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

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

25、this International Standard are consistent with those developed by the Codex Alimentarius Commission (CAC/RCP 19-1979, Rev. 2-200321, and Codex Stan 106-1983, Rev. 1-200322).This International Standard covers irradiation processes using the radionuclides 60Co or 137Cs, electron beams or X-ray genera

26、tors.The requirements given in this International Standard are the minimum necessary to control the food irradiation process.NOTE 2 The requirements can be addressed by a food safety management system (see ISO 22000).This International Standard does not specify requirements for the primary productio

27、n and/or harvesting, post-harvest treatment, storage and shipment, and packaging for foods that are to be irradiated. Only those aspects of the food production directly related to the irradiation process that may affect the safety or quality of the irradiated food are addressed.This International St

28、andard does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.This International Standard does not cover measuring or inspection devices that utilize ionizing radiation.The application of this International Standard does not exempt th

29、e user from compliance with current and applicable legislation.IMPORTANT Attention is drawn to regulatory and legal requirements that possibly exist for the irradiation and sale of irradiated food and the requirement for authorization to irradiate food.2 Normative referencesThe following referenced

30、documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 10012, Measurement management systems Requirements for measurement proc

31、esses and measuring equipmentISO 22000, Food safety management systems Requirements for any organization in the food chain3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply. ISO 2011 All rights reserved 1BS ISO 14470:20113.1absorbed dosequantity of io

32、nizing radiation energy imparted per unit mass of a specified materialNOTE 1 The unit of absorbed dose is the gray (Gy) where 1 Gy is equivalent to the absorption of 1 J/kg.NOTE 2 For the purposes of this International Standard, the term dose is used to mean “absorbed dose”.ISO 11137-1:20064, 3.13.2

33、calibrationoperation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this informa

34、tion to establish a relation for obtaining a measurement result from an indicationISO/IEC Guide 99:200716, 2.393.3correctionaction to eliminate a detected non-conformityNOTE A correction can be made in conjunction with a corrective action.ISO 9000:20052, 3.6.63.4corrective actionaction to eliminate

35、the cause of a detected non-conformity or other undesirable situationNOTE 1 There can be more than one cause of non-conformity.NOTE 2 Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence.NOTE 3 There is a distinction between correction and correct

36、ive action.ISO 9000:20052, 3.6.53.5cross-contaminationcontamination of a material or of a product with another material or productISO 15378:20117, 3.15NOTE Cross-contamination occurs when a product and/or raw material is contaminated directly or indirectly from another product and/or raw material th

37、rough physical contact or the environment.3.6customerorganization or person that receives a productISO 9000:20052, 3.3.5NOTE In the context of this International Standard, the “product” is irradiation treatment supplied by an irradiator operator under specified conditions.3.7dose distributionspatial

38、 variation in absorbed dose throughout a defined region and material, integrated over a complete treatmentISO 14470:2011(E)2 ISO 2011 All rights reservedBS ISO 14470:20113.8dose mappingmeasurement of dose distribution and variability in material irradiated under defined conditionsISO 11137-1:20064,

39、3.103.9dose uniformity ratioratio of the maximum to the minimum absorbed dose3.10dosimeterdevice having a reproducible, measurable response to radiation, which can be used to measure the absorbed dose in a given systemISO 11137-1:20064, 3.113.11dosimetrymeasurement of absorbed dose by the use of dos

40、imetersISO 11137-1:20064, 3.123.12dosimetry systeminterrelated elements used for determining absorbed dose, including dosimeters, instruments, associated reference standards and procedures for their useISO 11137-3:20065, 3.13.13food irradiationprocessing of food by ionizing radiation3.14food safetyc

41、oncept that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended useISO 22000:2005, 3.13.15good manufacturing practiceGMPcombination of manufacturing and quality procedures aimed at ensuring that products are consistently manufactured to their specifica

42、tions, and to avoid contamination of the product by internal or external sources3.16installation qualificationIQprocess of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specificationISO 11137-1:20064, 3.163.17irradiation containerholder in w

43、hich product is transported through the irradiatorNOTE The holder can be a carrier, cart, tray, product carton, pallet or other container.ISO 11137-1:20064, 3.17ISO 14470:2011(E) ISO 2011 All rights reserved 3BS ISO 14470:20113.18irradiation facilityestablishment where the irradiation process is per

44、formedNOTE 1 Irradiation facilities can consist of an irradiator, shipping and receiving docks, storage zones for irradiated and non-irradiated food, conveyor system, safety systems and the infrastructure for personnel and facility services including record control (generation, updating, control and

45、 file).NOTE 2 There are different types of irradiation facilities depending on the irradiator type, the conveyor system, the radiation source, the operating mode, among others.3.19irradiatorassembly that provides for safe and reliable irradiation processing, including the source of radiation, convey

46、or and source mechanisms, safety devices, and biological shield3.20irradiator operatorcompany or body responsible for irradiation of productISO 11137-1:20064, 3.183.21non-conformitynon-fulfillment of a requirementISO 9000:20052, 3.6.23.22operational qualificationOQprocess of obtaining and documentin

47、g evidence that installed equipment operates within predetermined limits when used in accordance with its operational proceduresISO 11137-1:20064, 3.223.23performance qualificationPQprocess of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operati

48、onal procedures, consistently performs in accordance with predetermined criteria and thereby yields product meeting its specificationISO 11137-1:20064, 3.233.24preventive actionaction to eliminate the cause of a potential non-conformity or other undesirable potential situationNOTE 1 There can be mor

49、e than one cause for a potential non-conformity.NOTE 2 Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.ISO 9000:20052, 3.6.43.25process interruptionintentional or unintentional stoppage of the irradiation processISO 11137-1:20064, 3.26ISO 14470:2011(E)4 ISO 2011 All rights reservedBS ISO 14470:20113.26process parameterspecified value for a process variableNOTE 1 The specification for a food irradiation pro