Radiation Protection - Sealed Radioactive Sources .

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ATTACHMENT #4INTERNATIONALSTANDARDISO2919Second edition1999-02-15aReprdumcd B, GLOBALENGINEERING DOCVU'IETSWihThePcn.omnf IbndcrRo *,lrsUAgcifl0Radiation protection - Sealed radioactivesources - General requirements andclassificationRadioprotection-Sources radioactivesscellees -g6nerales et classificationIzSOPrescriptionsReference numberISO 2919:1999(E)

ISO 2919:1999(E)Contents1 Scope .12 Normative references .13 Definitions .24 Classification and designation .34.1 Designation .34.2 Classification .44.3 Determination of classification .55 Activity level requirements .56 Performance requirements .66.1 General requirements .66.2 Requirements for typical usage .76.3 Procedure to establish classification and performance requirements .87 Test methods.87.1 General.7.2 Temperature test .87.3 External pressure test .97.4 Impact test .107.5etest .7.7 VibrationBending tests.10107.6 Puncture test.test.7.7 Bendture tests .10118. So rend aringtes .8 Source marking.1313 ISO 1999All rights reserved. Unless otherwise specified, no part of this publication may be reproducedor utilized in any form or by any means, electronic or mechanical, including photocopying andmicrofilm, without permission in writing from the publisher.International Organization for StandardizationCase postale 56 * CH-1211 Geneve 20 - [email protected] in Switzerlandii

ISOISO 2919:1999(E)9 Source certificate .1310 Quality assurance .13Annex A (informative) Classification of radionuclides according to their radiotoxicity .14Annex B (informative) Example of certificate for sealed radioactive source .16Annex C (informative) General information on adverse environmental conditions .17Annex D (informative) Additonal tests.18Annex E (informative) Bibliography .19iii

ISO 2919:1999(E)C ISOForewordISO (the International Organization for Standardization) isa worldwide federation of national standards bodies (ISOmember bodies). The work of preparing International Standardsis normally carried out through ISO technicalcommittees. Each member body interested in a subject forwhich a technical committee has been established hasthe right to be represented on that committee. Internationalorganizations, governmental and non-governmental, inliaison with ISO, also take part in the work. ISO collaboratesclosely with the International ElectrotechnicalCommission (IEC) on all matters of electrotechnical standardization.Draft International Standards adopted by the technical committeesare circulated to the member bodies for voting.Publication as an International Standard requires approval byat least 75 % of the member bodies casting a vote.International Standard ISO 2919 was prepared by TechnicalCommittee ISO/TC 85, Nuclear energy, SubcommitteeSC 2, Radiationprotection.This second edition cancels and replaces the first edition(ISO 2919:1980) and ISO 1677:1977, which have beentechnically revised.Annexes A to E of this International Standard are for informationonly.iv

ISOISO 2919:1999(E)IntroductionSafety is the prime consideration in establishing any standard for the use of sealed radioactivesources. Sealedsource users have established an enviable record of safe usage as a result of careful scrutiny ofthe application ofthe sealed radioactive source by the regulating authority, the supplier and the user. However. asthe application ofsealed radioactive sources becomes more diversified and as regulating agencies becomemore numerous, anInternational Standard is needed to specify the characteristics of a sealed radioactive sourceand the essentialperformance and safety testing methods for a particular application and, thus, maintain the recordof safe usage.v

