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Quality Assurance in Nuclear Medicine
Reference Sources and Solutions • Radiation Measurement Instruments
Surgical Guidance System • Education and Training
™
Fourth Edition
Gd-153 sources for SPECT Cameras (page 11)
Calibrated I-131 Capsules (page 22)
C-Thru™Co-57 Flood Source (page 3ff.)
C-Trak® Surgical Guidance System for Sentinel Lymph Node Diagnostic (page 25f.)
Ge-68 sources for PET Scanners (page 7ff.)
Quality Assurance in Nuclear Medicine
Reference Sources and Solutions • Radiation Measurement Instruments
Surgical Guidance System • Education and Training
™
Fourth Edition
Quality Assurance in Nuclear Medicine
Fourth Edition / 2004
Published by AEA Technology QSA
Printed in Germany
Designed and produced by
impulse Werbeagentur + Verlag GmbH,
D-38114 Braunschweig,Germany
3
Contents
In the sections listed below you can find Check Sources, Reference Sources andReference Solutions for:
C-Thru Flood Sources Page 4Positron Emission Tomography (PET) Page 7Single Photon Emission Computed Tomography (SPECT) Page 11Gamma cameras Page 12Scintigraphy Page 15Dose calibrators (Ionisation Chambers) Page 19Gamma counters Page 23
For Sentinal Lymph Node diagnostics you will find detailed information aboutthe new
C-Trak® Surgical Guidance System Page 25
A range of high-quality radiation measurement instruments and radiationsources is shown in
Health Physics Page 28
If you are looking for easy to use equipment for training in the basicproperties of radioactivity please see
Training Page 35
General information Page 36
Ordering information Page 40
Quality Assurance in Nuclear Medicine
4
Quality Assurance in Nuclear Medicine
Application
High uniformity Co-57 floodsources are used for gamma
camera image quality assurace. The objective of these routinequality assurance checks is to
ensure that the gamma camerafield-of-view image isfree from
non-uniformitiesand artifacts.
Construction
Isotrak’s unique C-Thru™ designand technology (patent peding)
Co-57 Flood Sources providesusers with exeptional perfor-mance in a user-friendly and
functional format. This repre-sents a considerable advance
and improvement over conven-tional flood source design.
The laser joined source holdermaterial is made of transparent,durable plastic. The radioactivearea is clearly visible, enabling
C-Thru™ sources to be easilypositioned on the gamma
camera head, assuring the fulland accurate coverage of the
field-of-view.
Dual head cameras can bechecked simultaneously as the
radiation field produced by theflood source is the same on
both sides. C-Thru™ flood sour-ces have two handles for safe
manipulation allowing hands tobe clear of the active area.
All C-Thru™ flood sources aresupplied in a stable, easy to
handle, lead-lined roller casefor safe transport and storage.The roller case is also a Type A
approved shipping containerthat meets all the requirements
of IAEA TS-R-1 and 49CFR.
Features
• Transparent, durable capsule material• Active area visible through its transparent holder• Lead-lined durable transport and storage roller case
(Type A approved)• Coefficient of variation < 1 % – typically the CoV is 0.5 %
or less (Unit cell size 1 cm2)• Integral uniformity < 2.0 % – typically it is 1.0 % - 1.7 %• Radionuclide impurity < 0.1 % (Co-58, Co-56, Co-60) • Sources are available for all common gamma cameras• Patented technology allows custom designs for most
dimensions and activities• Source return service
Image courtesy of SiemensMedical Solutions USA, Inc.
C-Thru™ Co-57 Flood Sources
5
Quality Assurance in Nuclear Medicine
Tolerances
The maximum deviation of the delivered activity from the nominalvalue is -10 % +20 %.
Control Scanner
Uniformity Measurement
The homogeneity of each C-Thru™ flood source is measured with aspecial dedicated gamma camera measuring system. 100 % of theactive area is measured with a unit cell size of 1 cm2. The results are stated in a certificate supplied with each source.
Akquisition date : 2.26.2003Product code : CTF10000Serial Number : 10029CModel Number : 1000R-COH-42-62Remarks : Date 26-FEB-2003Isotope : Co-57Activity (approx.) : 419 MBq
Unit Cell size : 1.07 cm 2
Mean in UFOV : 16450 (2128 Unit Cells)Standard Deviation : 60Coefficient of Variation : 0.36 %Integral uniformity : 1.17 %Differential uniformity : 0.91 %
Typical Gamma Camera Scanner Protocol
Certification
Each source is supplied with a test report, which states:- Activity of the nuclide- Reference time and date- Result and date of leakage test- Serial number - US NRC / Agreement State Model Number- ISO / ANSI Classification- Overall dimensions
Availability
Delivery within 2 to 4 weeks after receipt of order.
6
Quality Assurance in Nuclear Medicine
Model 1000R Series Rectangular Sources
Product Code Activity Active Dimensions Overall Dimensions
CTRF10000 370 MBq (10 mCi) 24.4" x 16.5" 620 x 420 mm 700 x 538 x 8 mm 27.5" x 21.2" x 0.32"CTRF10001 185 MBq (5 mCi) 24.4" x 16.5" 620 x 420 mm 700 x 538 x 8 mm 27.5" x 21.2" x 0.32"CTRF10002 555 MBq (15 mCi) 24.4" x 16.5" 620 x 420 mm 700 x 538 x 8 mm 27.5" x 21.2" x 0.32"CTRF10003 740 MBq (20 mCi) 24.4" x 16.5" 620 x 420 mm 700 x 538 x 8 mm 27.5" x 21.2" x 0.32"
CTRF10005 370 MBq (10 mCi) 18.1" X 14.2" 460 x 360 mm 540 x 478 x 8 mm 21.3" x 18.8" x 0.32"CTRF10006 185 MBq (5 mCi) 18.1" X 14.2" 460 x 360 mm 540 x 478 x 8 mm 21.3" x 18.8" x 0.32"CTRF10008 740 MBq (20 mCi) 18.1" X 14.2" 460 x 360 mm 540 x 478 x 8 mm 21.3" x 18.8" x 0.32"
CTRF10009 370 MBq (10 mCi) 29.1" x 18.1" 740 x 460 mm 820 x 578 x 8 mm 32.3" x 22.8" x 0.32"CTRF10011 740 MBq (20 mCi) 29.1" x 18.1" 740 x 460 mm 820 x 578 x 8 mm 32.3" x 22.8" x 0.32"
CTRF10012 370 MBq (10 mCi) 8.9" x 8.9" 225 x 225 mm 318 x 280 x 8 mm 12.5" x 11.0" x 0.32"
Model 1000C Series Circular Sources
Product Code Activity Active Dimensions Overall Dimensions
CTRF10050 370 MBq (10 mCi) 18.5" diameter 470 mm diameter 534 dia x 8 mm 21" dia x 0.32"CTRF10051 185 MBq (5 mCi) 18.5" diameter 470 mm diameter 534 dia x 8 mm 21" dia x 0.32"CTRF10053 740 MBq (20 mCi) 18.5" diameter 470 mm diameter 534 dia x 8 mm 21" dia x 0.32"
CTRF10054 370 MBq (10 mCi) 14.2" diameter 360 mm diameter 424 dia x 8 mm 16.7" dia x 0.32"CTRF10055 185 MBq (5 mCi) 14.2" diameter 360 mm diameter 424 dia x 8 mm 16.7" dia x 0.32"
CTRF10058 370 MBq (10 mCi) 24" diameter 610 mm diameter 674 dia x 8 mm 26.5" x 0.32"CTRF10059 185 MBq (5 mCi) 24" diameter 610 mm diameter 674 dia x 8 mm 26.5" x 0.32"CTRF10061 740 MBq (20 mCi) 24" diameter 610 mm diameter 674 dia x 8 mm 26.5" x 0.32"
Ordering information
C-Thru™ Model 1000R / 1000C Series flood sources are approved for licensing purposes by the
“Massachusetts Department of Public Health Radiation Control Program”. The Sealed Sources and Devices
Registration Number is MA-1059-S-359-S.
The individual sub-model numbers are stated in the certificate supplied with each source.
Source return
To return decayed sources for recycling or disposition please contact AEA Technology QSAor your local distributor for the provision of a source return authorization.
C-Thru™ Co-57 Flood Sources
7
Quality Assurance in Nuclear Medicine
Features
• High uniformity of Ge-68 activity• Meet requirements of the European Medical Device Directive,
CE marked• Return of spent sources is included in the service on request• On-site ring source installation service is available on request• Precision laser-welded ends• Clean laser engraving for enhanced legibility
Uniformity
• Rod- and ring sources better than ±5% for any 5mm length vs mean value
• Cylindrical phantom better than ±5% for any 1cm3 vs mean value• Plane source better than ±5% for any 1cm2 vs mean value
The linear attenuation coefficient for the cylindrical phantom has beenmeasured and checked with an active and a cold (inactive) cylindricalphantom µ=0.1029cm-1 ± 0.5% (511keV). The active volume is 5969ml ± 2%.The cylindrical phantom includes the supply of a low activity tube typereference source using the same polymer composition as used in thephantom.
