ASTM E2437 - 05

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Designation: E 2437 – 05

Standard Practice for

Designing and Validating Performance-Based Test Methods

for the Analysis of Metals, Ores, and Related Materials

This standard is issued under the ﬁxed designation E 2437; 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

1.1 This practice covers a model for designing and validat-

ing performance-based, ISO 17025-compliant, standard test

methods for the instrumental chemical analysis of metals, ores,

and related materials. The principles in this practice can also be

applied to the development of test methods used to determine

the composition of other materials.

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 appro-

priate safety and health practices and determine the applica-

bility of regulatory limitations prior to use.

2. Referenced Documents

2.1 ASTM Standards:

E 135 Terminology Relating to Analytical Chemistry for

Metals, Ores, and Related Materials

E 305 Practice for Establishing and Controlling Spectro-

chemical Analytical Curves

E 691 Practice for Conducting an Interlaboratory Study to

Determine the Precision of a Test Method

E 1329 Practice for Veriﬁcation and Use of Control Charts

in Spectrochemical Analysis

E 1601 Practice for Conducting an Interlaboratory Study to

Evaluate the Performance of an Analytical Method

E 1621 Guide for X-Ray Emission Spectrometric Analysis

E 2027 Practice for Conducting Proﬁciency Tests in the

Chemical Analysis of Metals, Ores, and Related Materials

E 2165 Practice for Establishing an Uncertainty Budget for

the Chemical Analysis of Metals, Ores, and Related

Materials

2.2 ISO Standards

ISO 17025 General Requirements for the Competence of

Testing and Calibration Laboratories

ISO Guide 31 Reference Materials—Contents of Certiﬁ-

cates and Labels

ISO Guide 32 Calibration in Analytical Chemistry and Use

of Certiﬁed Reference Materials

ISO Guide 34 General Requirements for the Competence of

Reference Material Producers

3. Terminology

3.1 Deﬁnitions—For deﬁnitions of terms used in this prac-

tice, refer to Terminology E 135.

3.2 Deﬁnitions of Terms Speciﬁc to This Standard:

3.2.1 aim interlaboratory uncertainty,n—the maximum

deviation (95 % conﬁdence) to be allowed in the design of the

total interlaboratory uncertainty of a test method, beginning

with the preparation of a homogeneous sample and ending with

a ﬁnal report value to the client.

3.2.2 aim uncertainty budget,n—during the development of

a standard performance-based test method, the target allocation

of interlaboratory measurement uncertainty among speciﬁc

components of a measurement process that contribute signiﬁ-

cantly to the overall deviation.

3.2.2.1 Discussion—The target allocation is made by the

task group as described in Practice E 2165 and serves as

guidance for interlaboratory test participants during method

testing.

3.2.3 interlaboratory uncertainty,n—in a performance

based standard test method, the precision (95 % conﬁdence)

that participating laboratories achieved during interlaboratory

studies, beginning with the preparation of a homogeneous

sample and ending with a ﬁnal report value to the client.

3.2.4 intralaboratory uncertainty,n—in a performance

based standard test method, the precision (95 % conﬁdence)

that a laboratory achieves when the method is used by more

than one operator. In test methods that establish maximum

allowable intralaboratory uncertainties, users must be able to

demonstrate compliance with those uncertainties in order to

report that a given test result was produced using the named

method.

3.2.5 performance based method,n—a test method that

deﬁnes (1) the general approaches for sampling, sample

This practice is under the jurisdiction of ASTM Committee E01 on Analytical

Chemistry for Metals, Ores, and Related Materials and is the direct responsibility of

Subcommittee E01.22 on Laboratory Quality.

Current edition approved May 1, 2005. Published July 2005.

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

Standards volume information, refer to the standard’s Document Summary page on

the ASTM website.

Available from American National Standards Institute (ANSI), 25 W. 43

St.,

Floor, New York, NY 10036 (www.ansi.org).

preparation, and making measurements on a speciﬁed type of

material, and (2) deﬁnes maximum allowable uncertainties for

each measured constituent over its validated concentration

range.

3.2.6 uncertainty budget,n—the allocation of intralabora-

tory measurement uncertainty among speciﬁc components of a

measurement process that contribute signiﬁcantly to the overall

deviation.

4. Signiﬁcance and Use

4.1 This practice provides guidance for methods-writing

task group leaders and members in planning, drafting, and

testing performance-based test methods. It also guides users of

performance-based methods in interpreting and applying them

properly.

4.2 Standard test methods, particularly those that cover the

instrumental analysis of commercial materials by speciﬁc

measurement techniques, such as point-to-plane atomic emis-

sion, x-ray ﬂuorescence, inductively-coupled plasma, and

atomic absorption spectroscopy, need sufficient ﬂexibility to

accommodate the various applicable makes and models of

instrumentation. At the same time, these standard test methods

must be capable of generating commercially-useful results that

are sufficiently accurate and precise. These needs can be met by

the use of performance-based test methods that rely more on

the demonstrated quality of the test results than on strict

adherence to speciﬁc procedural steps. One model for devel-

oping these methods is described in this practice.

