ASTM D1193-2006 Standard Specification for Reagent Water《试剂水标准规范》.pdf

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1、Designation: D 1193 06Federal Test MethodStandard No. 7916Standard Specification forReagent Water1This standard is issued under the fixed designation D 1193; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision

2、. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.This standard has been approved for use by agencies of the Department of Defense.1. Scope1.1 This specification describes the required charact

3、eristicsof waters deemed suitable for use with the Standards under thejurisdiction of ASTM.1.2 The alphanumeric characters ascribed to water types andgrades are specified in the ASTM Format and Style Manual.These have been assigned in order of historical precedence andshould not be taken as an indic

4、ation of a progression in waterpurity.1.3 Four types of waters have been specified, with threeadditional grades that can be applied to the four types. Thegrade specifications specifically address contaminants of mi-crobiological origin.1.4 All applicable ASTM Standards are expected to refer-ence one

5、 or more of these reagent water types where reagentwater is needed as a component of an analytical measurementprocess. Where a different water type or grade is needed for anASTM Standard, it may be added to this Specification throughthe ASTM Standard revision process.1.5 Although these water types a

6、nd associated grades havebeen defined specifically for use with ASTM Standards, theymay be appropriate for other applications. It is the responsi-bility of the users of this standard to ensure that the selectedwater types or grades are suitable for their intended use.Historically, reagent water Type

7、s I, II, III, and IV have beenlinked to specific processes for their production. Starting withthis revision, these types of waters may be produced withalternate technologies as long as the appropriate constituentspecifications are met and that water so produced has beenshown to be appropriate for th

8、e application where the use ofsuch water is specified. Therefore, the selection of an alternatetechnology in place of the technology specified in Table 1should be made taking into account the potential impact ofother contaminants such as microorganism and pyrogens. Suchcontaminants were not necessar

9、ily considered by the perfor-mance characteristics of the technology previously specified.1.6 Guidance for applications, the preparation, use andmonitoring, storage, handling, distribution, testing of thesespecified waters and validation of the water purification systemis provided in Appendix X1 of

10、this document.1.7 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 and health practices and determine the applica-bility of regulatory limitations prior to use.2

11、. Referenced Documents2.1 ASTM Standards:2D 1125 Test Methods for Electrical Conductivity and Re-sistivity of WaterD 1129 Terminology Relating to WaterD 1293 Test Methods for pH of WaterD 4453 Practice for Handling of Ultra-Pure Water SamplesD 4517 Test Method for Low-Level Total Silica in High-Puri

12、ty Water by Flameless Atomic Absorption Spectros-copy3D 5128 Test Method for On-Line pH Measurement of Waterof Low ConductivityD 5173 Test Method for On-Line Monitoring of CarbonCompounds in Water by Chemical Oxidation, by UV LightOxidation, by Both, or by High Temperature CombustionFollowed by Gas

13、Phase NDIR or by Electrolytic Conduc-tivityD 5245 Practice for Cleaning Laboratory Glassware, Plas-ticware, and Equipment Used in Microbiological AnalysesD 5391 Test Method for Electrical Conductivity and Resis-tivity of a Flowing High Purity Water SampleD 5542 Test Method for Trace Anions in High P

14、urity Waterby Ion ChromatographyD 5997 Test Method for On-Line Monitoring of Total Car-bon, Inorganic Carbon in Water by Ultraviolet, Persulfate1This specification is under the jurisdiction of ASTM Committee D19 on Waterand is the responsibility of Subcommittee D19.02 on General Specifications,Techn

15、ical Resources, and Statistical Methods.Current edition approved March 1, 2006. Published March 2006. Originallyapproved in 1951. Last previous edition approved in 1999 as D 1193 99e1.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm

16、.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Determination of Trace Silica in Industrial Process Waters by FlamelessAtomicAbsorption Spectrometry, Judith Rawa and Earl Henn, Analytical Chemistry, Vol 51,No 3, March 1979.1

17、Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.Oxidation and Membrane Conductivity DetectionD 6071 Test Method for Low Level Sodium in High PurityWater by Graphite FurnaceAtomAbsorption SpectroscopyD 6161 Terminology Used for Crossfl

18、ow Microfiltration,Ultrafiltration, Nanofiltration and Reverse Osmosis Mem-brane ProcessesD 6529 Test Method for Operating Performance of Con-tinuous Electrodeionization Systems on Feeds from501000 S/cmF 1094 Test Methods for Microbiological Monitoring ofWater Used for Processing Electron and Microe

19、lectronicDevices by Direct Pressure Tap Sampling Valve and by thePresterilized Plastic Bag Method3. Terminology3.1 Definitions For definitions used in this specificationrefer to Terminology D 1129.3.2 Definitions of Terms Specific to This Standard:3.2.1 reagent waterwater that is used specifically a

