ISO INTERNATIONAL STANDARD 14470 First edition 2011-12-01 Food irradiation Requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food lonisation des aliments - Exigences pour I'élaboration, la validation et le controle de routine du procedé d'irradiation utilisant le rayonnement ionisantdansletraitementdesaliments Reference number ISO 14470:2011(E) ISO @ISO2011 HS under I n or networking permitted without license from IHS Not for Resale ISO 14470:2011(E) COPYRiGHTPROTECTEDDOCUMENT ISO 2011 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing 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 + 41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland @ ISO 2011 - All rights reserved No reproduction or networking permited withoutlicense from IHS Not for Resale ISO 14470:2011(E) Contents Page Foreword V Introduction vi 1 Scope. 2 Normative references 3 Terms and definitions.. 4 Controlling the food irradiation process. 6 4.1 Responsibility and authority. 6 4.2 Product realization..... 6 4.3 Monitoring, measurement and analysis 4.4 Technical agreement 6 4.5 Documentation. 5 Irradiation facilities 5.1 5.2 Radiation sources 5.3 Equipment. 5.4 Personnel. 6 Product. 8 6.1 Product definition 8 6.2 Product specification 9 7 7.1 Process definition Dose range 9 7.2 Process specification 9 8 Dosimetry 10 9 Validation.... 10 9.1 Installation qualification (IQ) 10 9.2 Operational qualification (OQ) 10 9.3 Performance qualification (PQ) 11 9.4 Review and approval of validation 13 10 Routine monitoring and control 13 10.1 Process parameters.... 13 10.2 Product-ioading configuration... .14 10.3 14 10.4 Processing inventory control.. 14 10.5 14 10.6 Process interruptions.. 15 10.7 Irradiation process records 15 11 Product release from irradiation process.. .15 12 Maintaining process effectiveness. 15 12.1 Demonstration of continued effectiveness ..15 12.2 Equipment calibration... ..15 12.3 16 12.4 Maintenance of equipment 16 12.5 Requalification of the irradiation process 16 12.6 Assessment of change .. .16 Annex A (informative) Guidelines 17 Bibliography .19 ili No reproduction or networking permitted without license from IHS e with IS Not for Resale