4.3 It is expected that laboratories using performance-based

standard test methods developed in accordance with this

practice will prepare their own detailed work instructions.

These work instructions will include detailed operating instruc-

tions for the speciﬁc laboratory, the speciﬁc reference materials

(RMs) employed, and performance acceptance criteria to be

applied in that laboratory. It is also expected that those

laboratories will document their own performance data using

their work instruction to show that their data are consistent

with the standard test method’s Precision and Bias statement.

Over time, it is also expected that, when applicable, an

individual laboratory’s proﬁciency test results will also be

consistent with its documented performance.

4.4 Traditional ASTM Precision and Bias statements, devel-

oped during interlaboratory testing in accordance with Prac-

tices E 691 and E 1601, provide information on the perfor-

mance achieved by participating laboratories. Intralaboratory

precision can be estimated by dividing the Repeatability index,

r, in the Precision and Bias Table by the square root of 2, at any

tested concentration. Proﬁciency test programs, such as those

following Practice E 2027, periodically provide interlaboratory

performance data from larger numbers of laboratories, using a

variety of test methods, at many different concentrations over

an extended time period. Since interlaboratory precision ob-

tained during both method development and proﬁciency testing

using existing methods is a function of concentration, per

Practice E 2165, it follows that the interlaboratory testing of a

new test method should perform no worse than its predeces-

sors. Practice E 2165 describes how historical interlaboratory

test results can be used to set aim data quality objectives for

new test methods. This practice incorporates those aim data

quality objectives in developing uncertainty budgets used in

the design, development, and testing of performance-based

methods. This approach ensures that interlaboratory test data

included in Precision and Bias statements are consistent with

that associated with the other standard test methods.

5. Summary of Practice

5.1 The remaining parts of this practice provide instructions

for planning a performance-based method development

project, conducting the necessary validation and interlabora-

tory precision tests, and documenting the results.

5.2 The organization of the rest of the practice guides the

task group through the following steps:

5.2.1 Section 6—Sets overall objectives for the project,

detailed only to the extent needed to convince the task group

that the project can be accomplished as planned.

5.2.2 Section 7—Sets the technical parameters to be incor-

porated in the new test method. Establishes details needed to

facilitate organizing and drafting a test method.

5.2.3 Section 8—Addresses writing the ﬁrst draft of the test

method.

5.2.4 Section 9—Describes how to verify the draft method

before entering into more extensive interlaboratory testing.

5.2.5 Section 10—Discusses writing the interlaboratory

protocol plan so that all of the needed data is available in a

form that is easily processed.

5.2.6 Section 11—Describes task group work in conducting

the interlaboratory test.

5.2.7 Section 12—Describes performance-based method in-

formation to be included in the Research Report.

5.2.8 Section 13—Addresses ﬁnalizing the text of the test

method after interlaboratory testing is satisfactorily completed.

6. Setting Objectives

6.1 For the material to be tested, identify and list applicable

national and international product speciﬁcations, sampling

practices, and standard test methods. Be sure to reference these

documents appropriately in the new test method.

6.2 List the elements and concentration ranges to be in-

cluded in the materials to be analyzed using the method and list

the subset of those elements and concentration ranges to be

incorporated as analytes in the new test method.

6.3 Determine how measurement uncertainty and data qual-

ity objectives will be handled.

6.3.1 To comply with ASTM requirements, plan to prepare

a precision and bias statement. To comply with ISO 17025

requirements, plan to identify all signiﬁcant sources of mea-

surement uncertainty and to calculate the intralaboratory un-

certainty (3.2.3) from the information in the precision and bias

statement.

6.3.2 To help laboratories use the new performance-based

test method more effectively, the task group should consider

developing an uncertainty budget (3.2.5). That budget may be

developed as suggested in this practice, or in a different way,

provided that the minimum requirements in 6.3.1 are met.

6.3.3 If the task group elects to develop an uncertainty

budget as described in this practice, it should attempt to

establish each component of its aim uncertainty budget as

deﬁned in Practice E 2165. In some cases, the method of

E2437–05

choice may not be optimum for each analyte to be covered. In

those cases, if the anticipated performance meets applicable

speciﬁcation requirements, the task group should set its data

quality objectives in a way that is compliant with speciﬁcations

(commercial needs) and attainable performance. The compo-

nents of uncertainty will be useful in planning and developing

the performance-based test method.

7. Setting Technical Parameters

7.1 Select the Approach to Make the Measurements:

7.1.1 Select a measurement technique that represents an

optimum choice based on: (1) wide acceptance and use

throughout the industry, (2) anticipated ability to measure all

elements and concentration ranges in conformance with the

aim uncertainty budget, (3) anticipated sustained availability of

Certiﬁed Reference Materials (CRMs) for achieving traceable

calibrations (Note 1) of all elements and concentration ranges,

and (4) anticipated sustained availability of homogeneous

materials needed for statistical control of the method.

NOTE 1—This practice assumes the use of a Type III calibration as

deﬁned in ISO Guide 32. Types I and II do not require the use of CRMs.

