ISO 22926:2023

Implants for surgery — Specification and verification of synthetic anatomical bone models for testing

This document provides requirements and recommendations for specification and verification of synthetic anatomical bone models for use in testing of implants. The anatomical source of the synthetic model can be digital data from computed tomography (CT) scanning or any other sources such as from cadaveric specimens or statistically determined shape data. The specifications covered in this document are 3D shape and mechanical characteristics. Other characteristics, such as colour or cosmetic features, are not considered in this document.

Implants chirurgicaux — Spécification et vérification des modèles osseux anatomiques synthétiques pour les essais

Le présent document fournit des exigences et des recommandations pour la spécification et la vérification des modèles osseux anatomiques synthétiques pour une utilisation dans les essais d’implants. La source anatomique du modèle synthétique peut être les données numériques obtenues par tomodensitométrie, ou toute autre source telle que des échantillons cadavériques ou des données de forme déterminées statistiquement. Les spécifications abordées dans le présent document sont la forme 3D et les caractéristiques mécaniques. D’autres caractéristiques, telles que la couleur ou l’aspect esthétique, ne sont pas prises en compte dans le présent document.

General Information

• Status: Published
• Publication Date: 30-Jul-2023
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150 - Implants for surgery
• Drafting Committee: ISO/TC 150 - Implants for surgery
• Current Stage: 6060 - International Standard published
• Start Date: 31-Jul-2023
• Due Date: 15-Oct-2023
• Completion Date: 31-Jul-2023

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 22926
First edition
2023-07
Implants for surgery — Specification
and verification of synthetic
anatomical bone models for testing
Reference number
ISO 22926:2023(E)
© ISO 2023

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ISO 22926:2023(E)
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© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
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  © ISO 2023 – All rights reserved

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ISO 22926:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Design and development of a synthetic model . 2
4.1 General . 2
4.2 Identification of physical model characteristics . 2
4.3 Model verification . 3
4.3.1 General . 3
4.3.2 Model geometrical verification . 3
4.3.3 Model material verification . 3
4.3.4 Model mechanical verification . 3
5 Specification report .4
Annex A (informative) Background, detailed scope and rationale . 5
Annex B (informative) Example of model geometrical verification methods .8
Annex C (informative) Example of a specification report .10
Bibliography .17
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© ISO 2023 – All rights reserved

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ISO 22926:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established h
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