ML20217H425
| ML20217H425 | |
| Person / Time | |
|---|---|
| Issue date: | 10/13/1999 |
| From: | Bhachu U, Michele Burgess NRC |
| To: | |
| Shared Package | |
| ML20138G633 | List: |
| References | |
| SSD, NUDOCS 9910220127 | |
| Download: ML20217H425 (21) | |
Text
-
. -e -,,
6 1
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (ANENDED IN ITS ENTIRETY)
NQ2: 'NR-186-D-117-B DATE:
PAGE: 1 OF 10 gg g 3 pyg l
DEVICE TYPE: Gamma Gauge MODEL: NW-201 Series, NW-301 Series, NW-401 Series MANUFACTURER / DISTRIBUTOR:
Berthold Systems, Inc.
Hopewell Business Park 101 Corporation Drive Aliquippa, PA 15001 SEALED SOURCE MODEL DESIGNATION:
Berthold Systems, Inc. 39002 ISOTOPE:
MAXIMUM ACTIVITY:.
Cesium-137 900 microcuries (33.3 MBq)
Or no single source to Barium-133-exceed 10 microcuries (370 kBq) i LEAK TEST FREOUENCY:
Not Required PRINCIPAL USE:
(D) Gamma Gauge
-CUSTOM DEVICE:
YES X
NO l
l l
l 9910220127 991013 PDR RC SSD PDR
b l'
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES j
SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NQt: NR-186-D-117-B DATE:
OCT 13 (Me PAGE: 2 OF 10 p2(JCE TYPE:
Gamma Gauge DESCRIPTION:
The Model NW-201 Series, NW-301. Series, and NW-401 Series source housings are designed to be installed in fixed locations to measure material density or fill level in various applications including pipelines, tanks, and other containers or flow processes.
Each source housing contains multiple sources, each j
source containing no more than 10 microcuries (370 kBq). The multiple sources are installed into machined " pockets" and are held in place by epoxy.
Descriptions of each source housing are listed below.
i NW-201 Series The Model NW-201 Series source housings have variable dimensions ranging from 5-8" (12.7-20.3 cm) in diameter and 2-6" (5.1-15.2 cm) in height. The construction of the source housing is either lead, austenitic stainless steel series 300 (type 304,316 and 317) or tungsten shielding sandwiched between stainless steel plates.
i In its shipping condition, the source housing has the source sandwiched between two halves of the shielding. However, upon installation, one half of the shielding (the removable shipping cap) is removed and installed on the back of the other half of the shielding. This condition will expose the radiation beam while providing additional shielding at the back of the source housing. The' source housing does not have a shutter mechanism.
To' ensure that the dose rates at the accessible surfaces of the applications do not exceed 5 mrem /hr (50 Sv/hr), installation of the Model NW-201 Series source housings are subject to the following:
Pipes l
l no smaller than Schedule 10, 2"
(5.08 cm) pipe diameter, I
containing no more than 500 curies (18.5 Mbq), under any condition
c I
E-l l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l
SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
HQt: NR-186-D-117-5 DATE:
PAGE: 3 OF 10
]
g7 j 3 ;g3 DEVICE TYPE: Gamma Gauge DESCRIPTION (CONT.)-
Pipes (Cont.):
vessels:
. no smaller than 14" (35'.6 cm) diameter, schedule 40 pipe under any conditions.
NW-301 Series The Model NW-301 Series source housings have variable dimensions ranging from 12-60" (30.5-152.4 cm) in length, 1-4" (2.5-10.2 cm) in height, and 2-6" (5.1-15.2 cm) in width. The construction of the source housing is either solid tungsten, solid austenitic stainless steel series 300 (type 304, 316 and 317) or lead encased in steel.
Upon installation, the housing acts similar to a strip source mounted on the side of a vessel. The source j
housing does not have a shutter mechanism.
In its shipping condition,'the source housing is " folded" in half so that the beam ports of the two halves are facing each other.
To ensure that the dose rates at the accessible surfaces of the applications do not exceed 5 mrem /hr (50 Sv/hr) Model NW-301 Series source housings may only contain up to 900 microcuries (33.3 MBq) of Cesium-137 or Barium-133.
.NW-401 Series The Model NW-401 Series source housings have variable dimensions with a minimum diameter of 2.5"'(6.4 cm) and minimum height of 2.5"'(6.4 cm).
