Registry of Radioactive Sealed Sources & Devices,Safety Evaluation of (Device/Sealed Source) for Model Transmission gauge.Certificate:NR-122-D-101-SML20128M962 |
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01/29/1993 |
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NRC |
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Shared Package |
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ML20128M954 |
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References |
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SSD, NUDOCS 9610160240 |
Download: ML20128M962 (10) |
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Category:CERTIFICATES OF COMPLIANCE
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[Table view]Some use of "" in your query was not closed by a matching "". Category:TEXT-LICENSE APPLICATIONS & PERMITS
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[Table view]Some use of "" in your query was not closed by a matching "". |
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l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended page 1 - September 16, 1996)
NO.: NR-122-D-101-S DATE: January 29, 1993 PAGE 1 OF 7 DEVIGE TYF.El Transmission Gauge MODEL: MK 1.0 DISTRIBUTOR: Betacontrol (formerly Baumer of America, Inc.'
P.O. Box 235 435 route 202 Towaco, NJ 07082 MANUFACTURER: Betacontrol GMBH P.O. Box 1225, Am Weidekamp 10 D-5905 Freudenberg, Germany SEALED SOURCE MODEL DESIGNATION:
Amersham Buchler VZ-337 (Sr-90)
Amersham Corp. SIF.D1 (Sr-90)
Institute National de Radioelements 700-052.002/4 (Kr-85)
Amersham Corp. KAC.D1 (Kr-85) j Amersham Corp. KAC.D3 (Kr-85) 1 Amersham Corp. AMC.17 (Am-241)
Amersham Corp. PHC.C1 (Pm-147)
ISOTOPE: MAXIMUM ACTIVITY:
Strontium-90 50 millicuries (1.9 GBq)
Krypton-85 60 millicuries (2.2 GBq)
(700-052.002/4)
Krypton-85 500 millicuries (18.5 GBq)
(KAC.D1, KAC.D3)
Americium-241 300 millicuries (11.1 GBq)
Promethium-147 50 millicuries (1.9 GBq)
LEAK TEST FREOUENCY: 6 Months Not required for Kr-85 PRINCIPAL USE: (E) Beta Gauge or (D) Gamma Gauge CUSTOM DEVICE: YES X NO 9610160240 960917 PDR RC
-. - . _ . - . . . _ - . . _ _ . - . -. . _ . . . _ _ __ - _ - - .. - - - ~ . - --- - .
~
REGISTRY.0F RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO.: NR-122-D-101-S DATE: January 29, 1993 .PAGE 2 OF 7 DEVICE TYPE: Transmission Gauge DESCRIPTION:
The MK 1.0 is used for the measurement of the thickness of various material. The device can be mounted in an O-Frame, C-Frame or Fixed Head configuration. Air gaps vary according to the application with typical ranges between 0.37" (9.5 mm) to 1.97" (50 mm). However, in some applications the air gap may be as large as 13.2" (335 mm). The radioactive source is mounted in the base cf the device and is fixed in place by a source holder which is specifically manufactured for the installed source.
While in the " measuring off" position, a shutter with 0.08" (2 mm) of lead covers the source. When in the " measuring on" position the shutter is positioned out of the radiation beam by a electric magnet. If current is interrupted, a spring will automatically return the shutter to the "meesuring off" position. ,
A limit switch is connected to the magnet and indicates the i position of the shutter by a red, " Attention, radiation", source l unshielded lamp and a green, " Radiation Screened", source j shielded lamp. The green lamp will only illuminate when the i shutter is in the fully closed position. The lamps are mounted on either side of the device frame.
