ASTM D5196-06(2013)

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 Test Method D5127 be consulted.  
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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 31-Mar-2013
• ICS: 71.060.01 - Inorganic chemicals in general
• Technical Committee: D19 - Water
• Drafting Committee: D19.02 - Quality Systems, Specification, and Statistics

Relations

• Replaces: ASTM D5196-06 - Standard Guide for Bio-Applications Grade Water
• Effective Date: 01-Apr-2013
• Replaced By: ASTM D5196-06(2018) - Standard Guide for Bio-Applications Grade Water
• Effective Date: 15-Nov-2018
• Referred By: ASTM D5127-13(2018) - Standard Guide for Ultra-Pure Water Used in the Electronics and Semiconductor Industries
• Effective Date: 01-Apr-2013

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: D5196 − 06 (Reapproved 2013)
Standard Guide for
1
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 and Semiconductor Industries
D5173 Guide for On-Line Monitoring of Total Organic
1.1 This guide is intended to describe the chemical and
Carbon in Water by Oxidation and Detection of Resulting
biological characteristics of water to be used whenever critical
Carbon Dioxide
purity is essential to the use intended in laboratory Bio-
D5245 Practice for Cleaning Laboratory Glassware,
Applications, for example, clinical, pharmaceutical, and bio-
Plasticware, and Equipment Used in Microbiological
medical. The importance of such a reagent is often underesti-
Analyses
mated despite the impact that it can have.
D5391 Test Method for Electrical Conductivity and Resis-
1.2 This guide is not intended to be used as a reference in
tivity of a Flowing High Purity Water Sample
preparing water for injectables. Generally, the appropriate use
D5542 Test Methods for TraceAnions in High Purity Water
of this guide may include experiments involving tissue culture,
by Ion Chromatography
chromatography, mass spectrometry, Polymerase Chain Reac-
D5673 Test Method for Elements in Water by Inductively
tion (PCR), DeoxyriboNucleic Acid (DNA) sequencing, DNA
Coupled Plasma—Mass Spectrometry
hybridization, electrophoresis, molecular biology or analyses
D5996 Test Method for MeasuringAnionic Contaminants in
where molecular concentrations of impurities may be impor-
High-Purity Water by On-Line Ion Chromatography
tant.
F1094 Test Methods for Microbiological Monitoring of
1.3 ForalltheotherapplicationslinkedtoanASTMmethod Water Used for Processing Electron and Microelectronic
Devices by Direct Pressure Tap Sampling Valve and by
and not bio-sensitive that require purified water, it is recom-
mended that Specification D1193 or Test Method D5127 be the Presterilized Plastic Bag Method
consulted.
3. Terminology
1.4 This standard does not purport to address all of the
3.1 Definitions—For definitions of terms used in this guide,
safety concerns, if any, associated with its use. It is the
refer to Terminology D1129.
responsibility of the user of this standard to establish appro-
3.2 Definitions of Terms Specific to This Standard:
priate safety and health practices and determine the applica-
3.2.1 endotoxins—substances or by-products usually pro-
bility of regulatory limitations prior to use.
duced by gram negative micro-organisms that give a positive
2. Referenced Documents test for endotoxin in accordance with 13.2.
2
3.2.2 heterotrophic bacterial counts/100 mL— total number
2.1 ASTM Standards:
of viable micro-organisms present in the 100-mL sample,
D1125 Test Methods for Electrical Conductivity and Resis-
excluding anaerobic and microaerophilic bacteria.
tivity of Water
D1129 Terminology Relating to Water
3.2.3 total organic carbon—carbon in the form of organic
D1193 Specification for Reagent Water
compounds.
D4453 Practice for Handling of High Purity Water Samples
3.2.4 water—water complying with compositions given in
D5127 Guide for Ultra-Pure Water Used in the Electronics
Table 1.
4. Significance and Use
1
This guide is under the jurisdiction of ASTM Committee D19 on Water and is
4.1 The purity of water is relative and is usually character-
thedirectresponsibilityofSubcommitteeD19.02onQualitySystems,Specification,
ized by the limits of impurities found in the water as well as by
and Statistics.
the methods used to prepare and handle the water. Section 7
Current edition approved April 1, 2013. Published April 2013. Originally
approved in 1991. Last previous edition approved in 2006 as D5196 – 06. DOI:
mentions the suitable methods for water preparation.
10.1520/D5196-06R13.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
5. Composition
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
5.1 Water for Bio-Applications should be prepared (using
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. water purification technologies) starting from water complying
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D5196 − 06 (2013)
TABLE 1
ultrafiltration, nanofiltration, UV photo-oxidation, and/or
Analytes Maximum Concentration screen membrane filtration, to meet the compositions given in
Total Inorganic Analytes 1 µg/L or resistivity of
...