INTERNATIONAL [email protected] 2919:1999(E)Radiation protection - Sealed radioactive sourcesGeneral requirements and classification1 ScopeThis International Standard establishes a systemof classification of sealed radioactive sources basedon testperformance and specifies general requirements, performancetests, production tests, marking and certification.It provides a set of tests by which the manufacturerof sealed radioactive sources can evaluate the safetyof hisproducts in use and by which the user of suchsources can select types which are suitable forthe requiredapplication, especially where protection against therelease of radioactive material, with consequent exposuretoionizing radiation, is concerned. This International Standardmay also be of guidance to regulating authorities.The tests fall into several groups, including, for example,exposure to abnormally high and low temperatures,and avariety of mechanical tests. Each test can be appliedin several degrees of severity. The criterion of passor faildepends on leakage of the contents of the sealed radioactivesource.NOTE 1 Leakage test methods are given in ISO 9978.A list of the main typical applications of sealedradioactive sources with a suggested test schedulefor eachapplication is given in table 4. The tests are minimumrequirements corresponding to the applicationsin thebroadest sense. Factors to be considered for applicationsin especially severe conditions are listed in 4.2.NOTE 2 Manufacturers and test organizations shouldprepare their own programme for quality assurance, inaccordancewith the requirements of ISO 9000 to ISO 9004 or an equivalentnational standard.This International Standard makes no attempt toclassify either the design of sources and theirmethod ofconstruction or their calibration in terms of the radiationemitted. Radioactive materials inside a nuclear reactorincluding sealed sources and fuel elements are not coveredby this International Standard.2 Normative referencesThe following standards contain provisions which,through reference in this text, constitute provisionsof thisInternational Standard. At the time of the publication,the editions indicated were valid. All standards aresubject torevision, and parties to agreements based on thisInternational Standard are encouraged to investigatethepossibility of applying the most recent editions of thestandards indicated below. Members of IEC and ISOmaintainregisters of currently valid International Standards.ISO 361:1975, Basic ionizing radiationsymbol.ISO 9000-1:1994, Quality management and quality assurancestandards-Part 1: Guidelines for selection and use.ISO 9000-2:1997, Quality management and qualityassurance standards - Part2: Generic guidelinesfor theapplicationof ISO 9001, ISO 9002 and ISO 9003.ISO 9000-4:-'), Quality management and qualityassurance standardsprogramme management.-Part4: Guide to dependability1) To be published. (Revision of ISO 9000-4:1993)1

ISO 2919:1999(E)ISO 9001:1994, Quality systemsservicing.ISO 9002:1994, QualitysystemsQ ISO-Model for quality assurance in design, development, production, installation and-Model for quality assurance in production, installation,and servicing.ISO 9003:1994, Quality systems -Model for quality assurance in final inspectionand test.ISO 9004-1:1994, Quality management and quality system elements -Part 1: Guidelines.ISO 9004-2:1991, Quality managementand quality system elements - Part2: Guidelinesfor services.ISO 9004-3:1993, Quality management and quality system elements -Part3: Guidelines for processed materials.ISO 9004-4:1993, Quality managementand quality system elements - Part4: Guidelinesfor quality improvement.ISO 9978:1992, Radiationprotection -Sealed radioactivesources -Leakage test methods.3 DefinitionsFor the purposes of this International Standard, the following definitions apply. Theseare given in alphabeticalorder.3.1capsuleprotective envelope used to prevent leakage of radioactive material3.2dummy sealed sourcefacsimile of a sealed source, the capsule of which has the same construction andis made with exactly the samematerials as those of the sealed source that it represents but containing, in placeof the radioactive material, asubstance resembling it as closely as practical in physical and chemical properties3.3fluence ratenumber of particles and/or photons of ionizing radiation emitted per unit time fromthe sealed source in definedgeometryNOTEThis is best expressed interms of radiation fluence rate.3.4leakagetransfer of contained radioactive material from the sealed source to the environment3.5leaktightterm applied to sealed sources which, after leakage testing, have met the limitingvalues given in table 1 ofISO 9978:19923.6model designationunique term (number, code or combination of these) which is used to identify a specifictype of sealed source3.7non-leachableterm used to convey that the radioactive material in the form contained in the sealedsource is virtually insoluble inwater and is not convertible into dispersible products2