The MK 1.0 sensor transmission gauge may contain either a j promethium-it', krypton-85, strontium-90, or americium-241 ;
source, depending on the end user's specific needs. The type of source used is directly related to the material measured. The Amersham Buchler model VZ-337 strontium-90 source incorporates radioactive material contained in a sealed silverfoil into a sealed welded stainless steel capsule. The source models VZ-337
& 700-052.002/4 are not currently registered by the NRC'on any other certificate. Sufficient information has been submitted to '
allow use of these sources in the Model NK 1.0 device. The KAC.D1 and KAC.D3 scurces contain krypton-85 hermetically sealed in a titanium capsule. The promethium-147 and americium-241 i sources contain radioactive material incorporated in a ceramic l enamel which is sealed in a welded stainless steel capsule. Each source is contained in a custom source holder.and mounted on a steel carrier. The source holders contain the source with walls of 1.97" (5 mm) steel or 3.94" (10 mm) brass, except in the area of the radiation window which is only shielded by the shutter.
-r~, - _ _ - - . . . ,_ .-.m- - , . _ ~ ., , - _ _ , - , . ~
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO.: NR-122-D-101-S DATE: January 29, 1993 PAGE 3 OF 7 DEVICE TYPE: Transmission Gauge DIAGRAM:
See attachments 1-3.
LABELING:
The manufacturer claims that the devices are labeled in accordance with Section 20.203, 10 CFR Part 20. Two labels are attached to the device. One label identifies the device by the model number, manufacturer, and year of construction. The other label identifies the isotope, activity, date of construction and contains the trifoil symbol. The labels are made of stainless steel or aluminum and are permanently attached by rivets or scrcWs to the device.
CONDITIONS OF NORMAL USE:
The MK 1.0 transmission gauge will be used in industrial applications for the contactless measurement of the thickness of foils, plates or tubes of paper, rubber, plastic, metal, glass, coatings on foils and textiles, and the amount of color and impregnated materials on textiles and other porcus materials.
PROTOTYPE TESTING:
Baumer of America, Inc., did not supply prototype test results regarding mechanical operation (e.g., no specific data on retention of the source when the device is subjected to mechanical stimuli). In lieu of such submission, Baumer relied on the ANSI-N542 Classification of the sources and the past use of the device in Europe and the USA in industrial environments since 1985 without operational problems causing unnecessary radiation exposure to users.
Additionally, Baumer of America, Inc., provided the following ANSI-N538 Classifications for the device:
- 1. with source Kr-85, 60 mci (2.2 GBq), #
0.37 in (9.5 mm) gap: ANSI-33-355-775-R1
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES i SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO.: NR-122-D-101-S DATE: January 29, 1993 PAGE 4 OF 7 DEVICE TYPE: Transmission Gauge PROTOTYPE TESTING: (Cont'd)
- 2. with source Kr-85, 150 mci (5.6 GBq),
0.37 in (9.5 mm) gap: ANSI-33-245-665-R1
- 3. with source Sr-90, 10 mci (0.37 GBq),
1.3 in (33 mm) gap: ANSI-33-344-885-R1
- 4. With source Am-241, 300 mci (11.1 GBq),
13.2 in (335 mm) gap: ANSI-33-564-985-R1
- 5. with source Am-241, 300 mci (11.1 GBq),
1.97 in (50 mm) gap: ANSI-33-775-985-R1 These devices have been distributed under an NRC specific license by Baun er of Ar erica, Inc., since 1985. Baumer of America, Inc.,
states that nc 1.ncidents of failure of the device causing a radiological h.c:ard have been reported to date.
EXTERNAL RADIATION LEY '
1 The following are the dose rates reported by the manufacture for the Model MK 1.0 transmission gauge.
Sr-90, 50 mci (1.9 GBq), 1.3 in (33 mm) gap.
Max. Radiation Level (arem/hri/(mSv/hr) I Distance (in/cm) Shutter open Shutter closed 1.97/5 90.0/0.900 7.4/0.074 l 11.81/30 12.0/0.120 1.5/0.015 39.37/100 1.6/0.016 0.5/0.005 <
Kr-85, 500 mci (18.5 GBq), 0.37 in (9.5 mm) gap.
Max. Radiation Level (mrem /hr)/(mSv/hr)
Distance fin /cm) Shutter open Shutter closed 1.97/5 500.0/5.000 9.5/0.095 11.81/30 15.0/0.150 2.5/0.025 39.37/100 0.6/0.006 0.4/0.004
0 REGISTRY OF RADIOACTIVE SEALED SOURCFS AND DEVICES
' SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO.: NR-121-D-101-S DATE: January 29, 1993 PAGE 5 OF 7 DEVICE TYPE: Transmission Gauge EXTERNAL RADIATION LEVELS: (Cont'd)
Am-241, 300 mci (11.1 GBq), 13.2 in (335 mm) gap.
