ML20248A163

Registry of Radioactive Sealed Sources & Devices,Safety Evaluation of Sealed Source for Model Series 6500 & 6520. Certificate:NR-460-S-906-S

ML20248A163
Person / Time
Issue date:	06/22/1990
From:	Steven Baggett NRC
To:
Shared Package
ML20247R838	List: ML20247R833 ML20247R865 ML20247R917 ML20247R931 ML20247R951 ML20248A096 ML20248A134 ML20248A152 ML20248A163 ML20248A248 ML20248A495
References
SSD, NUDOCS 9805290303
Download: ML20248A163 (9)

Text

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I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF SEALED SOURCE

[ (AMENDED IN ITS ENTIRETY) l NO. NR-460-S-137-S PAGE: 1 of 7 DATE1 J[JN 2 2 g )

l l SEALED SOURCE TYPE: Tube Source MODEL: Series 6500, 6520 (formerly 6D6C)

MANUFACTURER / DISTRIBUTOR: Minnesota Mining and Manufacturing 3M Center St. Paul, MN 55101 l ISOTOPE: Cesium-137 MAXIMUM ACTIVITY: 500 mil 11 curies I

EAK TEST FREQUENCY

36 months l

PRINCIPAL USE: (V) General Medical Use CUSTOM SOURCE: YES X NO I l

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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)

NO: NR-460-S-137-S DATE: JUN 21 1990 PAGE: 2 of 7 SEALED SOURCE TYPE: Tube Source DESCRIPTION:

The cesium-137 tube sources consist of two stainless steel capsules, an outer casing and an inner core containing cesium-labeled ceramic microshperes packed along the active length. The inner core is sealed by two stainless steel balls pressed in and welded in place.* The welded inner core is placed inside an outer capsule engraved with nominal activity and serial number, and color-coded on the eyelet end. Each tube source is then nickel plated.

The tube sources are available in two lengths. Sources in series 6500 are standard size tubes, 20 mm long by 3.05 mm diameter, with an active length of approximately 14 mm. Series 6520 sources, available only upon special request, are short tubes, 16 mm long by 3.05 mm diameter, and approximately 10 mm active length.

Each source is color-coded on the eyelet and, according to the nominal activity, examples are listed below:

Color Milligram Radium Equivalent Millicuries of Cesium j Blue -

5 12.5 - 13.4 Green 10 25.2 - 27.7 Yellow 15 37.8 - 41.6 Orange 20 50.4 - 55.4 j Red 25 63 - 69.3 Violet 30 75.6 - 83.2 White 35 88.2 - 97.0 Black 40 100.8 -111.0 Maximum Activity 199 500

• NOTE: 3M made this design change in 1985. The previcus design used only one stainless ball to seal the end on the inner capsule. Both designs will be marketed by 3M until the stock of the old design is depleted.

Attachment 2 shows the old design.

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C) $ OO REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE l (AMENDED IN ITS ENTIRETY)

NO: NR-460-S-137-5 DATE: JUN 2 2 1990 PAGE: 3 of 7 I

SEALED SOURCE TYPE: Tube Source LABELING:

Each nickel plated tube source is engraved with the nominal activity and serial number and color-coded on the eyelet end according to the nominal activity. ,

DIAGRAM:

See Attachments 1 and 2.

1 CONDITIONS OF NORMAL USE: i i

The sources are used for intracavitary treatment of cancer, which is l accomplished by placing the radioactive source into a device, referred to as a l applicator. Sources may be placed in the applicator either before (preloaded) or following (afterload) insertion of the applicator in the body cavity to be irradiated.

PROTOTYPE TESTING:

The sources have been subjected to various prototype test (s) to demonstrate that the sources maintain their integrity under stresses of use and accidents, as described in ANSI N44.1-1973 and ANSI N542-1977. The tests performed on the ,

sources are as follows:

• Wipe (smear) test i e Soak test l

• Leak (bubble) test i

• Temperature tested up to 848'C i

• Impact test - dropped 9 meters onto an unyielding surface

• Percussion test - a 1.45 kg weight was dropped from 1 meter onto the source lying on an unyielding surface No source was found to have lost containment integrity.

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ic REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)

NO: NR-460-S-137-S DATE: JUN t,t 1990 PAGE: 4 of 7

SEALED SOURCE TYPE

Tube Source

! EXTERNAL RADIATION LEVELS: l The manufacturer calculated the following dose rates from rates provided by NBS:

Millirem per Hour Output Activity in Millicuries 100 cm 30 cm 5 cm 3.81 42.3 1,524 11.6 8.22 91.3 3,288 25.1 4 12.2 135.5 4,880 37.2 18.7 208 7,492 57.1 23.8 264 9,520 72.6 30.5 338.9 12,200 93.0 Note: The output activity allows for the 2% attenuation through the stainless steel walls of the source.

QUALITY ASSURANCE AND CONTROL:

The manufacturer subjects all sources to quality control tests prior to their transfer to a licensed recipient. These tests consist of leak test, wipe test, assay for radioactivity and soak test. These tests are performed on both the inner and outer capsules. Additionally, each source is visually inspected for workmanship. This quality assurance control program has been previously I

accepted by the NRC.

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Lj Q REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)

NO: NR-460-S-137-S DATE: IN 2 2 1990 PAGE: 5 of 7 SEALED SOURCE TYPE: Tube Source LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

o The source shall be distributed only to specific licensees of the NRC or Agreement States.

o Handling, storage, use, transfer, and disposal: To be determined by the licensing authority. In view that these sealed sources exhibit high sur-face dose rates when unshielded, these sealed sources should be handled only by experienced licensed personnel using adequate remote handling equipment and procedures.

o The licensing authority will have to obtain details on specific holders '

and any operational procedures, etc. from the license applicant to make a licensing determination.

o This registration sheet and the information contained within the references shall not be changed or transferred without the written consent of the NRC.

o The source shall be leak tested at three (3) year intervals using techniques capable of detecting 0.005 microcurie of removable contamination.

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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES

' SAFETY EVALUATION OF SEALED SOURCES (Amended in its entirety)

NO: NR-460-S-137-5 DATE: 393 g 2 1990 PAGE: 6 of 7 SEALED SOURCE TYPE: Tube Source SAFETY ANALYSIS

SUMMARY

Based on our review of the information and test data referenced below, we continue to conclude that this source series continues to be acceptable for specific licensing purposes. Over the past 20 years, 3M Company has distributed thousands of the sources with one incident of source damage and 7subseouent leakage of radioactive material during the recommended use and recommended handling procedures. .W e continue to conclude, therefore, that this source series would be expected to maintain their containment integrity for the specified uses and the conditions of use applicabic to these uses.

REFERENCES:

The following supporting documents for the Model 6500, 6520 series tube sources are hereby incorporated and are made a part of this registry document:

o Minnesota Mining and Manufacturing Company application dated May 1, 1980 for renewal of License No. 22-00057-59MD o .3M Company letter dated July 24, 1989 with enclosures thereto.

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l REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)

NO: NR-460-S-137-S DATE: JUN 21 1990 PAGE: 7 of 7 i

. SEALED SOURCE TYPE: Tube Source ISSUING AGENCY:

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U.S. Nuclear Regulatory Commission -

Date: Reviewer:

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Date: JUN 22 tooy Concurrence: >#* N "U 'O f

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( REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDED.IN ITS ENTIRETY)

@ NR-460-S-137-S DATE: 22 7990 ATTACHMENT 1

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l Schematic Diagram of Modified 3M Cesium-137 Source, Series 6500

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' REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE l (AMENDED IN ITS EN11RETY)

NO: NR-460-S-137-S DATE:

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