ASTM D5196-06

Standard Guide for Bio-Applications Grade Water

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 D 1193 or Test Method D 5127 be consulted.
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-2006
• ICS: 71.060.01 - Inorganic chemicals in general
• Technical Committee: D19 - Water
• Drafting Committee: D19.02 - Quality Systems, Specification, and Statistics

Relations

• Replaces: ASTM D5196-91(1999) - Standard Guide for Biomedical Grade Water
• Effective Date: 01-Apr-2006
• Replaced By: ASTM D5196-06(2013) - Standard Guide for Bio-Applications Grade Water
• Effective Date: 01-Apr-2013
• Referred By: ASTM D5127-13(2018) - Standard Guide for Ultra-Pure Water Used in the Electronics and Semiconductor Industries
• Effective Date: 01-Apr-2006

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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
StandardGuide 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 Test Method for On-Line Monitoring of Carbon
1.1 This guide is intended to describe the chemical and
Compounds in Water by Chemical Oxidation, by UV
biological characteristics of water to be used whenever critical
Light Oxidation, by Both, or by High Temperature Com-
purity is essential to the use intended in laboratory Bio-
bustion Followed by Gas Phase NDIR or by Electrolytic
Applications, for example, clinical, pharmaceutical, and bio-
Conductivity
medical. The importance of such a reagent is often underesti-
D5245 Practice for Cleaning Laboratory Glassware,
mated despite the impact that it can have.
Plasticware, and Equipment Used in Microbiological
1.2 This guide is not intended to be used as a reference in
Analyses
preparing water for injectables. Generally, the appropriate use
D5391 Test Method for Electrical Conductivity and Resis-
of this guide may include experiments involving tissue culture,
tivity of a Flowing High Purity Water Sample
chromatography, mass spectrometry, Polymerase Chain Reac-
D5542 Test Methods for TraceAnions in High Purity Water
tion (PCR), DeoxyriboNucleic Acid (DNA) sequencing, DNA
by Ion Chromatography
hybridization, electrophoresis, molecular biology or analyses
D5673 Test Method for Elements in Water by Inductively
where molecular concentrations of impurities may be impor-
Coupled Plasma—Mass Spectrometry
tant.
D5996 Test Method for MeasuringAnionic Contaminants in
1.3 ForalltheotherapplicationslinkedtoanASTMmethod High-Purity Water by On-Line Ion Chromatography
F1094 Test Methods for Microbiological Monitoring of
and not bio-sensitive that require purified water, it is recom-
mended that Specification D1193 or Test Method D5127 be Water Used for Processing Electron and Microelectronic
Devices by Direct Pressure Tap Sampling Valve and by
consulted.
the Presterilized Plastic Bag Method
1.4 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
3. Terminology
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
3.1 Definitions—For definitions of terms used in this guide,
bility of regulatory limitations prior to use.
refer to Terminology D1129.
3.2 Definitions of Terms Specific to This Standard:
2. Referenced Documents
3.2.1 endotoxins—substances or by-products usually pro-
2
2.1 ASTM Standards:
duced by gram negative micro-organisms that give a positive
D1125 Test Methods for Electrical Conductivity and Resis-
test for endotoxin in accordance with 13.2.
tivity of Water
3.2.2 heterotrophic bacterial counts/100 mL— total number
D1129 Terminology Relating to Water
of viable micro-organisms present in the 100-mL sample,
D1193 Specification for Reagent Water
excluding anaerobic and microaerophilic bacteria.
D4453 Practice for Handling of High Purity Water Samples
D5127 Guide for Ultra-Pure Water Used in the Electronics
3.2.3 total organic carbon—carbon in the form of organic
compounds.
3.2.4 water—water complying with compositions given in
1
This guide is under the jurisdiction of ASTM Committee D19 on Water and is
Table 1.
thedirectresponsibilityofSubcommitteeD19.02onQualitySystems,Specification,
and Statistics.
Current edition approved April 1, 2006. Published April 2006. Originally
4. Significance and Use
approved in 1991. Last previous edition approved in 1999 as D5196 – 91 (1999).
DOI: 10.1520/D5196-06.
4.1 The purity of water is relative and is usually character-
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
ized by the limits of impurities found in the water as well as by
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
the methods used to prepare and handle the water. Section 7
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. mentions the suitable methods for water preparation.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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D5196 − 06
TABLE 1
7.3 The purification of tap water shall be accomplished by a
Analytes Maximum Concentration single technology or a combination of suitable purification
Total Inorganic Analytes 1 µg/L or resistivity of 18.2 technologies such as distillation, deionization, elec
...

This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
An American National Standard Designation: D 5196 – 06
Designation:D 5196–91 (Reapproved 1999)
Standard Guide for
1
Biomedical Grade WaterBio-Applications Grade Water
This standard is issued under the fixed designation D 5196; 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
1.1This guide is intended to describe the physical and chemical characteristics of water to be used whenever critical purity is
essential to the use intended in clinical, pharmaceutical, biophysical, biomedical, chemical, physical research applications, or a
combination of these. This guide is not intended for use in preparing water for injectables. Generally, the appropriate use of this
guide may include experiments involving tissue culture, chromatography, mass spectroscopy, or analysis where molecular
quantities of impurities may be important.
1.2This standard does not purport to address all of the safety problems, 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.
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 ForalltheotherapplicationslinkedtoanASTMmethodandnotbio-sensitivethatrequirepurifiedwater,itisrecommended
that Specification D 1193 or Test Method D 5127 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D 1125 Test Methods for Electrical Conductivity and Resistivity of WaterWater
2
D 1129 Terminology Relating to Water Water
2
D1426Test Methods for Ammonia Nitrogen in Water 1193 Specification for Reagent Water
D1428Test Methods for Sodium and Potassium in Water and Water-Formed Deposits by Flame Photometry 4453 Practice for
Handling of Ultra-Pure Water Samples
D 5127 Guide for Ultra-Pure Water Used in the Electronics and Semiconductor Industries
2
D3919Practice for MeasuringTrace Elements inWater by Graphite FurnaceAtomicAbsorption Spectrophotometry 5173 Test
Method for On-Line Monitoring of Carbon Compounds in Water by Chemical Oxidation, by UV Light Oxidation, by Both,
or by High Temperature Combustion Followed by Gas Phase NDIR or by Electrolytic Conductivity
D3973Test Method for Low Molecular Weight Halogenated Hydrocarbons in Water 5245 Practice for Cleaning Laboratory
Glassware, Plasticware, and Equipment Used in Microbiological Analyses
2
D4453Practice for Handling of Ultra-Pure Water Samples 5391 Test Method for Electrical Conductivity and Resistivity of a
Flowing High Purity Water Sample
4
D4517Test Method for Low-LevelTotal Silica in High PurityWater by FlamelessAtomicAbsorption Spectroscopy 5542 Test
Methods for Trace Anions in High Purity Water by Ion Chromatography
D4779Test Method forTotal, Organic, and Inorganic Carbon in High PurityWater by Ultraviolet (UV), or Persulfate Oxidation,
1
ThisguideisunderthejurisdictionofASTMCommitteeD-19D19onWaterandisthedirectresponsibilityofSubcommitteeD19.02onGeneralSpecifications,Technical
Resources, and Statistical Methods.
Current edition approved Oct. 15, 1991. Published February 1992.
Current edition approved April 1, 2006. Published April 2006. Originally approved in 1991. Last previous edition approved in 1999 as D 5196 – 91 (1999).
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Serv
...