Ge-68 Sources for dedicated PET, PET/CT and Coincidence Cameras
Application
These sources are used in qualityassurance for positron emissiontomography (PET). Rod and line
sources are used for attenuationcorrection and detector set-up.The calibration of the detectorsin the PET scanner, the 2D- and
3D- normalization, is performedusing a cylindrical phantom or a
plane source.
Construction
Ceramic or polymer compoundsare used to permanently bind
the Germanium-68 into a highly-uniform solid matrix. The purity
of the Ge-68 used is measuredusing high resolution gamma rayspectrometry, and is better than99%. The activated compound is
sealed either in a stainless steeltube or in a cylindrical or plane
outer shell.The sources are supplied with a
measurement report stating theuniformity of the activity
distribution.
8
Quality Assurance in Nuclear Medicine
*) The cylindrical phantom always contains a tube type reference source taking an aliquot from the active resin ofthe phantom (Product code: GRRB9285)
ISO classification
Rod SourcesISO C.32312 (ANSI 77C32312)Cylinder PhantomISO C.22212 (ANSI 77C22212)
Availability
Within 6 weeks from receipt of order.The sources are shipped in a Type A approved packaging which can alsobe used for the spent sources.
Tolerances
The maximum deviation of the delivered activity from the nominalactivity is ±15%.
SIEMENS Ge-68 source set Drawing Outer Active Nominal Product codescanner type consisting of: Dimensions [mm] Dimensions [mm] Ge-68 activity
ECAT®EXACT 3 rod sources VZ-2464 Ø 3.2 x 190 168 3 x 122 MBq GRRB57761 cylindrical phantom*) VZ-2465 Ø 213 x 275 Ø200 x 190 120 MBq GRRB91161 cylindrical phantom*) VZ-2465 Ø 213 x 275 Ø200 x 190 44 MBq GRRB9115
ECAT EXACT™HR 3 rod sources VZ-2464 Ø 3.2 x 190 168 3 x 185 MBq GRRB5767and 1 cylindrical phantom*) VZ-2465 Ø 213 x 275 Ø200 x 190 120 MBq GRRB9116ECAT ACCEL 1 cylindrical phantom*) VZ-2465 Ø 213 x 275 Ø200 x 190 44 MBq GRRB9115
ECAT EXACT HR+ 3 rod sources VZ-2464 Ø 3.2 x 190 168 3 x 140 MBq GRRB99491 cylindrical phantom*) VZ-2465 Ø 213 x 275 Ø200 x 190 120 MBq GRRB91161 cylindrical phantom*) VZ-2465 Ø 213 x 275 Ø200 x 190 44 MBq GRRB9115
Biograph®PET/CT 2 rod sources VZ-2753 Ø 3.2 x 200 180 44MBq GRRB89791 cylindrical phantom*) VZ-2465 Ø 213 x 275 Ø200 x 190 44 MBq GRRB9115
ECAT ART™ 2 rod sources VZ-2467 Ø 3.2 x 183 168 2 x 37 MBq GRRB62861 cylindrical phantom*) VZ-2465 Ø 213 x 275 Ø200 x 190 37 MBq GRRB6287
Please enquire Ge-68 sources for other PET-Scanners
951R 3 rod sources VZ-2466 Ø 3.17 x 142.2 131 3 x 92.5 MBq GRRB62881 cylindrical phantom*) VZ-2465 Ø 213 x 275 Ø200 x 190 120 MBq GRRB9116
Ordering information
Sources for SIEMENS Medical Solutions PET Scanners
Ge-68 Sources for dedicated PET, PET/CT and Coincidence Cameras
9
Quality Assurance in Nuclear Medicine
GE Ge-68 source Drawing Outer Active Nominal Product codescanner type Dimensions [mm] Dimensions [mm] Activity
ADVANCE™ rod source VZ-2487 Ø 4 x 225.6 155 60 MBq GRRB8465ADVANCE™ NXI rod source VZ-2487 Ø 4 x 225.6 155 400 MBq GRRB8466Discovery™ LS
Discovery ST rod source VZ-3189 Ø 4 x 293 161 55 MBq GRRB11844
Please enquire Ge-68 sources for other PET-Scanners
Sources for GENERAL ELECTRIC (GE) PET Scanners
Type Ge-68 source Drawing Outer Active Nominal Product codeDimensions [mm] Dimensions [mm] Activity
ADAC MCD rod source VZ-2631 Ø 3.17 x 140 130 18.5 MBq GRRB8003
Source for Philips Medical Systems Scanners
Sources for HAMAMATSU PET Scanners
Set type Ge-68 source Drawing Outer Active Nominal Product codeDimensions [mm] Dimensions [mm] Activity
SHR-2000 rod source VZ-2624 Ø 1.65 x 59.5 54.0 18.5 MBq GRRB7833
SHR-2400 rod source VZ-2625 Ø 1.65 x 115.5 110.0 37 MBq GRRB7834
SHR-7700 rod source VZ-2506 Ø 1.7 x 124.0 118.0 74 MBq GRRB7036
SHR-22000 rod source VZ-2505 Ø 1.7 x 241.1 235.0 74 MBq GRRB7037(PCT-4300W)
Type Ge-68 source Drawing Outer Active Nominal Product codeDimensions [mm] Dimensions [mm] Activity
HZL™ and mPower™ rod source VZ-2632 Ø 6 x 190mm 172mm 185 MBq GRRB8004
Auricle™ and HZ™ rod source VZ-2633 Ø 6 x 146mm 127mm 185 MBq GRRB8005
Sources for Positron PET Scanners
10
Quality Assurance in Nuclear Medicine
Sources for SHIMADZU PET Scanners
Set type Ge-68 source Drawing Outer Active Nominal Product code Dimensions [mm] Dimensions [mm] Activity
SET-1300W rod source VZ-2537 Ø 6 x 116.0 78.0 74 MBq GRRB7024rod source VZ-2537 Ø 6 x 116.0 78.0 92.5 MBq GRRB8106
SET-1400W rod source VZ-2507 Ø 6 x 116.0 104.0 74 MBq GRRB6682rod source VZ-2507 Ø 6 x 116.0 104.0 111 MBq GRRB7853
SET-2200W rod source VZ-2591 Ø 3.17 x 230.1 117.4 111 MBq GRRB7498
SET-2300W rod source VZ-2538 Ø 3.17 x 230.1 167.4 37 MBq GRRB6687rod source VZ-2538 Ø 3.17 x 230.1 167.4 111 MBq GRRB6687rod source VZ-2538 Ø 3.17 x 230.1 167.4 140 MBq GRRB8104rod source VZ-2538 Ø 3.17 x 230.1 167.4 185 MBq GRRB6687cylindrical phantom VZ-2767 Ø 213 x 232 Ø 200 x 190 37 MBq GRRB9081
SET-2400W rod source VZ-2504 Ø 3.17 x 230.1 217.4 37 MBq GRRB6684rod source VZ-2504 Ø 3.17 x 230.1 217.4 185 MBq GRRB6683rod source VZ-2504 Ø 3.17 x 230.1 217.4 370 MBq GRRB7035cylindrical phantom VZ-2768 Ø 213 x 280 Ø 200 x 240 37 MBq GRRB9082
Sources for Concorde Microsystems® Scanners
Other Ge-68 reference sources, check sources and solutions are available on request
Ge-68 Sources for dedicated PET, PET/CT and Coincidence Cameras
Set type Ge-68 source Drawing Outer Active Nominal Product code Dimensions [mm] Dimensions [mm] Activity
micro PET® point source VZ-2758 Ø 3.4 x 59.3 18.5 MBq GRRB9004cylindrical phantom VZ-2757 Ø 110 x 125 Ø 100 x 100 18.5 MBq GRRB9002
11
Quality Assurance in Nuclear Medicine
Gd-153 sources for Single Photon Emission Computed Tomography (SPECT)
Features
• High uniformity of Gd-153 activity• Meet requirements of the European Medical Device Directive,
CE marked• Return of spent sources is included in the service
MDPH model number
GD.LIN 1 Drawing: VZ-2171GD.LIN 2 Drawing: VZ-2352
ISO classification
C.33333 Drawing: VZ-2171 (for Philips Cameras)C.44343 Drawing: VZ-2352 (for SIEMENS Cameras)
Tolerances
The maximum deviation of the delivered activity from the nominal value is: + 25% - 5% for sources for Philips cameras,+ 25% - 10% for sources for SIEMENS cameras.