ISOISO 2919:1999(E)3.8prototype sealed sourceoriginal of a sealed source which serves as a patternfor the manufacture of all sealed sources identified bythesame model designation3.9quality assuranceall the planned and systematic activities implementedwithin the quality system, and demonstrated as needed,toprovide adequate confidence that an entity will fulfil requirementsfor quality3.10radiotoxicitythe ability of a radionuclide to produce injury by virtueof its emitted radiations, when incorporated in the humanbody3.11sealed sourceradioactive material sealed in a capsule or associatedwith a material to which it is closely bonded, this capsuleorbonding material being strong enough to maintain leaktightnessof the sealed source under the conditions of useand wear for which it was designed3.12simulated sealed sourcefacsimile of a sealed source, the capsule of which hasthe same construction and is made with exactly thesamematerials as those of the sealed source that it representsbut containing, in place of the radioactive material,substance with physical and chemical properties asaclose as possible to those of the radioactive materialandcontaining radioactive material of tracer quantity onlyNOTEThe tracer should be soluble in a solvent which does not attackthe capsule and it should have a maximum activitycompatible with its use in a test environment (e.g. approximately1 MBq caesium 137).3.13source assemblysealed source contained within or attached to a sourceholder3.14source holderfixed or removable mechanical device to hold up or tosupport the source3.15source in devicesealed source which remains within the shielded equipmentduring exposure, thus providing some mechanicalprotection during use4 Classification and designation4.1 DesignationThe classification of the sealed source type shall be designatedby the code ISO/, followed by two digits to indicatethe year of approval of the standard used to determinethe classification, followed by a solidus (/), followedby aletter, followed by five digits and a set of parenthesescontaining one or more digits.The letter shall be either C or E:C indicates that the activity of the sealed source does notexceed the level specified in table 3;E indicates that the activity of the sealed source exceedsthe level specified in table 3.The five digits shall be the class numbers which describethe performances for temperature, external pressure,impact, vibration and puncture respectively, in the ordershown in table 2.3

ISO 2919:1999(E) ISOIf required, a number is inserted between the parentheses describing the type of bending test the source haspassed. Such bending tests, required for some particularly shaped sources (longslender sources, brachytherapyneedles), are established in table 1 and specific requirements are given in 7.7.Multiple tests may be performed anddescribed to satisfy the test criteria. The parentheses may be omitted if no bendingtest is required.EXAMPLES:a typical industrial radiography source design for unprotected use would bedesignated "ISO/98/C43515(1)" or-"ISO/98/C43515";-a typical brachytherapy source design would be designated "ISO/98/C53211(8)";-a typical irradiator source design would be designated "!SO/98/C53424(4,7)".Table I - Bending test classBending test classReference12345678XNo testB. Test7.7.1.B. Test7.7.1B. Test7.7.1B. Test7.7.1B. Test7.7.1B. Test7.7.2B. Test7.7.3Specialtest100 N(10,2 kg)500 N(51 kg)1 000N(102 kg)2000N(204 kg)4000N(408 kg)Static forceS.F. 4.2 ClassificationThe classification levels are given in tables 1 and 2. Table 2 provides a list ofenvironmental test conditions withclass numbers arranged in increasing order of severity. The classificationsgiven in table 4 do not consider theeffects of fire, explosion and corrosion. In the evaluation of sealed sources,the manufacturer and user shallconsider the probability of fire, explosion, corrosion, etc. and the possible resultsfrom such events. Factors whichshould be considered in determining the need for special testing are:a)consequences of loss of activity;b)quantity of radioactive material contained in the sealed source;c)radiotoxicity;d)chemical and physical form of the radioactive material;e)environment in which the source is stored, moved and used;f)protection afforded to the sealed source or source-device combination.The user and manufacturer should jointly decide the additional tests to which thesealed source shall be subjected,if any.Annex D contains examples of special tests.4

