ASTM D7282-06
(Practice)Standard Practice for Set-up, Calibration, and Quality Control of Instruments Used for Radioactivity Measurements
Standard Practice for Set-up, Calibration, and Quality Control of Instruments Used for Radioactivity Measurements
SIGNIFICANCE AND USE
This practice is consistent with a performance-based approach wherein the frequency of re-calibration and instrument testing is linked to a laboratory’continuing performance with its quality control results. Under the premise of this practice, a laboratory demonstrates that its instrument performance is acceptable for analyzing sample test sources.
When a laboratory demonstrates acceptable performance based on continuing instrument quality control data (that is, QC charts), batch QC samples (that is, blanks, laboratory control samples, replicates, matrix spikes, and other batch QC samples as may be applicable) and independent reference materials, traditional schedule-driven instrument recalibration is permissible but unnecessary.
When continuing instrument QC, batch QC, or independent reference material sample results indicate that instrument response has exceeded established control or tolerance limits, instrument calibration is required. Other actions related to sample analyses on the affected instruments may be required by the laboratory QM.
The data obtained while following this Practice will most likely reside in computer storage. This data remains in the computer storage where it is readily retrievable and as necessary is used to produce plots, graphs, spreadsheets and other types of displays and reports. Frequency and performance of data storage backup should be specified in the laboratory QM.
SCOPE
1.1 This practice covers consensus criteria for the calibration and quality control of nuclear instruments. This practice is provided for establishing appropriate quality control parameters at instrument startup, calibration of nuclear counting instruments and the continuing monitoring of quality control parameters. Calibrations are usually performed to establish the operating parameters of the instrument. This practice addresses the typically used nuclear counting instruments: alpha spectrometer, gamma spectrometer, gas proportional counter and liquid scintillation counter.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Standards Content (Sample)
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Designation: D7282 − 06
StandardPractice for
Set-up, Calibration, and Quality Control of Instruments Used
for Radioactivity Measurements
This standard is issued under the fixed designation D7282; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope ANSI N42.22 Traceability of Radioactive Sources to the
National Institute of Standards and Technology (NIST)
1.1 This practice covers consensus criteria for the calibra-
and Associated Instrument Quality Control
tion and quality control of nuclear instruments.This practice is
ANSI N42.23 Measurement andAssociated Instrumentation
provided for establishing appropriate quality control param-
Quality Assurance for Radioassay Laboratories
eters at instrument startup, calibration of nuclear counting
ANSI/HPS N13.30 Performance Criteria for Radiobioassay
instruments and the continuing monitoring of quality control
parameters. Calibrations are usually performed to establish the
3. Terminology
operating parameters of the instrument.This practice addresses
3.1 Definitions of Terms Specific to This Standard:
the typically used nuclear counting instruments: alpha
3.1.1 acceptable verification ratio (AVR)—ratio of the dif-
spectrometer, gamma spectrometer, gas proportional counter
ference between measured value of the verification sample and
and liquid scintillation counter.
the known value added to the verification sample to the square
1.2 The values stated in SI units are to be regarded as
root of the sum of the squares of their associated combined
standard. No other units of measurement are included in this
standard uncertainties. See Eq 10 in 16.2.13.
standard.
3.1.2 background subtraction count (BSC)—a source count
1.3 This standard does not purport to address all of the
used to determine the background to be subtracted from the
safety concerns, if any, associated with its use. It is the
sample test source count.
responsibility of the user of this standard to establish appro-
3.1.3 calibration—determining the instrument response to a
priate safety and health practices and determine the applica-
known amount of radioactive material.
bility of regulatory limitations prior to use.
3.1.4 calibration source (CS)—a known quantity of radio-
2. Referenced Documents
activematerial,traceabletoanationalstandardsbody,prepared
for the purpose of calibrating nuclear instruments.
2.1 ASTM Standards:
D1129 Terminology Relating to Water
3.1.5 continuing instrument quality control—measurements
D3648 Practices for the Measurement of Radioactivity
takentoensurethataninstrumentrespondsinthesamemanner
D4375 Practice for Basic Statistics in Committee D19 on
subsequent to its calibration.
Water
3.1.6 instrument check source (ICS)—a radioactive source,
2.2 Other Standards:
not necessarily traceable to a national standards body, that is
ISO/IEC 17025 General Requirements for the Competence
used to confirm the continuing satisfactory operation of an
of Testing and Calibration Laboratories
instrument.
ISO 1995 Guide to the Expression of Uncertainty in Mea-
3.1.7 instrument contamination check (ICC)—a measure-
surement
ment to determine if a detector is contaminated with radioac-
tivity.
