Radiation Protection Dosimetry, Volume II: Technical and Management System Requirements for Dosimetry Services. REGDOC-2.7.

Transcription

1 Radiation Potection Dosimety, Volume II: Technical and Management System Requiements fo Dosimety Sevices REGDOC-2.7.2, Volume II Apil 2018

2 Dosimety, Volume II: Regulatoy document REGDOC-2.7.2, Volume II Canadian Nuclea Safety Commission (CNSC) 20XX Cat. No. XXXXX ISBN XXXXX Extacts fom this document may be epoduced fo individual use without pemission povided the souce is fully acknowledged. Howeve, epoduction in whole o in pat fo puposes of esale o edistibution equies pio witten pemission fom the Canadian Nuclea Safety Commission. Également publié en fançais sous le tite : Dosimétie, tome II : Exigences techniques et elatives aux systèmes de gestion pou les sevices de dosimétie Document availability This document can be viewed on the CNSC website. To equest a copy of the document in English o Fench, please contact: Canadian Nuclea Safety Commission 280 Slate Steet P.O. Box 1046, Station B Ottawa, ON K1P 5S9 CANADA Tel.: o (in Canada only) Fax: cnsc.info.ccsn@canada.ca Website: nucleasafety.gc.ca Facebook: facebook.com/canadiannucleasafetycommission YouTube: youtube.com/cnscccsn LinkedIn: linkedin.com/company/cnsc-ccsn Publishing histoy [Month yea] Vesion x.0 i Daft

3 Peface This egulatoy document is pat of the CNSC s adiation potection seies of egulatoy documents. The full list of egulatoy document seies is included at the end of this document and can also be found on the CNSC s website. Regulatoy document Technical and Management System Requiements fo Dosimety Sevices, sets out equiements and guidance to ensue that licensed dosimety sevices meet technical equiements and implement quality assuance measues, in accodance with the pupose of the Nuclea Safety and Contol Act and the Radiation Potection Regulations. This document supesedes S-106, Rev. 1, Technical and Quality Assuance Requiements fo Dosimety Sevices, published in May REGDOC-2.7.2, Volume II, is intended to fom pat of the licensing basis fo a egulated facility o activity within the scope of the document. It is intended fo inclusion in licences as eithe pat of the conditions and safety and contol measues in a licence, o as pat of the safety and contol measues to be descibed in a licence application and the documents needed to suppot that application. Guidance contained in this document exists to infom the applicant, to elaboate futhe on equiements o to povide diection to licensees and applicants on how to meet equiements. It also povides moe infomation about how CNSC staff evaluate specific poblems o data duing thei eview of licence applications. Licensees ae expected to eview and conside guidance; should they choose not to follow it, they should explain how thei chosen altenate appoach meets egulatoy equiements. Impotant note: Whee efeenced in a licence eithe diectly o indiectly (such as though licenseeefeenced documents), this document is pat of the licensing basis fo a egulated facility o activity. The licensing basis sets the bounday conditions fo acceptable pefomance at a egulated facility o activity, and establishes the basis fo the CNSC s compliance pogam fo that egulated facility o activity. Whee this document is pat of the licensing basis, the wod shall is used to expess a equiement to be satisfied by the licensee o licence applicant. Should is used to expess guidance o that which is advised. May is used to expess an option o that which is advised o pemissible within the limits of this egulatoy document. Can is used to expess possibility o capability. Nothing contained in this document is to be constued as elieving any licensee fom any othe petinent equiements. It is the licensee s esponsibility to identify and comply with all applicable egulations and licence conditions. i Daft

4 Table of Contents 1. Intoduction Pupose Scope Relevant legislation Technical Requiements Dosimety Sevices fo Extenal Radiation Measuement quantities Minimum measuable dose equivalent Accuacy specifications and uncetainty limits Type testing Pefomance testing Independent testing Technical Requiements Neuton Dosimety Sevices Data and epots Independent testing Pefomance testing Documentation Technical Requiements Dosimety Sevices fo Intenal Radiation Measuement quantities In vito accuacy and pecision specifications Pefomance testing fo in vito measuements Independent testing fo in vito measuements In vivo accuacy and pecision specifications Independent testing fo in vivo measuements Intepetation of bioassay data Technical Requiements Dosimety Sevices fo Radon Pogeny and Radon Gas Measuement quantities Minimum measuable exposue o concentation Accuacy specifications fo adon pogeny measuements Type testing fo adon pogeny measuing instuments Independent testing fo the monitoing of adon pogeny Accuacy specifications fo adon gas measuements... 15

5 5.7 Type testing fo adon gas monitoing Independent testing fo adon gas measuements Technical Requiements Dosimety Sevices fo Intakes of Aibone Radioactive Mateial Measuement quantities Minimum measuable exposue o concentation Accuacy fo aibone adioactive mateial measuements Documentation Management System Requiements Management policy Quality assuance pogam desciption Management eview and self-assessments Oganization and authoity Pesonnel qualifications Pocuement Wok contol Change contol Document contol Calibation and maintenance Veification Non-confomance Coective action Recods Audits Appendix A: Accuacy and Uncetainty in Extenal Dose Measuement...24 A.1 Intoduction A.2 Conventionally tue value A.3 Accuacy and pecision A.4 Example calculations Appendix B: Type Test Specifications fo Extenal Dosimety...36 B.1 Intoduction B.2 Influence quantities and system chaacteistics... 36