The source housing is constructed of tungsten with a' machined area that would allow for mounting to a pipe.
.The radius of the machined area is the same as the pipe to which it will be~ attached.
The sources are mounted in the center of the cylindrical' construction.
l l
'In its shipping condition, a source is installed in the machined l:
area to provide shielding.
However, upon installation, the j
source cap is removed.
The source housing does not have a shutter mechanism, l
i l
EL
]
1 e-I t
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
)
SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
HQ2: NR-186-D-117-B' DATE: 3 h3 g; EhqE: 4 OF 10 j
DEVICE TYPE:
Gamma Gauge l
' DESCRIPTTON (CONT.)-
To ensure tnat the dose rates at the accessible surfaces of the applications do not exceed 5 mrem /hr (50 Sv/hr), Model NW-401 Series source housings may only contain up to 300 microcuries (11.1 MBq) of Cesium-137 or Barium-133 and may be attached to pipes with a minimum diameter of 2" (5.1 cm).
i 39002, Source The Berthold 39002 source is registered as part of this source housing and is not registered separately. The 39002 source is 0.373" (1.0 cm) in diameter by 0.008-0.009",
(0.20-0.23 mm) thick and may contai14 up to 10 microcuries (370 kBq) of Cesium-137 or Barium-133. The source is not manufactured by Berthold Systems but must be manufactured to Berthold's specifications.
i Since no single source used in the source housings exceeds 10 microcuries (370 kBq), leak testing of the source housings is not required.
LA.BELI.NCa.i.
Each source housing is labeled in accordance with 10 CFR 20.1901 and 10 CFR 20.1904.
Devices intended for distribution to general licensees will be labeled in accordance with requirements of 10 CFR 32.51.
The source housing serial number is engraved into each source housing. A stainless steel label, either attached to the source housings by rivetc or a stainless steel tether, will be engraved with the source housing model number, isotope, activity, date of an assay, the radiation symbol, and the name and telephone number of the distributor.
Source housing distributed for use under a general license will contain an additional labol as follows, engraved on a stainless steel tag:
Abandonment or disposal prohibited unless transferred to l
Berthold Systems, or persons specifically licensed by the
g i
1 s
~ REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
L l
i HQ2: NR-186-D-117-B DATE:
PAGE: 5 OF 10 GM 13 au l
DEVICE TYPE:
Gamma Gauge l
LABELING: (CONT.)
i l
U.S. Nuclear Regulatory Commission or an Agreement State.
Operations prohibited if there is indication of failure of or damage to housing or source containment.
Installation
- and relocation can only be performed using the specific instructions suppled in the operating manualoof the device.
l Dismantling, maintenance,' repair and testing involving the j
radioactive-material, its housing or containment shall be perform by Berthold Systems, Inc. and other specific l
licensees.
The device is not required to be tested for
]
radioactive leakage.
Loss, theft, or transfer of this j
L device and failure of or damage to.the shielding and source containment must be reported to Berthold Systems, Inc. and l
the U.S. Nuclear Regulatory Commission or an Agreement State.
The receipt, possession, use, and transfer of the l
device are subject to a general license or the equivalent and the regulations of the U.S. NRC or of a State with which the NRC has entered into an agreement of the exercise of regulatory authority.
This label shall be maintained on the device in a legible condition.
Removal of this label is prohibited. This device is registered with the U.S. Nuclear
' Regulatory Commis'sion.
l CAUTION - RADIOACTIVE MATERIAL Labeling.on devices relative to specific licensing will appear I
as shown'in Attachment VI.
1 i
The source housing is exempt from the conventional color requirements of'10 CFR 20.1901.
j 1
DIAGRAM:
}
See Attachments 1-5.
i
)
F 3+
,~,
i-REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
HQ.,_ : NR-186-D-117-B DATE:
gg } 3 ye PAGE: 6 OF 10 DEVICE TYPE:
Gamma Gauge CONDITIONS OF NORMAL USE:
The source' housings.will be used in industrial applications to measure material density or fill level in various applications including pipelines, tanks, and other containers or flow processes.
Possession and use of the source housings are restricted to environments that do not exceed the following conditions.
Temperature:
-25 to 100*C (-13 to 212*F)
Unlikely to be subjected to thermal shock Humidity:
0 to 100%
Impact:
Cannot be mounted at heights exceeding 30 feet (7.6 m).