This practice is under the jurisdiction ofASTM Committee D19 on Water and 3.1.8 instrument quality control chart—a chart developed to
is the direct responsibility of Subcommittee D19.04 on Methods of Radiochemical
evaluate the response of an instrument to predetermined,
Analysis.
statistically based limits.
Current edition approved Dec. 15, 2006. Published January 2007. DOI: 10.1520/
D7282-06.
3.1.9 instrument quality tolerance limit—a limit established
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
to evaluate the acceptable response of an instrument.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3 4
Available from International Organization for Standardization (ISO), 1 rue de Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland, http://www.iso.ch. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
D7282 − 06
3.1.10 known value (KV)—known value of the analyte 5. Significance and Use
activity added to the verification sample. See Eq 7 in 16.2.11.
5.1 This practice is consistent with a performance-based
3.1.11 mean and standard deviation—see Practice D4375.
approach wherein the frequency of re-calibration and instru-
ment testing is linked to a laboratory’s continuing performance
3.1.12 measured value (MV)—measured value of the veri-
with its quality control results. Under the premise of this
fication sample. See Eq 4 in 16.2.9.
practice, a laboratory demonstrates that its instrument perfor-
3.1.13 measurement quality objective (MQO)—quantitative
mance is acceptable for analyzing sample test sources.
or qualitative statement of a performance objective or require-
5.2 When a laboratory demonstrates acceptable perfor-
ment for a particular method performance characteristic (1).
mance based on continuing instrument quality control data
3.1.14 national standards body—an organization such as
(that is, QC charts), batch QC samples (that is, blanks,
National Institute of Standards and Technology (NIST) or
laboratory control samples, replicates, matrix spikes, and other
another national standards body that provides standards trace-
batch QC samples as may be applicable) and independent
able to BIPM (Bureau International des Poids et Mesures
reference materials, traditional schedule-driven instrument
(International Bureau of Weights and Measures)). Traceability
recalibration is permissible but unnecessary.
is accomplished with guidance from ANSI N42.22.
5.3 When continuing instrument QC, batch QC, or indepen-
3.1.15 quality manual (QM)—a document stating the man-
dent reference material sample results indicate that instrument
agement policies, objectives, principles, organizational struc-
response has exceeded established control or tolerance limits,
ture and authorities, accountability, and implementation of a
instrument calibration is required. Other actions related to
laboratory’s quality system, to assure the quality of its data.
sample analyses on the affected instruments may be required
3.1.15.1 Discussion—The quality manual shall document
by the laboratory QM.
the process by which appropriate analytical methods are
selected, their capability is evaluated and their performance is
5.4 The data obtained while following this Practice will
documented. The analytical methods manual and standard
mostlikelyresideincomputerstorage.Thisdataremainsinthe
operating procedure manuals shall be part of but not necessar-
computer storage where it is readily retrievable and as neces-
ily included in the quality manual. The quality manual or
sary is used to produce plots, graphs, spreadsheets and other
standard operating procedures, or both, shall also include
types of displays and reports. Frequency and performance of
instructionsthatprescribecorrectiveaction,forexample,inthe
data storage backup should be specified in the laboratory QM.
eventofinstrumentchecksource(ICS),orinstrumentcontami-
6. Hazards
nationcheck(ICC),orbackgroundsubtractioncount(BSC),or
a combination thereof, failure.
6.1 The vendor supplied safety instructions and laboratory
safety regulations should be consulted before using electronic
3.1.16 relative standard deviation (RSD)—relative standard
and electrical equipment.
deviationofthemeanexpressedasapercentage(alsoknownas
coefficient of variation). See Practice D4375 and 16.2.7.
6.2 Corrosive, flammable, reactive and toxic materials may
3.1.17 sample test source (STS)—a sample, sample aliquant,
be used when performing some steps in this practice. Be
or final product of a chemical or physical process prepared for cognizant of hazards involved with all materials and processes
the purpose of activity determination.
employed and comply with any and all applicable health and
safety procedures, plans and regulations. Material Safety Data
3.1.18 working calibration source (WCS)—a calibration
Sheets are a source of information.
source (see 3.1.4), including those diluted or prepared by
chemical procedure for the purpose of calibrating an instru-
INSTRUMENT SET-UP
ment.
7. Scope
3.2 Fordefinitionofothertermsusedinthispracticereferto
Terminology D1129.
7.1 Instructionsareprovidedforinitialset-upofinstruments
usedforactivitymeasurements.Theseinstructionsmayalsobe
4. Summary of Practice
applied when the operating parameters of an instrument are
being reestablished.
