO 13179-1ASTM F1580ASTM F1926/F1926MISO 4288ASTM F1377ASTM F1854ASTM F2024ISO 13485ISO 14243-2ISO 12417-1ISO 14242-2ASTM F1978ASTM F1044ISO/TR 14283ASTM F1147ISO 14577-4ISO 25539-2ISO 14155ISO/IEC 17025ASTM C633ASTM F1160JIS H 8666ISO 4287ASTM F1609ISO 25539-3All current amendments available at time of purchase are included with the purchase of this document.