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.