Application
Gd-153 line sources are used forattenuation correction to
improve SPECT camera images.
Construction
The activity is incorporated into aceramic matrix. These ceramic
rods are inserted into analuminium tube. The assembly isthen welded into a stainless steel
tube. The line sources for theSIEMENS E.CAM™ camera are
mounted into aspecial source holder.
Availability
Sources are delivered within 6 to8 weeks of receipt of order.
Type Gd-153 source Drawing Outer Active Nominal Product codeDimensions [mm] Dimensions [mm] Activity
Prism 2000XP line source VZ-2171 Ø 6.35 x 267 Ø 5.35 x 235 2.2 GBq GDRB5451Prism 3000XP
Sources for Philips Medical Systems Cameras
Type Gd-153 source Drawing Outer Active Nominal Product codeset consisting of Dimensions [mm] Dimensions [mm] Activity
E.CAM 4 line sources VZ-2352 Ø 3.05 x 207 Ø1.6 x 199.9 4 x 740 MBq GDRB8066
Sources for SIEMENS Medical Solutions E.CAM
12
Quality Assurance in Nuclear Medicine
Check sources for gamma camerasPoint sources
Application
For checking: • Homogeneity• Resolution• Field of view• Centre of rotation
Construction
The Co-57 is electrodeposited onto a metal disc or incorporated into anion exchange bead, which is sealed in a welded stainless steel capsuleof drawing VZ-2761.
ISO Classification
C.64444
Activity tolerance
The maximum deviation of the delivered activity from the nominalactivity is + 20%, - 10%.
Availability
Within 6 weeks of receipt of order.
Radionuclide Nominal activity Product code[MBq]
Co-57 37 CTCB 10122Co-57 111 CTCB 10123
Activity
Ordering information
Features
• Robust, sealed, source• Small active area (point source geometry)
3
10
13
Quality Assurance in Nuclear Medicine
Ø 2
200225
Ø 6,5
Activity
Application
Line sources are used fordetermining
the centre of rotation ofgamma cameras.
Availability
Within 4 - 6 weeks of receipt of order.
Tolerances
The maximum deviation of the delivered activity from the nominalactivity is ± 30%.
Construction
Co-57 is mixed homogeneouslywith a plastic resin in a flexible
tube (2 mm in diameter, 200 mmlong) which is sealed in an
aluminium tube. The tube ismounted in an acrylic glass
holder. The line source (totaldimensions: 6.5 mm diameter x225 mm length) is supplied in a
lead-shielded woodenpresentation box. Drawing: VZ-503
Radionuclide Nominal activity [MBq] Product code
Co-57 55 CTRK1716
Ordering information
Check sources for gamma camerasLine sources
14
Quality Assurance in Nuclear Medicine
Application
These sources are designed forchecking gamma cameras and
scanners and for demonstrationpurposes.
Construction
The radioactive material is homogeneously distributed in a plasticresin, covered with a protective coating. The phantom has the shape ofa normal thyroid with ‘hot’ and ‘cold’ nodules.
The phantom is available containing:Ba-133 (92%)/ Cs-137 (8%) to simulate I-131 or Co-57 to simulate Tc-99m.
Drawing: VZ-361
Tolerances
The maximum deviation of thedelivered activity from thenominal activity is ± 30%.
Availability
Within 6 - 8 weeks of receipt oforder.
9
18
Radionuclide Nominal activity [MBq] Product code
Ba-133/Cs-137 1.85 IZR36105Co-57 3.7 CTR36110
Ordering information
Check sources for gamma camerasThyroid phantom
18
9
15
Quality Assurance in Nuclear Medicine
Ordering information
Application
Spot marker sources are intended to be held in place on the subjectwith adhesive tape to mark anatomically significant points or toorientate the scintigram.
Construction
The activity is adsorbed onto an organic ion exchange resin bead with adiameter of 1 mm and mounted at the centre of a transparent epoxyresin disc. The sources are available either as single sources inunshielded storage boxes or as sets of three sources of the same nuclidein a wooden storage box with lead shielding.
ISO Classification
C.34313 Drawing: VZ-584
Tolerances
The maximum deviation of thedelivered activity from the
nominal value stated is -25% to +0%.
Availability
Within 3 - 4 weeks of receipt of order.
Type Radionuclide Nominal activity Product code[MBq]
Single source Ba-133 0.37 BDR81003.7 BDR8200
Source set Ba-133 3 x 0.37 BDR381003 x 3.7 BDR38200
Single sources Co-57 0.37 CTR81003.7 CTR8200
Source sets Co-57 3 x 0.37 CTR381003 x 3.7 CTR38200
Activity
Anatomical markersSpot marker sources
25
3
16
Quality Assurance in Nuclear Medicine
Ordering information
Tolerance
The maximum deviation of thedelivered activity from the
nominal value stated is-25% to +0%.
Availability
Within 2 - 3 weeks of receipt oforder.
Application
This source is used for tracing theoutlines of anatomical features
on the patient.
Construction
The Co-57 activity is incorporated in a 1mm diameter bead, sealed inthe tip of an aluminium holder shaped like a pen. Each source isprovided with a brass cap to shield the active end when the source isnot in use.
ISO Classification
C.34344Drawing: VZ-1186
Radionuclide Nominal activity Product code[MBq]
Co-57 3.7 CTR710
Activity
Anatomical markersPenpoint marker source
150
Ø7
17
Quality Assurance in Nuclear Medicine
Ordering information
Application
Rigid marker sources can be used to outline or scale anatomical featuresduring scintigraphy using gamma cameras and scanners. They are also
useful for demonstration purposes.
Construction
The activity is sealed within a plastic matrix with 20 mm long active andinactive zones, which are mounted into a transparent plastic ruler.
The active zones are coloured.The source is supplied in a wooden storage box.
Tolerances
The maximum deviation of thedelivered activity from thenominal value stated is ±30%.
Availability
Within 6 weeks of receipt oforder.
Radionuclide Nominal activity [MBq] Product code
Co-57 3.7 CTR415
Activity
Anatomical markersRigid marker source
300
20
20
6
6
18
Quality Assurance in Nuclear Medicine
Ordering information
Application
These sources can be used to outline or scale anatomical featuresduring scintigraphy. They can be held in place with adhesive tape, ifnecessary.
Construction
Flexible marker sources can be supplied with the activity eitheruniformly dispersed in an inner core of active plastic and sealed in PVCtubing, or loaded in 20mm long active and inactive zones (scalingtype). The inner diameter is approximately 0.9mm and the activelength is 500mm. The inner tubing is mounted into a outer PVC-tubing (length approximately 550mm, 3mm diameter) and sealedwith inactive plastic at the ends.
VZ-432 (uniformly dispersed)VZ-413 (scaling type)
Tolerances
The maximum deviation of the delivered activity from the nominalvalues stated is ± 30%.
Availability
Within 4 - 6 weeks of receipt of order.
Type Radionuclide Nominal activity [MBq] Product code
uniformly Co-57 3.7 CTR432dispersed
scaling Co-57 3.7 CTR413
ActivityActivity
Anatomical markersFlexible marker source
33
19
Quality Assurance in Nuclear Medicine
Application
These sources are designed to perform periodic calibration checks onradionuclide calibrators to demonstrate the measurement stability of the
equipment. The QC-tests may be required by national or stateregulations. This source type meet the requirements of the American
USNRC Regulatory Guide 10.8 (Revision 2, Aug. 1987), Appendix C, part 3.
Construction
The active material is homogeneously incorporated in approximately10ml resin in a 25ml plastic vial. The active layer is colour coded by
nuclide and is covered by inactive resin. The source is supplied in a leadcontainer.
Tolerances
The maximum deviation of thedelivered activity from thenominal values stated is ± 15%.
The activities are calibrated with a measurement uncertaintyof ±5%.
Availability
Within 3 - 4 weeks of receipt oforder.
ISO Classification
C.22222 Drawing: VZ-505
Inactiveresin
Resincontainingradionuclide
Dose calibrator check sourcesReference sources for radionuclide calibrators
Ordering Information
Radionuclide*) Nominal activity MDPH Colour code Product code [MBq] model number
Co-57 37 CTC.V1 blue CTR564111 blue CTR566185 blue CTR568
Cs-137 9.3 CDC.V1 yellow CDR562Co-60 1.9 CKC.V1 light green CKR560Ba-133 9.3 BDC.V1 brown BDR562
*) For Ge-68 sources please enquire.
Ø27
61
20
Quality Assurance in Nuclear Medicine
Ordering information
Application
Dose calibrators must be checked regularly to demonstrate that theyare operating correctly. Such checks may be required by national orstate authorities.