External Pressure:
3.6 psi to 1 atmosphere Vibration:
Low - simple harmonic motion having a maximum amplitude of 0.03" (0.76 mm)'nd maximum frequency of 50 Hz.
Corrosion:
Slight -
i.e.,
low concentrations of corrosive fumes / chemicals.
Fire ^and Explosion:
Environments where fire and explosion are unlikely.
PROTOTYPE TESTING:
Prototypes of the source _ housings were constructed and subjected to the' tests listed below.
No malfunction occurred nor was there c
any loss of shielding or containment integrity as a result of the L
testing.
i Tempbrature
. Cycle testing from -25 C to 100*C (-13 to 212*F).
l Held at 538*C,(1000*F) for 5 minutes.
l i
l 1
[:
p i
i*
1 I
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (ANENDED IN ITS ENTIRETY)
HQ : NR-186-D-117-B DATE:
PAGE: 7 OF 10 y)
DEVICE TYPE: Gamma Gauge PROTOTYPE TESTING (CONT.)-
Humidity 100c/o at 50 C (122 F) for 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br />.
Impact Drop from 30 feet (7.6 m).
The sealed sources wars tested as part of the source housings.
No information was submitted concerning prototype testing of the sources when not installed in the source housings.
EXTERNAL' RADIATION LEVELS:
Berthold has committed to verify that the dose rates at the surface of each source housing will not exceed 2 mrem /hr (20 Sv/hr), except at the surface of the beam port, which will not, exceed 100 mrem /hr (1 mSv/hr).
In addition, Berthold has demonstrated that the dose rates on all accessible surfaces of the installation will not exceed 5 mrem /hr (50 gSv/hr).
OUALITY ASSURANCE AND CONTROL:
Berthold maintains a quality' assurance and control program which has been deemed acceptable for licensing purposes by NRC.
A copy of the program is on file with the NRC.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
The device shall be distributed to persons generally or specifically licensed by the NRC or an Agreement State.
Devices users are not subject to leak testing requirements.
Handling, storage, use, transfer, and disposal: as required by 10 CFR 31.5 and 10 CFR Part 20 or Agreement State equivalent.
. Barriers required for access space greater than 3.94 inches j
(10 cm)
E l
L l
\\
l 1
l-1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) l HQ : NR-186-D-117-B DATE:
PAGE: 8 OF 10 gg7 4 3 ggg DEVICE TYPE:
Gamma Gauge LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (CONT.)-
specific and general licensees may install the devices provided the installation is in accordance with the instructions provided by Berthold Systems, Inc.
- However, general licensees may not perform any other type of servicing of.the devices.
This registration sheet and the information contained within the references shall not be changed without the written
. consent of the.NRC.
SAFETY AND ANALYSIS
SUMMARY
Berthold.has submitted sufficient information to provide.
reasonable assurance that:
. The device csn be safely operated by persons not having l
training in radiological protection.
L
= Under ordinary conditions of handling, storage, and use of i
.the device, the byproduct material contained in the device will not be released or inadvertently remored from the l
source housing, and it is unlikely that any person will l
receive in any period of one year a dose in excess of 10 percent of the limits specified in Section 20.1201(a),
~
10'CFR Part 20.
1 l
. Under accident conditions associated with handling, l
storage, and use of the source housing, it is unlikely that l
l any person would receive an external radiation dose or dose L
commitment. in excess of'the dose'to the appropriate organ l
as specified in the chart shown on the following page:
i f,.
N
7-i e
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
HQ : NR-186-D-117-B DATE: 'gy.3lg33 PAGE: 9 OF 10 DEVICE TYPE: Gamma Gauge SAFETY AND' ANALYSIS
SUMMARY
(CONT.)
PART OF BODY DOSE Whole body; head and trunk; active blood-forming organs; i
gonads; or lens of eye 15 rem (0.15 Sv)
Hands and forearms; feet and ankles; localized areas of_ skin averaged over areas no larger than 1 CMa.(0-15 in2) 2'O rem (2.0 Sv)
Other organs 50 rem (0.50 Sv)
Based on review of the Models NW-201 Series, NW-301 Series, and j
NW-401 Series source housings, and the information and test data cited herein, we conclude that'the source housing is acceptable for licensing purposes.
i Furthermore, we conclude that the_ source housing would be expected to maintain it's containment integrity for normal conditions of use and accidental conditions which might occur during uses specified in this registration certificate.
