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BS ISO 6474-1:2019

$102.76

Implants for surgery. Ceramic materials – Ceramic materials based on high purity alumina

Published By Publication Date Number of Pages
BSI 2019 18
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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.

PDF Catalog

PDF Pages PDF Title
2 National foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
11 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
13 5 Preparation of specimens
6 Test methods
6.1 Bulk density
6.2 Chemical composition
6.3 Microstructure
14 6.4 Strength properties
6.4.1 General
6.4.2 Biaxial flexural strength
15 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
16 6.7 Hardness
6.8 Wear
6.9 Cyclic fatigue
17 Bibliography
BS ISO 6474-1:2019
$102.76