ASTM C1156-03
(Guide)Standard Guide for Establishing Calibration for a Measurement Method Used to Analyze Nuclear Fuel Cycle Materials
Standard Guide for Establishing Calibration for a Measurement Method Used to Analyze Nuclear Fuel Cycle Materials
SIGNIFICANCE AND USE
Calibration is a fundamental part of making measurements and its effect on the quality of measurement data is significant. Thus, sufficient attention must be given to calibration when it is established for a measurement method so that the data produced will be acceptable. The use of an inappropriate calibration standard, inadequate instructions for calibration, and poor documentation of the calibration process are examples of circumstances that can adversely affect the validity of a calibration. Thus, the calibration process must conform to criteria established to ensure the validity of calibration results. Such criteria are given in Guide C 1009, in which calibration is identified as a component of laboratory quality assurance (see Fig. 1). This guide expands upon those criteria to provide more comprehensive guidance for establishing calibration.
The manner of calibration and other technical requirements for calibrating a measurement method are usually established when a method is first introduced into a laboratory, which may be through validation and qualification as defined by Guide C 1068 (see Fig. 1). However, calibration involves more than the technical aspects of the calibration process. The other dimension of the process is the operational requirements that are necessary to ensure that calibration results are valid and that they are documented and verifiable should their integrity be questioned. The provisions of this guide provide those operational requirements and should be considered whenever calibration is planned and established.
FIG. 1 Quality Assurance of Analytical Laboratory Data
SCOPE
1.1 This guide provides the basis for establishing calibration for a measurement method typically used in an analytical chemistry laboratory analyzing nuclear materials. Guidance is included for such activities as preparing a calibration procedure, selecting a calibration standard, controlling calibrated equipment, and documenting calibration. The guide is generic and any required technical information specific for a given method must be obtained from other sources.
1.2 The guidance information is provided in the following sections:SectionGeneral Considerations4Calibration Procedure5Calibration Standard6Control of Calibrated Equipment7Documentation8Keywords9
1.3 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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Designation:C1156–03
Standard Guide for
Establishing Calibration for a Measurement Method Used to
1
Analyze Nuclear Fuel Cycle Materials
This standard is issued under the fixed designation C1156; 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 C1210 Guide for Establishing a Measurement System
Quality Control Program for Analytical Chemistry Labo-
1.1 Thisguideprovidesthebasisforestablishingcalibration
ratories Within the Nuclear Industry
for a measurement method typically used in an analytical
C1215 Guide for Preparing and Interpreting Precision and
chemistry laboratory analyzing nuclear materials. Guidance is
Bias Statements in Test Method Standards Used in the
included for such activities as preparing a calibration proce-
Nuclear Industry
dure, selecting a calibration standard, controlling calibrated
C1297 Guide for Qualification of Laboratory Analysts for
equipment, and documenting calibration. The guide is generic
the Analysis of Nuclear Fuel Cycle Materials
and any required technical information specific for a given
2.2 ISO Standard:
method must be obtained from other sources.
ISO 17025 General Requirements for the Competence of
1.2 The guidance information is provided in the following
3
Calibration and Testing Laboratories
sections:
Section
3. Significance and Use
General Considerations 4
Calibration Procedure 5
3.1 Calibration is a fundamental part of making measure-
Calibration Standard 6
ments and its effect on the quality of measurement data is
Control of Calibrated Equipment 7
significant. Thus, sufficient attention must be given to calibra-
Documentation 8
Keywords 9
tion when it is established for a measurement method so that
the data produced will be acceptable. The use of an inappro-
1.3 This standard does not purport to address all of the
priate calibration standard, inadequate instructions for calibra-
safety concerns, if any, associated with its use. It is the
tion, and poor documentation of the calibration process are
responsibility of the user of this standard to establish appro-
examples of circumstances that can adversely affect the valid-
priate safety and health practices and determine the applica-
ity of a calibration.Thus, the calibration process must conform
bility of regulatory limitations prior to use.
to criteria established to ensure the validity of calibration
2. Referenced Documents results. Such criteria are given in Guide C1009, in which
2
calibration is identified as a component of laboratory quality
2.1 ASTM Standards:
assurance (see Fig. 1). This guide expands upon those criteria
C1009 Guide for Establishing a QualityAssurance Program
to provide more comprehensive guidance for establishing
for Analytical Chemistry Laboratories Within the Nuclear
calibration.
Industry
3.2 The manner of calibration and other technical require-
C1068 Guide for Qualification of Measurement Methods by
ments for calibrating a measurement method are usually
a Laboratory Within the Nuclear Industry
established when a method is first introduced into a laboratory,
C1128 Guide for Preparation of Working Reference Mate-
which may be through validation and qualification as defined
rials for Use in Analysis of Nuclear Fuel Cycle Materials
by Guide C1068 (see Fig. 1). However, calibration involves
more than the technical aspects of the calibration process. The
1
This guide is under the jurisdiction ofASTM Committee C26 on Nuclear Fuel
other dimension of the process is the operational requirements
Cycle and is the direct responsibility of Subcommittee C26.08 on Quality Assur-
that are necessary to ensure that calibration results are valid
ance, Statistical Applications, and Reference Materials.
Current edition approved July 10, 2003. Published August 2003. Originally and that they are documented and verifiable should their
e1
approved in 1990. Last previous edition approved in 1995 as C1156 – 95 . DOI:
integrity be questioned. The provisions of this guide provide
10.1520/C1156-03.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 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.
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C1156–03
4.5 The organizational responsibility and authority for cali-
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