L i
I l
i
/
l 1
f.
I I
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES i
SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
IEL.: NR-186-D-117-B DATE:
gg7;p3 g PAGE: 10 OF 10 DEVICE TYPE: Gamma Gauge-
REFERENCES:
The following supporting documents for the Model NW-201 Series, NW-301 Series, NW-401 Series source housings are hereby incorporated by reference and are made part of this registration.
Berthold System's letters dated July 2,
- 1998, July 29, 1998, August 21, 1998 and August 25, 1998, with enclosures thereto.
l Berthold System's facsimile dated August 25, 1998, with enclosures thereto.
Berthold System's letter dated July 16, 1999, September 21, 1999 and enclosures thereto.
Berthold System's facsimile dated October 5, 1999.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission Date:
NI II W Reviewer:
J otA.M chu Ls J e* :, 10EI I 3 I!39 Reviewer:
M up Michele L. 'B'urgess
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
\\
E: NR-186-D-117-B DATE:
ATTACHMENT: 1
- t.': r,'.r.
s s
s sx
+
/
(on anato to acu s)
>= u t a J
~
- * * * ^ " "
'l
_ y.4 (B(8Pt Etatt3
, - *.==.v::.:
' ' ' ~
f:
"A'M
- N c
y _.
4Jg 4:
i 4
p 8'"'"""
mr =
i
\\ W-20 i feRiEs
1 1
I i
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE i
(AMENDED IN ITS ENTIRETY)
I 1
NO.~: NR-186-D-117-E DATE:
ATTACHMENT: 2
~ ~
1 j
ie*-w
.3 2
?
y's v l
],
[6]
e (5'
[6]
q at:::q.
l
=.................................................
- u. a'O..$O...O....O...O....O...O....O.,.O....O...O....O....O........,
e*4* *N081"ATC,l I K.
OOOOOOOO
.O......O...O....O.................................
.........................................e..r:::4.
11
->:::1>
g l-
- tar, b
90fM VICVS SHowN v11H HINGC lf lf ll h
1 ILJl i
I I
I I
I 1
1 1
1 I
ILJI I I IbJl I
I I
I I
I I
I I
I I
ILJl 1
P P
P P
l I ', l ee:::(
la 4* aPPROMinATC
.p:::4m L
.J 5
SCC 110NAL CND vlCws
\\,
/j u
FDLDCD FOR IN UEC 170mmLC DR TRANSPDR1 I
i XN 30!. swes
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-186-D-117-B DAT_S:
ATTACHMENT: 3 p 2.50 MIN. q 4
4 SOURCE PDCKET w
,=,
N MOUNTING HDLE I
SOURCE CAP m
TETHERED TO BODY BODY 2.50 MIN DI A.
blW-fo\\
SERIES
(;
O e.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATI(<ts OF DEVICE O
-(mmmen IN ITS ENTIRETY) '
. E: NR-186-D-117-B DATE:
ATTACHMENT: 4
,ri s
--.~.n.-~
I Diameter Of aCt ive source-0.12"
(
)
)
<'....o 1
0.375" i
Cover ing Disk U
[
d BaCk ing Disk
,003_,oog" l
4 l
SOURCE-10 Ci CESIUM-137 AND BARIUM-133
~
1 i
i
~
[.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
L: NR-186-D-117-B J26.TE:
ATTACHMENT: 5 4.25" I
h O
Modele_
O 180t0Pe:___________ A ctivi ty:____
_ Assay Date-1.50" CAUT101 RADIATION MATERIAL BIRTROLD SYSTEM 8110.
O '12tu spa,r 1s001 t a n e74.easi f
l J
PHOTON SHIELD LABEL SPECIFIC LICENSE i
1 I
l Mr. G.M. Smith, President October 13, 1999
[
Berthold Syst:ms, Inc.
Hopewell Business Park i
101 Corporation Drive Aliquippa, PA 15001
Dear Mr. Smith:
p Based on your letters dated July 16,1999, and September 21,1999 we have amended in it's entirety the registration certificate NR-186-D-117-G. The scope of the certificate has been expanded to allow for previous distribution of gamma gauges to generallicensees and the additional distribution you wish to extend to specific licensees in Cesium-137 and Barium-133 isotopes. Accordingly the registration certificate has been allocated a new a number NR 186-D-117-B.