Max. Radiation Level (mrem /hr)/(mSv/hr)
Distance (in/cm) Shutter open Shutter closed 1.97/5 5.0/0.050 0.10/0.001 11.61/30 1.0/0.010 Background 39.37/100 0.3/0.003 Background Pm-147, 50 mci (1.9 GBq), 0.71 in (18 mm) gap.
Max. Radiation Level (mrem /hri/(mSv/hri Distance (in/cm) Shutter open Shutter closed 19.69/50 0.4/0.004 n/a 39.37/100 0.1/0.001 n/a OUALITY ASSURANCE AND CONTROL:
Betacontrol does not manufacture the components of the device or source, but rather receives them from sub-contractors and performs the final assembly of the device and installati^n of the source. Betacontrol's quality control (QC) procedures, therefore, consist of checking the various components for proper fit, rejecting non-conforming components, assembly checks during installation of the source, and a one week full operational check.
Additionally, if the end user receives the device directly from !
Betacontrol, then the end user is responsible for performing an a
initial qu'lity check of the device upon receipt, as well as assuring the device is properly maintained and serviced. The initial check consists of comparing the device to a design drawing (supplied by Betacontrol), performing a full operational check and measuring external radiation levels and external contamination levels.
Baumer of America, Inc., performs installation and servicing of i the device if requested, but relies on the manufacturer's QC program for product conformance. The installation consiets of QC procedures equivalent to those mentioned above.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
. SAFETY EVALUATION OF DEVICE l 3
(Amended in its Entirety)
NO.: NR-122-D-101-S DATE: January 29, 1993 PAGE 6 OF 7 DEVICE TYPE: Transmission Gauge LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
The devicy is to be distributed only to persons specifically licensed by the NRC or an Agreement State The device shall be serviced only by Baumer of America, Inc., or persons specifically licensed to do so by the NRC or an Agreement State.
REVIEWER NOTE: If the end user is to initially install and/or service the device, then the licensee must have an adequate radiation safety program to ensure the device is properly installed and serviced and that adequate emergency procedures are in place. ,
The device shall be leak tested at intervals not to exceed 6 l months using techniques capable of detecting 0.005 microcurie (185 Bq) of removable contamination.
Handling, storage, use, transfer, and disposal: To be determined by the licensing authority.
This registration sheet and the information contained within the references shall not be changed without the written j consent of the NRC.
SAFETY ANALYSIS
SUMMARY
1 The Model MK 1.0 devices have been in use in the US and Europe since 1985 with no reported incidents of failure. Based on this information, the test data referenced below and the claimed ANSI-N538 ratings, we continue to conclude that the device is acceptable for licensing purposes as specified in this certificate.
Furthermore, we continue to conclude that the Model MK 1.0 transmission gauge would be expected to maintain its integrity for normal conditions of use and accidental conditions which might occur during uses specified in this certificate.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO.: NR-122-D-101-S DATE: January 29, 1993 PAGE 7 OF 7 DEVICE TYPE: Transmission Gauge l
REFERENCES:
The following supporting documents for the Model MK 1.0 are hereby incorporated by reference and are made a part of this registry document.
Baumer of America, Inc. letters dated March 5, 1984, April 2, 1984, April 13, 1984, July 16, 1984, November 1, 1984, November 26, 1984, February 22, 1985, February 26, 1985, August 5, 1991, February 7, 1992, February 10, 1992, 4
February 11, 1992, May 28, 1992, June 8, 1992, June 17, 1992, June 25, 1992, and September 23, 1992, with enclosures thereto.
I ISSUING AGENCY:
U.S. Nuclear Regulatory Commission i
Date: January 29, 1993 Reviewer: /
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1 Date: January 29, 1993 Concurrence: 1
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