Q ISOISO 2919:1999(E)Table 2 - Classification of sealed source performance (5 digits)TestTemperatureClass123456XNo test-40 0C (20 min) 80*C(lh)- 40 0C (20 min) 1800C(lh)-40 00 (20 mm) 400'C(1 h)and thermalshock to-40 'C (20 min) 600 0 C(1h)and thermalshock to- 40 00 (20 min) 800'C(1h)and thermalshock toSpecial testIExternalpressureNo test25 kPa absoluteto atmosphericImpactNo test50 g from 1 mor equivalentimparted energyVibrationPunctureNo testNo test25 kPa absoluteto 2 MPaabsolute200 g from 1 mor equivalentimparted energy200C20'C20'CI25 kPa absoluteto 7 MPaabsolute25 kPa absoluteto 70 MPaabsolute25 kPa absoluteto 170 MPaabsoluteSpecial test2 kg from 1 mor equivalentimparted energy5 kg from 1 mor equivalentimparted energy20 kg from 1 mor equivalentimparted energySpecial testNot usedSpecial test1 kg from 1 mor equivalentimparted energySpecial test3times 10 min3 times 10 min3 times 3m0rin25 to 500 Hz at25 to 50 Hz at25 to 80 Hz at49 rms 2 (5 gn) 1) 49 Mrs2(5 gn) 1) 1.5 mm amplitudeNot usedand 50 to 90 Hz peak to peak andat 0.635 mm80 to 2 000 Hz at2amplitude peak 196 Mr/s(20 gn) 1to peak and90 to 500 Hz at98 m/s 2 (10 gn) 1)1 g from 1 mlog from 1 m50 g from 1 m300 g from 1 mor equivalentor equivalentor equivalentor equivalentimparted energy imparted energy imparted energy imparted energy1) Acceleration maximum amplitude4.3 Determination of classificationThe classification of each sealed source type shall be determinedby either of the following methods:actual testing of two sealed sources (specimen, dummy or simulated)of that type for each test in table 2;derivation from previous tests which demonstrate that the sealedsource would pass the test if the test wasperformed.Different specimens may be used for each of the tests.Compliance with the tests shall be determined by the abilityeach test is performed. After each test, the source shall bepass an appropriate leakage test in accordance with ISOsensitivity of the chosen method shall be justified.A source with more than one encapsulation shall be deemedleast one encapsulation is leaktight after the test.of the sealed source to maintain its leaktightness afterexamined visually for loss of integrity and it shall also9978. When leakage-testing a simulated source, theto have passed a test if it can be demonstrated that at5 Activity level requirementsThe specified activity of sealed sources, below which a separateevaluation of the specific usage and design is notrequired, is given in table 3 for each of the four radiotoxicity groupsgiven in annex A.Sealed sources containing more than the specified activity shallbe subject to further evaluation of the specificusage and design. For purposes of classification, the activity levelof a sealed source according to table 3 shall beconsidered at the time of its manufacture.5

ISO 2919:1999(E) ISOExcept if required, evaluation of the effect of fire, explosion, corrosion and radiotoxicity of the radionuclideshall beconsidered only when the activity of the sealed source exceedsthe value shown in table 3. If the activity exceedsthis value, the specifications of the sealed sources shall be consideredon an individual basis. If the activity does notexceed the values shown in table 3, table 4 may be used withoutfurther consideration of either radiotoxicity orsolubility.Table 3 -Specified activity level according to radionuclide groupRadionuclide group(from annex A)Specified activityTBq (Ci)Leachable'Non-leachable"'A0,01 (about 0.3)0,1 (about 3)B11 (about 30)10 (about 300)B210 (about 300)100 (about 3 000)C20 (about 500)200 (about 5 000)1) Leachable: greater than 0.01 % of the total activity in 100 ml in still H20 at 50 C for 4 hconforming to 5.1.1 of ISO 9978:1992.2) Non-leachable: less than 0,01 % of the total activity in 100 ml in stillH2 0 at 50 'C for 4 hconforming to 5.1.1 of ISO 9978:1992.6 Performance requirements6.1General requirementsAll sealed sources shall be tested after manufacture to ensurefreedom from surface contamination. This shall bedone in accordance with one of the tests specified in 5.3 of ISO9978:1992.All sealed sources shall be tested after manufacture to ensurefreedom from leakage. This shall be done inaccordance with one or more of the methods specified in ISO 9978.All sealed sources shall be measured after manufacture to determinetheir radiation output.The content activity of all sealed sources shall be estimated. Thiscan be done from the result of the radiation outputmeasurement or from radioactive assay of the batch of materialused in manufacture.Specimen sealed sources shall be subjected, as specified herein,to the tests described in clause 7. A classificationfor the sealed source model shall be given in accordance with clause4.A certificate containing the results of tests, etc. on each sealedsource shall be provided in accordance withclause 9.Each sealed source shall be marked in accordance with clause8.The sealed source capsule shall be physically and chemically compatiblewith its contents. In the case of a sealedsource produced by direct irradiation, the capsule shall not containsignificant quantities of radioactive materialunless that material is adequately bonded into the capsule materialand it can be shown that the sealed source isleaktight.The tracer in a simulated sealed source shall be soluble in a solventwhich does not attack the capsule and it shallhave a maximum activity compatible with its use in a test environment(e.g. approximately 1 MBq ' 37Cs).6

