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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14-Oct-2018
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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.
Designation: D6362 −98 (Reapproved 2018)
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 ISO Guide 31 Contents of Certificates of Reference Materi-
als
1.1 This practice covers the information that must be
ISOGuide35 CertificationofReferenceMaterials—General
provided on certificates of analysis of reference materials
and Statistical Principles
designated to supportASTM methods. It provides end users of
ISO/REMCO N280
these materials with a defined set of data that is required to be
on a certificate of analysis and provides information to assist
3. Terminology
the end user in evaluating the independence of the material.
3.1 Definitions:
Similarly, it provides the suppliers of reference materials with
3.1.1 For definitions of terms used in this standard, refer to
a consistent format for the presentation of certification data.
Terminology D1129 and ISO Guide 30.
1.2 The values stated in SI units are to be regarded as
3.2 Definitions of Terms Specific to This Standard:
standard. No other units of measurement are included in this
3.2.1 prepared value, n—the best estimate of the concentra-
standard.
tion of a given analyte based upon the purity of raw materials
1.3 This standard does not purport to address all of the
and the method of preparation of the material.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
4. Significance and Use
priate safety, health, and environmental practices and deter-
4.1 This practice is designed to assist suppliers and users of
mine the applicability of regulatory limitations prior to use.
referencematerialsbyidentifyingtheinformationnecessaryon
1.4 This international standard was developed in accor-
the certificate of analysis of materials designated for use in
dance with internationally recognized principles on standard-
ASTM test methods. This practice is specifically designed to
ization established in the Decision on Principles for the
ensure that materials suitable for use as either calibration or
Development of International Standards, Guides and Recom-
quality control standards are available. This practice does not
mendations issued by the World Trade Organization Technical
define a specific certification protocol, but rather provides
Barriers to Trade (TBT) Committee.
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
5. Certificate of Analysis
2.2 ISO Standards:
ISO Guide 30 Terms and Definitions Used in Connection
5.1 The certificate of analysis is a summary of the analysis
with Reference Materials
performed to support the designated use of the material. As a
summary, the certificate must be brief, but it must provide
This practice is under the jurisdiction ofASTM Committee D19 on Water and
sufficientinformationtoallowthepotentialuserofthematerial
is the direct responsibility of Subcommittee D19.02 on Quality Systems,
to assess the suitability of the material for his intended use.
Specification, and Statistics.
Therefore, reference material suppliers are encouraged to
Current edition approved Oct. 15, 2018. Published November 2018. Originally
approved in 1998. Last previous edition approved in 2013 as D6362 – 98 (2013).
supply method information and analytical data in a summary
DOI: 10.1520/D6362-98R18.
that clearly and unambiguously allows the user to make an
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
informed decision about the suitability of the material.The use
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 of terms as defined by ISO or ASTM is required.
the ASTM website.
3 5.2 The certificate of analysis must be supported by a
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org. certification report for the material. The certification report
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
D6362 − 98 (2018)
must contain the details of the analyses performed to develop insure usability for the expected life of the material. Similarly,
the certified values reported on the certificate of analysis. It the supplier should identify the period of time for which they
must contain the method(s) used for analysis, details of the will assume responsibility for the validity of the certified
method of preparation, if appropriate, including gravimetric values.
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- to identify the method of analysis by appropriate standard
ing organization then this section should contain the name and method number. Modifications or exceptions to the given
address of the supplier of the material. method may be annotated in another section of the certificate.
6.1.4 Preparer of the Material (Optional)—If the material Likewise, if the values certified are dependent upon certain
was not prepared by the supplier or the certifying organization, conditions, for example temperature, these can be identified in
then this section should include the name and address of the footnotestothetable.Valuesforpropertiesthatarenotcertified
preparer of the material. should be included in a separate table.
