ISO INTERNATIONAL STANDARD 19213 First edition 2017-07 Implants for surgery Test methods of material for use as a cortical bone model Implants chirurgicaux - Methodes d'essai des materiaux destinés d servir de modele d'os cortical Reference number IS0 19213:2017(E) osi International Organization for Standardization @ IS0 2017 nitted without license from IHS IS0 19213:2017(E) COPYRIGHT PROTECTED DOCUMENT IS0 2017, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form 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 [email protected] www.iso.org Internatinir DrganizationforStandardization @ IS0 2017 - All rights reserved No reproduction or networking permited without license from IHS IS0 19213:2017(E) Contents Page Foreword ..V Introduction. ...vi 1 Scope. 2 Normative references 3 Terms and definitions 4 Selection of test method ..2 4.1 General .2 4.2 Fundamental tests. 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) 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. .1 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 11.6 Tip angle. ..8 12 Test method using a bone drill 12.1 Drillingtest 12.2 Position of drill to bone model surface ..8 Intemaional oganzation @stS2017 - All rights reserved iii d without license from IHS