ISOISO 2919:1999(E)6.2 Requirements for typical usageA list of some typical applications in which a sealed source, sourceassembly or source in device is used. togetherwith minimum performance requirements, is given in table 4.One or more of the bending tests specified in 7.7 may also be required.For test sources having an active length (L) to minimum outer capsulediameter (D) ratio equal to or greater than 15(i.e. L/D -- 15), the bending tests required are those describedin 7.7.1. For example, for sealed sources used incategory I irradiators, class 4 is required, and for category II, Ill andIV irradiators, class 5 is required.For test sources having an active length (L) to minimum outercapsule diameter (D) ratio of 10 or greater(i.e. L/D -- 10) and an active length equal to or greater than 100mm (i.e. L -- 100 mm), the bending test required isthat described in 7.7.2 and is class 7.For sealed sources in the form of brachytherapy needles havingan active length (L) equal to or greater than 30 mm(i.e. L 30 mm), the bending test required is that described in 7.7.3and is class 8.Table 4-Sealed source classification (performance) requirements for typical usageSealed source usageoltpy--IIIUUtIrIalMedicalGamma gauges(medium and high energy)Sealed source class, depending on testTemperature PressureImpactVibration PunctureSealeo source43515Source to be used indevice43313312Radiography32Gamma teletherapy535Brachytherapy [6] 1)532Surface applicators 2)433Unprotected source433Source in device433232225232331223244Beta gauges and sources for low-energy gammagauges or X-ray fluorescence analysis 2)23Oil-well loggingPortable moisture and density gauge (including handheld or dolly-transported)4General neutron source application (excluding reactorstartup)4Calibration source activity 1 MBq222433534Gamma irradiation sources[3], [5]Category I 2)Categories II, Iland IV 3)Ion generators 3)334Chromatography.2311232-4IIStatic eliminators2222Smoke directors 2)32223111) Sources of this nature may be subject to severe deformationin use. Manufacturers and users may wish to formulate additionalor specialtest procedures.2) Excluding gas-filled sources.3) 'Source in device" or a "source assembly" may be tested.7

