ISO 22926:2023 PDF

Name: ISO 22926:2023 — Implants for surgery — Specification and verification of synthetic anatomical bone models for testing
SKU: ISO 22926:2023
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Implants for surgery — Specification and verification of synthetic anatomical bone models for testing

Название (английский):

ISO 22926:2023

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

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 17
Дата публикации:: 31 июля 2023 г.
Издание:: ISO IS 22926 edition 1 version 1
ICS:: 11.040.40

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Описание (английский):

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.

Abstract

Похожие стандарты

Упомянутые в описании и другие стандарты ISO

Overview

ISO 22926:2023 - Implants for surgery: Specification and verification of synthetic anatomical bone models for testing defines requirements and recommendations for specifying, verifying and reporting synthetic anatomical bone models used in implant testing. The standard focuses on 3D shape and mechanical characteristics (not cosmetic features). Digital anatomical sources can include CT scans, cadaveric-derived data or statistically determined shape datasets that are used to produce physical synthetic models via casting, machining or additive manufacturing.

Key technical topics and requirements

Scope and focus

Covers specification and verification of synthetic bone models for implant testing.
Excludes colour and cosmetic characteristics.

Digital and physical models

Defines a digital anatomical bone model (STL, CAD/STEP, voxel models) and the resulting synthetic anatomical bone model.

Required physical model characteristics

3D overall shape and segmented anatomy (e.g., cortical, cancellous, intramedullary canal).
Material properties: density, hardness, porosity, Young’s modulus, surface roughness.
Structural mechanical characteristics: stiffness, ultimate strength, fatigue strength under specified loading.
Other relevant characteristics: thermal/chemical resistance, residual stress, dimensional stability, fluid absorption.

Verification process

Three-step verification: model geometrical verification, model material verification, and model mechanical verification (when required).
Geometrical verification requires comparison to the digital model and consideration of measurement protocol, device and software errors (fiducial points, registration variability).
Material and mechanical verifications are compared to the specified properties and reported.

Traceability and reporting

Producers must ensure traceability through design and manufacturing.
A specification report must document intended use, geometry, measurement methods and protocols, test results (mean, max, deviations), material tests and any limitations or contraindications. Annex C provides an example report; Annex B gives geometrical verification examples.

Practical applications

Standardizes how synthetic bone models are specified and verified for:

Mechanical testing of orthopaedic implants and fixation constructs (stiffness, strength, fatigue).
Preclinical device development, bench testing and comparative performance studies.
Verification of manufacturing processes for medical device test fixtures and surgical tool validation.

Helps users choose models with appropriate anatomical fidelity and mechanical behavior for their specific implant tests.

Related standards

ISO 19213 - Test methods for synthetic cortical bone materials (referenced for material testing)

ASTM F1839 - Specification for rigid polyurethane foam (material commonly used as cancellous bone analogue)

Keywords: ISO 22926, synthetic anatomical bone models, implant testing, 3D shape verification, model material verification, geometrical verification, specification report, CT-based bone models.

ISO 22926:2023 PDF

Abstract

Похожие стандарты

Overview

Key technical topics and requirements

Practical applications

Who should use this standard

Related standards

Технические детали

ISO 19213:2017

Implants for surgery — Test methods of material for use as a cortical bone model

BS ISO 22926:2023

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

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