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ASTM D6808-02(2012)

(Practice)

Standard Practice for Competency Requirements of Reference Material Producers for Water Analysis

Standard Practice for Competency Requirements of Reference Material Producers for Water Analysis

SIGNIFICANCE AND USE
This practice is for the use by RM producers in the development and implementation of their quality system and by those concerned with assessing the competence of RM producers. It should be recognized that a RM needs to be characterized mainly to the level of accuracy required for its intended purpose (that is, appropriate measurement uncertainty). The RM producer shall describe the procedure for establishing the quality of materials as a component of the quality system.
This practice is for the use of RM users in the establishment if a RM producer has a quality system adequate to produce high quality RMs. It can be used by users to determine if the scientific and technical competence of a RMs producer is adequate to ensure the quality of RMs. This practice is consistent with the requirements for RM producers established in ISO Guide 34.
This practice does not specify specific protocols for the contents of RMs certificates of analysis, for calibration in analytical chemistry and use of certified RMs and for certification of RMs. For this information, users are referred to Practice D6362, ISO Guide 32, and ISO Guide 35.
SCOPE
1.1 This practice establishes the general requirements with which a reference materials (RM) producer has to demonstrate that it operates, if it is to be recognized as competent to produce RMs used for water analysis.  
1.2 This practice establishes the quality system requirements in accordance with which waters RMs shall be produced. It is intended to be used as part of a RM producer's general QA procedures. RM producers shall define their scope in terms of the application, the measurement methods used in the homogeneity, stability and characterization studies.
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.

General Information

Status
Historical
Publication Date
14-Jun-2012
ICS
71.040.40 - Chemical analysis
Technical Committee
D19 - Water
Drafting Committee
D19.02 - Quality Systems, Specification, and Statistics
Current Stage
Ref Project

Relations

Replaces
ASTM D6808-02(2007) - Standard Practice for Competency Requirements of Reference Material Producers for Water Analysis
Effective Date
15-Jun-2012
Replaced By
ASTM D6808-02(2018)e1 - Standard Practice for Competency Requirements of Reference Material Producers for Water Analysis
Effective Date
01-Aug-2018