ISO 2919:1999(E) ISOThese requirements take into account normal usage and reasonableaccidental risks but do not include exposure tofire, explosion or corrosion. For sealed sources normally mountedin devices, consideration is given to the additionalprotection afforded to the sealed source by the device when theclass number for a particular usage was assigned.Thus, for all usages shown in table 4, the class numbers specifythe tests to which the sealed source shall besubjected, except that for the ion generator category: for thesethe complete source assembly or source in devicemay be tested.The tests specified herein do not cover all sealed source usagesituations. If the conditions of a particular usage orconditions relating to potential accidents do not match the classificationspecified in table 4, the manufacturer anduser shall consider making appropriate tests on an individual basis.The numbers shown in table 4 refer to the class numbers used intable 2.NOTEIAEA tests for special form radioactive material [1] are not of generalapplication, but may be relevant whenformulating additional tests.6.3 Procedure to establish classification and performancerequirements6.3.1Establish the radiotoxicity group from annex A.6.3.2 Determine the specified activity value in accordance withtable If the sealed source activity does not exceed the specifiedactivity given in table 3, an evaluation of hazardsdue to fire, explosion, corrosion, etc. shall be made. If no significanthazard is identified, the minimum classificationrequired for the sealed source and its application may be used (see6.2). If significant hazards are identified, then afull evaluation of the tests required shall be made (see 4.2), payingparticular attention to the temperature andimpact requirements.6.3.4 If the sealed source activity exceeds the allowable levelgiven in table 3, a separate evaluation of the testsrequired shall be made which shall include source design andspecific usage as well as hazards due to fire,explosion, corrosion, etc.6.3.5 After the required minimum classification for the sealedsource for the particular application or usage hasbeen established, the performance standards required can be obtaineddirectly from tables 1 and Alternatively, the sealed source class can be determinedfrom tables 1 and 2 and suitable applications maybe selected from table 4.Since table 2 is arranged in order of increasing severity fromclass 1 through to class 6, sealed sources of anestablished classification may be used in any suitable applicationhaving the same or less stringent specificperformance requirements.7 Test methods7.1 GeneralThe test procedures given in this clause present acceptable proceduresfor determining performance classificationnumbers. All the criteria set are the minimum requirements. Procedureswhich can be demonstrated to be at leastequivalent are also acceptable. All tests, except the temperature tests,shall be carried out at ambient temperature.Criteria for compliance with this International Standard after testingare given in Temperature test7.2.1 ApparatusThe heating or cooling equipment shall have a test zone volumeof at least five times the volume of the testspecimen. If a gas- or oil-fired furnace is used, an oxidizingatmosphere shall be maintained throughout the test.8

per,%ISO 2919:1999(E)7.2.2 ProcedurePerform all tests in air.NOTEIn the low-temperature test an atmosphere of carbon dioxide("dry ice") is a permitted alternative, with which atemperature lower than that required will be achieved.Sealed sources to be subjected to temperatures below ambientshall be cooled to the test temperature in less than45 min.Sealed sources to be subjected to temperatures above ambientshall be heated to the test temperature within themaximum time limit specified in table 5.Table 5 - Temperature-time relationship for testsat temperatures above ambientTemperatureMaximum time limit0Cmin8051801040025600408001)701) Part of this test for class 6 is similar in principle tothe test givenby IAEA [1].teFor classes 2 and 3, retain sealed sources at theupper test temperature for at least 1 h and thenallow to coolslowly to ambient temperature in the furnace or laboratoryatmosphere.For classes 4, 5 and 6, retain sealed sources at the uppertest temperature for at least 1 h and then subject tothermal shock by transferring them, within 15 s, to waterat ambient temperature (about 20 C) and at a flow rateofat least ten times the sealed source volume per minute or,if the water is stationary, it shall have a volume of at leasttwenty times the sealed source volume.7.3 External pressure test7.3.1 ApparatusThe pressure gauge shall have been recently calibratedand should have a pressure range at least 10 % greaterthan the test pressure. The vacuum gauge shall read to apressure at least as low as 20 kPa absolute. Different testchambers may be used for the low and high pressure tests.7.3.2 ProcedurePlace the sealed source in the chamber and expose it tothe test pressure for two periods of 5 min each. Return thepressure to atmospheric between the periods.Conduct the low-pressure test in air. Conduct the high-pressuretest by a hydraulic method using water as themedium in contact with the sealed source.NOTEHydraulic oil should not be used in direct contact with the sealedsource because of the possibility of temporaryblockage of small leaks.9

ISO 2919:1999(E) ISO7.4 Impact test7.4.1 Apparatus7.4.1.1 Steel hammer, the upper part of which is equipped with means of attachment,and the lower part of whichshall have an external diameter of (25 1) mm and a flat striking surface with itsouter edge rounded to a radius of(3,0 0,3) mm.The centre of gravity of the hammer shall lie on the axis of the circle which definesitself passing thro

Feb 15, 1999 · ISO 9002:1994, Quality systems -Model for quality assurance in production, installation, and servicing. ISO 9003:1994, Quality systems -Model for quality assurance in final inspection and test. ISO 9004-1:1994, Quality management and quality system elements -Part 1: Guidelines. ISO 9004-2:1991, Quality management and quality system elementsFile Size: 1MB