4.1 This practice summarizes information and guidance for
set-up, calibration and quality control for nuclear counting
8. Significance and Use
instruments. The procedure is divided into four main sections:
8.1 Successful set-up of an instrument and its subsequent
Introduction Sections 1 through 6
Instrument set-up Sections 7 through 9 routine use depend, at least in part; on how well the manufac-
Initial instrument quality control Sections 10 through 13
turer’s instructions are written and followed. Thus the manu-
testing
facturer’s recommendations are an integral part of this process.
Calibration Sections 14 through 19
Continuing instrument quality Sections 20 through 25 Success also depends on how well the laboratory has planned,
control testing
developed and documented its own protocol for instrument use
and how well personnel are trained.
9. Instrument Set-up
The boldface numbers in parentheses refer to the list of references at the end of
this standard. 9.1 Gas Proportional Counting Initial Instrument Set-up:
D7282 − 06
9.1.1 Upon initial set-up, after major repair or service, or has changed, an investigation into the potential impact of the
when QC results indicate the need to reestablish operating changes shall be conducted and appropriate corrective action
taken.
parameters for an instrument, measure a suitable calibration
source (that is, ICS or WCS) as specified in the laboratory QM 9.2.3 Establish the energy range for the spectrometer to
and/or manufacturer’s protocol to confirm that the instrument include all gamma emission energies of interest to the labora-
tory. Adjust the amplifier gain, ADC range, or equivalent
responds according to QM or manufacturer’s specifications.
digitalspectrometersettings,toestablishthedesiredenergyper
The instrument set up and initial calibration records should be
channel relationship. When the instrument operational param-
maintainedperapplicablerecordrequirements.ISO/IEC17025
eters are satisfactorily established, record the instrument set-
includes information regarding the type of records to save.
tings for future reference.
9.1.2 Iftheinstrumentbeingconfiguredhaspreviouslybeen
used to generate sample test source results, the “as-found”
9.3 Alpha Spectrometry Initial Instrument Set-up:
instrumentsettings(thatis,operatingvoltageanddiscriminator
9.3.1 Upon initial set-up, after major repair or service, or
settings) should be recorded and compared to previous “as-
when QC results indicate the need to reestablish operating
left” parameters to ensure that instrument configuration has
parameters for an instrument, measure a suitable calibration
been maintained. If the instrument configuration has changed,
source (that is, ICS or WCS) as specified in the laboratory QM
an investigation into the potential impact of the changes shall
and/or manufacturer’s protocol to confirm that the instrument
be conducted and appropriate corrective action taken.
responds according to QM or manufacturer’s specifications
(for example, bias voltage setting, full-width at half maximum
9.1.3 Establish appropriate instrument operational param-
resolution, detector efficiency and background). The instru-
eters for the intended measurements. For example, acquire
ment set-up and initial calibration records should be main-
voltage plateaus and establish the alpha or beta, or both,
tained per applicable record requirements. ISO/IEC 17025
plateauoperatingvoltages,andalphaorbeta,orboth,discrimi-
includes information regarding the type of records to save.
nator settings (that is, adjust for crosstalk). Instrument set up
9.3.2 Iftheinstrumentbeingconfiguredhaspreviouslybeen
and configuration should be optimized for the intended appli-
used to generate sample test source results, the “as-found”
cations. For example, it may be desirable to perform voltage
instrument settings (for example, detector bias) should be
plateaus and optimize discriminator settings using a distributed
recorded and compared to previous “as-left” parameters to
source or a specific radionuclide (for example, a 2-in. diam-
230 ensure that instrument configuration has been maintained. If
eter Th source as opposed to a point source contain-
the instrument configuration has changed, an investigation into
ing Po) when intended applications use a different source
the potential impact of the changes shall be conducted and
geometry or radionuclide. If instrument set-up and configura-
appropriate corrective action taken.
tion deviates from the defaults recommended by the manufac-
9.3.3 Establish the energy range for the spectrometer to
turer, the configuration and procedure to be used shall be
includeallalphaemissionenergiesofinteresttothelaboratory.
specified in detail in the laboratory QM. Operating parameters
Adjust the amplifier gain andADC range, or equivalent digital
should be established to produce consistency in detection
spectrometer settings, to establish the desired energy per
characteristics across multiple detectors used for a common
channel relationship. When the instrument operational param-
application. When the instrument operational parameters are
eters are satisfactorily established, record the instrument set-
satisfactorily established, record the “as-left” instrument set-
tings for future reference.
tings for future reference.
9.4 Liquid Scintillation Counting Initial Instrument Set-up:
9.2 Gamma Spectrometry Initial Instrument Set-up:
9.4.1 Upon initial set-up, after major repair or service, or
9.2.1 Upon initial set-up, after major repair or service, or
when QC results indicate the need to reestablish operating
when QC results indicate the need to reestablish operating
parameters for an instrument, measure a suitable
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