ASTM E3330-22
(Guide)Standard Guide for Contents of Documentation and Statistical Treatments for Reference Materials for Metals, Ores, and Related Materials
Standard Guide for Contents of Documentation and Statistical Treatments for Reference Materials for Metals, Ores, and Related Materials
SIGNIFICANCE AND USE
5.1 This guide is intended for use by developers of RMs and CRMs for the metals and mining industries.
5.2 The guidance is related to uniform procedures and requirements and is intended to prevent the proliferation of widely varying documentation practices, definitions, and terminology. Where the statements in this guide are made as imperatives, it is because the stated practices are fundamental to chemical metrology, not to CRM/RM development.
5.3 The material in this guide is intended to supplement and to clarify the contents of ISO Guide 31 and to provide guidance specific to the needs of the metals and mining industries.
5.4 The documents described in this guide are intended to contain the minimum amount of information required for a user to understand the material, to help a user judge the quality of the product, and to help a user employ it in appropriate ways. Neither this guide nor resultant documents are meant to be encyclopedic.
5.5 Because this document is a standard guide, it is intended to educate those who are involved in laboratory operation, quality system development and maintenance, reference material development, and accreditation of laboratory operations within the scope of a quality system. It must be understood by all parties that the elements of this guide discuss optional practices having numerous choices for accomplishment and documentation. However, this guide does not constitute requirements for assessment and accreditation. An obvious example is statistical evaluation for consensus value and uncertainty calculations, which can take many forms with no single, correct choice for any given case.
5.6 When using this guide, CRM developers will set goals for the material under development, such as target uncertainties for homogeneity and for overall coverage intervals for assigned values. These choices are based on the intended uses of a CRM. The material, property values, and their uncertainties may or may not meet the set goals...
SCOPE
1.1 This guide is designed to explain and to clarify documentation that accompanies an RM or a certified reference material (CRM). It explains the contents of certificates of analysis for CRMs and product information documents for RMs, based on existing international standards and guides. It briefly touches on the minimum requirements for a label attached to the CRM/RM unit or unit container and to the package containing the unit or unit container.
1.2 This guide provides some basic guidance on calculation of consensus values and uncertainty estimates for CRMs and RMs with examples of approaches commonly used by national metrology institutes and suggestions for sources of information.
1.3 Units—The values stated in SI units are to be regarded as the standard, whenever applicable. Values can be traceable to other higher-order reference systems, including Rockwell Hardness, pH, and other systems defined by an international standard or peer-reviewed publication.
1.4 Contents—Sections and topics within this guide are enumerated below:
Section
Title
1
Scope
2
Referenced Documents
3
Terminology
4
Summary of Guide
5
Significance and Use
6
Contents of a Certificate of Analysis or Reference Material Documentation
7
Labels
8
Technical and Statistical Evaluations
9
Procedures for Consensus Value Calculations
10
Estimation of Uncertainty
11
Reporting Values and Uncertainty Estimates
12
International System of Units
13
Keywords
Appendix X1
Working Near Zero
Appendix X2
Working Near 100 %
Appendix X3
Censored Values
Appendix X4
Examples of Language for Sections of a Certificate of Analysis
1.5 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 enviro...
General Information
Relations
Standards Content (Sample)
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: E3330 − 22
Standard Guide for
Contents of Documentation and Statistical Treatments for
1
Reference Materials for Metals, Ores, and Related Materials
This standard is issued under the fixed designation E3330; 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
Appendix X4 Examples of Language for Sections of a Certificate of
Analysis
1.1 This guide is designed to explain and to clarify docu-
1.5 This standard does not purport to address all of the
mentation that accompanies an RM or a certified reference
safety concerns, if any, associated with its use. It is the
material (CRM). It explains the contents of certificates of
responsibility of the user of this standard to establish appro-
analysis for CRMs and product information documents for
priate safety, health, and environmental practices and deter-
RMs, based on existing international standards and guides. It
mine the applicability of regulatory limitations prior to use.
briefly touches on the minimum requirements for a label
1.6 This international standard was developed in accor-
attached to the CRM/RM unit or unit container and to the
dance with internationally recognized principles on standard-
package containing the unit or unit container.
ization established in the Decision on Principles for the
1.2 This guide provides some basic guidance on calculation
Development of International Standards, Guides and Recom-
of consensus values and uncertainty estimates for CRMs and
mendations issued by the World Trade Organization Technical
RMs with examples of approaches commonly used by national
Barriers to Trade (TBT) Committee.
metrology institutes and suggestions for sources of informa-
tion.
2. Referenced Documents
2
1.3 Units—The values stated in SI units are to be regarded 2.1 ASTM Standards:
as the standard, whenever applicable. Values can be traceable
E18 Test Methods for Rockwell Hardness of Metallic Ma-
to other higher-order reference systems, including Rockwell terials
Hardness, pH, and other systems defined by an international
E29 Practice for Using Significant Digits in Test Data to
standard or peer-reviewed publication. Determine Conformance with Specifications
E382 Test Method for Determination of Crushing Strength
1.4 Contents—Sections and topics within this guide are
of Iron Ore Pellets and Direct-Reduced Iron
enumerated below:
E1447 Test Method for Determination of Hydrogen in Tita-
Section Title
nium and Titanium Alloys by Inert Gas Fusion Thermal
1 Scope
2 Referenced Documents
Conductivity/Infrared Detection Method
3 Terminology
E2972 Guide for Production,Testing, andValueAssignment
4 Summary of Guide
of In-House Reference Materials for Metals, Ores, and
5 Significance and Use
6 Contents of a Certificate of Analysis or Reference Material
Other Related Materials
Documentation
3
2.2 ISO/ANSI Standards:
7 Labels
8 Technical and Statistical Evaluations ANSI/NCSL Z540-2-1997 (R2012) American National
9 Procedures for Consensus Value Calculations
Standard for Expressing Uncertainty – U.S. Guide to the
10 Estimation of Uncertainty
Expression of Uncertainty in Measurement
11 Reporting Values and Uncertainty Estimates
12 International System of Units ISO Guide 30:2015 Reference Materials – Selected Terms
13 Keywords
and Definitions
Appendix X1 Working Near Zero
ISO Guide 31:2015(E) Reference Materials – Contents of
Appendix X2 Working Near 100 %
Appendix X3 Censored Values
Certificates, Labels and Accompanying Documentation
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
This guide is under the jurisdiction of ASTM Committee E01 on Analytical contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Chemistry for Metals, Ores, and Related Materials and is the direct responsibility of Standards volume information, refer to the standard’s Document Summary page on
Subcommittee E01.22 on Laboratory Quality. the ASTM website.
3
Current edition approved April 1, 2022. Published April 2022. DOI: 10.1520/ Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
E3330-22. 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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E3330 − 22
ISO Guide 33:2015 Reference Materials – Good Practice in are never seen or never recorded.Truncation is not the same as
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