ASTM_D_5196_-_06_2018.pdf

Designation:D519606(Reapproved 2018)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 parentheses 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 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 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 the other applications linked to anASTM methodand not bio-sensitive that require purified water,it is recom-mended that Specification D1193 or Guide D5127 be con-sulted.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.5 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2D1125 Test Methods for Electrical Conductivity and Resis-tivity of WaterD1129 Terminology Relating to WaterD1193 Specification for Reagent WaterD4453 Practice for Handling of High Purity Water SamplesD5127 Guide for Ultra-Pure Water Used in the Electronicsand Semiconductor IndustriesD5173 Guide for On-Line Monitoring of Total OrganicCarbon in Water by Oxidation and Detection of ResultingCarbon DioxideD5245 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 SampleD5542 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 Monitoring ofWater Used for Processing Electron and MicroelectronicDevices by Direct Pressure Tap Sampling Valve and bythe Presterilized Plastic Bag Method3.Terminology3.1 Definitions:3.1.1 For definitions of terms used in this standard,refer toTerminology D1129.3.2 Definitions of Terms Specific to This Standard:3.2.1 endotoxins,nsubstances 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,ntotal num-ber of viable micro-organisms present in the 100-mL sample,excluding anaerobic and microaerophilic bacteria.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 approved Nov.15,2018.Published November 2018.Originallyapproved in 1991.Last previous edition approved in 2013 as D5196 06(2013).DOI:10.1520/D5196-06R18.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,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 StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 3.2.3 total organic carbon,ncarbon in the form of organiccompounds.3.2.4 water,nwater 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 methods used to prepar