ISO 13779-4:2018 PDF
Implants for surgery — Hydroxyapatite — Part 4: Determination of coating adhesion strength
Implants for surgery — Hydroxyapatite — Part 4: Determination of coating adhesion strength
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 6
- Дата публикации:
- 3 декабря 2018 г.
- Издание:
- ISO IS 13779 edition 2 version 1
- ICS:
- 11.040.40
This document specifies a test method for measurement of the adhesion strength of hydroxyapatite coatings intended for use on metallic-substrate components of surgical implants. NOTE Requirements for the competence of testing laboratories can be found in ISO/IEC 17025.
Abstract
Overview
ISO 13779-4:2018 specifies a laboratory test method for measurement of adhesion strength of hydroxyapatite (HA) coatings applied to metallic substrates of surgical implants. The standard defines how to prepare coated coupons, assemble a bonded test specimen, apply a uniaxial tensile load, record maximum load at failure and calculate adhesion strength (σ = F / A). It is intended for quality control, batch release, R&D and regulatory documentation for implants for surgery.
Key topics and requirements
- Test principle: tensile testing of a cylindrical test assembly (coated coupon bonded to an uncoated counterface) with load applied normal to the coating plane.
- Apparatus:
- Mechanical testing machine with load capacity ≥ 30 kN and accuracy ±2% of full scale (verify per ISO 7500-1).
- A loading assembly that minimizes off-axis loading (pins/yoke arrangement illustrated in the standard).
- Test specimens:
- Coated coupons nominal diameter 24.8–25.6 mm (tolerance
Технические детали
- Технический комитет
- ISO/TC 150/SC 1 - Materials
- SKU
- ISO 13779-4:2018
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