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ASTM D6808-02(2012) - Standard Practice for Competency Requirements of Reference Material Producers for Water AnalysisASTM D6808-02(2012) - Standard Practice for Competency Requirements of Reference Material Producers for Water Analysis
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ASTM D6808-02(2012) - Standard Practice for Competency Requirements of Reference Material Producers for Water Analysis
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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: D6808 − 02 (Reapproved 2012)
Standard Practice for
Competency Requirements of Reference Material Producers
1
for Water Analysis
This standard is issued under the fixed designation D6808; 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/IEC Guide 2:1996 Standardization and Related
Activities—General Vocabulary
1.1 This practice establishes the general requirements with
ISO Guide 30:1992 Terms and Definitions used in Connec-
which a reference materials (RM) producer has to demonstrate
tion with Reference Materials
that it operates, if it is to be recognized as competent to
ISO Guide 31:2000 Contents of Certificates and Labels of
produce RMs used for water analysis.
Reference Materials
1.2 This practice establishes the quality system require-
ISO/IEC Guide 32:1997 Calibration inAnalytical Chemistry
ments in accordance with which waters RMs shall be pro-
and Use of Certified Reference Materials
duced. It is intended to be used as part of a RM producer’s
ISO Guide 34:2000 General Requirements for the Compe-
general QAprocedures. RM producers shall define their scope
tency of Reference Material Producers
in terms of the application, the measurement methods used in
ISO Guide 35:1989 Certification of Reference Materials—
the homogeneity, stability and characterization studies.
General and Statistical Principles
1.3 This standard does not purport to address all of the
ISO 3534 Series: 1993 Statistics—Vocabulary and Symbols
safety concerns, if any, associated with its use. It is the VIM: 1993 International Vocabulary of Basic and General
responsibility of the user of this standard to establish appro-
Terms in Metrology (issued by ISO, IEC, BIPM, IFCC,
priate safety and health practices and determine the applica- IUPAC, IUPAP and OIML)
bility of regulatory limitations prior to use.
ISO Guide to the Expression of Uncertainty in Measure-
ment: 1995 (issued by ISO, IEC, BIPM, IFCC, IUPAC,
2. Referenced Documents
IUPAP and OIML)
2
2.1 ASTM Standards:
3. Terminology
D1129 Terminology Relating to Water
D6362 Practice for Certificates of Reference Materials for
3.1 Definitions:
Water Analysis
3.1.1 For the purposes of this practice, the definitions given
3
2.2 ISO Documents: inTerminologyD1129,ISO/IECGuide2,ISO/IEC17025,ISO
Guide 30, ISO 8402, ISO 3534, VIM and the following
ISO/IEC 17025:1999 General Requirements for the Compe-
tence of Calibration and Testing Laboratories definitions apply.
3.1.2 collaborator—technically competent body (organiza-
ISO 8402:1994 Quality Management and Quality
Assurance—Vocabulary tion or firm, public or private) that undertakes aspects of the
manufacture, or characterization, of the (certified) RM on
ISO 10012-1:1992 Quality Assurance Requirements for
Measuring Equipment—Part 1: Metrological Confirma- behalf of the RM producer, either on a contractual (as a
sub-contractor) or voluntary basis.
tion Systems for Measuring Equipment
3.1.3 reference material producer—technically competent
body (organization or firm, public or private) that is fully
1
This practice is under the jurisdiction of ASTM Committee D19 on Water and
responsible for assigning the certified or other property values
is the direct responsibility of Subcommittee D19.02 on Quality Systems,
of the RMs it produces and supplies, which have been
Specification, and Statistics.
produced in accordance with ISO Guide 35, Practice D6362,
Current edition approved June 15, 2012. Published June 2012. Originally
approved in 2002. Last previous edition approved in 2007 as D6808 – 02 (2007).
and ISO Guide 31.
DOI: 10.1520/D6808-02R12.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4. Significance and 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
4.1 This practice is for the use by RM producers in the
the ASTM website.
3
development and implementation of their quality system and
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org. by those concerned with assessing the competence of RM
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
D6808 − 02 (2012)
producers. It should be recognized that a RM needs to be produced. Documentation used in this quality system shall be
characterized mainly to the level of accuracy required for its communicatedto,understoodby,availabletoandimplemented
intended p
...