6.1.5 Source of the Material (Mandatory)—For a solution
NOTE 1—Several different procedures can be used to certify reference
standard, or a matrix material, this section must identify the
materials.These depend upon the nature of the material to be certified and
sourceoftherawmaterialsorthesourceofthematrixmaterial,
thetechnicalcapabilityofthesupplierandcertifyingbody.Thethreemost
common procedures for certification are detailed in Section 7. The
used in the preparation of the material. The supplier may
procedure used to certify property values must be provided under the
identify the source of the material as proprietary. If the source
heading of statistical estimators and uncertainty referenced below.
of the material is declared to be proprietary then the supplier
6.1.12 Uncertified Properties (Optional)—Many times
must provide contact information on the certificate in order to
properties of the material are known but without sufficient
assist end users.
accuracy or precision to support certification. These values
6.1.6 Description and Intended Use of the Material
maybereportedbythesupplierinthissectiontoassisttheuser
(Optional)—Most reference materials are designed to be used
in the selection of appropriate materials.
for a specific purpose. This section should designate the
6.1.13 Values Obtained by Individual Laboratories or Meth-
intended use of the material. It should also contain a suffi-
ods (Optional)—Many times materials are certified based upon
ciently detailed description of the material to allow the user to
interlaboratory studies or by using several different methods of
estimate its usability in their application.
analysis. In these cases, this section can be used to report
This material is designed to be used in DXXXX as a
individual data by laboratory or method where appropriate. If
calibration standard. The material was prepared in Type I
water to contain 1 mg/mL of the certified components.
thesupportingdataaretoovoluminoustoreportinthissection,
6.1.7 Stability, Transportation, and Storage Conditions a reference to the certification report may be made here to
(Mandatory)—Any known temperature, storage, or transporta- identify the source and availability of supporting data.
tion factors that could influence the stability of the material 6.1.14 Statistical Estimator and Uncertainty (Mandatory)—
must be identified. It is required that the supplier identify The meaning and nature of the certified values must be given,
proper storage and handling conditions that are necessary to that is, the statistical estimator must be named. Where the
D6362 − 98 (2018)
estimator cannot be named then the mathematical expression 7.1.1 Most reference materials, and properties of interest,
used in calculation must be presented. arecertifiedbyoneofthefollowingthreeprocedures:(1)direct
comparison method, most frequently used for assay work, or
The certified values are based upon the unweighted
mean of nine independent measurements by each
analysis of calibration materials where a suitable NIST stan-
method reported.
dard reference material (SRM) exists; (2) verification of the
prepared value, used to certify the prepared value of a material
The certified values are based upon a biweight estimate
of the mean of the center 50 % of the reported data
if an SRM is not available for direct comparison; and, (3)
using the Tukey Bisquare Procedure with a tuning
interlaboratorycertificationprocedure,usedtoestablishtypical
constant of 3.97. Details of the procedure may be
method performance values or an assigned value for matrix
obtained from the certifier.
materials.
NOTE 2—The method used to estimate the uncertainty associated with
7.1.2 In the case of the direct comparison method, the
the certified value of the property is important. Therefore, the supplier
must identify the factors considered in estimation of uncertainty and the certified value is based upon analysis to a known calibrant
method used for calculation. If the uncertainty is estimated by a coverage
prepared from an SRM or other national standard. In the
=
factor, such as 2s/ n, then the formula and the values for each variable
second case, where an SRM calibrant does not exist, the value
in the formula must be provided on the certificate.
certified is the prepared value. In the case of interlaboratory
6.1.15 Measurement Methods Used for Certification studies, the certified value is a best estimate of typical
performance.
(Optional)—This section should provide the exceptions to, or
modifications of, the standard or reported method(s) used for
7.2 Direct Comparison Method—In cases where an SRM or
certification. Sufficient details of the analysis must be provided
other national standard exists and well defined methods are
in the certification report to allow independent verification of
available,amaterialshouldbecertifiedbydirectcomparisonto
the analytical values. However, only those details which are
the SRM or other national standard. If the reference material is
essential to reproducibility need to be reported.
used as the calibrant in the analytical system, then the certified
6.1.16 Identification of Analysts or Laboratories
values are linked to the SRM or other national standard. The
(Optional)—This section may be used to identify the contribu-
valuecertifiedinthisprocedureisusuallythemeanofreplicate
tion of individual analysts or laboratories to the certification
analyses. The appropriate number of samples to be analyzed is
effort. The identification of analysts or laboratories may assist
dependent upon the material, the precision of the method, and
...

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