ISO 6474-1:2019
Implants for surgery — Ceramic materials — Part 1: Ceramic materials based on high purity alumina
This document specifies the characteristics of, and corresponding test methods for bio-stable ceramic bone substitute material based on high purity alumina for use as bone spacers, bone replacements and components of orthopaedic joint prostheses.
This document does not cover biocompatibility (see ISO 10993-1). It is the responsibility of the manufacturer to evaluate the biocompatibility of ceramic materials which are produced within the framework of this document.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
4.1 Material types
4.2 Test categories
4.2.1 General
4.2.2 Category 1: Required tests representative for the periodical production control
4.2.3 Category 2: Required tests representative for the general material specification
4.3 Material properties
5 Preparation of specimens
6 Test methods
6.1 Bulk density
6.2 Chemical composition
6.3 Microstructure
6.4 Strength properties
6.4.1 General
6.4.2 Biaxial flexural strength
6.4.3 4-point flexural strength
6.4.4 Weibull modulus
6.5 Young's modulus
6.6 Fracture toughness
6.6.1 General
6.6.2 SEVNB
6.6.3 SEPB
6.6.4 SCF
6.7 Hardness
6.8 Wear
6.9 Cyclic fatigue
Bibliography
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Related Information
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AS/NZS 2817:1997
Implants for surgery - Care and handling of orthopaedic implants
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
4.1 Material types
4.2 Test categories
4.2.1 General
4.2.2 Category 1: Required tests representative for the periodical production control
4.2.3 Category 2: Required tests representative for the general material specification
4.3 Material properties
5 Preparation of specimens
6 Test methods
6.1 Bulk density
6.2 Chemical composition
6.3 Microstructure
6.4 Strength properties
6.4.1 General
6.4.2 Biaxial flexural strength
6.4.3 4-point flexural strength
6.4.4 Weibull modulus
6.5 Young's modulus
6.6 Fracture toughness
6.6.1 General
6.6.2 SEVNB
6.6.3 SEPB
6.6.4 SCF
6.7 Hardness
6.8 Wear
6.9 Cyclic fatigue
Bibliography