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。 本文件不适用于由除钛或钛-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？质量管理体系可能有用，如ISO 13485所述。测试实验室的能力要求见ISO/IEC？17025。

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.