BS ISO 14470-2012 Food irradiation Requirements for the development validation and routine control of the process of irradiation using ionizing radiation for the treatment of food《.pdf
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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS ISO 14470:2011Food irradiation Requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of foo
2、dBS ISO 14470:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 14470:2011. The UK participation in its preparation was entrusted to T e c h n i c a l Committee AW/90, Quality systems for the food industry.A list of organizations represented on this committe
3、e can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012 ISBN 978 0 580 66364 2 ICS 67.020 Compliance with a British Standard cannot
4、 confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2012.Amendments issued since publicationDate T e x t a f f e c t e dBS ISO 14470:2011Food irradiation Requirements for the development, validat
5、ion and routine control of the process of irradiation using ionizing radiation for the treatment of foodIonisation des aliments Exigences pour llaboration, la validation et le contrle de routine du procd dirradiation utilisant le rayonnement ionisant dans le traitement des aliments ISO 2011Reference
6、 numberISO 14470:2011(E)First edition2011-12-01ISO14470INTERNATIONAL STANDARDBS ISO 14470:2011ISO 14470:2011(E)COPYRIGHT PROTECTED DOCUMENT ISO 2011All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or me
7、chanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.or
8、gPublished in Switzerlandii ISO 2011 All rights reservedBS ISO 14470:2011ISO 14470:2011(E) ISO 2011 All rights reserved iiiContents PageForeword .vIntroduction .vi1 Scope 12 Normative references .13 Terms and definitions .14 Controlling the food irradiation process .64.1 Responsibility and authority
9、 64.2 Product realization 64.3 Monitoring, measurement and analysis 64.4 Technical agreement 64.5 Documentation .75 Irradiation facilities .75.1 Design .75.2 Radiation sources .75.3 Equipment .75.4 Personnel .86 Product .86.1 Product definition 86.2 Product specification .97 Process 97.1 Process def
10、inition Dose range .97.2 Process specification .98 Dosimetry 109 Validation .109.1 Installation qualification (IQ) 109.2 Operational qualification (OQ) .109.3 Performance qualification (PQ) .119.4 Review and approval of validation .1310 Routine monitoring and control 1310.1 Process parameters 1310.2
11、 Product-loading configuration .1410.3 Routine dosimetry .1410.4 Processing inventory control .1410.5 Labelling 1410.6 Process interruptions .1510.7 Irradiation process records 1511 Product release from irradiation process .1512 Maintaining process effectiveness .1512.1 Demonstration of continued ef
12、fectiveness 1512.2 Equipment calibration 1512.3 Recalibration .1612.4 Maintenance of equipment .1612.5 Requalification of the irradiation process 1612.6 Assessment of change 16Annex A (informative) Guidelines .17Bibliography .19BS ISO 14470:2011ForewordISO (the International Organization for Standar
13、dization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to
14、 be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Stand
15、ards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an Inter
16、national Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 14470 was
17、 prepared by Technical Committee ISO/TC 34, Food products.ISO 14470:2011(E)iv ISO 2011 All rights reservedBS ISO 14470:2011IntroductionFood irradiation is the process where food is exposed to ionizing radiation in order to improve its safety and quality. It is intended to be used only on food that h
18、as been produced under good manufacturing practice (GMP) principles. Many countries are using irradiation as a technological choice at some stage in food processing, making relevant the establishment of standards to assist customers, irradiator operators, and consumers.The irradiation of food can be
19、 used for different purposes including control of pathogenic microorganisms and parasites, reduction of the number of spoilage microorganisms, inhibition of the sprouting of bulbs, tubers and root crops, extension of product shelf life or phytosanitary treatment.When applicable, food irradiation sho
20、uld be incorporated as part of a food safety management system (ISO 22000). The irradiation of food is a critical control point (CCP) of a Hazard Analysis and Critical Control Points (HACCP) programme, contributing to the minimization of risks from the transmission of pathogenic microorganisms to co
21、nsumers.The main purposes of this International Standard are to:a) provide requirements for the irradiation of food consistent with current standards and practices;b) provide directions for a technical agreement between the customer and the irradiator operator;c) establish a documentation system to
22、support the controls on the food irradiation process.To facilitate the application of this International Standard, it has been constructed in a form that can be used by internal and external parties, including certification bodies, for auditing an irradiator operator to assess its ability to fulfil
23、all requirements for the irradiation of food.ISO 14470:2011(E) ISO 2011 All rights reserved vBS ISO 14470:2011BS ISO 14470:2011INTERNATIONAL STANDARD ISO 14470:2011(E)Food irradiation Requirements for the development, validation and routine control of the process of irradiation using ionizing radiat
24、ion for the treatment of food1 ScopeThis International Standard specifies requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food, and establishes guidelines for meeting the requirements.NOTE 1 Requirements in
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