ISO 19213:2017
(Main)Implants for surgery — Test methods of material for use as a cortical bone model
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
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 19213:2017(E)
©
ISO 2017
---------------------- Page: 1 ----------------------
ISO 19213:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 19213:2017(E)
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
© ISO 2017 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 19213:2017(E)
12.3 Test report . 8
13 Final report . 8
Annex A (informative) Rationale . 9
Bibliography .14
iv © ISO 2017 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 19213:2017(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 has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
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.
© ISO 2017 – All rights reserved v
---------------------- Page: 5 ----------------------
ISO 19213:2017(E)
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 bone models. The mechanical properties of the cortical bone itself such as
tensile strength and compressive strength have been measured for some time, and several models have
been produced based on the results. However, these fundamental mechanical properties do not strictly
conform to the tactile feedback experienced by physicians. Material models have differences in tensile,
compressive and shear strengths properties since they do not reproduce the complex anisotropic
bone structure. For example, a material can be an excellent bone model based on tensile strength, but
have significant differences in compressive and shear strengths. Therefore, the model needs to be
specific for the application to match the material properties as needed. This is because many kinds of
fundamental properties are related in practical uses. Then, it is also necessary to perform practical
tests of the bone model using devices and to show relationships of mechanical characteristics between
from fundamental tests and from practical tests.
This document shows the relations and covers test methods for fundamental and practical tests. The
final goal of this document is to facilitate the availability of good medical devices and instruments
to patients. The mechanical properties under practical tests can also be useful to produce models of
training and lectures of new devices, informed consent for patients and performances of pre-operation
or surgical planning.
vi © ISO 2017 – All rights reserved
---------------------- Page: 6 ----------------------
INTERNATIONAL STANDARD ISO 19213:2017(E)
Implants for surgery — Test methods of material for use as
a cortical bone model
1 Scope
This document 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 this document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitute requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 179 (all parts), Plastics — Determination of Charpy impact properties
ISO 180, Plastics — Determination of Izod impact strength
ISO 291, Plastics — Standard atmospheres for conditioning and testing
ISO 527 (all parts), Plastics — Determination of tensile properties
ISO 604, Plastics — Determination of compressive properties
ISO 2039-2, Plastics — Determination of hardness — Part 2: Rockwell hardness
ISO 2602, Statistical interpretation of test results — Estimation of the mean — Confidence interval
ISO 7500-1, Metallic materials — Calibration and verification of static uniaxial testing machines — Part 1:
Tension/compression testing machine — Calibration and verification of the force-measuring system
ISO 18397, Dentistry — Powered scaler
ASTM D256, Standard Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics
ASTM D638, Standard Test Method for Tensile Properties of Plastics
ASTM D695, Standard Test Method for Compressive Properties of Rigid Plastics
ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws
JIS T 5750, Dentistry — Dental Handpieces — Ultrasonic Instruments And Tips For Multi-purpose Treatment
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
© ISO 2017 – All rights reserved 1
---------------------- Page: 7 ----------------------
ISO 19213:2017(E)
3.1
cortical bone model
material with the mechanical characteristics of cortical bone for performing mechanical tests for
devices or instruments used in orthopaedic surgery, plastic surgery, neurosurgery, and oral and
maxillofacial surgery
4 Selection of test method
4.1 General
Mechanical test methods to evaluate cortical bone model materials are selected from tests for
compressive strength, tensile strength, shear strength, hardness, Charpy and Izod impact, pull-out
strength, strengths using ultrasonic or acoustic methods and drilling.
Annex A provides rationale on the relation of the test methods in this document to the properties that
will affect the mechanical properties cortical bone model materials.
4.2 Fundamental tests
Shear strength, compressive strength, hardness tests, and Charpy and Izod impact can be performed
using conventional ISO or ASTM methods, as described in Clauses 5 to 8. In the case of ductile materials,
tensile strength measurements can be performed using ISO 527 (Clause 6). However, the Diametral
Tensile Strength (DTS) test (Clause 10) is useful in the case of a cortical bone because cortical bone
behaves more like a brittle material than a ductile material.
4.3 Practical tests
Pull-out stre
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.