Please be ad*ed that you must manufacture and distribute the product in accordance with the -
statements and representations contained in the application submitted by Berthold Systems, Inc. with enclosures thereto, and the information set out in the attached registration certificate.
As a general rule, you must request and obtain an amendment to the certificate before you make changes or modifications to the information submitted to obtain the registration certificate. You are obligated to notify us promptly in writing should you decide to no longer menufacture or offer service support for the product.
l Please be aware that, as a holder of an NRC registration, you may be subject to the NRC's licensing fees in accordance with 10 CFR Part 170, and annual fees in accordance with 10 CFR Part 171. If you have any questions concerning the fee requirements, please contact the License Fee and Debt Collection Branch at (301) 415-6096.
Please read over the registration certificate in its entirety and notify us immediately of any errors or omissions, if you have any questions, please contact me at (301) 415-7894 or Michele Burgess at (301) 415 5868.
Sincerely, (orig, signed by)
Ujagar S. Bhachu, Mechanical Engineer Materials Safety and Inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
As stated cc w/ encl: SKimberley, LFDCB Distributio_nX lMNS r/f SSD 99-49 NE01 DOCUMENT NAME:
Tm,aceive e copy of this document, indicate in the box: *C" = Copy without attachment / enclosure
'E' = Copy with attachment / enclosure
'N' = No copy OFFICE MSIB lC MSl$ S lC NAME USBhachu C MEIu$ss DATE 10/d/99 10/iU99 OFFICIAL RECORD COPY wwoo IP.
'REGISTRYJOF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
E : NR-186-D-117-B DATE:
p g3 g PAGE: 1 OF 10 DEVICE TYPE: Gamma Gauge U
'NW-201 Series, NW-301 Series, NW-_401 Series MODEL:
MANUFACTURER / DISTRIBUTOR:
Berthold. Systems, Inc.
Hopewell Business Park 131 Corporation Drive Aliquippa, PA 15001 I
p l SEALED SOURCE MODEL DESIGNATION:
Berthold Systems, Inc. 39002 ISOTOPE:
MAXIMUM ACTIVITY:
Cesium-137 900 microcuries (33.3 MBq)
'Or-no single source to Barium-133
. exceed 10 microcuries (370 kBq)
LEAK TEST FREOUENCY:
Not Required 3
PRINCIPAL USE:
(D) Gamma Gauge CUSTOM ~ DEVICE:
YES X
NO
'qqp't? c(g - ICPP '
\\
c
V l
j
\\
1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE-(AMENDED IN ITS ENTIRETY) 4 HQt: NR-186-D-117-B DATE:
ggy ;y ggy PAGE: 2 OF 10 DEVICE TYPE:
Gamma Gauge DESCRIPTION:
The Model NW-201 Series, NW-301 Series, and NW-401 Series source housings are designed to be installed in fixed locations to measure material density or fill. level in various applications including pipelines, tanks, and other containers or flow processes. 'Each source housing contains multiple sources, each source containing no more than 10 microcuries (370 kBq). The multiple sources are installed into machined " pockets" and are held in place by epoxy.
Descriptions of each source housing are listed below.
NW-201 Series I
The'Model NW-201 Series source housings have variable dimensions ranging from 5-8"-(12.7-20.3 cm) in diameter and 2-6" (5.1-15.2 cm) in height. The construction of the source housing is either lead, austenitic stainless steel series 300 (type 304,316 and 317) or tungsten shielding sandwiched between stainless steel plates.
In its shipping condition, the source housing has the source sandwiched between two halves of the shielding. However, upon i
installation, one half of the shielding (the removable shipping cap) is removed and installed on the back of the other half of the shielding. This condition'will expose the radiation beam while~providing additional shielding at the back of the source housing. The source housing does not have a shutter mechanism, i
To ensure that the dose rates at the accessible surfaces of the i
applications do not' exceed 5 mrem /hr (50 Sv/hr), installation of the Model NW-201 Series source housings are subject to the following.
Pipes:
'no smaller than Schedule 10, 2"
(5.08 cm) pipe diameter, containing no more than 500 curies (18.5 Mbq), under any l
condition
p.
i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
.g.
