registry of radioactive sealed sources and devices …bm06-33 38.8 10.3 1.4 0.09 bm06-37 45.2 11.8...

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICESSAFETY EVALUATION OF A SEALED SOURCE

No.: NR-1235-S-102-S DATE: May 25, 2005 PAGE 1 of 7(Supercedes TX-1153-S-102-S)

SEALED SOURCE TYPE: Medical Reference Source

MODEL: BM06 Series

MANUFACTURER/DISTRIBUTOR: International Isotopes Idaho, Inc.4137 Commerce CircleIdaho Falls, ID 83401

ISOTOPE: MAXIMUM ACTIVITY:

Cobalt-60 0.1 mCi Barium-133 0.5 mCiCesium-137 0.5 mCi

LEAK TEST FREQUENCY: 6 months

PRINCIPAL USE: Medical Reference Source (X)

CUSTOM SOURCE: YES X NO




DESCRIPTION:

The Model BM06 Series sealed sources are intended for use asreference standards to check the response of dose calibratorsused to measure research, diagnostic, and therapeuticradiopharmaceuticals. The BM06 Series consists of a radioisotopein a chloride complex uniformly dispersed in high impact epoxycasting resin (Emerson & Cuming Stycast 1264 or equivalent) colorcoded to visually differentiate the radioisotopes, which is thencured in a 30 ml dose calibrator vial. The epoxy containing thedispersed radioactivity is sandwiched between two layers of epoxywhich does not contain radioactive material. A rubber septum orequivalent material is chemically welded into the neck of thevial and a color coded (to visually differentiate theradioisotopes) screw top cap is chemically welded onto the vialso that disassembly without destruction of the vial is notpossible. Each source is supplied to the customer in ashielded storage pig.

The BM06 Series consists of six models. The only differencebetween the models is the isotope used. Each source isapproximately 1.25 inches in diameter and 3.5 inches in heightfor all models. The following table delineates the isotopedifferences between the Models of the BM06 Series:

Model Number Isotope

BM06-33 Barium-133

BM06-37 Cesium-137

BM06-60 Cobalt-60

Models of the BM06 Series




LABELING:

Each source and storage pig is conspicuously labeled with thesource isotope and activity and bears the warning "CAUTION:RADIOACTIVE MATERIAL" as well as the trefoil radiation symbol inmagenta on a yellow background, the designer's name, and the nameof the manufacturer. Each label also contains the source modelnumber, serial number and a reference date for the sourceactivity. The label will be affixed to the exterior of the vialand will be laminated to prevent wear as a result of use.

DIAGRAM:

See Attachments 1 and 2.

CONDITIONS OF NORMAL USE:

The sources are designed for use in a medical or commercialpharmacy environment and are not expected to experience extremeenvironmental factors. The sources are intended for use asreference standards to check the response of dose calibratorsused to measure research, diagnostic, and therapeuticradiopharmaceuticals. The manufacturer expects that the workinglife of the Cs-137, Ba-133, and Co-60 sources will be at least 5years.

PROTOTYPE TESTING:

A prototype source, containing Co-57, designated as Model BM06-57, was constructed and tested in accordance with ANSIN43.6-1997 and achieved a sealed source classification of ANSI97C22312. Only a prototype BM06-57 was tested because themaximum activity of this model was significantly higher than theother models and a failure of the source that would releaseradioactive material would be more readily detected. There is nodifference in the construction materials or assembly methods forthe different models in the BM06 Series.




EXTERNAL RADIATION LEVELS:

Maximum radiation levels for these sources are as follows:

Model ContactDose

Dose at5 cm

Dose at30 cm

Dose at100 cm

BM06-33 38.8 10.3 1.4 0.09

BM06-37 45.2 11.8 1.6 0.13

BM06-60 160 30 1 0.2

External Radiation Levels in mrem/hr

Dose rates for Models BM06-33, 37, and 60 measured on NISTtraceable sources of similar construction and geometry andcorrected to the maximum activities for these sources.