6 B.3 Phantoms B.4 Angle of incidence of adiation B.5 Photon enegies B.6 Beta enegies Appendix C: Independent Test Specifications fo Extenal Photon Dosimety...40 C.1 Intoduction C.2 Potocol fo dosimetes that equie pocessing C.3 Potocol fo dosimetes that do not equie pocessing C.4 Repoting Appendix D: Independent Test Specifications fo Extemity Dosimety...42 D.1 Intoduction D.2 Potocol fo dosimetes that equie pocessing D.3 Potocol fo dosimetes that do not equie pocessing D.4 Repoting Appendix E: Independent Test Specifications fo Neuton Dosimety...44 E.1 Intoduction E.2 Potocol fo pesonal dosimetes that equie pocessing E.3 Potocol fo pesonal dosimetes that do not equie pocessing E.4 Repoting Appendix F: Independent Test Specifications fo Intenal Dosimety...46 F.1 Intoduction F.2 In Vito measuement independent tests F.3 In Vivo measuement independent tests F.4 Repoting Appendix G: Independent Test Specifications fo Radon Pogeny and Radon Gas...48 G.1 Intoduction G.2 Potocol fo pesonal monitos G.3 Gab sampling G.4 Repoting Appendix H: Example Calculations fo Minimum Measuable Concentation and Counting Uncetainty...50

7 H.1 Example calculation fo the detemination of the minimum measuable concentation H.2 Example calculation fo uncetainty Appendix I: Specifications fo Dose Recods...52 I.1 Intoduction I.2 Individual identification I.3 Dose data I.4 Suppoting infomation Appendix J: Refeence Calibation Centes...54 J.1 Independent test specifications fo extenal photon dosimety, extemity dosimety, and neuton dosimety J.2 Independent test specifications fo in vito measuements, in vivo measuements, and intepetation of bioassay data J.3 Independent test specifications fo adon gas and adon pogeny Glossay...56 Refeences...57

8 1. Intoduction 1.1 Pupose Regulatoy document Technical and Management System Requiements fo Dosimety Sevices, sets out equiements and guidance to ensue that licensed dosimety sevices meet technical equiements and implement quality assuance measues, in accodance with the pupose of the Nuclea Safety and Contol Act (NSCA) and the Radiation Potection Regulations. 1.2 Scope This egulatoy document sets out the technical and management system equiements fo a dosimety sevice licensed by the CNSC. 1.3 Relevant legislation The elevant povisions of the NSCA and the egulations made unde the act to this standad ae as follows: 1. Section 24(4) of the NSCA povides that No licence shall be issued, enewed, amended o eplaced and no authoization to tansfe one given unless, in the opinion of the Commission, the applicant o, in the case of an application fo an authoization to tansfe the licence, the tansfeee (a) is qualified to cay on the activity that the licence will authoize the licensee to cay on; and (b) will, in caying on that activity, make adequate povision fo the potection of the envionment, the health and safety of pesons and the maintenance of national secuity and measues equied to implement intenational obligations to which Canada has ageed. 2. Section 24(5) of the NSCA states that a licence may contain any tem o condition that the Commission consides necessay fo the puposes of the Act. 3. Section 18 of the Radiation Potection Regulations lists the infomation that is equied fo an application fo a licence to opeate a dosimety sevice. 4. Section 19 of the Radiation Potection Regulations lists the infomation that the licensee of a dosimety sevice must supply to the National Dose Registy fo each nuclea enegy woke. 5. Section 28(1) of the Geneal Nuclea Safety and Contol Regulations povides that Evey peson who is equied to keep a ecod by the Act, the egulations made unde the Act o a licence shall etain the ecod fo the peiod specified in the applicable egulations made unde the Act o, if no peiod is specified in the egulations, fo the peiod ending one yea afte the expiy of the licence that authoizes the activity in espect of which the ecods ae kept. 6. Section 28(2) of the Geneal Nuclea Safety and Contol Regulations states that No peson shall dispose of a ecod efeed to in the Act, the egulations made unde the Act o a licence unless the peson a) is no longe equied to keep the ecod by the Act, the egulations made unde the Act o the 1 Daft

9 licence; and b) has notified the Commission of the date of disposal and of the natue of the ecod at least 90 days befoe the date of disposal. 2. Technical Requiements Dosimety Sevices fo Extenal Radiation Requiements that apply to neuton dosimety sevices ae descibed in section 3. An extenal dosimety sevice shall comply with the following equiements: 1. Identify, at the licensing stage, the types of adiation and the expected espective enegy anges to which the dosimetes will be exposed duing use. 2. Measue the quantity of inteest within the accuacy specifications and uncetainty limits that apply to that quantity, as descibed in section 2.3, Accuacy specifications and uncetainty limits. 3. Demonstate its ability to satisfy oveall specifications though type testing at the licensing stage and when changes ae made, as descibed in section 2.4, Type testing. 4. Demonstate that it opeates in a pedictable and consistent way though outine and special pefomance testing, as descibed in section 2.5, Pefomance testing. 5. Have its pefomance and the calibation of its system veified though independent testing, as descibed in section 2.6, Independent testing. 6. Notify the CNSC immediately, in witing (electonic fomat acceptable), when it fails one of its peiodic tests (i.e., pefomance o independent test). 7. Within 30 days, submit a detailed witten epot to the CNSC outlining the cause and consequence of any peiodic test failue and a desciption of coective action taken. 8. Repeat the test as soon as pacticable in consultation with the CNSC, and submit the esults to the CNSC. If epetition of the test esults in a second consecutive failue, the CNSC may take futhe licensing action. 2.1 Measuement quantities Toso The quantity to be measued is the pesonal dose equivalent, H p (d), as defined by the Intenational Commission on Radiation Units and Measuements in Repot 47 [1]. The values of d diffe depending on tissue depth, as follows: 1. d = 0.07 mm fo a shallow (o skin) dose 2. d = 10 mm fo a deep (o whole-body) dose The conventionally tue value of d seves as the efeence value fo estimating eos in measuements. In the following sections, H p,c (d) designates the conventionally tue value of the quantity H p (d). Fo moe infomation on conventionally tue values, see section A.2 of appendix A, Accuacy and Uncetainty in Extenal Dose Measuement. 2 Daft