This Cs-137 source has been designed to check the stability of dosecalibrators. Note: For this type of instrument, it is important that standards used toverify the calibration factors should match the form of the samples tobe assayed. This source is therefore not suitable for checkingcalibration factors, and reference solutions should be used.In some countries AEA Technology QSA offers a range of standardizedsolutions containing short lived nuclides often used in nuclearmedicine. Please see next page.
Tolerance
The maximum deviation of thedelivered activity from thenominal value stated is -20% to +0%.
License1
Nds 180/78
Construction
The Cs-137 is incorporated in aceramic pellet and welded in a
stainless steel capsule. Thiscapsule is then encased in an
aluminium holder and securedwith epoxy resin. For safe
handling, the source is suppliedin a wooden storage container
with integral lead shielding. Theshape of the source allows easy
handling with forceps.
ISO Classification
C.23323 Drawing: VZ-322
Availability
Within 3-4 weeks of receipt oforder.
1 The design of this source has been tested by the Physikalisch-Technische Bundesanstalt (PTB) and is approved by the German legal authorities.
Radionuclide Nominal activity Product code[MBq]
Cs-137 (including 3.7 CDRB1548shielded container)
Activity
Ø 20 mm
57 m
m
Dose calibrator check sourcesCs-137 dose calibrator check source
21
Quality Assurance in Nuclear Medicine
Reference Solutions
Application
These solution standards ofradiopharmaceutical nuclides
are supplied in standard P6 vialsfor accurate, traceable,
calibration of the RadionuclideCalibrators.
These solutions are traceable tonational standards (including
NIST, PTB, NPL, BNM-LNHB etc).Each source is supplied with a
UKAS or DKD Certificate ofMeasurement stating:
• Activity • Reference date
• Measurement uncertainty• Gamma-ray emitting
impurities• Traceability Availability
Within 4 weeks of receipt of order. An annual delivery scheme isavailable for customers in Germany, Austria and Switzerland. Pleasecontact your local office for details.
Ordering information
Radionuclide Nominal activity Volume Availability Product code
In-111 40MBq 10ml please enquire INY95*)I-131 20MBq 10ml four times a year IBY95I-131 4MBq 10ml four times a year IBY75Ga-67 40MBq 10ml please enquire GJY95*)Tc-99m 40MBq 10ml on request TKY95**)I-123 40MBq 10ml please enquire IRYK7576**)
*) Europe only**) United Kingdom only
for customers in Germany, Austria and Switzerland
Radionuclide Nominal activity Volume Availability Product code(no carrier added)I-131 10MBq 2ml twice a year IBYB2495Tl-201 10MBq 2ml twice a year TDYB2495Tc-99m 40MBq 10ml twice a year TKYB2495
ø ≈ 20≈
58
Active Solution
Label
Al-cap
Plug
≈58
Ø ≈ 20
22
Quality Assurance in Nuclear Medicine
Calibrated Sodium Iodide Capsules(Use only for measurement purposes)
Application
Calibration figures onradionuclide calibrators often
assume that the sample has theform of liquid in a glass vial. If the
sample has a different form, thereported activity can be in error
as a result. This capsule can beused for an accurate, traceablecalibration of dose calibrators
which are used to check theactual activity of a I-131 therapy
capsule.
Features
• Matches the geometry of I-131 therapy capsules for accurate calibration
• Traceable to national standards and international standards• Activity of 74MBq chosen to keep operator dose as low as reasonably
practicable but yield accurate measurement results
Availability
The capsules are delivered 3 times a year. An annual delivery
scheme is available. Pleasecontact your local office for
details.
Ordering information
Construction
The I-131 capsules are manufactured at the Amersham Health facilityin Braunschweig. They are exactly of the same design as the I-131 TheraCap™ radiopharmaceutical. The capsule is supplied in thespecifically designed lead pot with the applicator to put it into thedose calibrator. A detailed operating instruction will be supplied withthe product.They will be calibrated in our accredited measurement laboratory andare traceable to national standards (including NIST, PTB, NPL, BNM-LNHB etc). Each source is supplied with a DKD Certificate ofMeasurement.
Tolerance
The maximum deviation of the delivered activity from the nominalvalues stated is +/-10%.
Radionuclide Nominal Drawing Availability Product codeactivity
I-131 74MBq VZ-2578 twice a year IBRB4571
23
Quality Assurance in Nuclear Medicine
Ordering information - Reference sources, calibrated, DKD- certificate
Radionuclide2) Nominal activity Overall Product code[kBq] uncertainty [%]
Am-241 3.7 3 AMRB4541Ba-133 3.7 3 BDRB4543Cs-137 3.7 3 CDRB4545Co-57 3.7 3 CTRB4547Co-60 3.7 3 CKRB4549Eu-152 3.7 3 EFRB4551Na-22 3.7 3 SKRB4555I-129 3.7 3 ISRB4557I-125 3.7 3 IMRB58291)
Ordering information - Check sources, uncalibrated
Radionuclide Nominal activity Product code[kBq]
Ba-133/Cs-137 3.7 IZR5410Ba-133 3.7 BDR5410Cs-137 3.7 CDR5410Co-57 3.7 CTR5410Co-60 3.7 CKR5410Mn-54 3.7 MFR5410Na-22 3.7 SKR5410I-129 3.7 ISR5410I-125 3.7 IMRB56041)
1) Please allow 12 weeks for delivery of this source from receipt of order.2) For Ge-68 source please see page 10.
Inactiveresin
75
Resincontainingradionuclide
Construction
The nuclide is homogeneouslyincorporated in 1ml resin in a
plastic tube. The empty volumeis filled with inactive plastic. For
easy identification of theradionuclide the active volume is
colour coded.
ISO Classification
C.23233 Drawing: VZ-1236
Tolerances
The maximum deviation of thedelivered activity from the
nominal values stated is ± 20 %.
Availability
Within 3 - 4 weeks of receipt oforder.
Gamma counter checking sourcesTube type sources
Application
The sources are used either forenergy calibration of gammacounters (uncalibrated) or fordetector efficiency calibration
(calibrated). Calibrated sourcesare supplied with a certificate of
the German Calibration Service (DKD) and are traceable
to international standards.
ø 12
24
Quality Assurance in Nuclear Medicine
Ordering information
Instrument Radionuclide Nominal activity Product code
EG & G Berthold I-129 12 x 2kBq ISRB6539Model LB21..series
Stratec PC-RIA.MAS I-129 12 x 1kBq ISRB2355
Construction
The nuclide is homogeneously incorporated in 1ml of resin in a plastictube and the empty volume is filled with inactive plastic. The set oftubes is mounted in a holder to match the measurement equipment.
ISO Classification
C.22212 Drawing: VZ-2417(Berthold)
Tolerance
The sources are selected so that the emission rate from any oneparticular source is less than 1% from the mean emission rate of all ofthe sources.
Note
These sources are intended for quality control checks only. Calibrationof the instruments should be performed using I-125 calibrated singletubes.
Availability
Please enquire.Approx. within 4 weeks of
receipt of order.
Gamma counter checking sourcesMultifinger checking sources
Application
These uncalibrated sources areused for convenient and rapid
testing of multi-well gammacounters.
25
Quality Assurance in Nuclear Medicine
Description
C-Trak has been designed to detect trace quantities of radiolabelledcompounds in lymph nodes in the presence of high backgroundradiation from the injection site. The instrument consists of a surgi-cal probe and an Automatic Analyzer which work together to mini-mize the background and give high sensitivity for locating thelymph nodes.The probe consists of a CsI crystal mounted in the tip of a stainlesssteel tube which is angled for better manoeuvrability. The crystal isinside a tungsten collimator so that it is shielded from radiation stri-king the side of the tube. Patented additional collimators can besnapped onto the probe to change the field of view from wide (forsurveying) to narrow (for probe-guided resection), or to match thetissue or background radiation. A tungsten shielding plate is alsoavailable to further reduce the radiation from outside the selectedfield of view.
C-Trak® Surgical Guidance System for Sentinel Lymph Node Diagnostics*)
Application:
The C-Trak Surgical GuidanceSystem has been designed to be
used by a surgeon to detecttissues which contain a
radioisotope label. The heart ofthe system is a small, hand-heldgamma detector (probe), whichis specifically developed for usein surgery. With this probe, the
surgeon can also determinewhether surgically removed
tissue contains radioactivematerial and, by repeated assay,
can determine whether allradioisotope-containing
material has been removed fromthe operative site.
