ASTM D6362-98(2003)

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 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: 09-Aug-2003
• ICS: 13.060.45 - Examination of water in general
• Technical Committee: D19 - Water
• Drafting Committee: D19.02 - Quality Systems, Specification, and Statistics

Relations

• Replaces: ASTM D6362-98 - Standard Practice for Certificates of Reference Materials for Water Analysis
• Effective Date: 10-Aug-2003
• Replaced By: ASTM D6362-98(2008) - Standard Practice for Certificates of Reference Materials 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: 10-Aug-2003
• Referred By: ASTM D6596-00(2021) - Standard Practice for Ampulization and Storage of Gasoline and Related Hydrocarbon Materials
• Effective Date: 10-Aug-2003
• Referred By: ASTM D6808-02(2018)e1 - Standard Practice for Competency Requirements of Reference Material Producers for Water Analysis
• Effective Date: 10-Aug-2003
• Referred By: ASTM D5847-22 - Standard Practice for Writing Quality Control Specifications for Standard Test Methods for Water Analysis
• Effective Date: 10-Aug-2003

Standards Content (Sample)

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: D 6362 – 98 (Reapproved 2003)
Standard Practice for
Certificates of Reference Materials for Water Analysis
This standard is issued under the fixed designation D 6362; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope 3.2 Definitions of Terms Specific to This Standard:
3.2.1 prepared value, n—the best estimate of the concen-
1.1 This practice covers the information that must be
tration of a given analyte based upon the purity of raw
provided on certificates of analysis of reference materials
materials and the method of preparation of the material.
designated to supportASTM methods. It provides end users of
these materials with a defined set of data that is required to be
4. Significance and Use
on a certificate of analysis and provides information to assist
4.1 This practice is designed to assist suppliers and users of
the end user in evaluating the independence of the material.
referencematerialsbyidentifyingtheinformationnecessaryon
Similarly, it provides the suppliers of reference materials with
the certificate of analysis of materials designated for use in
a consistent format for the presentation of certification data.
ASTM test methods. This practice is specifically designed to
1.2 This standard does not purport to address all of the
ensure that materials suitable for use as either calibration or
safety concerns, if any, associated with its use. It is the
quality control standards are available. This practice does not
responsibility of the user of this standard to establish appro-
define a specific certification protocol, but rather provides
priate safety and health practices and determine the applica-
guidance in the development of adequate data to support the
bility of regulatory limitations prior to use.
use of the material as either a calibration or quality control
2. Referenced Documents standard. Suppliers are referred to ISO Guide 35 for guidelines
on acceptable certification protocols. End users are referred to
2.1 ASTM Standards:
ISO Guide 31 for a more complete description of the elements
D 1129 Terminology Relating to Water
of typical certificates of analysis.
E 826 PracticeforTestingHomogeneityofMaterialsforthe
Development of Reference Materials
5. Certificate of Analysis
2.2 ISO Standards
5.1 The certificate of analysis is a summary of the analysis
ISOGuide30 Termsanddefinitionsusedinconnectionwith
3 performed to support the designated use of the material. As a
reference materials
summary, the certificate must be brief, but it must provide
ISO Guide 31 Contents of certificates of reference materi-
3 sufficientinformationtoallowthepotentialuserofthematerial
als
to assess the suitability of the material for his intended use.
ISO Guide 35 Certification of reference materials—General
3 Therefore, reference material suppliers are encouraged to
and statistical principles
3 supply method information and analytical data in a summary
ISO/REMCO N280
that clearly and unambiguously allows the user to make an
3. Terminology informed decision about the suitability of the material.The use
of terms as defined by ISO or ASTM is required.
3.1 Definitions—For definitions of terms used in this prac-
5.2 The certificate of analysis must be supported by a
tice, refer to Terminology D 1129 and ISO Guide 30
certification report for the material. The certification report
must contain the details of the analyses performed to develop
This practice is under the jurisdiction ofASTM Committee D19 on Water and
the certified values reported on the certificate of analysis. It
is the direct responsibility of Subcommittee D19.02 on General Specifications,
must contain the method(s) used for analysis, details of the
Technical Resources, and Statistical Methods.
method of preparation, if appropriate, including gravimetric
Current edition approved Aug. 10, 2003. Published November 2003. Originally
approved in 1998. Last previous edition approved in 1998 as D 6362–98.
data, supporting instrumental data, and the results of support-
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
ing statistical analysis reported on the certificate of analysis.
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
The certification report must be provided to the end user of the
Standards volume information, refer to the standard’s Document Summary page on
material if requested.
the ASTM website.
Available from American National Standards Institute, 11 W. 42nd St., 13th
Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
D 6362 – 98 (2003)