10 2.1.2 Extemities The quantity to be measued fo a specific extemity is the dose equivalent at a depth of 0.07 mm. In its Publication 103 [2], the ICRP ecommends the depth of 0.07 mm, which is designated as H e fo the pupose of this document. In the following sections, H e,c designates the conventionally tue value of the quantity H e. Fo moe infomation on conventionally tue values, see section A.2 of appendix A, Accuacy and Uncetainty in Extenal Dose Measuement. 2.2 Minimum measuable dose equivalent The dosimety sevice shall detemine the lowest values of H p,c (d) and H e,c that it can measue at the 95% confidence level. These values shall be detemined unde good laboatoy conditions, using the usual calibation adiation at nomal incidence to the dosimete. The method used to detemine these quantities is left to the discetion of the dosimety sevice. Howeve, the efeence used shall be indicated in the licence application. 2.3 Accuacy specifications and uncetainty limits Table 1 lists the oveall specifications fo accuacy and pecision. Type testing (which is descibed in section 2.4, Type testing, and appendix B, Type Test Specifications fo Extenal Dosimety) detemines a dosimety system s ability to meet these specifications. Section A.3 of appendix A, Accuacy and Uncetainty in Extenal Dose Measuement, descibes the calculation methods fo analyzing type test esults. Section A.4 of appendix A povides example calculations. Table 1: Accuacy and pecision specifications Quantity Dose (msv) Specifications H p,c (10) 4 to 10,000-33% / +50% % / +100% H p,c (0.07) 100 to 10,000-33% / +50% 10-50% / +100% H e,c 100 to 10,000-67% / +200% 10-67% / +200% 2.4 Type testing The dosimety sevice shall comply with the following equiements: 1. Demonstate the ability of its dosimety system to satisfy oveall specification equiements though type testing at the licence application stage. 2. Repeat the type tests when the dosimety sevice makes changes that may affect the esult of a dose measuement to the extent necessay to demonstate that the specifications of table 1 (section 2.3, Accuacy specifications and uncetainty limits), continue to be met. Examples of such changes ae dosimete design, badge case filtes, dose algoithm and tempeatue cycles (fo themoluminescent dosimety). 3 Daft

11 3. Repot the esults of these type tests which have been epeated following changes made to the system, to the CNSC, along with the ecods descibed in section 2.4.1, Documentation, and obtain CNSC appoval pio to the implementation of these changes. 4. Comply with the specifications descibed in appendix B, Type Test Specifications fo Extenal Dosimety Documentation The dosimety sevice shall maintain: 1. Type test esults in a fomat that clealy shows all the influence quantities and system chaacteistics that wee consideed and thei ange of possible values, as expected by the dosimety sevice, based on the intended use of that paticula dosimety system. 2. Sample calculations that show how the mean esponse and the combined standad uncetainty wee calculated. 3. The justification fo any assumptions made and techniques used. 2.5 Pefomance testing Routine pefomance tests The dosimety sevice shall conduct outine pefomance tests. The dosimety sevice shall include povisions fo outine pefomance tests duing evey outine dosimete issue peiod. In the case of biweekly issue peiods, the test should be completed at least monthly. Fo extemity dosimety, pefomance tests shall be pefomed at least once evey thee months. The fequency and natue of special pefomance tests shall be specified in the licence application. Fo outine pefomance tests, the dosimety sevice shall comply with the following equiements: 1. Iadiate test dosimetes to known doses, usually unde standad exposue conditions (e.g., at nomal incidence with the calibation adiation). 2. Teat test dosimetes in the same way as outine dosimetes; if pocessing is equied, povide test dosimetes without identifying them to the pocessing laboatoy. 3. In test iadiations, include doses compaable to o less than the smalle values in table 1 (section 2.3, Accuacy specifications and uncetainty limits). 4. Establish, in consultation with the CNSC, contol limits on the test esults. The dosimety sevice may maintain constant iadiation conditions and doses ove time to pemit moe valid tend analysis Special pefomance tests In addition to the outine pefomance tests, the dosimety sevice shall conduct special pefomance tests at a minimum of evey five yeas to confim that the pefomance of the dosimety system emains consistent with the esults of the oiginal type tests. Fo special pefomance tests, the dosimety sevice should subject the dosimetes to a subset of those influence quantities that the type tests showed to be significant and to which the esponse of the dosimety system may have changed as a esult of aging o eplacement of components. 4 Daft

