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ASTM D6362-98(2008)

(Practice)

Standard Practice for Certificates of Reference Materials for Water Analysis

Standard Practice for Certificates of Reference Materials for Water Analysis

SIGNIFICANCE AND USE
This practice is designed to assist suppliers and users of reference materials by identifying the information necessary on the certificate of analysis of materials designated for use in ASTM test methods. This practice is specifically designed to ensure that materials suitable for use as either calibration or quality control standards are available. This practice does not define a specific certification protocol, but rather provides guidance in the development of adequate data to support the use of the material as either a calibration or quality control standard. Suppliers are referred to ISO Guide 35 for guidelines on acceptable certification protocols. End users are referred to ISO Guide 31 for a more complete description of the elements of typical certificates of analysis.
SCOPE
1.1 This practice covers the information that must be provided on certificates of analysis of reference materials designated to support ASTM methods. It provides end users of these materials with a defined set of data that is required to be on a certificate of analysis and provides information to assist the end user in evaluating the independence of the material. Similarly, it provides the suppliers of reference materials with a consistent format for the presentation of certification data.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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.

General Information

Status
Historical
Publication Date
14-Jul-2008
ICS
13.060.45 - Examination of water in general
Technical Committee
D19 - Water
Drafting Committee
D19.02 - Quality Systems, Specification, and Statistics
Current Stage
Ref Project

Relations

Replaces
ASTM D6362-98(2003) - Standard Practice for Certificates of Reference Materials for Water Analysis
Effective Date
15-Jul-2008
Replaced By
ASTM D6362-98(2013) - Standard Practice for Certificates of Reference Materials for Water Analysis
Effective Date
01-Jan-2013
Referred By
ASTM D6808-02(2018)e1 - Standard Practice for Competency Requirements of Reference Material Producers for Water Analysis
Effective Date
15-Jul-2008
Referred By
ASTM D6596-00(2021) - Standard Practice for Ampulization and Storage of Gasoline and Related Hydrocarbon Materials
Effective Date
15-Jul-2008
Referred By
ASTM D5847-22 - Standard Practice for Writing Quality Control Specifications for Standard Test Methods for Water Analysis
Effective Date
15-Jul-2008
Referred By
ASTM D6568-00(2018) - Standard Guide for Planning, Carrying Out, and Reporting Traceable Chemical Analyses of Water Samples
Effective Date
15-Jul-2008

