ISO INTERNATIONAL STANDARD 11137-3 Second edition 2017-06 Sterilization of health care products Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control Stérilisation des produits de santé - Irradiation - Partie 3: Directives relatives aux aspects dosimétriques de développement, la validation et le controle de routine Reference number IS0 11137-3:2017(E) osi @ IS0 2017 IS0 11137-3:2017(E) COPYRIGHT PROTECTEDDOCUMENT 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 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 [email protected] www.iso.org ii @ IS0 2017 - All rights reserved IS0 11137-3:2017(E) Contents @Page Foreword .V Introduction. ..vi 1 Scope. 2 Normative references 3 Terms, definitions and symbols 3.1 General .1 3.2 Symbols. 4 Measurement of dose. ..4 4.1 General .4 4.1.1 Direct and indirect dose measurements ..4 4.1.2 Dosimetry systems. 4 4.1.3 Best estimate of dose .4 4.2 Dosimetry system selection and calibration .5 4.2.1 General ..5 4.2.2 Selection of dosimetry systems. .5 4.2.3 Calibration of dosimetry systems. .5 4.3 Dose measurement uncertainty .6 4.3.1 General concepts ..6 4.3.2 The Guide to the expression of uncertainty in measurement (GUM) methodology 6 4.3.3 Radiation sterilization specific aspects of dose measurement uncertainty .7 5 Establishing the maximum acceptable dose. ..8 6 Establishing the sterilization dose 7 Installation qualification ..10 8 Operational qualification ..11 8.1 General .11 8.2 Gamma irradiators. .11 8.3 Electron beam irradiators .13 8.4 X-ray irradiators.. ..15 9 Performance qualification ..17 9.1 General .17 9.2 Gamma irradiators. 18 9.2.1 Loading pattern .18 9.2.2 Dosimetry 19 9.2.3 Analysis of dose mapping data .20 9.3 Electron beam irradiators. 20 9.3.1 Loading pattern 20 9.3.2 Dosimetry 22 9.3.3 Analysis of dose mapping data 23 9.4 X-ray irradiators. 23 9.4.1 Loading pattern 23 9.4.2 Dosimetry 24 9.4.3 Analysis of dose mapping data 25 10 Routine monitoring and control .25 10.1 General. .25 10.2 Frequency of dose measurements ..26 Annex A (informative) Mathematical modelling .27 Annex B (informative) Tables of references for dosimetry-related testing during IQ/OQ/PQ ...30. @ IS0 2017 - All rights reserved iii