12 The esults should be pesented in a manne that is consistent with the oiginal type test esults and should indicate that the accuacy and specification equiements outlined in table 1 (section 2.3) ae met Documentation The dosimety sevice shall keep a ecod of the following infomation: 1. outine pefomance test pocedues 2. outine and special pefomance test esults The dosimety sevice shall submit the outine pefomance test pocedues to the CNSC fo appoval at the licensing application stage. 2.6 Independent testing The equiements fo independent testing include the following: 1. Extenal dosimety sevices shall undego and pass independent testing of each of its dosimete designs pio to licensing. 2. Upon eceipt of a licence, the dosimety sevice shall undego independent testing at egula intevals with a fequency of at least once evey 12 months. 3. The dosimety sevice shall have the independent tests pefomed by the elevant efeence calibation cente fo extenal dosimety in Canada (see appendix J). 4. The dosimety sevice shall comply with the specifications descibed in appendix C, Independent Test Specifications fo Extenal Photon Dosimety, and appendix D, Independent Test Specifications fo Extemity Dosimety, as applicable. 5. If the dosimetes used by the dosimety sevice equie pocessing (e.g., themoluminescent dosimetes [TLDs]), and moe than one pocessing unit (e.g., TLD eade) is used, each pocessing unit shall be tested annually by using each unit to pocess at least one set of test dosimetes iadiated by the efeence calibation cente. Note: If the dosimety sevice has documented evidence that shows that all of its pocessing units espond in a consistent manne, only one unit shall be tested annually though the efeence calibation cente. Howeve, the dosimety sevice shall establish esponse consistency of the pocessing units by showing that the mean esponse (i.e., the mean calculated dose) of a set of dosimetes pocessed by any given unit is within ±5% (at the 95% confidence level) of the aveage of the mean esponses obtained fom all of the pocessing units. Fo whole-body dosimetes, the coefficient of vaiation of dosimetes pocessed by each unit shall not be geate than 0.075, and fo extemity dosimetes, the coefficient of vaiation of dosimetes pocessed by each unit shall not be geate than Accuacy specifications The accuacy specifications that a dosimety sevice shall maintain in each of the independent tests fo photon and beta adiation ae epesented in table 2 by the mean esponse R and by the coefficient of vaiation of the esponses fo the complete set of measuements. Fo dosimetes won on the toso, the mean esponse coesponds with the complete set of measuements of the collision ai kemas (o exposues) deliveed. Fo dosimetes won on the extemities, the mean esponse coesponds with the complete set of measuements of tissue doses deliveed. 5 Daft

13 Table 2: Accuacy specifications fo dosimetes Dosimete Mean esponse R Coefficient of vaiation Won on the toso 0.9 R Won on the extemities 0.80 R Note: Fo these tests, table 2 defines the esponse elative to the conventionally tue value of the appopiate quantity. 3. Technical Requiements Neuton Dosimety Sevices A neuton dosimety sevice shall comply with the following equiements: 1. Ensue compatibility between the dosimety sevice s neuton dosimetes and the neuton fields in which they ae to be used, and whee possible, include a desciption of the neuton souces and the expected neuton specta to which wokes will be exposed. 2. Document detailed technical desciptions of the dosimetes and associated equipment. 3. Recod data and pepae epots with quantitative infomation on the pefomance of the dosimetes and the sevice (type testing is not equied, except to show that the esponse is appopiate to the neuton enegy specta to which wokes may be exposed). 4. Have the calibation of its system diectly taceable to the efeence calibation cente (see appendix J) o anothe ecognized national o intenational laboatoy, in consultation with the CNSC. If neuton suvey metes ae used instead of pesonal neuton dosimetes, the dosimety sevice shall meet the equiements listed above egading such instuments. It shall also establish a outine calibation pogam with the elevant efeence calibation cente (see appendix J) o anothe ecognized national o intenational laboatoy, in consultation with the CNSC. 3.1 Data and epots Futhe to item 3 in section 3, the following infomation shall be ecoded as data and povided in epots: 1. A desciption of the calibation souce, the calibation field and a efeence to the calibation potocol 2. The dose equivalent enegy esponse of the dosimetes 3. A statement on the limitations of the dosimety system and a qualitative estimate of its accuacy and pecision in measuing H p,c (10), unde the conditions that the dosimetes ae intended to be used, including the vaiability among the pocessing components 4. An estimate of the lowest value of H p,c (10) that the dosimety system is capable of measuing at the 95% confidence level 5. The minimum epotable dose 3.2 Independent testing The dosimety sevice shall undego independent testing with the elevant efeence calibation cente (see appendix J) pio to licensing and, upon eceipt of a licence, at egula intevals with a fequency of at least once evey 12 months. 6 Daft

14 This is a consistency test that enables dosimety sevices to demonstate consistency of pefomance on a peiodic basis. The conditions upon which the consistency will be judged ae established at the time of licensing. Table 3 shows the pass citeia fo the complete set of measuements. Table 3: Accuacy specifications fo neuton dosimetes Dosimete Mean esponse R Coefficient of vaiation All types 0.7 R When neuton suvey metes ae used fo dosimety, the equiement fo an annual independent test may be combined with the equiement descibed in section 2.7, Requiements fo outine neuton dosimety sevices, fo outine calibation. It is sufficient to send one neuton suvey mete fo such a test, poviding that any additional neuton suvey metes used by the dosimety sevice ae calibated against the one sent to the efeence calibation cente. The dosimety sevice shall comply with the specifications descibed in appendix E, Independent Test Specifications fo Neuton Dosimety. 3.3 Pefomance testing The dosimety sevice shall comply with the following equiements: 1. Establish a pogam fo outine pefomance tests on the dosimety systems. 2. Include povisions fo outine pefomance tests duing evey outine dosimete issue peiod. In the case of biweekly issue peiods o the use of suvey instuments fo dose assessment, the test should be completed at least monthly. 3. Submit elevant documentation, including the fequency of the testing, to the CNSC at the licence application stage. 3.4 Documentation The neuton doses shall be ecoded and epoted sepaately fom othe types of doses. 4. Technical Requiements Dosimety Sevices fo Intenal Radiation An intenal dosimety sevice shall comply with the following equiements: 1. Measue the activities and activity concentations fo selected adionuclides, as descibed in section 4.1, Measuement quantities. 2. Measue the quantity of inteest within the accuacy and pecision specifications, as descibed in section 4.2, In vito accuacy and pecision specifications, and section 4.5, In vivo accuacy and pecision specifications. 3. Demonstate that the intenal dosimety sevice opeates in a pedictable and consistent way though pefomance testing, as descibed in section 4.3, Pefomance testing fo in vito measuements. 4. Demonstate that it opeates in a eliable way by paticipating in independent testing, as descibed in section 4.4, Independent testing fo in vito measuements, and section 4.6, Independent testing fo in vivo measuements. 5. Ascetain doses as descibed in section 4.7, Ascetaining the committed effective dose. 6. Notify the CNSC immediately, in witing (electonic fomat acceptable), when it fails one of its peiodic tests (i.e., pefomance o independent test). 7 Daft

