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PS 2749-1-2025
Active
Implants for surgery — Coatings on metallic surgical implants — Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders
Committee:
Medical Devices and Supplies
Sector:
Health and Personal Care
Available Standards
Original Standard
إنجليزي (English)
15
Page
2025
International Classification for Standards (ICS)
| Code | Classification |
|---|---|
| 11.040.40 | Implants for surgery, prosthetics and orthotics |
Adopted Standards
| Standards / Amendment / Corrigendum | |
|---|---|
| 1 | ISO 13179-1:2021 |
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.