ASTM D5196-06(2018)
(Guide)Standard Guide for Bio-Applications Grade Water
Standard Guide for Bio-Applications Grade Water
SIGNIFICANCE AND USE
4.1 The purity of water is relative and is usually characterized by the limits of impurities found in the water as well as by the methods used to prepare and handle the water. Section 7 mentions the suitable methods for water preparation.
SCOPE
1.1 This guide is intended to describe the chemical and biological characteristics of water to be used whenever critical purity is essential to the use intended in laboratory bio-applications, for example, clinical, pharmaceutical, and biomedical. The importance of such a reagent is often underestimated despite the impact that it can have.
1.2 This guide is not intended to be used as a reference in preparing water for injectables. Generally, the appropriate use of this guide may include experiments involving tissue culture, chromatography, mass spectrometry, polymerase chain reaction (PCR), deoxyribonucleic acid (DNA) sequencing, DNA hybridization, electrophoresis, molecular biology or analyses where molecular concentrations of impurities may be important.
1.3 For all the other applications linked to an ASTM method and not bio-sensitive that require purified water, it is recommended that Specification D1193 or Guide D5127 be consulted.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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 environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 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.
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: D5196 − 06 (Reapproved 2018)
Standard Guide for
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Bio-Applications Grade Water
This standard is issued under the fixed designation D5196; 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 2. Referenced Documents
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2.1 ASTM Standards:
1.1 This guide is intended to describe the chemical and
D1125 Test Methods for Electrical Conductivity and Resis-
biological characteristics of water to be used whenever critical
tivity of Water
purity is essential to the use intended in laboratory bio-
D1129 Terminology Relating to Water
applications, for example, clinical, pharmaceutical, and bio-
D1193 Specification for Reagent Water
medical. The importance of such a reagent is often underesti-
D4453 Practice for Handling of High Purity Water Samples
mated despite the impact that it can have.
D5127 Guide for Ultra-Pure Water Used in the Electronics
1.2 This guide is not intended to be used as a reference in and Semiconductor Industries
D5173 Guide for On-Line Monitoring of Total Organic
preparing water for injectables. Generally, the appropriate use
Carbon in Water by Oxidation and Detection of Resulting
of this guide may include experiments involving tissue culture,
Carbon Dioxide
chromatography, mass spectrometry, polymerase chain reac-
D5245 Practice for Cleaning Laboratory Glassware,
tion (PCR), deoxyribonucleic acid (DNA) sequencing, DNA
Plasticware, and Equipment Used in Microbiological
hybridization, electrophoresis, molecular biology or analyses
Analyses
where molecular concentrations of impurities may be impor-
D5391 Test Method for Electrical Conductivity and Resis-
tant.
tivity of a Flowing High Purity Water Sample
1.3 ForalltheotherapplicationslinkedtoanASTMmethod
D5542 Test Methods for TraceAnions in High Purity Water
and not bio-sensitive that require purified water, it is recom-
by Ion Chromatography
mended that Specification D1193 or Guide D5127 be con-
D5673 Test Method for Elements in Water by Inductively
sulted.
Coupled Plasma—Mass Spectrometry
D5996 Test Method for MeasuringAnionic Contaminants in
1.4 The values stated in SI units are to be regarded as
High-Purity Water by On-Line Ion Chromatography
standard. No other units of measurement are included in this
F1094 Test Methods for Microbiological Monitoring of
standard.
Water Used for Processing Electron and Microelectronic
Devices by Direct Pressure Tap Sampling Valve and by
1.5 This standard does not purport to address all of the
the Presterilized Plastic Bag Method
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
3. Terminology
priate safety, health, and environmental practices and deter-
3.1 Definitions:
mine the applicability of regulatory limitations prior to use.
3.1.1 For definitions of terms used in this standard, refer to
1.6 This international standard was developed in accor-
Terminology D1129.
dance with internationally recognized principles on standard-
3.2 Definitions of Terms Specific to This Standard:
ization established in the Decision on Principles for the
3.2.1 endotoxins, n—substances or by-products usually pro-
Development of International Standards, Guides and Recom-
duced by gram negative micro-organisms that give a positive
mendations issued by the World Trade Organization Technical
test for endotoxin in accordance with 13.2.
Barriers to Trade (TBT) Committee.
3.2.2 heterotrophic bacterial counts/100 mL, n—total num-
ber of viable micro-organisms present in the 100-mL sample,
excluding anaerobic and microaerophilic bacteria.
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This guide is under the jurisdiction of ASTM Committee D19 on Water and is
thedirectresponsibilityofSubcommitteeD19.02onQualitySystems,Specification,
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and Statistics. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Nov. 15, 2018. Published November 2018. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1991. Last previous edition approved in 2013 as D5196 – 06 (2013). Standards volume information, refer to the standard’s Document Summary page on
DOI: 10.1520/D5196-06R18. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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D5196 − 06 (2018)
3.2.3 total organic carbon, n—carbonintheformoforganic will depend on the end use for
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