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SCOPE
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SIGNIFICANCE AND USE
4.1 This practice is for the use by RM producers in the development and implementation of their quality system and by those concerned with assessing the competence of RM producers. It should be recognized that a RM needs to be characterized mainly to the level of accuracy required for its intended purpose (that is, appropriate measurement uncertainty). The RM producer shall describe the procedure for establishing the quality of materials as a component of the quality system.  
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5.1 Matrix spiking of samples is commonly used to determine the bias under specific analytical conditions, or the applicability of a test method to a particular sample matrix, by determining the extent to which the added spike is recovered from the sample matrix under these conditions. Reactions or interactions of the analyte or component of interest with the sample matrix may cause a significant positive or negative effect on recovery and may render the chosen analytical, or monitoring, process ineffectual for that sample matrix.  
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5.4 Special precautions shall be observed when nonlaboratory personnel perform spiking in the field. It is recommended that all spike preparation work be performed in a laboratory by experienced analysts so that the field operation consists solely of adding a prepared spiking solution to the sample matrix. Training of field personnel and validation of their spiking techniques are necessary to ensure that spikes are added accurately and reproducibly. Consistent and acceptable recoveries from duplicate field spikes can be used to document the reproducibility of sampling and the spiking technique....
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5.1 Ion chromatography provides for both qualitative and quantitative determination of seven common anions, F−, Cl−, NO2−, HPO4 −2, Br−, NO3−, and SO4−2, in the milligram per litre range from a single analytical operation requiring only a few millilitres of sample and taking approximately 10 to 15 min for completion. Additional anions, such as carboxylic acids, can also be quantified.
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Note 1: Order of elution is dependent upon the column used; see Fig. 1.  
1.3 It is the user's responsibility to ensure the validity of this test method for other matrices.  
1.4 Concentrations as low as 0.01 mg/L were determined depending upon the anions to be quantified, in single laboratory work. Utilizing a 50-μL sample volume loop and a sensitivity of 3000 μS/cm full scale, the approximate detection limits shown in Table 1 can be achieved. Lower detection limits have been observed with newer instrumentation, column technology and eluents. The analyst must assure optimum instrument performance to maintain a stable baseline at more sensitive conductivity full-scale settings. (A) Data provided by U.S. EPA/EMSL Laboratory, Cincinnati, OH.(B) Column: as specified in 7.1.4.
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Eluent: as specified in 8.3.
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1.6 Using alternate separator column and eluents may permit additional anions such as acetate, formate, or citrate to be determined. This is not the subject of this test method.  
1.7 This test method update approves the use of electrolytically generated eluent, electrolytically regenerated eluent, electrolytic suppression (not autozeroing), and electrolytic trap columns also known as reagent-free ion chromatography. This approval is based on acceptance by the U.S. EPA as referenced in Appendix X2.  
1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.9 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.  
1.10 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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Standard Test Method for On-Line Measurement of Residue After Evaporation of High-Purity Water

SIGNIFICANCE AND USE
5.1 Even so-called high-purity water will contain contaminants. While not always present, these contaminants may contribute one or more of the following: dissolved active ionic substances such as calcium, magnesium, sodium, potassium, manganese, ammonium, bicarbonates, sulfates, nitrates, chloride and fluoride ions, ferric and ferrous ions, and silicates; dissolved organic substances such as pesticides, herbicides, plasticizers, styrene monomers, deionization resin material; and colloidal suspensions such as silica. While this test method facilitates the monitoring of these contaminants in high-purity water, in real time, with one instrument, this test method is not capable of identifying the various sources of residue contamination or detecting dissolved gases or suspended particles.  
5.2 This test method is calibrated using weighed amounts of an artificial contaminant (potassium chloride). The density of potassium chloride is reasonably typical of contaminants found in high-purity water; however, the response of this test method is clearly based on a response to potassium chloride. The response to actual contaminants found in high-purity water may differ from the test method's calibration. This test method is not different from many other analytical test methods in this respect.  
5.3 Together with other monitoring methods, this test method is useful for diagnosing sources of RAE in ultra-pure water systems. In particular, this test method can be used to detect leakages such as colloidal silica breakthrough from the effluent of a primary anion or mixed-bed deionizer. In addition, this test method has been used to measure the rinse-up time for new liquid filters and has been adapted for batch-type sampling (this adaptation is not described in this test method).  
5.4 Obtaining an immediate indication of contamination in high-purity water has significance to those industries using high-purity water for manufacturing components; production can be halted immediate...
SCOPE
1.1 This test method covers the determination of dissolved organic and inorganic matter and colloidal material found in high-purity water used in the semiconductor, and related industries. This material is referred to as residue after evaporation (RAE). The range of the test method is from 0.001 μg/L (ppb) to 60 μg/L (ppb).  
1.2 This test method uses a continuous, real time monitoring technique to measure the concentration of RAE. A pressurized sample of high-purity water is supplied to the test method's apparatus continuously through ultra-clean fittings and tubing. Contaminants from the atmosphere are therefore prevented from entering the sample. General information on the test method and a literature review on the continuous measurement of RAE has been published.2  
1.3 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard.  
1.4 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. For specific hazards statements, see Section 8.  
1.5 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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