Features
• Self-calibrating Automatic Analyzer• 11mm OmniProbe™ with superior spatial and energy resolution• New laparoscopic probe• Only one probe with shielding and collimation for Tc-99m,
I-131 and In-111• High sensitivity to detect radioactivity in tissue• Commonly used isotopes selectable by simple push button functions• User adjustable window and threshold for specific isotopes• Co-57 check source included for quality assurance• Complies with Medical Device Directive, CE-marked and FDA cleared• Wide range of accessories available (e.g. Tungsten shielding plates)• Supplied in a roller case
*) The C-Trak Automatic Analyzer System is manufactured by CareWise Medical Products Inc.
26
Quality Assurance in Nuclear Medicine
C-Trak® Surgical Guidance System for Sentinel Lymph Node Diagnostics
Technical data
Analyzer:
Energy range: 27keV – 600keVPower: Battery operated, 9V DC, Main and reserve
batteriesAudio: variable tone generator coupled to the
ratemeter, volume controlDisplay: LCD with 6-digit display of counts per second or
timed counts 4 range analog ratemeterDimensions: Height 17.8cm, Width 31.2cm, Depth 25.4cmWeight : approx. 4.5kg including full battery
complementExternal Ports: PHA out for external pulse-height analyzer
Printer outputExternal LED DisplayRemote for Footswitch
Omni Probe:
Energy range: 27keV – 400keVDimensions: Length 17cm, Tip 11mm
Tip of Tc Collimator 15mmTip of In Collimator 25mm
Weight: Probe 130gProbe with Tc Collimator 185gProbe with In Collimator 872g
Sterilization: A sterile sheath is recommended.
Laparoscopic / endoscopic / minimally invasive probe:
Energy range: 27keV - 364keVDimensions: Total length 46.6cm
Shaft length 33.7cmØ10mm tip
Weight: 255gSterilization: Probe can be sterilized using ethylene oxide.
The Automatic Analyzer registers the level of radiation detected bythe probe. The analyzer has digital and analogue readouts, and anaudible signal. The frequency of the audible signal is proportional tothe radiation level so that the node can be located accurately. Forsurgery, the analyzer has simple push button operation, but there isalso a menu driven LCD display for more detailed options.A Co-57 check source is also included to ensure that the instrument isoperating correctly and is stable.
27
Quality Assurance in Nuclear Medicine
Availability
Within 4 weeks from receipt of order.
Ordering information
Product CodeC-Trak Automatic Analyzer System
• with OmniProbe, standard- and Lechner collimatorfor Tc-99m, external LED display NIGB7900
• with OmniProbe, standard- and Lechner collimator for Tc-99m, external LED display; collimator and shielding for In-111 NIGB7901
• with MiniProbe™ and standard technetium collimator NIGB7902
• with laparoscopic probe NIGB10110
• with laparoscopic probe and OmniProbe with standard collimator for Tc-99m NIGB10111
NEW
NEW
NEWProduct Code
C-Trak – laparoscopic probe for Automatic Analyzer NIGB9252Printer, footswitch and tungsten shielding platefor NIGB7900 to NIGB7902, NIGB10110, NIGB10111 NIGB7918C-Trak OmniProbe Shield and collimator for In-111 NIGB7904C-Trak OmniProbe with standard collimator for Tc-99m NIGB7917C-Trak MiniProbe without collimator NIGB7916C-Trak MiniProbe - collimator for Tc-99m NIGB7915C-Trak Automatic Analyzer NIGB7914C-Trak printer and buffer system with cable NIGB7913Tungsten shielding plate NIGB7912C-Trak external LED display with 3m cable NIGB7919Probe cable NIGB7911Footswitch NIGB7910Probe and Analyzer Carrying Case NIGB7909C-Trak OmniProbe custom collimator Lechner 5mm NIGB7908Replacement Co-57 check source Nominal activity: 185kBq, uncalibrated CTRB7874
Accessories
28
Quality Assurance in Nuclear Medicine
Health PhysicsLow energy personal alarm dosimeter – Dose GUARD Plus
Features:
• Photon energy response 17keV to 6MeV• Sensitive to x and γradiation, β particles• Suitable for all commonly used radionuclides (including I-125, I-131,
Tc-99m, …)• Records whole-body and surface dose (Hp(10) and Hp(0.07))• Infra-red communication port available• Uses standard AA batteries
Application/Description:
The new DoseGUARD Plus personal alarm dosimeter has been designedto meet the requirement in hospitals to measure low energy photonsfrom medical X-ray machines and low energy photon emitters (forexample, the photons emitted by I-125 seeds).
The instrument is based on proven technology, and incorporatesmultiple PIN diodes so that the low energy photon and beta dose ratescan be determined. The case is lightweight (95 grams), and isconstructed from high impact ABS / polycarbonate. Protection againstexternal electromagnetic fields is greatly in excess of internationalstandards. The instrument uses a standard AA lithium battery (givingtypically 5 months continuous use) or an AA alkaline battery (typically55 days continuous use).
Audible alarms can be set on dose and dose rate. The alarm volume andpitch can be chosen so that patients are not disturbed if an alarmshould sound. There is also a ‘chirp’ alarm to give a continuous warningif a source is exposed.
The instrument meets the requirements of relevant internationalstandards (IEC1283, ANSI 13.11, 13.27 and 42.20).
Options
DoseGUARD Plus dosimeters use standard IrDA infra-red protocol to communicate with a computer or accesscontrol terminal from up to 1 metre distance. IrDA eliminates the need for special dosimeter readers. This new,fast communication allows issue and return times of under 1 second. An enhanced range of features includesuser settable alarms, with all display options switched via the PC to make the new DoseGUARD Plus as simple orcomplex as the user wishes. The infra-red detector is connected to the serial port of the PC and is supplied withthe neccessary communications software.
29
Quality Assurance in Nuclear Medicine
Technical data
Radiation type: Beta, gamma and X-ray Photon energy range: Hp(10) 17keV to 1.5MeV better than +/- 20%
Hp(10) 1.5MeV to 6MeV better than +/- 30%Hp(0.07) 20keV to 6MeV better than +/- 30%
Dose rate range: up to 4Sv/h Dose range: up to 16SvAccuracy: Hp(10) Cs-137 +/-10%
Hp(0.07) Sr-90 +/-20% Display: Dose or dose rate
Whole body (Hp(10)) or surface (Hp(0.07))Alarms: 2 thresholds on each of dose/ dose rate (Hp(10))Chirp alarm: Can be set from 0.01mSv/chirp to 100mSv/chirpAlarm pitch / volume: High or low tone
7 volume levelsContinuous or intermittent soundMaximum volume 98dBA at 20cm
Power supply: Standard AA lithium battery (typically 5 months continuous use) or standard AA alkaline battery (typically 55 dayscontinuous use)
Dimensions: 85mm x 63mm x 19mm Weight: 93g including battery Case: High impact ABS / polycarbonate blend Clip: High impact plastic, easily renewed, Lanyard
available Operating temperature range: -10 to +40°C Storage temperature range: -25 to +70°CHumidity range: 20% to 90% relative humidity, non-condensing
*) The new DoseGUARD Plus is currently available in North America. For other countries, please enquire.
Ordering information *)
Product code
DoseGUARD Plus NIGB8000IR Connector and software NIGB8001
Availability
Within 2 weeks from receipt of order.
30
Quality Assurance in Nuclear Medicine
Health PhysicsPersonal electronic alarm dosimeter – DoseGUARD™
Application/ Decription
For ensuring doses are as low asreasonably practicable. A robustcost effective instrument, for use
where the low energy response(below 50keV) is not required.
The dose rate or cumulative doseis shown on an LCD display. The
dosimeter is normally used in thestand alone mode using the pre-
set configuration. A moreindividual configuration can be
set by using a reader head whichcan be connected to a PC.
Availability
Within 2 weeks from receipt of order.
Features
• Energy response matches most radionuclides used for diagnosis, therapy and quality control (eg, Tc-99m, In-111, Ga-67, Tl-201, I-131, Ir-192, Co-60, Cs-137)
• Three independent audible alarm systems (dose, dose rate, chirper function)
• Alarms can be switched off to avoid disturbing patients• Robust, splash proof casing• Battery operated using standard AAA size alkaline cell
Options
The DoseGUARD dosimeter canbe configured for particular
applications using a reader headconnected to a PC (not included)
via the serial port. With thereader head it is possible to:
• Prevent a user changingsettings using the pushbutton
• Obtain a hard copy printout ofthe recorded dose
• Prevent a user to reset the doseto zero level and to switch off
the dosimeter
• Customise the alarm settingsand chirp rate.
