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DRAFT

This document specifies general requirements for plasma-sprayed titanium coatings on metallic surgical implants. This document applies to plasma spraying in atmosphere and in vacuum. This document does not apply to coatings made of other materials than titanium or titanium 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.