15 7. Within 30 days, submit a detailed witten epot to the CNSC outlining the cause and consequence of the failue of any peiodic test and a desciption of coective actions taken. 8. Repeat any failed test as soon as pacticable in consultation with the CNSC and submit the esults to the CNSC. If a epetition of the test esults in a second consecutive failue, the CNSC may take futhe licensing action. 4.1 Measuement quantities Licensed intenal dosimety sevices ae intended to suppot adiation potection pogams; theefoe, this document does not cove equiements egading the dosimety sevice s detection capabilities (e.g., minimum detectable activity). The intenal dosimety sevice shall paticipate in independent tests involving quantities, activities o activity concentations equal to o geate than the minimum testing levels (MTLs) shown in table 4, up to a maximum of 20 times the elevant MTL, fo the adionuclides fo which they ae licensed. This does not peclude the dosimety sevice fom caying out its pefomance tests at levels below the MTLs. Radionuclide activities and activity concentations ae measued in becqueels (Bq) and becqueels pe lite (Bq/L). The list of adionuclides in table 4 is not compehensive fo fission and activation poducts, but is epesentative fo demonstating competence in measuement techniques. To simulate woking conditions, adionuclides othe than those listed in table 4 may be intoduced duing the equied independent testing descibed in section 4.4, Independent testing fo in vito measuements, and section 4.6, Independent testing fo in vivo measuements. These adionuclides ae consideed sepaate fom the test, but ae added as intefeences to challenge the sevice s analytical system. Consequently, the dosimety sevice may pass the test without identifying o measuing them. Howeve, failue to coect fo such intefeences would jeopadize pefomance of the test and may esult in a failed test. Table 4: Minimum testing levels Radionuclide In vito bioassay (pe lite o pe sample) In vivo bioassay (Bq) Hydogen Bq Test not available Cabon Bq 3 x 10 5 (lung) Ion-59 Test not available 2,500 Cobalt-57 a 25 Bq 2,500 Cobalt Bq 2,500 Stontium-90 2 Bq Test not available Ziconium-95 + Test not available 2,000 Niobium-95 Antimony-124 Test not available 2,000 Iodine-125 b 20 Bq 1,000 Iodine-131 c 20 Bq 1,000 Cesium Bq 2,000 Ceium Bq 25,000 Radium Bq 5,000 8 Daft

16 Radionuclide In vito bioassay (pe lite o pe sample) In vivo bioassay (Bq) Thoium Bq Test not available Natual thoium d 0.02 Bq 150 (lung) Natual uanium e 5 μg 10 mg (lung) Uanium Bq 30 (lung) Plutonium-238/239/ Bq 9,000 (lung) Plutonium (TIMS f ) 0.02 pg/l Test not available Ameicium Bq 100 (lung) Notes: a) Cobalt-57 is used as a suogate fo ceium-144. b) If iodine (I)-129 is used as a suogate fo I-125, the same MTL values apply as fo I-125. c) If baium-133 is used as a suogate fo I-131, the same MTL values apply as fo I-131. d) One gam of natual thoium contains equal quantities, 4.06E+03 Bq, of thoium (Th)-232 and Th-228. The mass pecentages ae %, 1.3E-08% fo Th-232 and Th-228 espectively, while the specific activity is 8.12E+03 Bq/gam (g). e) One gam of natual uanium contains equal quantities, 1.26E+04 Bq, of uanium (U)-234 and U-238, and 569 Bq of U-235. The mass pecentages ae %, % and % fo U-238, U-235 and U-234 espectively; and the specific activity is 2.52E+04 Bq/g. f) TIMS: themal ionization mass spectomety 4.2 In vito accuacy and pecision specifications The mean elative bias, B, shall be calculated fom eplicate measuements, A i, of each concentation o level of activity, A. Since bias is often geate at lowe concentations nea the limits of detection than at highe concentations, dosimety sevice laboatoies shall be tested at seveal concentations no lowe than the MTL. The in vito accuacy and pecision specifications fo independent and pefomance tests ae such that the oot mean squaed eo (RMSE) of B and S B must be less than o equal to 0.25, as follows: RMSE = BB 2 + SS BB Pefomance testing fo in vito measuements The dosimety sevice shall conduct outine pefomance tests. It shall include povisions fo outine pefomance tests fo in vito bioassay, which ae to be pefomed at least once evey thee months, o, fo infequently used in vito measuements, at a fequency detemined in consultation with the CNSC. Fo outine pefomance tests, the dosimety sevice shall comply with the following equiements: 1. Pepae the test samples to concentations of analyte not known to the peson analyzing the test samples. 2. Detemine the concentation of analyte in the test samples. 3. Teat the test samples in the same way as outine in vito bioassay samples, so that the two ae indistinguishable. 9 Daft