Technical data
Radiation type: Photons Energy range: 50keV to 3MeV Dose measurement range: 1µSv to 9.99Sv Dose rate measurement range: 5µSv/h to 3Sv/h Calibration accuracy: Better than ±5% at 662keV Dimensions: 78mm x 67mm x 22mm Weight: 80g (including battery)
Ordering information
Product code
Dosimeter DoseGUARD NIGB2000Dosimeter DoseGUARD S10 GB3000*)Dosimeter DoseGUARD S10 (special calibration) NIGB3001*)Reader Head ADR-1 and software ADR-1/50 NIGB4955Calibrated checking device for NIGB3000 and NIGB3001including 3.7MBq Cs-137 source CDRB7000
*) Für Kunden in Deutschland:Das Dosimeter ist unter der Bezeichnung DoseGUARD S10 zur innerstaatlichen Eichung zugelassen undist auch bereits geeicht unter der Bestellnummer NIGB3001 erhältlich. Die zugehörige radioaktiveKontrollvorrichtung wird bereits geeicht geliefert. Weitere Details sind auf Anfrage verfügbar.
31
Quality Assurance in Nuclear Medicine
Technical data
Radiation type: Photons Energy range: 60keV to 1.3MeV Dose measurement range: 0.01µSv to 99.9mSv Dose rate measurement range: 0.01µSv/h to 9.99mSv/h Calibration accuracy: Better than 5% at 662keV Dimensions: 130 x 80 x 29mm Weight: approx. 400g
Ordering information
Product code
Survey instrument 6150AD6 NIGB6001
Alpha-beta-gamma counting tube 6150AD17 with window NIGB4974
Gamma counting tube 6150AD18 (low dose tube) NIGB5945
Belt bag for 6150AD6 NIGB6248
Carry case for 6150AD6 survey meter and counting tube NIGB6242
Features
• Robust, waterproof, housing• Energy response matches most radionuclides used in diagnosis,
therapy and quality control• Analogue and digital display of dose rate• Averaging facility for accurate measurement of very low dose rates• Audible alarms on dose / dose rate
Availability
With 2 weeks from receipt of order.
Health PhysicsSurvey meter
32
Quality Assurance in Nuclear Medicine
Health PhysicsContamination monitors
LB124 - Technical data
• Sensitive detector for gamma/ beta emitting radionuclides• Detector: Sealed Xenon filled proportional counter• Window area: 150cm area, protection grid with 80% transmission• Display: Monochrome LCD 192 x 64pixel, electro-luminescence
illumination• Power supply: 3 batteries type C (LR14)• Stored calibration factors for more than 50 radionuclides• Dimensions: 240mm x 140mm x 110mm• Weight:1620g with batteries
Availability
Please ask for more details andthe availability in your country
via your local distributor or AEATechnology QSA office.
AB100B - Technical data
• Sensitive detector for gamma/ beta emitting radionuclides• Detector: Sealed Xenon filled proportional counter• Window area: 12cm x 19cm• Display:4 digit LCD, backlit by LED’s• Power supply:3 batteries type C (LR14) located in the handle• Stored calibration factors for more than 25 radionuclides• Dimensions: 234mm x 140mm x 126mm• Weight:2200g with batteries
Instrument Product code
Beta/ Gamma contamination monitor AB100B
Wall mounting console including mains power supply LB122W
Sr-90 beta check source (nominal activity 220Bq) SIRB1011
Monitor set, including monitor, wall-mounted console,
power supply, beta check source SIRB5353
Ordering information
Instrument Product code
LB124 contamination monitor NIGB11532
Ordering information
Availability
Please ask for more details andthe availability in your country
via your local distributor or AEATechnology QSA office.
33
Quality Assurance in Nuclear Medicine
Reference sources for surface contamination monitors
Features
• Traceable to national standards• Robust sealed sources• Suitable for functionality testing and calibration
Application
Surface contamination monitors should be checked and calibratedregularly, in accordance with national regulations. The sources shownbelow are a short selection from the wide range available; for furtherdetails, please see the Instrument Calibration catalogue available freeof charge from your local representative.
CoMo170 - Technical Data
• Sensitive detector for alpha/beta and gamma emitting radionuclides
• Detector type: thin-layer plastic scintillation detector with ZnS coating
• Detector size: 170cm2
• Display: large-area, graphical LC display 128 x 64pixels,with illumination
• Dimensions: 280mm x 125mm x 135mm• Weight: approx. 750g with batteries• Power supply: 2 batteries, Type AA (LR6) or corresponding
rechargeable batteries (NiCd, NiMH)
Ordering information
Instrument Product code
CoMo 170 Contamination monitor NIGB9820
Availability
Please ask for more details andthe availability in your country
via your local distributor or AEATechnology QSA office.
Activearea
Ø 25
Ø 16
3.0
34
Quality Assurance in Nuclear Medicine
ISO classification
C.34645Drawings: VZ-626 and VZ-1366
Reference sources for surface contamination monitors
Construction
The activity is homogeneously incorporated into the anodized surfaceof an 0.3mm thick aluminium foil. The foil is mounted on an aluminium backing plate, 3mm thick. The source is calibrated by theGerman National Calibration Service (DKD) and is supplied with a DKDcertificate of measurement.
Availability
Within 6 weeks of receipt of order.
Ordering information – rectangular type sources
Radionuclide Nominal activity Appoximate particle Beta end-point Product code[kBq] emission rate [1/s] energy [MeV]
Co-57 3 0.122 (gamma) CTR06032I-129 3 0.297 (gamma) ISRB5895I-129 10 ISRB4180C-14 1 380 0.157 CFR06022Tc-99 1 490 0.294 TCR06022
Ordering information – disc type sources
Radionuclide Nominal activity Product code
Co-57 3kBq CTR01032I-129 1.85kBq ISR5016
3.0
100.0
120.0120.0
100.0
Activity
35
Quality Assurance in Nuclear Medicine
Experiments that can be performed include:• The statistics of radioactive decay• Measuring the plateau of a detector• Determining the half life of Ba-137m• The absorption of gamma-rays in lead• The inverse square law• Estimating the activity of a radioactive source
A complete demonstration setincluding a radionuclide
generator has been developedby AEA Technology QSA for
illustrating the properties ofradioactivity in laboratorycourses and school lessons.
The ratemeter can be connectedto a PC via a serial port. All
experiments can be performedusing the PC.
AktivLab™Demonstration set for experiments on radioactivity
Ordering information
Instrument Product code
AktivLab CDRB5645
36
Quality Assurance in Nuclear Medicine
General information
Applications
The sources in this catalogue areintended for quality control of
measurement devices andequipment in nuclear medicine
departments.The applications of the sources
are described in each section.
Certification
Each source is supplied with a certificate which states:• Reference time and date• Nominal activity of radionuclide• ISO Classification of source• Source serial number• Results and date of leakage test• Measured activity (calibrated sources only)• Overall uncertainty (calibrated sources only)
Uncertainties
Reported is the expandeduncertainty U=k*uc, with U
determined from a combinedstandard uncertainty uc (ie.
estimated standard deviation)and a coverage factor k=2.U=2uc defines an interval
having a level of confidence ofapproximately 95%.
Traceability
The sources are traceable tostandards held by national
laboratories such as thePhysikalisch-Technische
Bundesanstalt (Germany), theNational Physical Laboratory
(UK), the National Institute ofStandards and Technology
(USA), the Bureau National deMétrologie - LaboratoireNational Henri Becquerel(France), and many other
countries world-wide.
Quality assurance and quality control
The sources are calibrated at AEA Technology´s DKD accreditedmeasurement laboratory in Braunschweig, Germany. Themanufacturing facility operates a Quality Management System whichhas been independently audited and approved to ISO9001:2000.
CE Marking
All medical devices and accessories to medical devices sold in Europemust comply with the Council Directive 93/42/EEC of 14th June 1993(as enacted in national regulations).
The directive classifies medical devices in four classes I, IIa, IIb and III.The classification depends on the intended purpose of the device and isbased on the vulnerability of the human body taking account of thepotential risks associated with the technical design and manufacture ofthe devices. The conformity assessment for class I devices can be carriedout under the sole responsibility of the manufacturer whereas class IIand class III need the intervention of a Notified Body.
To indicate conformity with the directive, the devices should bear theCE mark.
AEA Technology’s radiation sources for quality assurance in nuclearmedicine have always been manufactured according to the latestquality standards and also comply with the new European regulationsand are CE marked.
According to the classification rules of the directive the radiationsources concerned are classified as class I medical devices. The CE markappears on the outer packaging and on the sealed source certificate(test report).
A conformity declaration is available on request.
Ordering information
Please see page 40f.
Recommended working life(RWL)
The Recommended working life(RWL) is the maximum period
within AEAT expects the sourceto meet it’s design requirementsunder proper conditions of envi-
ronment and usage. A sourceshould be replaced within the
RWL or a proper assessmentshould be made to verify it‘s sui-
tability for continued use.