7.1.2 Select the sampling equipment and procedure. Re-

solve any questions about the adequacy of the sampling

process. Ensure its acceptability to users. If a new or revised

sampling practice is needed, arrange for the development of

that practice and establish acceptability with those who are

responsible for performing the sampling.

7.1.3 Select a sample preparation technique that is compat-

ible with the selected sampling and measurement technique

and current industry practices. If a new or revised sample

preparation practice is needed, arrange for the development of

that practice as part of the new test method.

7.2 Design the Measurement Approach:

7.2.1 Calibration Approach—Based on the measurement

technique selected in 7.1.1, determine if calibration is to be

achieved by matrix-matched CRMs or by laboratory-prepared

RMs that are traceable to CRMs. Matrix-matched CRMs are

preferred, when available, and are most frequently used when

solid samples are analyzed. RMs that are traceable to CRMs

are often used in test methods calibrated with solutions. In

these cases, materials of known purity are added to CRM

solutions in order to match the overall composition of sample

solutions. Refer to ISO Guide 32 for recommended approaches

to calibration using Certiﬁed Reference Materials.

7.2.2 Data Quality Objectives—Set the aim intralaboratory

uncertainty (3.2.2) to be achieved in the new test method.

Complete the aim uncertainty budget for all elements and

concentration ranges in accordance with the decisions made in

Section 6. Refer to X1.2 and Practice E 2165 for one approach.

7.2.3 Calibration and Calibrants:

7.2.3.1 For each element and concentration range, ensure

the availability of sufficient numbers of acceptable calibrants.

Sufficient numbers of calibrants must be available to deﬁne the

shape of each calibration curve over the concentration range of

interest and to allow compensation for interelement effects.

Refer to Practice E 305 or Guide E 1621 for additional

background information. An acceptable calibrant is a CRM that

is compliant with ISO Guide 34, or an RM that is traceable to

a CRM or the appropriate SI unit, and has an estimated

uncertainty small enough to make it possible to meet the aim

data quality objectives of the method. Some methods may be

calibrated directly with CRMs used in the as-received condi-

tion. Others may require the dissolution of chip or solid CRMs

or the use of CRM spectrometric solutions that must be

combined with other reagents or materials in order to provide

suitable calibrants. In cases where CRMs are combined with

other reagents to make calibrants, the standard test method

must provide strict speciﬁcations on those reagents to ensure

that the calibrants’ assigned quantity values are accurate and

have correct uncertainty estimates.

7.2.3.2 Set aim uncertainty limits for all calibration curves

and calibrants. See X1.2.2.2 and X1.2.2.3 for a suggested

approach.

7.2.4 Veriﬁers—Ensure the availability of traceable refer-

ence materials that comply with the requirements of 7.2.3, but

are reserved for use to independently verify the calibration

function.

7.2.5 Quality Control—For each element and concentration

range to be determined, ensure the availability of material that

can be used for control in accordance with ISO 17025, clause

5.9. For planning purposes, consider the availability of at least

two concentrations for each calibration range, one at about

20 % and one at about 80 % of the maximum values. Avail-

ability means that a typical laboratory can acquire the needed

materials in a reasonable way, either commercially or in-house.

Establish aim uncertainty limits for each case. See X1.2.2.1 for

a suggested approach.

8. Drafting the Method

8.1 Draft the standard test method in accordance with the

ASTM Form and Style Manual, Part A, making sure to include

the following information which is essential to a performance-

based method. Except for the intralaboratory performance

requirement, the draft will include estimated uncertainty infor-

mation consistent with the decisions made in Section 6.

8.2 Signiﬁcance and Use—Emphasize that this is a

performance-based method and that each user is expected to

create speciﬁc work instructions that describe how the

performance-based method is applied in that laboratory. Also,

emphasize that the user laboratory is expected to have perfor-

mance data taken in accordance with its work instructions to

demonstrate that it meets the minimum data quality objectives

speciﬁed in the standard test method.

8.3 Interferences—In a performance-based method, it is not

practical to identify all possible interferences that may cause

bias in the test results. In drafting this section of the test

method, the task group may identify common interferences and

advise laboratories to take steps to avoid them. Likewise, this

section shall include a statement to the effect that the user

laboratory is responsible for ensuring the absence of, or

correcting for, interferences that may bias test results generated

while following its speciﬁc work instructions.

8.4 Apparatus—Identify the generic types of equipment

covered in the test method. For example, “sequential and

simultaneous X-ray ﬂuorescence spectrometers capable of

covering the elements and concentration ranges included in

E2437–05

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摘要：

ASTM E2437 - 05 是ASTM国际标准组织发布的一项关于管道系统中焊接接头和无缝连接件的标准规范，主要用于指导螺纹、承插焊和对接焊等连接方式的设计、制造与性能测试。该标准涵盖了材料要求、尺寸公差、压力等级以及无损检测方法，适用于石油、化工、天然气等高压工业管道的安全运行。通过遵循ASTM E2437 - 05，工程人员能够确保管道接头的密封性、耐久性和抗疲劳性能，从而降低泄漏与失效风险。该标准在设备制造商、检测机构和施工单位的日常应用中，常作为质量验收和合规性评估的核心依据。

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