17 4. Include the same categoies of adionuclides in the pefomance tests that ae included in the independent tests in which the dosimety sevice paticipates Documentation The dosimety sevice shall keep ecods of pefomance test pocedues and pefomance test esults. The dosimety sevice shall submit the pefomance test pocedues to the CNSC fo appoval at the licence application stage. 4.4 Independent testing fo in vito measuements Intenal dosimety sevices shall undego and pass independent testing pio to licensing. Upon eceipt of a licence, the dosimety sevice shall undego independent testing at egula intevals at least evey 12 months, o at othe intevals detemined in consultation with the CNSC. If a dosimety sevice uses moe than one measuement instument (e.g., seveal liquid scintillation countes fo titium analysis), the instuments that wee not used fo the independent test shall be veified at egula intevals at least evey 12 months against the measuement instument that was used fo the test. The laboatoy shall show that all othe measuement instuments also meet the accuacy and pecision equiements. It shall conside factos such as chemical ecovey, quenching, concentation ange, sample pepaation methods and so on, whee applicable. The dosimety sevice shall have the independent tests pefomed by the elevant efeence calibation cente (see appendix J) unless othewise stated in the dosimety sevice licence. If the elevant efeence calibation cente does not offe the test, the dosimety sevice shall seek CNSC appoval to use a diffeent oganization to pefom the independent tests. Dosimety sevices shall also have thei analytical pefomance tested at levels of activity encounteed in outine pesonnel monitoing as well as at expected levels following accidental exposues. Test samples will be spiked with a known quantity of a taceable activity geate than o equal to the MTL. Measuement epoducibility will be tested by poviding seveal identical samples of each level of activity. The dosimety sevice shall comply with the specifications descibed in appendix F, Independent Test Specifications fo Intenal Dosimety. 4.5 In vivo accuacy and pecision specifications The mean elative bias, B, shall be calculated fom measuements, A i, of each level of activity, A, included in the test. Since bias is often geate at lowe levels of activity nea the limits of detection than at highe levels of activity, dosimety sevice laboatoies shall be tested at seveal levels of activity no lowe than the MTL. The in vito accuacy and pecision specifications fo independent and pefomance tests ae such that the oot mean squaed eo (RMSE) of B and S B must be less than o equal to 0.25, as follows: RMSE = BB 2 + SS BB Daft

18 4.6 Independent testing fo in vivo measuements Intenal dosimety sevices shall undego and pass independent testing pio to licensing. Upon eceipt of a licence, the dosimety sevice shall undego independent testing at egula intevals at least evey 12 months, o at othe intevals detemined in consultation with the CNSC so that continuing competence can be demonstated even if no changes ae made to the measuement system. Such factos as vaiation of souce distibution within the phantom, vaiations in ambient backgound, and positioning eo shall be taken into account whee applicable. The dosimety sevice shall have the independent tests pefomed by the elevant efeence calibation cente (see appendix J) unless othewise stated in the dosimety sevice licence. If the elevant efeence calibation cente does not offe the test, the dosimety sevice shall seek CNSC appoval to use a diffeent oganization to pefom the independent tests. If the dosimety sevice makes alteations to the detectos, counting geomety, o the electonics of the measuement system that may affect the calibation, a futhe independent test is equied. Phantoms used fo calibation at photon enegies below 100 kiloelecton volts (kev) shall be constucted of tissueequivalent mateial and shall be anthopomophic. Fo photon enegies above 100 kev, acceptable phantoms can be made fom othe mateials. The dosimety sevice shall comply with the specifications descibed in appendix F. 4.7 Intepetation of bioassay data Ascetaining the committed effective dose Intenal dosimety sevices shall ascetain and ecod the committed effective dose to wokes fom the types of measuements efeed to in the licence, taking into consideation appopiate human physiological paametes and othe elevant infomation on the conditions of exposue. The method used to ascetain the dose shall be submitted to the CNSC fo appoval. When ascetaining the committed effective dose to wokes, dosimety sevices shall conside sitespecific paametes, unless othe values (e.g., default values) have been peviously appoved by the CNSC. All key paametes shall be documented Documentation The dosimety sevice shall submit the pocedues fo ascetaining the committed effective dose to wokes to the CNSC fo appoval at the licence application stage. 5. Technical Requiements Dosimety Sevices fo Radon Pogeny and Radon Gas Exposues to adon pogeny and adon gas ae estimated fom gab-sampling measuements combined with occupancy time ecods o fom pesonal monitoing. A dosimety sevice fo adon pogeny and adon gas shall comply with the following equiements: 1. Detemine the lowest exposue o concentation in ai that the dosimety sevice can measue at the 95% confidence level with the oveall accuacies specified, as descibed in section 5.2, Minimum measuable exposue o concentation. 11 Daft

19 2. Measue the quantity of inteest within the accuacy specifications and uncetainty limits that apply to that quantity, as descibed in section 5.3, Accuacy specifications fo adon pogeny measuements, and section 5.6, Accuacy specifications fo adon gas measuements. 3. Demonstate its ability to satisfy oveall specifications though type testing, as descibed in section 5.4, Type testing fo adon pogeny measuing instuments, and section 5.7, Type testing fo adon gas monitoing. 4. Demonstate that it opeates in a eliable way though independent testing, as descibed in section 5.5, Independent testing fo the monitoing of adon pogeny, and section 5.8, Independent testing fo adon gas measuements. 5.1 Measuement quantities The quantities to be measued include the following chaacteistics: 1. the concentation in ai of potential alpha enegy fom shot-lived adon pogeny 2. the exposue to aibone shot-lived adon pogeny 3. the concentation in ai of adon gas Thee ae histoical and Intenational System of Units (SI), o SI-compatible units of measuement fo the concentation of shot-lived adon pogeny in ai and exposue to adon pogeny. The woking level (WL) is the histoical unit fo the measuement of adon pogeny concentation in ai. The coesponding SI unit is the joule pe cubic mete (J m -3 ), whee 1 WL = 20.8 μj m -3 and 1 μj m -3 = 4.8 x 10-2 WL The woking-level month (WLM) is the histoical unit used to expess exposues to adon pogeny. The SI-compatible unit is the joule-hou pe cubic mete (J h m -3 ) whee 1 WLM = 3.54 mj h m -3 and 1 mj h m -3 = WLM The concentation of adon gas in ai is measued in activity pe unit volume of that atmosphee (i.e., Bq m -3 ). The intake (Bq) fom this concentation is calculated by multiplying the concentation by a defined beathing ate (i.e., 1.2 m 3 h -1 ) and the occupancy time (h). Altenatively, exposue can be detemined in Bq h m -3 and the intake would be this value multiplied by the beathing ate. 5.2 Minimum measuable exposue o concentation The dosimety sevice shall pefom the following tasks: 1. Detemine and ecod the lowest exposue o concentation in ai that it can measue at the 95% confidence level with the oveall accuacies of +50% / -33%. 2. Expess the minimum measuable exposue in the same units as the measued quantity. Section H.1 of appendix H povides examples of the statistical method used to detemine the minimum measuable activity concentation. 5.3 Accuacy specifications fo adon pogeny measuements Two categoies of instuments monito individual exposues to adon pogeny: 1. pesonal monitos, which give a diect estimation of individual exposues 12 Daft