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ASTM D6362-98(2008) - Standard Practice for Certificates of Reference Materials for Water AnalysisASTM D6362-98(2008) - Standard Practice for Certificates of Reference Materials for Water Analysis
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ASTM D6362-98(2008) - Standard Practice for Certificates of Reference Materials for Water Analysis
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:D6362 −98(Reapproved 2008)
Standard Practice for
Certificates of Reference Materials for Water Analysis
This standard is issued under the fixed designation D6362; 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 3. Terminology
1.1 This practice covers the information that must be
3.1 Definitions— For definitions of terms used in this
provided on certificates of analysis of reference materials
practice, refer to Terminology D1129 and ISO Guide 30
designated to supportASTM methods. It provides end users of
3.2 Definitions of Terms Specific to This Standard:
these materials with a defined set of data that is required to be
3.2.1 prepared value, n—the best estimate of the concentra-
on a certificate of analysis and provides information to assist
tion of a given analyte based upon the purity of raw materials
the end user in evaluating the independence of the material.
Similarly, it provides the suppliers of reference materials with and the method of preparation of the material.
a consistent format for the presentation of certification data.
4. Significance and Use
1.2 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
4.1 This practice is designed to assist suppliers and users of
standard.
referencematerialsbyidentifyingtheinformationnecessaryon
1.3 This standard does not purport to address all of the
the certificate of analysis of materials designated for use in
safety concerns, if any, associated with its use. It is the
ASTM test methods. This practice is specifically designed to
responsibility of the user of this standard to establish appro-
ensure that materials suitable for use as either calibration or
priate safety and health practices and determine the applica-
quality control standards are available. This practice does not
bility of regulatory limitations prior to use.
define a specific certification protocol, but rather provides
guidance in the development of adequate data to support the
2. Referenced Documents
use of the material as either a calibration or quality control
2.1 ASTM Standards:
standard. Suppliers are referred to ISO Guide 35 for guidelines
D1129 Terminology Relating to Water
on acceptable certification protocols. End users are referred to
E826 Practice for Testing Homogeneity of a Metal Lot or
ISO Guide 31 for a more complete description of the elements
Batch in Solid Form by Spark Atomic Emission Spec-
of typical certificates of analysis.
trometry
2.2 ISO Standards
5. Certificate of Analysis
ISO Guide 30 Terms and definitions used in connection with
5.1 The certificate of analysis is a summary of the analysis
reference materials
performed to support the designated use of the material. As a
ISO Guide 31 Contents of certificates of reference materials
summary, the certificate must be brief, but it must provide
ISO Guide 35 Certification of reference materials—General
sufficientinformationtoallowthepotentialuserofthematerial
and statistical principles
to assess the suitability of the material for his intended use.
ISO/REMCO N280
Therefore, reference material suppliers are encouraged to
supply method information and analytical data in a summary
that clearly and unambiguously allows the user to make an
This practice is under the jurisdiction ofASTM Committee D19 on Water and
is the direct responsibility of Subcommittee D19.02 on Quality Systems, informed decision about the suitability of the material.The use
Specification, and Statistics.
of terms as defined by ISO or ASTM is required.
Current edition approved July 15, 2008. Published August 2008. Originally
approved in 1998. Last previous edition approved in 2003 as D6362 – 98 (2003).
5.2 The certificate of analysis must be supported by a
DOI: 10.1520/D6362-98R08.
certification report for the material. The certification report
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 must contain the details of the analyses performed to develop
Standards volume information, refer to the standard’s Document Summary page on
the certified values reported on the certificate of analysis. It
the ASTM website.
3 must contain the method(s) used for analysis, details of the
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org. method of preparation, if appropriate, including gravimetric
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
D6362−98 (2008)
data, supporting instrumental data, and the results of support- 6.1.8 Instructions for Use (Mandatory) —If the material
ing statistical analysis reported on the certificate of analysis. requiresspecialhandling,dilution,drying,oranyotherspecific
The certification report must be provided to the end user of the
manipulation in order to achieve the certified values, these
material if requested. procedures must be clearly identified in this section.
6.1.9 Method of Preparation (Optional) —If the method of
6. Certificate Headings
preparation gives the user an idea of the care taken by the
6.1 The following sections detail the headings to be used on
supplier, significant details of the preparation procedure may
the certificate of analysis.ASTM methods require the use of a
be included in this section.
diverse set of reference materials.Therefore, it is expected that
6.1.10 State of Homogeneity (Mandatory) —As it relates to
all headings will not be appropriate for all materials. However,
the certification of reference materials, homogeneity refers to
exceptions should be avoided in order to insure sufficient
the analysis and demonstration of uniformity of final packaged
information for evaluation of materials. Therefore, each of the
units. Every certificate must contain a homogeneity statement.
following sections is designated as either mandatory or op-
This section must include the sampling, analytical method(s),
tional based upon ensuring a minimum data set. Appendix X1
and procedure used to evaluate the homogeneity of the
containsexamplesoftypicalcertificatesofanalysisdesignedto
material. Appendix X2 provides a suggested procedure for
meet these requirements.
homogeneity testing and references to alternative internation-
6.1.1 Name and Address of Certifying Organization
ally accepted homogeneity testing procedures. If the homoge-
(Mandatory)—Thisisthenameandaddressoftheorganization
neityofthematerialhasnotbeendetermined,thenthismustbe
thatacceptsresponsibilityfortheinformationonthecertificate.
stated on the certificate.
Organizations that provided analytical data or prepared the
6.1.11 Certified Property Values and Their Associated Un-
material may be provided elsewhere on the certificate.
certainties (Mandatory)—The information in this section
6.1.2 Material Identification (Mandatory) —This section
should be given in tabular form with appropriate subsection
must identify the material by name, as labeled, and must
headings. The minimum information to be provided includes
include a lot or batch number that can be used to uniquely
the property, the certified value of the property, the associated
identify the material.
uncertainty, and the method of analysis. Since the certificate is
6.1.3 Supplier of the Reference Material (Optional)—If the
a synopsis of the certification report, suppliers are encouraged
supplier of the reference material is different from the certify-
ing organization then this section should contain the name and to identify the method of analysis by appropriate standard
method number. Modifications or exceptions to the given
address of the supplier of the material.
6.1.4 Preparer of the Material (Optional) —If the material method may be annotated in another section of the certificate.
was not prepared by the supplier or the certifying organization, Likewise, if the values certified are dependent upon certain
then this section should include the name and address of the conditions, for example temperature, these can be identified in
preparer of the material. footnotestothetable.Valuesforpropertiesthatarenotcertified
6.1.5 Source of the Material (Mandatory) —For a solution
should be included in a separate table.
standard, or a matrix material, this section must identify the
NOTE 1—Several different procedures can be used to certify reference
sourceoftherawmaterialsorthesourceofthematrixmaterial,
materials.These depend upon the nature of the material to be certified and
used in the preparation of the material. The supplier may
thetechnicalcapabilityofthesupplierandcertifyingbody.Thethreemost
identify the source of the material as proprietary. If the source
common procedures for certification are detailed in Section 7. The
of the material is declared to be proprietary then the supplier
procedure used to certify property values must be provided under the
heading of statistical estimators and uncertainty referenced below.
must provide contact information on the certificate in order to
assist end users.
6.1.12 Uncertified Properties (Optional) —Many times
6.1.6 Description and Intended Use of the Material
properties of the material are known but without sufficient
(Optional)—Most reference materials are designed to be used
accuracy or precision to support certification. These values
for a specific purpose. This section should designate the
maybereportedbythesupplierinthissectiontoassisttheuser
intended use of the material. It should also contain a suffi-
in the selection of appropriate materials.
ciently detailed description of the material to allow the user to
6.1.13 Values Obtained by Individual Laboratories or Meth-
estimate its usability in their application.
ods (Optional)—Many times materials are certified based upon
This material is designed to be used in D XXXX as a
interlaboratory studies or by using several different methods of
calibration standard. The material was prepared in Type I
analysis. In these cases, this section can be used to report
water to contain 1 mg/ml of the certified components.
individual data by laboratory or method where appropriate. If
6.1.7 Stability, Transportation, and Storage Conditions
thesupportingdataaretoovoluminoustoreportinthissection,
(Mandatory)—Any known temperature, storage, or transporta-
a reference to the certification report may be made here to
tion factors that could influence the stability of the material
identify the source and availability of supporting data.
must be identified. It is required that the supplier identify
proper storage and handling conditions that are necessary to 6.1.14 Statistical Estimator and Uncertainty (Mandatory)—
The meaning and nature of the certified values must be given,
insure usability for the expected life of the material. Similarly,
the supplier should identify the period of time for which they that is, the statistical estimator must be named. Where the
estimator cannot be named then the mathematical expression
will assume responsibility for the validity of the certified
values. used in calculation must be presented.
D6362−98 (2008)
analysis of calibration materials where a suitable NIST stan-
The certified values are based upon the unweighted
mean of nine independent measurements by each
dard reference material (SRM) exists; 2) verification of the
method reported.
prepared value, used to certify the prepared value of a material
The certified values are based upon a biweight estimate if an SRM is not available for direct comparison; and, 3)
of the mean of the center 50 % of the reported data
interlaboratorycertificationprocedure,usedtoestablishtypical
using the Tukey Bisquare Procedure with a tuning
method performance values or an assigned value for matrix
constant of 3.97. Details of the procedure may be
obtained from the certifier. materials.
7.1.2 In the case of the direct comparison method, the
NOTE 2—The method used to estimate the uncertainty associated with
certified value is based upon analysis to a known calibrant
the certified value of the property is important. Therefore, the supplier
must identify the factors considered in estimation of uncertainty and the
prepared from an SRM or other national standard. In the
method used for calculation. If the uncertainty is estimated by a coverage
second case, where an SRM calibrant does not exist, the value
factor, such as 2s/=n , then the formula and the values for each variable
certified is the prepared value. In the case of interlaboratory
in the formula must be provided on the certificate.
studies, the certified value is a best estimate of typical
6.1.15 Measurement Methods Used for Certification
performance.
(Optional)—This section should provide the exceptions to, or
7.2 Direct Comparison Method—In cases where an SRM or
modifications of, the standard or reported method(s) used for
other national standard exists and well defined methods are
certification. Sufficient details of the analysis must be provided
available,amaterialshouldbecertifiedbydirectcomparisonto
in the certification report to allow independent verification of
the SRM or other national standard. If the reference material is
the analytical values. However, only those details which are
used as the calibrant in the analytical system, then the certified
essential to reproducibility need to be reported.
values are linked to the SRM or other national standard. The
6.1.16 Identification of Analysts or Laboratories
valuecertifiedinthisprocedureisusuallythemeanofreplicate
(Optional)—This section may be used to identify the contribu-
analyses. The appropriate number of samples to be analyzed is
tion of individual analysts or laboratories to the certification
dependent upon the material, the precision of the method, and
effort. The identification of analysts or laboratories may assist
the desired level of uncertainty.
the user in establishing the quality of the certification data.
7.2.1 In cases where multiple methods are used in the
6.1.17 Legal Notice (Optional)—Disclaimers or legal limi-
certification procedure, it is important to identify the analytical
tations of liability for the information on the certificate should
results from each method, and to explain how results were
appear in this section.
combined to establish the values certified. This information
6.1.18 Reference to Certification Report (Mandatory)—The
must be reported under 6.1.15.
certification report supporting the summary provided on the
7.2.2 Suitable procedures for the certification of refe
...

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5.2.1 Water system management is necessary to maintain L. pneumophila concentrations below hazardous levels. Through routine measurement of L. pneumophila levels, a monitoring program can ensure that control measures are effective and implemented when necessary in response to increasing levels. Water samples may be examined for L. pneumophila during epidemiological investigations as part of local authority, industrial, or hospital programs, or in order to validate treatment control methods. Routine sampling could also be carried out based on risk assessments or on local, state, or federal requirements or guidelines.
SCOPE
1.1 This test method describes a simple procedure for the detection of Legionella pneumophila (L. pneumophila) in potable water and non-potable waters (cooling towers, for example). This procedure describes a liquid culture method based on a bacterial enzyme technology. The detection of L. pneumophila is signaled through the utilization of a substrate present in the Legiolert reagent. L. pneumophila cells grow rapidly and reproduce using the rich supply of amino acids, vitamins and other nutrients present in the Legiolert reagent. Actively growing strains of L. pneumophila use the added substrate to produce a brown color indicator or produce turbid growth with or without brown coloration. Legiolert can detect this bacterial species at the following minimum concentrations based on the protocol employed:  
1.1.1 Potable Water:  
1.1.1.1 ≥1 organism / 100 mL at 7 days for 100 mL potable protocol.
1.1.1.2 ≥1 organism / 10 mL at 7 days for 10 mL potable protocol.  
1.1.2 Non-potable Water:  
1.1.2.1 ≥1 organism / 1.0 mL at 7 days for 1.0 mL non-potable protocol.
1.1.2.2 ≥1 organism / 0.1 mL at 7 days for 0.1 mL non-potable protocol.  
1.1.3 This test method can be used for potable (drinking) waters and non-potable waters such as cooling tower waters (1).3 It is the user’s responsibility to ensure the validity of this test method for waters of untested matrices.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM D7366-08(2019)(Practice)
Standard Practice for Estimation of Measurement Uncertainty for Data from Regression-based Methods

SIGNIFICANCE AND USE
5.1 Appropriate application of this practice should result in an estimate of the test-method’s uncertainty (at any concentration within the working range), which can be compared with data-quality objectives to see if the uncertainty is acceptable.  
5.2 With data sets that compare recovered concentration with true concentration, the resulting regression plot allows the correction of the recovery data to true values. Reporting of such corrections is at the discretion of the user.  
5.3 This practice should be used to estimate the measurement uncertainty for any application of a test method where measurement uncertainty is important to data use.
SCOPE
1.1 This practice establishes a standard for computing the measurement uncertainty for applicable test methods in Committee D19 on Water. The practice does not provide a single-point estimate for the entire working range, but rather relates the uncertainty to concentration. The statistical technique of regression is employed during data analysis.  
1.2 Applicable test methods are those whose results come from regression-based methods and whose data are intra-laboratory (not inter-laboratory data, such as result from round-robin studies). For each analysis conducted using such a method, it is assumed that a fixed, reproducible amount of sample is introduced.  
1.3 Calculation of the measurement uncertainty involves the analysis of data collected to help characterize the analytical method over an appropriate concentration range. Example sources of data include: (1) calibration studies (which may or may not be conducted in pure solvent), (2) recovery studies (which typically are conducted in matrix and include all sample-preparation steps), and (3) collections of data obtained as part of the method’s ongoing Quality Control program. Use of multiple instruments, multiple operators, or both, and field-sampling protocols may or may not be reflected in the data.  
1.4 In any designed study whose data are to be used to calculate method uncertainty, the user should think carefully about what the study is trying to accomplish and much variation should be incorporated into the study. General guidance on designing studies (for example, calibration, recovery) is given in Appendix X1. Detailed guidelines on sources of variation are outside the scope of this practice, but general points to consider are included in Appendix X2, which is not intended to be exhaustive. With any study, the user must think carefully about the factors involved with conducting the analysis, and must realize that the computed measurement uncertainty will reflect the quality of the input data.  
1.5 Associated with the measurement uncertainty is a user-chosen level of statistical confidence.  
1.6 At any concentration in the working range, the measurement uncertainty is plus-or-minus the half-width of the prediction interval associated with the regression line.  
1.7 It is assumed that the user has access to a statistical software package for performing regression. A statistician should be consulted if assistance is needed in selecting such a program.  
1.8 A statistician also should be consulted if data transformations are being considered.  
1.9 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.10 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM D3975-93(2019)(Practice)
Standard Practice for Development and Use (Preparation) of Samples for Collaborative Testing of Methods for Analysis of Sediments

SIGNIFICANCE AND USE
5.1 The objective of this practice is to provide guidelines for the preparation of samples for use in collaborative tests, to evaluate methods during their development, and for the evaluation of the precision and bias of proposed test methods.  
5.2 Statements of the precision and bias are a mandatory part of ASTM test methods. Such an evaluation is necessary to provide guidance to the user as to the reliability of measurements that can be expected by its use. The statements are developed on the basis of user experience (ordinarily collaborative tests) with the test method.  
5.3 The availability of test samples is a key requirement for collaborative evaluation of test methods.
SCOPE
1.1 This practice establishes uniform general procedures for the development (preparation) and use of samples in the collaborative testing of methods for chemical analysis of sediments and similar materials.  
1.2 The principles of this practice are applicable to aqueous samples with suitable technical modifications.  
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM D6362-98(2018)(Practice)
Standard Practice for Certificates of Reference Materials for Water Analysis

SIGNIFICANCE AND USE
4.1 This practice is designed to assist suppliers and users of reference materials by identifying the information necessary on the certificate of analysis of materials designated for use in ASTM test methods. This practice is specifically designed to ensure that materials suitable for use as either calibration or quality control standards are available. This practice does not define a specific certification protocol, but rather provides guidance in the development of adequate data to support the use of the material as either a calibration or quality control standard. Suppliers are referred to ISO Guide 35 for guidelines on acceptable certification protocols. End users are referred to ISO Guide 31 for a more complete description of the elements of typical certificates of analysis.
SCOPE
1.1 This practice covers the information that must be provided on certificates of analysis of reference materials designated to support ASTM methods. It provides end users of these materials with a defined set of data that is required to be on a certificate of analysis and provides information to assist the end user in evaluating the independence of the material. Similarly, it provides the suppliers of reference materials with a consistent format for the presentation of certification data.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM D6568-00(2018)(Guide)
Standard Guide for Planning, Carrying Out, and Reporting Traceable Chemical Analyses of Water Samples

SIGNIFICANCE AND USE
4.1 This guide establishes basic requirements which should be met by water and environmental laboratories that generate and report test chemical analyses which the laboratory client desires to be traceable to SI units (Note 1) or certified reference materials traceable to SI units. Traceability of chemical analyses is important because it provides a uniform basis for the comparison of results from different measurement systems and because it relates those results to our current knowledge of physical laws (Note 2).
Note 1: A certified reference material traceable to SI units is a certified reference material whose value can be related with a stated uncertainty through an unbroken change of comparisons to stated references (usually national or international standards) in SI units, such as a primary measurement made in SI units or a national standard certified in SI units.
Note 2: Not all chemical analysis results can be traceable to SI units or to certified reference material’s traceable to SI units, such as turbidity and or total suspended solids.  
4.2 Many waters-related laboratories comply with ISO Guide 17025 and participate in Proficiency Testing Programs. Laboratories that are connected to the same accreditation bodies and Proficiency Test providers can be expected to report statistically similar results on the same sample. However, some test methods and some certified reference materials are not supported with data traceable to SI units. Therefore, fully compliant laboratories that are not connected to the same providers may report statistically different chemical analysis results if they used the same nontraceable test method on the same sample. This problem could be minimized if they used test methods, measurement devices, and certified reference materials that are traceable to SI units, where available.  
4.3 Although some standard test methods and certified reference materials provide evidence of traceability to SI units, many others do not. Therefor...
SCOPE
1.1 This guide sets a protocol for generating and reporting chemical analyses that are traceable to SI units or to certified reference materials in laboratories that serve the water and environmental industry.  
1.2 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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