ISO 13179-1:2021 PDF

Implants for surgery — Coatings on metallic surgical implants — Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders

Название (английский):

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

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 6
Дата публикации:: 30 сентября 2021 г.
Издание:: ISO IS 13179 edition 2 version 1
ICS:: 11.040.40

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Описание (английский):

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.

Технические детали

Технический комитет: ISO/TC 150 - Implants for surgery
SKU: ISO 13179-1:2021

Abstract

Overview

ISO 13179-1:2021 specifies general requirements for plasma-sprayed titanium coatings on metallic surgical implants. This international standard applies to coatings derived from titanium or titanium-6 aluminum-4 vanadium (Ti-6Al-4V) alloy powders produced by atmospheric plasma spraying or vacuum plasma spraying methods. It aims to ensure consistent quality and performance of coatings used in surgical implants to enhance their longevity and biocompatibility.

The standard addresses raw materials, coating properties, and testing procedures rather than the design or fabrication of final medical devices. It highlights the importance of chemical composition, microstructure, mechanical properties, and abrasion resistance of plasma-sprayed coatings for surgical implant applications.

Key Topics

Plasma Spraying Techniques: This standard covers two primary plasma spraying technologies:
- Atmospheric plasma spraying (APS)
- Vacuum plasma spraying (VPS)
Materials and Powders: Specifies the use of titanium or Ti-6Al-4V powders compliant with ASTM F1580 for coating, prohibiting coatings made from other materials or techniques.
Chemical Composition Requirements: Defines strict mass fraction limits for impurities such as carbon, hydrogen, iron, nitrogen, and oxygen, with distinct limits for APS and VPS coatings to ensure biocompatibility and coating integrity.
Microstructure and Morphology: Establishes methods to assess coating thickness, roughness, void content, and microstructure, applying standards like ASTM F1854 and ISO 4288 for surface texture evaluation.
Mechanical Properties:
- Static shear strength (≥ 20 MPa)
- Shear fatigue strength (withstand ≥ 10 cycles at 10 MPa)
- Static tensile strength (≥ 22 MPa)
- Abrasion resistance (loss

Overview

Key Topics

Plasma Spraying Techniques: This standard covers two primary plasma spraying technologies:
- Atmospheric plasma spraying (APS)
- Vacuum plasma spraying (VPS)
Materials and Powders: Specifies the use of titanium or Ti-6Al-4V powders compliant with ASTM F1580 for coating, prohibiting coatings made from other materials or techniques.
Chemical Composition Requirements: Defines strict mass fraction limits for impurities such as carbon, hydrogen, iron, nitrogen, and oxygen, with distinct limits for APS and VPS coatings to ensure biocompatibility and coating integrity.
Microstructure and Morphology: Establishes methods to assess coating thickness, roughness, void content, and microstructure, applying standards like ASTM F1854 and ISO 4288 for surface texture evaluation.
Mechanical Properties:
- Static shear strength (≥ 20 MPa)
- Shear fatigue strength (withstand ≥ 10 cycles at 10 MPa)
- Static tensile strength (≥ 22 MPa)
- Abrasion resistance (loss

ISO 13179-1:2021 PDF

Технические детали

Abstract

Overview

Key Topics

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Abstract

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