20 2. gab-sampling instuments, which povide a measue of adon pogeny concentation at a given place and time, and whose eadings ae used in combination with occupancy time ecods to calculate individual exposues Both categoies of instuments shall meet the coesponding equiements of this section Pesonal monitos The test fo pesonal monitos shall be conducted in an envionment with stable and fixed concentation. The 95% confidence limit calculated fom the test esults shall fall within the confidence inteval limits indicated in table 5. Histoical units ae given fist, followed by SI o SI-compatible units in paentheses. Table 5: Accuacy specifications fo measuement of exposue to adon pogeny fo one dosimety peiod Range of measuement Oveall accuacy (95% confidence) 0.05 WLM (177 μj h m -3 ) to +100% / -50% < 0.10 WLM (354 μj h m -3 ) 0.10 WLM (354 μj h m -3 ) +50% / -33% Gab sampling The 95% confidence limit calculated fom the test esults shall fall within the confidence inteval limits indicated in table 6. Histoical units ae given fist, followed by SI o SI-compatible units in paentheses. Table 6: Accuacy specifications fo measuement of concentation of potential alpha enegy in ai Range of measuement 0.05 WL (1.03 μj m -3 ) to < 0.10 WL (2.08 μj m -3 ) Oveall accuacy (95% confidence) +100% / -50% 0.10 WL (2.08 μj m -3 ) +50% / -33% Fo gab sampling, the testing pogam highlighted in section G.3 of appendix G, Independent Test Specifications fo Radon Pogeny and Radon Gas, may be used to assess compliance with the accuacy equiements of table Type testing fo adon pogeny measuing instuments The dosimety sevice shall demonstate its ability to satisfy oveall specification equiements though type testing at the licence application stage. The type testing equiements fo adon pogeny measuing instuments ae as follows: 1. Type testing fo pesonal monitos shall identify all possible souces of eo and quantify thei contibution to the oveall eo and uncetainty in individual exposues. 2. In addition to establishing a pesonal monito s oveall accuacy, the type testing shall indicate the limitations of the device (such as conditions that may esult in the onset of filte satuation poblems), the time duing which the device can be eliably used without the need to echage the battey, and so on. 13 Daft

21 3. Type testing fo gab-sampling instuments shall identify and quantify all possible souces that contibute to the oveall eo and uncetainty in measued instantaneous adon pogeny concentations, except fo eos and uncetainties in actual pesonal exposues deived fom gab-sampling measuements, which ae excluded. 4. When the dosimety sevice makes changes (e.g., to the instumentation o methods used) that may affect the pefomance of pesonal monitos and gab-sampling instuments, the dosimety sevice shall epeat the type tests fo measuement accuacy and pecision to the extent necessay to demonstate that the specifications of tables 5 and 6 continue to be met. 5. The dosimety sevice shall epot the esults of these type tests, which have been epeated following changes made to the system, to the CNSC along with the ecods descibed in section 5.4.2, Documentation, and shall obtain CNSC appoval pio to the implementation of these changes Influence quantities that may affect accuacy o uncetainty The dosimety sevice shall conside the following influence quantities and evaluate those that ae likely to significantly affect accuacy o uncetainty. Othe influence quantities that may contibute to oveall uncetainty shall also be consideed (i.e., all influence quantities contibuting to the uncetainty of the measuement) shall be taken into account. Fo sampling paametes of pesonal monitos, the following quantities shall be taken into account: 1. duation of opeation at design pefomance at full chage of the battey 2. sampling flow ate 3. flow ate vaiability 4. influence of paticle size distibution, paticulaly unattached faction of adon pogeny on sampling efficiency Fo detection and counting paametes of pesonal monitos, the following quantities shall be taken into account: 1. filte-detecto geomety 2. enegy-dependent detection efficiency 3. sensitivity to adiation emitted fom souces othe than adon pogeny 4. sensitivity to deviations fom detecto pocessing specifications 5. sensitivity to time vaiability of adon pogeny concentations Fo gab-sampling instuments, the following quantities shall be taken into account: 1. sampling flow ate 2. flow ate vaiability 3. sensitivity to paticle size distibution, paticulaly unattached faction of adon pogeny in the test atmosphee 4. calibation and stability of field alpha countes 5. the method used to calculate adon pogeny concentations 14 Daft

