ISO 19213:2017

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

ISO 19213:2017 specifies mechanical test methods for characterizing cortical bone model materials for use as a standard model for performing mechanical tests for devices or instruments used in orthopaedic surgery, plastic surgery, neurosurgery, and oral and maxillofacial surgery. The document specifies static mechanical test and properties. Dynamic and viscoelastic/poroelastic tests and properties are not included in the scope of ISO 19213:2017.

Implants chirurgicaux — Méthodes d’essai des matériaux destinés à servir de modèle d’os cortical

General Information

• Status: Published
• Publication Date: 11-Jul-2017
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150/SC 5 - Osteosynthesis and spinal devices
• Drafting Committee: ISO/TC 150/SC 5 - Osteosynthesis and spinal devices
• Current Stage: 9092 - International Standard to be revised
• Completion Date: 26-Jul-2024

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 19213
First edition
2017-07
Implants for surgery — Test methods
of material for use as a cortical bone
model
Implants chirurgicaux — Méthodes d’essai des matériaux destinés à
servir de modèle d’os cortical
Reference number
©
ISO 2017
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ii © ISO 2017 – All rights reserved

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Selection of test method . 2
4.1 General . 2
4.2 Fundamental tests . 2
4.3 Practical tests . 2
5 Compressive test . 2
6 Tensile test . 2
7 Hardness test . 2
8 Charpy and Izod impact tests . 2
9 Torque and axial pull-out test . 2
10 Diametral Tensile Strength (DTS) test . 2
10.1 Materials and apparatus . 3
10.1.1 Compression testing machine . 3
10.1.2 Compression tool . 3
10.1.3 Measuring instrument . 3
10.2 Test specimen . 3
10.2.1 Shape and dimensions . 3
10.2.2 Specimen inspection . 3
10.3 Anisotropic materials . 4
10.4 Number of test specimens . 4
10.5 Test procedure . 4
10.5.1 Test specimen . 4
10.5.2 Test atmosphere . 4
10.5.3 Setup . 4
10.6 Preload . 5
10.7 Recording of data . 5
10.8 Calculation and expression of results. 5
10.8.1 DTS . 5
10.8.2 Strain (as measured by extensometry) . 6
10.8.3 Maximum strain. 6
10.8.4 Statistical parameters . 6
10.8.5 Test report . 6
11 Test method using ultrasonic bone cutting device (or ultrasonic surgical unit,
instrument with an oscillating scalar tip) for cutting model . 7
11.1 Test method references . 7
11.2 Cutting under a constant feed rate or under a constant load . 7
11.3 Key terms . 7
11.3.1 Cutting depth . 7
11.3.2 Cutting volume . 7
11.4 Burning . 7
11.5 Bounce-off . 7
11.6 Tip angle . 8
12 Test method using a bone drill . 8
12.1 Drilling test . 8
12.2 Position of drill to bone model surface . 8
12.3 Test report . 8
13 Final report . 8
Annex A (informative) Rationale . 9
Bibliography .14
iv © ISO 2017 – All rights reserved

Foreword
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bodies (ISO member bodies). The work of preparing International Standards is normally carried out
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electrotechnical standardization.
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described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
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URL: w w w . i s o .org/ iso/ foreword .html
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 5, Osteosynthesis and spinal devices.
Introduction
This document details requirements for a set of mechanical test methods to evaluate material used as
a cortical bone model. Bone models have long been used in mechanical tests for devices or instruments
such as those used in the orthopaedic surgery. The characteristics of the bone model, especially those of
a cortical bone model, strongly influence the test results. Many devices and instruments are evaluated
using bone models.
Newer bone models are needed because conventional bone model properties change the primary
outcome of interest such as failure mode. This results in devices not being evaluated correctly. Animal
bones such as those from pigs are still used. However, animal bones have many sanitary problems
and can introduce large errors (standard deviation). Recently, several new bone models have been
introduced and standardized methods for evaluating these materials are required.
This document introduces applicable standardized mechanical test methods for characterizing the
material properties of cortical bo
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