6. Certificate Headings 6.1.9 Method of Preparation (Optional)—If the method of
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,
exceptions should be avoided in order to insure sufficient the certification of reference materials, homogeneity refers to
information for evaluation of materials. Therefore, each of the the analysis and demonstration of uniformity of final packaged
following sections is designated as either mandatory or op-
units. Every certificate must contain a homogeneity statement.
tional based upon ensuring a minimum data set. Appendix X1 This section must include the sampling, analytical method(s),
containsexamplesoftypicalcertificatesofanalysisdesignedto
and procedure used to evaluate the homogeneity of the
meet these requirements.
material. Appendix X2 provides a suggested procedure for
6.1.1 Name and Address of Certifying Organization
homogeneity testing and references to alternative internation-
(Mandatory)—Thisisthenameandaddressoftheorganization
ally accepted homogeneity testing procedures. If the homoge-
thatacceptsresponsibilityfortheinformationonthecertificate.
neityofthematerialhasnotbeendetermined,thenthismustbe
Organizations that provided analytical data or prepared the
stated on the certificate.
material may be provided elsewhere on the certificate.
6.1.11 Certified Property Values and Their Associated Un-
6.1.2 Material Identification (Mandatory)—This section
certainties (Mandatory)—The information in this section
must identify the material by name, as labeled, and must
should be given in tabular form with appropriate subsection
include a lot or batch number that can be used to uniquely
headings. The minimum information to be provided includes
identify the material.
the property, the certified value of the property, the associated
6.1.3 Supplier of the Reference Material (Optional)—If the
uncertainty, and the method of analysis. Since the certificate is
supplier of the reference material is different from the certify-
a synopsis of the certification report, suppliers are encouraged
ing organization then this section should contain the name and
to identify the method of analysis by appropriate standard
address of the supplier of the material.
method number. Modifications or exceptions to the given
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
sourceoftherawmaterialsorthesourceofthematrixmaterial,
NOTE 1—Several different procedures can be used to certify reference
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
must provide contact information on the certificate in order to
heading of statistical estimators and uncertainty referenced below.
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
intended use of the material. It should also contain a suffi- maybereportedbythesupplierinthissectiontoassisttheuser
in the selection of appropriate materials.
ciently detailed description of the material to allow the user to
estimate its usability in their application.
6.1.13 Values Obtained by Individual Laboratories or Meth-
This material is designed to be used in D XXXX as a cali-
ods (Optional)—Manytimesmaterialsarecertifiedbasedupon
bration standard. The material was prepared in Type I
interlaboratory studies or by using several different methods of
water to contain 1 mg/ml of the certified components.
analysis. In these cases, this section can be used to report
6.1.7 Stability, Transportation, and Storage Conditions
individual data by laboratory or method where appropriate. If
(Mandatory)—Any known temperature, storage, or transporta-
thesupportingdataaretoovoluminoustoreportinthissection,
tion factors that could influence the stability of the material
a reference to the certification report may be made here to
must be identified. It is required that the supplier identify
identify the source and availability of supporting data.
proper storage and handling conditions that are necessary to
6.1.14 Statistical Estimator and Uncertainty (Mandatory)—
insure usability for the expected life of the material. Similarly,
The meaning and nature of the certified values must be given,
the supplier should identify the period of time for which they
that is, the statistical estimator must be named. Where the
will assume responsibility for the validity of the certified
estimator cannot be named then the mathematical expression
values.
used in calculation must be presented.
6.1.8 Instructions for Use (Mandatory)—If the material
The certified values are based upon the unweighted
requiresspecialhandling,dilution,drying,oranyotherspecific
mean of nine independent measurements by each
manipulation in order to achieve the certified values, these method reported.
procedures must be clearly identified in this section.
D 6362 – 98 (2003)
if an SRM is not available for direct comparison; and, 3)
The certified values are based upon a biweight estimate
of the mean of the center 50 % of the reported data us-
interlaboratorycertificationprocedure,usedtoestablishtypical
ing the Tukey Bisquare Procedure with a tuning constant
method performance values or an assigned value for matrix
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 contri-
analyses. The appropriate number of samples to be analyzed is
bution 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
certificate must be unambiguously identified in this section.
materials using a direct comparison method may be found in
Instructions for obtaining the full certification report must be
ISO Guide 35.
provided in this section.
7.3 Verification of the Prepared Value—Where a suitable
6.1.19 Signature of Certifying Offıcer (Mandatory)—It is
SRM or other national standar
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