标准摘要
[中文适用范围]： 本文件规定了金属外科植入物上等离子喷涂钛涂层的一般要求。 本文件适用于大气等离子喷涂和真空等离子喷涂。 本文件不适用于钛或钛6铝4钒合金以外的其他材料制成的涂层，也不适用于通过等离子喷涂以外的其他技术实现的涂层。 注：质量管理体系可能很有用，例如 ISO 13485 中所述。 测试实验室能力的要求可在 ISO/IEC 17025 中找到。 [外文原描述]： This document specifies general requirements for plasma-sprayed titanium coatings on metallic surgical implants. This document applies to atmospheric plasma spraying and vacuum plasma spraying. This document does not apply to coatings made of other materials than titanium or titanium-6 aluminum-4 vanadium alloy or to coatings realized by another technology than plasma spraying. NOTE A quality management system can be useful, e.g. as described in ISO 13485. Requirements for the competence of testing laboratories can be found in ISO/IEC 17025.
英文名称Implants for surgery — Coatings on metallic surgical implants — Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders