ASTM D6362-98(2013)
(Practice)Standard Practice for Certificates of Reference Materials for Water Analysis
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 and health practices and determine the applicability of regulatory limitations prior to use.
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:D6362 −98 (Reapproved 2013)
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 Jan. 1, 2013. Published January 2013. Originally
approved in 1998. Last previous edition approved in 2008 as D6362 – 98 (2008).
5.2 The certificate of analysis must be supported by a
DOI: 10.1520/D6362-98R13.
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 (2013)
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 (2013)
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 reference
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