ISO 13179-1:2021 PDF

Scope: 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.

ISO 13179-1:2021 Referenced Document

ISO 4288 Geometrical Product Specifications (GPS) - Surface texture: Profile method - Rules and procedures for the assessment of surface texture; Technical Corrigendum 1

2021 ISO 13179-1:2021 Implants for surgery - Coatings on metallic surgical implants - Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders
2014 ISO 13179-1:2014 Implants for surgery - Plasma-sprayed unalloyed titanium coatings on metallic surgical implants - Part 1: General requirements