HQ : NR-186-D-117-B DATE:
PAGE: 3 OF 10 ggy j 3 ;gg REVICE TYPE: Gamma Gauge DESCRIPTION (CONT.)*
Pipes (Cont.):
vessels:
no smaller than 14" (35.6 cm) diameter, schedule 40 pipe under any conditions.
+
NW-301 Series The Model NW-301 Series source housings have variable dimensions ranging from 12-60" (30.5-152.4 cm) in length, 1-4" (2.5-10.2 cm, in height, and 2-6" (5.1-15.2 cm) in width. The construction of the source housing is either solid tungsten, solid austenitic stainless steel series 300 (type 304, 316 and 317) or lead encased'in steel.
Upon installation, the housing acts similar to a strip source mounted on the side of a vessel. The source housing does not have a shutter mechanism.
In its shipping condition, the source housing is " folded" in half so that the i
beam ports of the two halves are facing each other, i
To ensure that the dose rates at the accessible surfaces of the applications do not exceed 5 mrem /hr (50 Sv/hr) Model NW-301 Series source housings may only contain up to 900 microcuries (33.3 MBq) of Cesium-137 or Barium-133.
NW-401 Series The Model NW-401 Series source housings have variable dimensions with a minimum diameter of 2.5" (6.4 cm) and minimum height of 2.5" (6.4 cm).
The source housing is constructed of tungsten with a machined area that would allow.for mounting to a pipe.
The radius of the machined area is the same as the pipe to which it.will be attached.
The sources are mounted in the center of the cylindrical construction.
In its shipping condition, a source is installed in the machined area to provide shielding.
However, upon installation, the source cap is removed.
The source housing does not have a shutter mechanism.
l' I
l.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
- HQ : NR-186-D-117-B DATE:
PAGE: 4 OF 10 gz g3 y DEVICE TYPE:
Gamma Gauge DESCRIPTION (CONT.):
To ensure that the dose rates at the accessible surfaces of the applications do not exceed 5 mrem /hr (50 Sv/hr), Model NW-401 Series source housings may only contain up to 300 microcuries (11.1 MBq) of Cesium-137 or Barium-133 and may be attached to pipes with a minimum diameter of 2" (5.1 cm).
39002 Source The Berthold 39002 source is registered as part of this source housing and is not registered separately. The 39002 source is 0.373" (1.0 cm) in diameter by 0.008-0.009",
(0.20-0.23 mm) thick and may contain up to 10 microcuries (370 kBq) of Cesium-137 or
. Barium-133. The source is not manufactured by Berthold Systems
~
but.must be manufactured to Berthold's specifications.
Since no single source used in the source housings exceeds 10 microcuries (370 kBq), leak testing of the source housings is not required.
LABELING:
Each source housing is labeled in accordance with 10 CFR 20.1901 and 10 CFR 20.1904.
Devices intended for distribution to general licensees will be labeled in accordance with requirements of 10 CFR 32.51.
The source housing serial number is engraved into each source housing. A stainless steel label, either attached to the source housings by rivets or a stainless steel tether, will be engraved with the source housing model number, isotope, activity, date of an assay, the radiation symbol, and the name ano telephone number j
of the distributor.
Source housing distributed for use under a i
general license will contain an additional label as follows, l
engraved on'a stainless steel tags Abandonment or disposal prohibited unless transferred to Berthold Systems, or persons specifically licensed by the
L.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
. SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
HQ : NR-186-D-117-B DATE:
PAGE: 5 OF 10 On 13 nu DEVICE TYPE:
Gamma Gauge LABELING: (CONT.)
U.S. Nuclear Regulatory Commission or an Agreement State.
Operations prohibited if there is indication of failure of or damage to housing or source containment.
Installation and relocation can only be performed using the specific instructions suppled in the operating manual of the device.
Dismantling, maintenance, repair and testing involving ~the radioactive material, its housing or containment shall be perform by Berthold Systems, Inc. and other specific licensees. 'The device is not required to be tested for radioactive leakage.
Loss, theft, or transfer of this device and failure of or damage to the shielding and source containment must be reported to Berthold Systems, Inc. and the U.S. Nuclear Regulatory Commission or an Agreement State.
The receipt, possession, use, and transfer of the device are subject to a general license or the equivalent and'the regulations of the U.S. NRC or of a. State with which the NRC has entered into an agreement of the exercise of regulatory authority.