20、s acomponent of an analytical measurement process and meets orexceeds the specifications for these waters.3.2.2 electrodeionizationa process that removes ionizedand ionizable species from liquids using electrically activemedia and using an electrical potential to influence iontransport, where the io

21、nic transport properties of the activemedia are a primary sizing parameter. ElectrodeionizationTABLE 1 Processes for Reagent Water ProductionType Grade Production ProcessA,B,C,DS/cmE(max)MVcmF(min)pHGTOCg/LH(max)Sodiumg/LI(max)Chlorideg/LJ(max)TotalSilicag/L(max)HBCKcfu/mL(max)Endotoxin,EU/mLL(max)I

22、 Purify to 20 S/cm by dist. or equiv.,followed by mixed bed DI, 0.2 mfiltrationA0.0555 18 50 1 1 3I A Purify to 20 S/cm by dist. or equiv.,followed by mixed bed DI, 0.2 mfiltrationA0.0555 18 50 1 1 3 10/1000 0.03I B Purify to 20 S/cm by dist. or equiv.,followed by mixed bed DI, 0.2 mfiltrationA0.055

23、5 18 50 1 1 3 10/100 0.25I C Purify to 20 S/cm by dist. or equiv.,followed by mixed bed DI, 0.2 mfiltrationA0.0555 18 50 1 1 3 100/10II DistillationB1.0 1.0 50 5 5 3II A DistillationB1.0 1.0 50 5 5 3 10/1000 0.03II B DistillationB1.0 1.0 50 5 5 3 10/100 0.25II C DistillationB1.0 1.0 50 5 5 3 100/10I

24、II Distillation, DI, EDI, and/or RO,followed by 0.45 m filtration.C0.25 4.0 200 10 10 500III A Distillation, DI, EDI, and/or RO,followed by 0.45 m filtration.C0.25 4.0 200 10 10 500 10/1000 0.03III B Distillation, DI, EDI, and/or RO,followed by 0.45 m filtration.C0.25 4.0 200 10 10 500 10/100 0.25II

25、I C Distillation, DI, EDI, and/or RO,followed by 0.45 m filtration.C0.25 4.0 200 10 10 500 1000/100IV Distillation, DI, EDI, and/or RO.D5.0 0.2 5.0 to 8.0 50 50IV A Distillation, DI, EDI, and/or RO.D5.0 0.2 5.0 to 8.0 50 50 10/1000 0.03IV B Distillation, DI, EDI, and/or RO.D5.0 0.2 5.0 to 8.0 50 50

26、10/100 0.25IV C Distillation, DI, EDI, and/or RO.D5.0 0.2 5.0 to 8.0 50 50 100/10AType I grade of reagent water shall be prepared by distillation or other equal process, followed by polishing with a mixed bed of ion-exchange materials and a 0.2-mmembrane filter. Feed water to the final polishing ste

27、p must have a maximum conductivity of 20 S/cm at 298K (25C). Type I reagent water may be produced with alternatetechnologies as long as the appropriate constituent specifications are met and that water so produced has been shown to be appropriate for the application where the useof such water is spe

28、cified.BType II grade of reagent water shall be prepared by distillation using a still designed to produce a distillate having a conductivity of less than 1.0 S/cm at 298 K (25C).Ion exchange, distillation, or reverse osmosis and organic adsorption may be required prior to distillation, if the purit

29、y cannot be attained by single distillation. Type II reagentwater may be produced with alternate technologies as long as the appropriate constituent specifications are met and that water so produced has been shown to beappropriate for the application where the use of such water is specified.CType II

30、I grade of reagent water shall be prepared by distillation, ion exchange, continuous electrodeionization, reverse osmosis, or a combination thereof, followed bypolishing with a 0.45-m membrane filter. Type III reagent water may be produced with alternate technologies as long as the appropriate const

31、ituent specifications are metand that water so produced has been shown to be appropriate for the application where the use of such water is specified.DType IV grade of reagent water may be prepared by distillation, ion exchange, continuous electrodeionization, reverse osmosis, electrodialysis, or a

32、combinationthereof. Type IV reagent water may be produced with alternate technologies as long as the appropriate constituent specifications are met and that water so produced hasbeen shown to be appropriate for the application where the use of such water is specified.EElectrical conductivity at 25C.