22 5.4.2 Documentation The dosimety sevice shall maintain: 1. type test esults in a fomat that clealy shows all the influence quantities and system chaacteistics that wee consideed, and the ange of possible values expected of them by the dosimety sevice, based on the intended use of that paticula dosimety system 2. sample calculations that show how the mean esponse and the combined standad uncetainty wee calculated 3. the justification fo any assumptions made and techniques used 5.5 Independent testing fo the monitoing of adon pogeny The dosimety sevice shall comply with the following equiements: 1. Undego independent testing to demonstate that it meets the accuacy specifications, as descibed in section 5.3, Accuacy specifications fo adon pogeny measuements. 2. Pefom the independent tests though the elevant efeence calibation cente fo the monitoing of adon pogeny in Canada (see appendix J). 3. Send a epesentative sample of its pesonal monitos to the efeence calibation cente at egula intevals at least evey 12 months, o at othe intevals detemined in consultation with the CNSC, and also following any changes in design that could affect the pefomance of monitos. 4. Comply with the specifications fo gab sampling descibed in appendix G, Independent Test Specifications fo Radon Pogeny and Radon Gas. 5. Notify the CNSC immediately, in witing (electonic fomat acceptable), when it fails one of its independent tests. 6. Within 30 days, submit a detailed witten epot to the CNSC outlining the cause and consequence of failue and a desciption of coective action taken. 7. Immediately epeat the failed test and submit the esults to the CNSC. If a epetition of the test esults in a second consecutive failue, the CNSC may take futhe licensing action. 5.6 Accuacy specifications fo adon gas measuements Pesonal monitos The test fo pesonal monitos shall be conducted in an envionment with stable and fixed concentation. The 95% confidence limit calculated fom the test esults shall fall within the confidence inteval limits indicated in table 7. Table 7: Accuacy specifications fo measuement of pesonal adon gas exposue fo a dosimety peiod Range of measuement Oveall accuacy (95% confidence) 2.0 MBq h m -3 to < 4.0 MBq h m % / -50% 4.0 MBq h m % / -33% 15 Daft

23 5.6.2 Gab sampling Table 8 shows the specifications with which monitoing systems shall comply unde expected conditions of use. Table 8: Accuacy specifications fo measuement of concentation of adon gas in ai Range of measuement Oveall accuacy (95% confidence) 10 kbq m -3 to < 20 kbq m % / -50% 20 kbq m % / -33% 5.7 Type testing fo adon gas monitoing Though type testing at the licence application stage, the dosimety sevice shall demonstate its ability to satisfy the following oveall specification equiements: 1. Type testing fo instuments used to detemine exposues to adon gas shall identify all possible souces of eo and shall quantify thei contibution to the oveall eo and uncetainty in individual exposues. 2. If the dosimety sevice changes the monito design o the measuement method (e.g., diffeent detecto o filtes, diffeent casing, diffeent sampling potocol), it shall epeat the type tests to the extent necessay to demonstate the influence on oveall accuacy and uncetainty Influence quantities that may affect accuacy o uncetainty The dosimety sevice shall conside the following influence quantities and evaluate those that ae likely to significantly affect accuacy o uncetainty. Othe influence quantities that may contibute to the oveall uncetainty, in addition to those listed hee, shall also be consideed. Fo pesonal adon gas monitos, the following quantities shall be taken into account: 1. detecto efficiency 2. sensitivity to adiation emitted fom souces othe than adon pogeny 3. sensitivity to deviations fom detecto pocessing specifications 4. duability fo the wok envionment Fo gab-sampling instuments, the following quantities shall be taken into account: 1. sampling flow ate 2. flow ate vaiability 3. detecto efficiency 4. sensitivity to adiation othe than fom adon 5. sensitivity to othe physical and chemical agents in the envionment 6. satuation 7. duability fo the wok envionment 16 Daft

24 5.7.2 Documentation The dosimety sevice shall maintain: 1. Type test esults in a fomat that clealy shows all the influence quantities and system chaacteistics that wee consideed, and the ange of possible values expected of them by the dosimety sevice, based on the intended use of that paticula dosimety system 2. Sample calculations that show how the mean esponse and the combined standad uncetainty wee calculated 3. The justification fo any assumptions made and techniques used 5.8 Independent testing fo adon gas measuements The dosimety sevice shall comply with the following equiements: 1. Undego independent testing to demonstate that it meets the accuacy specifications descibed in section 5.6, Accuacy specifications fo adon gas measuements. 2. Pefom the independent tests though the elevant efeence calibation cente fo the monitoing of adon gas in Canada (see appendix J). 3. Send a epesentative sample of its pesonal monitos to the efeence calibation cente at egula intevals at least evey 12 months, o at othe intevals detemined in consultation with the CNSC, and also following any changes in design that could affect the pefomance of monitos. 4. Comply with the specifications fo gab sampling descibed in appendix G, Independent Test Specifications fo Radon Pogeny and Radon Gas. 5. Notify the CNSC immediately, in witing (electonic fomat acceptable), when it fails one of its independent tests. 6. Within 30 days, submit a detailed witten epot to the CNSC, outlining the cause and consequence of failue and a desciption of coective action taken. 7. Immediately epeat the failed test and submit the esults to the CNSC. If a epetition of the test esults in a second consecutive failue, the CNSC may take futhe licensing action. 6. Technical Requiements Dosimety Sevices fo Intakes of Aibone Radioactive Mateial Aibone adioactive mateial efes to any suspension in ai of adioactive mateial whose chaacteistics o concentations ae such that thee is no pactical means to detemine dose though bioassay. Such mateials may include, but ae not limited to, U-238 and its decay poducts (othe than adon and adon pogeny), Th-232, and some plutonium isotopes. Aibone adioactive mateials exist in vaious physical and chemical foms including dust, gas, fumes, o vapous. This section applies to measuements of adioactive mateial in ai that ae used fo dosimety puposes. Monitoing fo aibone adioactive mateial helps to estimate individual doses o exposues to those adiological isks fo wokes in uanium pocessing facilities, eseach facilities, and at othe facilities whee adioactive-mateial-laden atmosphees ae found. Estimates ae made fom pesonal monitoing. 6.1 Measuement quantities The concentations of aibone adioactive mateial in ai ae measued in activity o mass pe unit volume of that atmosphee (e.g., Bq m -3 ). The intake (e.g., Bq) fom this concentation is calculated by 17 Daft