37
Quality Assurance in Nuclear Medicine
ISO classification
The International Organization for Standardization (ISO) has proposeda system of classification of sealed radioactive sources based on thesafety requirements for typical uses (see ISO2919:1999). This systemprovides a manufacturer of sealed radioactive sources with a set oftests to evaluate the safety of his products. It also assists a user of suchsealed sources to select types which suit the application in mind. The tests to which specimen sources are subjected are listed in thefollowing table.Each test can be applied in several degrees of severity. Test results areexpressed as a five figure code to indicate the severity of the tests.These figures are preceded by the letter C or E to show whether thesource activity is less than or greater than certain limits. These limitsdepend upon the toxicity, solubility and reactivity of the activecomponent of the source.C indicates that the activity level of the source does not exceed theprescribed limit andE that the limit is exceeded.
Test Class 1 Class 2 Class 3 Class 4 Class 5 Class 6
Temperature No test -40oC (20min) -40oC (20min) -40oC (20min) -40oC (20min) -40oC (20min)+80oC (1h) +180oC (1h) +400oC (1h) +600oC (1h) +800oC (1h)
and thermal shock and thermal shock and thermal shock400oC to 20oC 600oC to 20oC 800oC to 20oC
External No test 25kPa absolute 25kPa absolute to 25kPa absolute to 25kPa absolute to 25kPa absolute topressure to atmospheric 2MPa absolute 7MPa absolute 7MPa absolute 170MPa absolute
Impact No test 50g from 1m 200g from 1m 2kg from 1m 5kg from 1m 20kg from 1m
Vibration No test 3 x 10min 3 x 10min 3 x 30min25kHz to 500Hz 25Hz to 50Hz 25Hz to 80Hzat 5g peak at 5g peak at 1.5mm amplitude amplitude and amplitude peak
50Hz to 90Hz to peak andat 0.635mm 80Hz to amplitude peak 2000Hz at 20gto peak and 90Hz peak amplitudeto 500Hz at 10g peak amplitude
Puncture No test 1g from 1m 10g from 1m 50g from 1m 300g from 1m 1kg from 1m
Technical appendicesQuality control
Classification of sealed radioactive source performance standards according to ISO 2919
38
Quality Assurance in Nuclear Medicine
Quality control
Leakage and contaminationtests
Stringent tests for leakage are anessential feature of radioactive
sources production. They arebased on ISO9978. Some
standard methods used fortesting radiation sources are
listed.
Wipe test I (A)
The source is wipedwith a swab or tissue,moistened withethanol or water; theactivity removed ismeasured.
Limit 185Bq
Immersion test II (L)
The source isimmersed in asuitable liquid at 50°Cfor 4 hours and theactivity removed ismeasured.
Limit 185Bq
Nuclear decay scheme data for selected radionuclides
Radionuclide half-life Decay mode Beta energy Intensity Photonenergy Intensity[MeV] [%] [MeV] [%]
Co-57 271.4d ec 100.0 0.014 9.60.122 85.50.136 10.70.692 0.2
Ge-68 270.82d ec 100.0 0.009 - 0.010 44% X-rays
via Ga-68 1.13h ec 11.0 1.077 3.0in equilibrium β+ 0.822 1.0
1.899 88.0
Mo-99 2.75d β- 0.436 16.6 0.041 1.10.848 1.2 0.140 4.91.214 82.0 0.181 6.1
0.366 1.20.740 12.20.778 4.3
via Tc-99m 6.02h it 100.0 0.140 89.0in equilibrium
Tc-99m 6.02h it 0.140 89.00
I-125 60.1d ec 100.0 0.035 6.70.028 140% X-rays
I-129 1.57x107y β- 0.150 100.0 0.040 7.50.030 65% X-rays
39
Quality Assurance in Nuclear Medicine
Nuclear decay scheme data for selected radionuclides
Radionuclide half-life Decay mode Beta energy Intensity Photonenergy Intensity[MeV] [%] [MeV] [%]
I-131 8.04d β- 0.248 2.1 0.080 2.60.304 0.6 0.284 6.10.334 7.4 0.364 81.20.606 89.4 0.637 7.30.807 0.4 0.723 1.8
via Xe-131m 11.9d it 100.0 0.164 2.0
Ba-133 10.52y ec 100.0 0.053 2.20.080 2.60.081 34.10.161 0.60.223 0.40.276 7.20.303 18.30.356 62.10.384 8.9
Cs-137 30.00y β- 0.512 94.61.173 5.4
via Ba-137m 2.55m it 0.662 85.1in equilibrium 0.033 7% X-rays
Gd-153 242.0d ec 100.0 0.070 2.40.075 0.10.083 0.20.089 0.10.097 29.50.103 21.1
Tl-201 3.04d ec 100.0 0.031 0.30.032 0.30.135 2.80.166 0.20.167 10.6
Quality control
40
Quality Assurance in Nuclear Medicine
Ordering information
For customers in North America
In the USA and Canada persons or organizations purchasing, possessing,processing, using or selling radioactive materials must be licensed by anational authority and/or state government agency. Users ofradioisotopes should familiarize themselves with all applicableregulations. In the United States, a person who wishes to employradioactive material must possess an appropriate USNRC or AgreementState, or Licensing State License. In Canada all users must possess an CNSC license.The licensing of radioactive material in the United States is handled bymore than one regulatory agency; the regulatory agency that hasjurisdiction in any particular instance depends on the type of radioactivematerial.The Nuclear Regulatory Commission (NRC), a federal agency, hasjurisdiction for the types of radioactive materials known as by-product,source and special nuclear material. The NRC may delegate this authorityto states that have developed programs that meet NRC guidelines.These states are commonly known as ‘Agreement States’.There is another broad category of radioactive material which is notregulated by the NRC. It is known as ‘NARM’ – Naturally-occuring andAccelerator-produced Radioactive Materials. Regulations on thelicensing and use of NARM are published and enforced by individualstates. Examples of some NARM nuclides are cobalt-57, sodium-22,yttrium-88, radium-226 and bismuth-207.AEA Technology QSA must have written certification that a customer ispermitted to possess the type, form and quantity of radioactive materialbeing ordered. This information or the customer’s license or registrationnumber, name of the licensing agency and expiration date of thelicensing document must be on file before a shipment of radioactivematerial can be made.An address listing of federal and state licensing authorities can beobtained by contacting AEA Technology QSA.In Canada purchasers of radioactive material should possess aradioisotope license which can be obtained from:
A l’attention des clients francais
La fabrication des sources parAEA Technology QSA est faite
sous programme assurancequalité certifié par le label
ISO9001-1994. Une copie ducertificat délivré par un
organisme indépendant estdisponsible sur simple demande.
Pour la France uniquement:Toute commande livrable en
France est soumise àl’approbation de la CIREA et doit
être accompagnée d’uneDemande de Fournitures
dûment complétée et signée,exceptions faites des
établissements du C.E.A et quelque soit l’établissement, des
sources scellées d’activitéinférieure aux limites du décretde 1986 (EURATOM). Il en est demême des sources non scellées.
Conditions Particulièresd’Autorisation:
en sont dispensées les sourcesscellées d’activité inférieure à
5kBq (groupe 1), 5MBq (groupe2 et 3), 50MBq (groupe 4) àusage d’étalonnage ou de
calibration.
N’hésitez pas à contacter AEATechnology QSA France si vous
avez des doutes.
FranceAEA Technology QSA
12 avenue des TropiquesHightec Sud-Bâtiment B
Courtaboeuf Cedex 91955
Téléphone: 01 64 86 22 22Télécopie: 01 69 86 10 65e-mail: jeanrene.caramelle
@aea-technology.fr
Canadian Nuclear SafetyCommission280 Slater StreetP.O. Box 1046Ottawa, Canada K1P559Tel.: (613) 995-5894Fax: (613) 992-2915e-mail: [email protected]
United States & CanadaAEA Technology QSA, Inc.40 North AvenueBurlington, MA 01803Tel.: (781) 272-2000Fax: (781) 359-9179Toll-free: (888) 272-2242
41
Quality Assurance in Nuclear Medicine
For customers in other countries
In most countries regulations exist which control the use of radioactivematerials. Users or potential users of AEA Technology´s Isotrakstandardized solutions or other reference sources must ensure thatthey fully understand and comply with their local regulations beforeplacing any order with AEA Technology QSA or its local representative.
AEA Technology QSA is represented in most countries worldwide. Ifyou do not know your local AEA Technology QSA representative,please enquire via one of the above-mentioned sales offices.
