ISO INTERNATIONAL STANDARD 19233-1 First edition 2017-05 Implants for surgery - Orthopaedic joint prosthesis - Part 1: Procedure for producing parametric 3D bone models from CT data of the knee Implants chirugicaux Protheses articulaires orthopédiques - Partie 1: Mode opératoire de production de modeles parametriques d'os en 3D a partir de donnees de CT du genou Reference number ISO 19233-1:2017(E) International Organization for Standardization @ IS0 2017 ZHEJIANG INST OF STANDARDIZATION C1 5956617 ed without license from IHS IS0 19233-1:2017(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 copyright@iso.org www.iso.org Internationai ibrg DrganizationforStandardization icensee-ZHEJIANG INSTOF STANDARDIZAoISQ 07 - All rights reserved networking permited without license from IHS IS0 19233-1:2017(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. 2 Normative references 3 Terms, definitions and abbreviated terms 4 Principles ..2 5 Requirements .2 5.1 Imaging conditions. 2 5.1.1 Medical imaging apparatus. 2 5.1.2 Region of interest .2 5.1.3 Body position. .3 5.1.4 Field of view (FOV) 3 5.1.5 Slice thickness and slice spacing .3 5.1.6 Reconstruction kernel 4 5.1.7 X-ray tube current. .4 5.1.8 X-ray tube voltage 4 5.1.9 Precautions. .4 5.1.10 Leg alignment. .4 5.2 Software regulatory requirements .5 5.3 Generation of bone models .5 5.3.1 Segmentation methods for bone and cartilage region .5 5.3.2 3D reconstruction. 5.3.3 Data format .6 Annex A (informative) Method of the software validation ..7 Annex B (informative) CT scanning conditions .8 Bibliography 9 iii icensee=ZHEJIANG INST OF STANDARDIZATION C1 5956617 vided by IHS under lic se with ISt Not for Resale, 2017/8/21 01:22:10 without license from IHS