QUALITY ASSURANCE AND CONTROL:

International Isotopes Idaho, Inc. maintains a quality assuranceand quality control program which has been deemed acceptable forlicensing purposes by the Nuclear Regulatory Commission. Periodic audits by International Isotopes Idaho, Inc. QualityAssurance staff will ensure that the program continues to performat an acceptable level.

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

• The sources shall be distributed to persons specificallylicensed by the NRC, an Agreement State or a Licensing State.

• Handling, storage, use, transfer and disposal to be determinedby the licensing authority but should be, at a minimum, inaccordance with the product information pamphlet provided bythe distributor.

• The sources shall be leak tested at intervals not to exceed 6months using techniques capable of detecting 0.005 microcurie(185 Bq) of removable contamination.




LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (Cont’d):

• The sources shall not be subjected to conditions that exceedtheir ANSI/HPS N43.6-1997 classification of 97C22312.

• The sources should be stored and transported in themanufacturer's shielded case.

• This registration sheet and the information contained withinthe references shall not be changed without the writtenconsent of the U.S. Nuclear Regulatory Commission.

• International Isotopes Idaho, Inc. provides for designcontrol, procurement control, process quality control, andfinal quality assurance pertaining to the manufacture of thesesources. Distribution will be directly from themanufacturer's facility to the customer.

• Licensees in possession of sources that have decayed belowtheir useful range of activities may contact InternationalIsotopes Idaho, Inc. for instructions regarding return to themanufacturer.

• Reviewer’s Note: the sources had been previously registered bythe State of Texas under registration No. TX-1153-S-102-S,which also included the following sources with NARM/NORMmaterials: BM06-22 (Sodium-22, 0.5 mCi), BM06-57 (Cobalt-57,15 mCi), and BM06-68 (Germanium-68, 0.5 mCi). RegistrationNo. TX-1153-S-102-S was reissued by NRC as NR-1235-S-102-Sunder the licensee’s address in Idaho. Registration No. NR-1235-S-102-S lists only those sources which contain byproductmaterials in accordance with 10CFR 30.71.




SAFETY ANALYSIS SUMMARY:

The BM06 Series sources are intended for use as quality controland reference sources for dose calibrators and are expected tomaintain their integrity for normal conditions of use and likelyaccidental conditions. Rupture of the encapsulating materialwould not reasonably be expected to allow dispersion ofradioactive material due to the epoxy matrix with which theradioactive material is mixed.

The most severe accident scenario involving these sources wouldbe a fire, and would most likely result in a release ofradioactive material. Temperatures exceeding 200 degrees C wouldresult in combustion of the resin in which the radioisotope isdispersed, as well as the plastic which constitutes the vial.

Based on review of the information and test data submitted forthe BM06 Series sources and the references cited below, weconclude the these sources are acceptable for licensing purposesas described within this certificate.




REFERENCES:

The following supporting documents for International IsotopesIdaho, Inc. Model BM06 Series reference sources are herebyincorporated by reference and are made a part of this registrydocument.

• International Isotopes application dated July 12, 2002, sentto Texas Department of Health, with enclosures thereto.

• International Isotopes letters dated September 18, 2002,October 16, 2002, August 20, 2003, and November 27, 2003, sentto Texas Department of Health, with enclosures thereto.

• International Isotopes letter dated March 31, 2005, to TexasDepartment of Health, requesting transfer of certificate toNRC.

• Texas Department of Health letter dated April 27, 2005,transferring International Isotopes Model BM-06 Series file toNRC.

ISSUING AGENCY:

U.S. Nuclear Regulatory Commission

Date: May 25, 2005 Reviewer: /RA/ Nima Ashkeboussi

Date: May 25, 2005 Concurrence: /RA/ John P. Jankovich


No.: NR-1235-S-102-S DATE: May 25, 2005 Attachment 1(Supercedes TX-1153-S-102-S)



No.: NR-1235-S-102-S DATE: May 25, 2005 Attachment 2(Supercedes TX-1153-S-102-S)


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