Für Kunden in Deutschland
Voraussetzungen für den Bezugvon radioaktiven Stoffen:
Der Umgang mit radioaktivenStoffen ist in der BundesrepublikDeutschland gemäß Atomgesetz
genehmigungspflichtig. DieGenehmigungsbedingungen für
den Umgang mit den in diesemKatalog aufgeführtenProdukten sind in der
Strahlenschutzverordnung(StrlSchV) in der jeweils gültigen
Fassung geregelt.Für den Bezug von Produkten,mit denen nur aufgrund einer
Genehmigung umgegangenwerden darf, senden Sie uns
bitte mit der ersten Bestellungeine Kopie Ihrer gültigen
Umgangsgenehmigung zu.Verfügen Sie über keine
Umgangsgeneh-migung undmöchten Produkte beziehen, für
die der Umganggenehmigungspflichtig ist,
informieren wir Sie gern überdie für Sie zuständige
Aufsichtsbehörde und sind beider Beantragung einer
Umgangsgenehmigungbehilflich.
For customers in the UK
Anyone possessing, transporting, selling or using radioactive materialmust ensure that they fully comply with The Radioactive SubstancesAct 1993 (RSA’93) and The Ionising Radiations Regulations 1999(IRRs’99).
Prior to receiving and using radioactive material, users will normallyrequire a registration from the Environment Agency. Some categoriesof low activity sealed reference sources used for checking and testingmeasurement instruments are exempt from registration under RSA’93.Details can be found in The Radioactive Substances (TestingInstruments) Exemption Order 1985.
Other categories of radioactive substances of low activity used ineducational establishments may also be exempt from registrationunder RSA’93. Details can be found in The Radioactive Substances(Schools etc.) Exemption Order 1963.
New users should also normally notify their local office of The Healthand Safety Executive (HSE) prior to undertaking work with radioactivematerial for the first time. For small quantities of radioactivity,notification may not be necessary. For details of notification limits,users should refer to Schedule 1 and Schedule 8 of the IRRs’99.
If users or potential users of AEA Technology’s Isotrak™ products are inany way unclear about whether registration and notification of use isrequired, they should contact their local Environment Agency office, orAEA Technology QSA for advice.
Ordering information
42
Quality Assurance in Nuclear Medicine
Notes
43
Quality Assurance in Nuclear Medicine
Notes
44
Quality Assurance in Nuclear Medicine
Notes
SwedenLaborel SverigeKungsgatan 109SE-753 18 Uppsala
tel +46 18 14 83 00fax +46 18 14 83 01
NorwayLaborel ASCaspar Stormsvei 2Postboks 109 Alnabru0614 Oslo
tel +47 2305 1930fax +47 2263 0751
FinlandSonar OyTaivalmäki 11Niittykumpu02201 Espoo
tel +358 9 542 5420fax +358 9 452 2523
Distributors for isotrak products
AustriaMedPro Vertrieb für medizinisch-diagnostische Produkte GesmbHGersthofer Str. 91180 Viennatel +43 1 479 15690fax +43 1 479 835217
Netherland / DenmarkCanberra Eursiys Benelux NVResearch ParkPontbeeklaan 57B-1731 ZellikGeneral +32 2 481 8530tel NL +31 (0) 187 63 0176fax NL +31 (0) 187 63 05850tel DK +43 69 9051fax DK +31 (0) 187 63 0580
SwitzerlandUehlinger Pfiffner AGPicardiestraße 35040 Schöftland
tel +41 62 721 2281fax +41 62 721 5170
United KingdomHigh Technology Sources Ltd.Unit 6, MoorbrookSouthmead Industrial EstateDidcot, OxfordshireOX11 7HPtel +44 1235 514 200fax +44 1235 514 219
JapanChiyoda Technol Corporation7 - 12, 1-chomeYushima Bunkyo-kuTokyo, 113 - 8681tel +81 3 3816 7965fax +81 3 5803 1939
KoreaHan Mac Engineering Co. Ltd.305-335, 451-7, 2F Gung-dongYusung-Gu, DeajeonSouth Koreatel +82 42 822 7315fax +82 42 822 7316
TaiwanKerma Inc.1-5, Alley 2, Lane 129Ershjung Road, ShindianTaipei 231tel +886 2 8667 5320fax +886 2 8667 5321
Belgium / LuxemburgCanberra Packard Benelux N.V./S.A.Research ParkPontbeeklaan 571731 Zelliktel +32 (0) 2 481 8530fax +32 (0) 2 481 8550
PolandBiker Ltd.ul. Sekocinska 3 m 202-313 Warszawa
tel +48 22 823 3269fax +48 22 823 3269
Czech Republic/ Slowac RepublicM.G.P. spol. s.r.o. (Ltd)Kvitkova 157576001 Zlin
tel +420 67 721 1539fax +420 67 721 1724
HungaryIzotop - Institute of Izotopes Co., LtdKonkoly Thege M. ut. 29-331121 Budapest
tel +36 1 39 10 815fax +36 1 39 59 247
BulgariaElectroncommerce LtdSamokovsko Shose 11738 Sofia
tel +352 9 75 4106fax +352 9 75 3360
Croatia / Slovenia / RomaniaBiomedica Ges.mbHOffice GrazKärntner Str. 1878053 Graztel +43 316 38 1782fax +43 316 38 17823
ItalyCampoverde SRLVia Quintiliano 31Milan20138
tel +39 02 5803 9020fax +39 02 5803 9021
SpainNuclear IbericaHierro 928045 Madrid
tel +34 91 530 6611fax +34 91 539 4330
EireParlamar Ltd.33 GranitefieldRochestown AvenueDun LoaghaireDublintel +353 1 285 3659fax +353 1 285 4338
New ZealandLife Sciences New Zealand Ltd.PO Box 33 109TakapunaAukland 9tel +64 9 480 7775fax +64 9 480 7757
AustraliaANSTO Australian RadioisotopesLucas HightsMenaiNew South Walestel +61 2 9717 3111fax +61 2 9543 7179
Please contact the German salesoffice of AEA Technology QSA.
Other countries
MexicoVicont, S.A. de C.V.Cuauhtemoc No. 178Col. El Carmen TotoltepecToluca, Edo. de MexicoC.P. 50200tel +527 2221 16041 fax +527 2221 65770
IsraelEldan Electronic instruments6 Hashiloch st.Kiryat MatalonPetach Tikvatel +972 3 9371 154fax +972 3 9371 144
Saudi ArabiaAbdulla Fouad Company LimitedP.O. Box 257Damman 31422
tel +966 3 834 0032fax +966 3 835 1181
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AEA Technology QSA offices
United KingdomHeadquarter AEA Technology QSA329 HarwellDidcotOxfordshire OX 11 0QJ
USASales Office for: North and South America,Middle East, Australia,New ZealandAEA Technology QSA Inc.40 North AvenueBurlington, MA 01803tel +1 (888) 272 2242, Ext. 259tel +1 (781) 505 8259 fax +1 (781) 359 9179
China / Hong KongSouth East Asia Sales OfficeAEA Technology QSA Inc.Suite 3503, 35 / FloorChina Resources Building26, Harbour Roadtel +852 2596 7711tel +852 2596 7722fax +852 2586 1600
FranceSouthern European Sales OfficeAEA Technology QSA12 avenue des TropiquesHightec Sud - Bâtiment BF 91955 Courtaboeuf Cedextel +33 (0) 1 64 86 22 22fax +33 (0) 1 69 86 10 65
GermanySales Office for:Europe, Africa, India, JapanAEA Technology QSA GmbHGieselweg 1D-38110 Braunschweigtel +49 (0) 5307 932 555fax +49 (0) 5307 932 194
AEA Technology QSA’s radiation sources business brands:
ISOTRAK™ • Calibration sources • Sources for Nuclear medicine• Calibration Service• Instruments for measuring radioactivity
SOURCES™ • Radiation sources• Industrial applications• Smoke detectors
SENTINEL™ • Products and services for non-destructive testing
Internet: http://www.isotrak.dehttp://www.aeat-qsa.com
Email: [email protected]
© AEA Technology plc 2004. All rights reserved.AEA Technology plc. AEA Technology QSA, 329 Harwell, Didcot, Oxfordshire OX11 0RA,United KingdomAll goods and services are sold subject to the terms and conditions of sale ofthe company within the AEA Technology group which supplies them. A copy of these terms and conditions is available on request.
isotrak, AktivLab, C-Thru DoseGUARD and DoseGUARD Plus are trademarksof AEA Technology plc..C-Trak is a registered trademark of CareWise Medical Products.OmniProbe and MiniProbe are trademarks of CareWise Medical Products.ECAT is a registered trademark of CTI PET Systems, Inc. (CPS).ART is a trademark of CTI PET Systems, Inc. (CPS).E.CAM and ECAT EXACT are trademarks of Siemens Medical Systems, Inc..Theracap is a trademark of Amersham Health plc..