1、Designation:D519606(Reapproved 2013)Standard Guide forBio-Applications Grade Water1This standard is issued under the fixed designation D5196;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parent
2、heses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide is intended to describe the chemical andbiological characteristics of water to be used whenever criticalpurity is essential to the use intended
3、in laboratory Bio-Applications,for example,clinical,pharmaceutical,and bio-medical.The importance of such a reagent is often underesti-mated despite the impact that it can have.1.2 This guide is not intended to be used as a reference inpreparing water for injectables.Generally,the appropriate useof
4、this guide may include experiments involving tissue culture,chromatography,mass spectrometry,Polymerase Chain Reac-tion(PCR),DeoxyriboNucleic Acid(DNA)sequencing,DNAhybridization,electrophoresis,molecular biology or analyseswhere molecular concentrations of impurities may be impor-tant.1.3 For all t
5、he other applications linked to anASTM methodand not bio-sensitive that require purified water,it is recom-mended that Specification D1193 or Test Method D5127 beconsulted.1.4 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility o
6、f 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 Documents2.1 ASTM Standards:2D1125 Test Methods for Electrical Conductivity and Resis-tivity of WaterD1129 Terminology Relating to Wa
7、terD1193 Specification for Reagent WaterD4453 Practice for Handling of High Purity Water SamplesD5127 Guide for Ultra-Pure Water Used in the Electronicsand Semiconductor IndustriesD5173 Test Method for On-Line Monitoring of CarbonCompounds in Water by Chemical Oxidation,by UVLight Oxidation,by Both,
8、or by High Temperature Com-bustion Followed by Gas Phase NDIR or by ElectrolyticConductivityD5245 Practice for Cleaning Laboratory Glassware,Plasticware,and Equipment Used in MicrobiologicalAnalysesD5391 Test Method for Electrical Conductivity and Resis-tivity of a Flowing High Purity Water SampleD5
9、542 Test Methods for Trace Anions in High Purity Waterby Ion ChromatographyD5673 Test Method for Elements in Water by InductivelyCoupled PlasmaMass SpectrometryD5996 Test Method for Measuring Anionic Contaminants inHigh-Purity Water by On-Line Ion ChromatographyF1094 Test Methods for Microbiological
10、 Monitoring ofWater Used for Processing Electron and MicroelectronicDevices by Direct Pressure Tap Sampling Valve and bythe Presterilized Plastic Bag Method3.Terminology3.1 DefinitionsFor definitions of terms used in this guide,refer to Terminology D1129.3.2 Definitions of Terms Specific to This Sta
11、ndard:3.2.1 endotoxinssubstances or by-products usually pro-duced by gram negative micro-organisms that give a positivetest for endotoxin in accordance with 13.2.3.2.2 heterotrophic bacterial counts/100 mL total numberof viable micro-organisms present in the 100-mL sample,excluding anaerobic and mic
12、roaerophilic bacteria.3.2.3 total organic carboncarbon in the form of organiccompounds.3.2.4 waterwater complying with compositions given inTable 1.4.Significance and Use4.1 The purity of water is relative and is usually character-ized by the limits of impurities found in the water as well as bythe
13、methods used to prepare and handle the water.Section 7mentions the suitable methods for water preparation.1This guide is under the jurisdiction of ASTM Committee D19 on Water and isthe direct responsibility of Subcommittee D19.02 on Quality Systems,Specification,and Statistics.Current edition approv
14、ed April 1,2013.Published April 2013.Originallyapproved in 1991.Last previous edition approved in 2006 as D5196 06.DOI:10.1520/D5196-06R13.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume inf
15、ormation,refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 5.Composition5.1 Water for Bio-Applications should be prepared(usingwater purification technologies)starting from wat
16、er complyingwith the U.S.Environmental Protection Agency(EPA)Na-tional Primary Drinking Water Regulations,or from compa-rable regulations from the European Union or Japan.The use ofsuch a minimum standard quality for feed water is important todecrease the risk of producing and using final purified waterthat would be compliant with the compositions given in Table1 but could contain certain specific contaminants in concen-trations that could affect the applications.5.2 Recommendations for purity o