33、FElectrical resistivity at 25C.GpH at 25C, not applicable to higher resistivity waters.HTotal organic carbon.ISodium.JChloride ion.KHeterotrophic bacteria count.LEndotoxin in endotoxin units per mL.D1193062devices typically comprise semi-permeable ion-exchangemembranes and permanently charged ion-ex

34、change media (seeTest Method D 6529).3.2.3 reverse osmosis (RO)the separation process whereone component of a solution is removed from another compo-nent by flowing the feed stream under pressure across asemipermeable membrane. RO removes ions based on electro-chemical forces, colloids, and organics

35、 down to 150 molecularweight. May also be called hyperfiltration (see TerminologyD 6161)4. Composition and Characteristics4.1 The types and grades of water specified in this Standardshall conform to the requirements in Table 1.5. Test Methods5.1 Electrical Conductivity and ResistivityRefer to TestMe

36、thods D 1125 and D 5391.5.2 pHRefer to Test Methods D 1293 and D 5128.5.3 SilicaRefer to Test Method D 4517.5.4 SodiumRefer to Test Methods D 6071.5.5 ChloridesRefer to Test Method D 5542.5.6 TOCRefer to Test Methods D 5173 and D 5997.5.7 EndotoxinsRefer to LAL Test Method.45.8 Microbiological Conta

37、minationRefer to Test MethodsF 1094.6. Keywords6.1 laboratory analysis; reagent; waterAPPENDIX(Nonmandatory Information)X1. POTENTIAL REAGENT WATER ISSUESINTRODUCTIONThis Appendix is provided as a guide to various issues in the production, application, storage, andmonitoring of Reagent Water. These

38、issues are very complex and extensive. This guidance is notintended to be comprehensive or complete. Producers and users of Reagent Water are encouraged toseek out additional sources of guidance in this area.X1.1 PreparationX1.1.1 Historically, reagent water Types I, II, III, and IVhave been linked

39、to specific process for their production.Starting with this revision, these types of waters may beproduced with alternate technologies as long as the appropriateconstituent specifications are met and that water so producedhas been shown to be appropriate for the application where theuse of such wate

40、r is specified.X1.1.2 The preparation methods of the various grades ofreagent water influences the limits of impurities. Therefore, theselection of an alternate technology in place of the technologyspecified in the Table 1 should be made taking into account thepotential impact of other contaminants

41、such as micro-organismand pyrogens, even if a grade is not specified. Such contami-nants were not necessarily considered by the performancecharacteristics of the technology previously specified.X1.2 Use and ApplicationX1.2.1 Type I and Type III Water:X1.2.1.1 Contact with the ion-exchange materials

42、maycause an addition of organic contaminants to the water. Thiswill depend on the resin type/quality, quality of the regenera-tions (if regenerated), environmental conditions in which thewater purification system is used and actual system use (forexample, duration of non-use periods). Practices may

43、be put inplace to decrease the risk or organic contamination:(1) Periodic rinsing of the purification media to limitbacteriological (organic) contamination is recommended.(2) After each period of non-usage, drawing off a quantityof water is necessary before use. Refer to the supplier speci-fications

44、 for the recommended volume.(3) Synthetic activated carbon and/or UV (dual wave-lengths 185 nm and 254 nm) may be used in the polishingstages to decrease the level of organic contaminants (to reachType I water specifications), and/or to reach lower organiclevels.X1.2.1.2 The quality of the water pro

45、duced depends uponthe type, age, and method of regeneration of the ion exchangematerials (if regenerated). Likewise, the flow rate through theion exchange resin bed will change the conductivity of theproduct water. The manufacturers instructions for resins or theresin cartridge bed should be followe

46、d.X1.2.1.3 The use of the membrane filter in the preparationof Type I and Type III water may add a small amount oforganic components to the water initially produced. Theamount of organic components released differs depending onthe type and brand of the membrane filter used. Then themembrane should b

47、e rinsed according to the manufacturers4Published in the U.S. Pharmacopeia by The U.S. Pharmacopeial Convention,Inc.D1193063instructions. The use of a qualified membrane filter on theorganic release is recommended.X1.2.1.4 Producing Type I water specifications is achievedutilizing a combination of p

48、urification technologies. Thechoice of technologies can vary depending on the feed waterquality, system usage and cost considerations. Particular atten-tion should be taken regarding the location and sequence ofparticular purification technologies in the process, as these canhave an impact on the fi

49、nal water quality.X1.2.2 Type II Water:X1.2.2.1 The description of Type II reagent water wasintended to characterize product water from distillation pro-cesses. Therefore, the selection of an alternate technology inplace of the one specified should be made by taking intoaccount the potential impact of other contaminants (such asmicro-organism and pyrogen) than those specified in Table 1for the Type II water.X1.2.2.2 Type II grade of reagent water is typically sterileand pyrogen-free as produced and generally may be usedwhenever freedom from