This label shall be maintained on the device in a legible condition.
Removal of this label is prohibited. This device'is registered with the U.S. Nuclear Regulatory Commission.
CAUTION - RADIOACTIVE MATERIAL Labeling on devices relative to specific licensing will appear l
as shown in Attachment VI.
The source housing is exempt from the conventional color requirements of 10 CFR 20.1901.
i DIAGRAM:
See' Attachments 1-5.
l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
HQm: NR-186-D-117-B DATE:
ggy } ) hu PAGE: 6 OF 10 DEVICE TYPE:
Gamma Gauge CONDITIONS OF NORMAL USE:
The source housings will be used in industrial applications to measure material density or fill level in various applications including pipelines, tanks, and other containers or flow processes.
Possession and use of the source housings are restricted to environments that do not exceed the following conditions.
Temperature:
-25 to 100 C (-13 to 212*F)
Unlikely to be subjected to thermal shock i
Humidity:
0 to 100%
Impact:
Cannot be mounted at heights exceeding 30 feet (7.6 m).
External Pressure:
3.6 psi to 1 atmosphere Vibration:
Low - simple harmonic motion having a maximum amplitude of 0.03" (0.76 mm)and maximum frequency of 50 Hz.
Corrosion:
Slight -
i.e.,
low concentrations of corrosive fumes / chemicals.
I Fire and Explosion:
Environments where fire and explosion are unlikely.
PROTOTYPE TESTING:
I Prototypes of the source housings were constructed and subjected to the tests listed below.
No malfunction occurred nor was there l
any loss of shielding or containment integrity as a result of the testing.
Temperature Cycle testing from -25 C to 100 C (-13 to 212 F).
Held at 538 C (1000 F) for 5 minutes.
I
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NQ : NR-186-D-117-B DATE:
PAGE: 7 OF 10 g ) gg DEVICE TYPE: Gamma Gauge PROTOTYPE TESTING (CONT.):
Humidity 100% at 50*C (122 F) for 12 hour1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br />.
Impact Drop from 30 feet (7.6 m).
The sealed sources were tested as part of the source housings.
No information was submitted concerning prototype testing of the sources when not installed in the source housings.
EXTERNAL RADIATION LEVELS:
Berthold has committed to verify that the dose rates at the surface of each source housing will not exceed 2 mrem /hr (20 Sv/hr), except at the surface of the beam port, which will not, exceed 100 mrem /hr (1 mSv/hr).
In addition, Berthold has
-demonstrated that the dose rates on all accessible surfaces of the installation will not exceed 5 mrem /hr (50 Sv/hr).
OUALITY ASSURANCE AND CONTROL:
Berthold maintains a quality assurance and control program which has been deemed acceptable for licensing purposes by NRC.
A copy of.the progran is on file with the NRC.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
The device shall be distributed to persons generally or specifically licensed by the NRC or an Agreement State.
Devices' users are not subject to leak testing requirements.
l Handling, storage, use, transfer, and disposal: as required
=
by 10 CFR 31.5 and 10 CFR Part 20 or Agreement State equivalent.
Barriers required for access space greater than 3.94 inches (10'an)
L
r-l l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NQt: NR-186-D-117-B DATE:
PAGE: 8 OF 10 ggy 4 3 gg DEVICE TYPE:
Gamma Gauge LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (CONT.}-
Specific and general licensees may install the devices provided the installation is in accordance with the instructions provided by Berthold Systems, Inc.
- However, general licensees may not perform any other type of servicing of the devices.
This registration sheet and the information contained within the references shall not be changed without the written consent of the NRC.
SAFETY AND ANALYSIS
SUMMARY
Berthold has submitted sufficient information to provide reasonable assurance that:
The device can be safely operated by persons not having training in radiological protection.
Under ordinary conditions of handling, storage, and use of the device, the byproduct material contained in the device will not be released or inadvertently removed from the source housing, and it is unlikely that any person will receive in any period of one year a dose in excess of 10 percent of the limits specified in Section 20.1201(a),
. Under accident conditions associated with handling, storage, and use of the source housing, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in the chart shown on the following page:
1 L
I i
i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
HQ2: NR-186-D-117-B DATE: gy y 3 gg PAGE: 9 OF 10 DEVICE TYPE: Gamma Gauge SAFETY AND ANALYSIS
SUMMARY
(CONT.)
