ISO INTERNATIONAL STANDARD 16087 First edition 2013-10-01 Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants Implants chirurgicaux - Analyse steréophotogrammétrique Roentgen pour I'évaluation de la migration des implants orthopediques Reference number ISO 16087:2013(E) ISO @ IS0 2013 IS0 16087:2013(E) COPYRIGHTPROTECTED DOCUMENT @IS02013 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 Case postale 56 . CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 4122 74909 47 E-mail [email protected] Web www.iso.org Published in Switzerland @ IS0 2013 - All rights reserved IS0 16087:2013(E) Contents Page Foreword .iv Introduction. ..V 1 Scope. ..1 2 Terms and definitions ..1 3 Measurement .3 3.1 Size of markers. 3 3.2 Virtual markers. .3 3.3 Number and distribution of markers 4 3.4 Mean error of rigid body fitting .4 3.5 Condition number.. ..4 3.6 Three-dimensional implant models .4 4 Radiographic arrangement ..4 5 Calibration cages and reference plates ..4 6 Radiographs 6.1 General .5 6.2 Double examinations .5 7 Software ..5 8 Coordinate systems ..5 8.1 Global coordinate system .5 8.2 Implant coordinate system ..5 8.3 Reference rigid body .6 9 Migration .6 9.1 Translations .6 9.2 Rotations. ..6 10 Maximum total point motion ..7 10.1 General .7 10.2 Signed versus unsigned values. .8 11 Validation .8 11.1 Accuracy. .8 11.2 Precision. ..8 12 Practical issues. .8 12.1 Weight bearing. ..8 12.2 Follow-up intervals 12.3 Radiation dose. .9 12.4 Exclusion of patients 13 Standardised output Annex A (informative) Relevant formulae .11 Bibliography .12 ..sn.?013..l rightsreserved ii