PART OF BODY DOSE Whole body; head and trunk active blood-forming organs; gonads; or lens of eye 15 rem (0.15 Sv) j Hands and forearms; feet and j
ankles; localized areas of skin l
averaged over areas no larger than 1 CM2 (0-15 in )
200 rem (2.0 Sv) a Other organs 50 rem (0.50 Sv)
Based on review of the Models NW-201 Series, NW-301 Series, and NW-401 Series source housings, and the information and test data cited herein, we conclude that the source housing is acceptable for licensing purposes.
Furthermore, we conclude that the source housing would be expected to maintain it's containment integrity for normal conditions of use and accidental conditions which might occur during uses specified in this registration certificate.
l i
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
^
E: NR-186-D-117-B DATE:
jgg7);33 PAGE: 10 OF 10 DEVICE TYPE: Gamma Gauge
REFERENCES:
The following supporting documents for the Model NW-201 Series, NW-301 Series, NW-401 Series source housings are hereby incorporated by reference and are made part of this registration.
Berthold System's letters dated July 2,
- 1998, July 29, 1998, August 21, 1998 and August 25, 1998, with enclosures thereto.
. Berthold System's facsimile dated August 25, 1998, with enclosures thereto.
- Berthold System's letter dated July 16, 1999, September 21, 1999 and enclosures thereto.
- Lorthold System's facsimile dated October 5, 1999.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission Date:
NY !$ 91 Reviewer:
J utuM.
Ujagar achu Date: [0CI I 3 I333 Reviewer:
e ug.e Michele L.
'B' urges 6 l
l l
L
r' REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS EVIIRETY)
E: NR-186-D-117-B DATE:
ATTACHMENT: 1 l
eNme5'ErE s
4 BAL s
sN
+
j (ca vnxto to ntu s)
I46ent M Lagt h Pat * %
f- - 5
= 4",7,',=,,,,!
wr.=.n,x f.
=
M
=
6 5....
9-
=
k-
- +
Q..
7
===
i aarfunnus i
l'
.\\ W-20 L SERIES
c REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-186-D-117-B DATE:
ATTACHMENT: 2 y3 se.w 2
vis y b
b i
...................................................... a>:::(-
.>:::im
,..... O...O.... O...O....O...O....O... O....O... O....O.....
u
....O....O...O....O...O....O...O....O... O....O....O.........
e'.e epeoxiert
>:::4-
.>:::4m...........................
...................................................e..
t 6
sota vitws smww witw winc,c d
e i
e a
e a
a a
a a
a a
a a
u a
e a
a a
1 a
a a
i a
a 1
T IhJI I
I I
I I
I I
I I
I I
a Jl
} I ILJI I
I I
I I
I I
I I
I.
1 IhJI I
Ih i'
1 c..
eenoxiutt p:::4.
l w
a 3
5 sccticut cwn vicvs
/E
/E a
(
1 l.
rotxo roa
- i. usc a
sioneGc oR fRANSPoRf 1
I t\\ N-30!. seems 1
L
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) liq,_ : NR-186-D-117-B DATE:
ATTACHMENT: 3 p 2.50_ MIN. q 4-
- \\
SOURCE PDCKET s
\\
,=.
\\
MOUNTING HDLE M
medy J
TETHEREDTOBODY[
SOURCE CAP BODY 2.50 MIN DI A.
t h W-. 40 {
SEglES
\\,
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
' SAFETY EVALUATION OF DEVICE (ANENDED IN ITS ENTIRETY)
E: NR-186-D-117-B DATE:
ATTACHMENT: '4 Diameter Of act ive source-0.12" l
'N,,,,/
0.375" Cover ing Disk V
il Back ing D isc
.008.009" SOURCE'10 Ci CESIUM-137 AND BARIUM-133 l-l._
(4
I
. REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) l E: NR-186-D-117-B DATE:
ATTACHMENT: 5
- y f~
4.25" l
=
i b
Modelt.__
O
)
laotope:---
_. Actiff ty:-_
_ Assay Date:__
l t
]
'.50' f
CAUTION RADIATICI MATHIAL i
BIRTHOLD SYSTEM 8 IIC.
U O ' A1164 ppa, Pa 15001 140027H681 O
PHOTON SHIELD LABEL SPECIFIC LICENSE