ASTM D1193-2006(2011) Standard Specification for Reagent Water《试剂水标准规范》.pdf

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1、Designation: D1193 06 (Reapproved 2011)Federal Test MethodStandard No. 7916Standard Specification forReagent Water1This standard is issued under the fixed designation D1193; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year

2、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.This standard has been approved for use by agencies of the Department of Defense.1. Scope1.1 This specification describes the r

3、equired characteristicsof 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 ta

4、ken as an indication 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

5、 refer-ence one 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 thes

6、e water types and 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, rea

7、gent water Types 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 app

8、ropriate for the 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 we

9、re not necessarily 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

10、Appendix X1 of this document.1.7 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.8 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of th

11、is 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 WaterD1293 Test M

12、ethods for pH of WaterD4453 Practice for Handling of High Purity Water Samples3D4517 Test Method for Low-Level Total Silica in High-Purity Water by Flameless Atomic Absorption Spectros-copyD5128 Test Method for On-Line pH Measurement of Waterof Low ConductivityD5173 Test Method for On-Line Monitorin

13、g of CarbonCompounds in Water by Chemical Oxidation, by UV LightOxidation, by Both, or by High Temperature CombustionFollowed by Gas Phase NDIR or by Electrolytic Conduc-tivityD5245 Practice for Cleaning Laboratory Glassware, Plas-ticware, and Equipment Used in MicrobiologicalAnalysesD5391 Test Meth

14、od for Electrical Conductivity and Resis-tivity of a Flowing High Purity Water SampleD5542 Test Methods for TraceAnions in High Purity Water1This specification is under the jurisdiction of ASTM Committee D19 on Waterand is the responsibility of Subcommittee D19.02 on Quality Systems, Specifica-tion,

15、 and Statistics.Current edition approved May 1, 2011. Published June 2011. Originallyapproved in 1951. Last previous edition approved in 2006 as D1193 06. DOI:10.1520/D1193-06R11.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org.

16、 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 ,Vol51, No 3, March 1979.1Copyr

17、ight ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.by Ion ChromatographyD5997 Test Method for On-Line Monitoring of Total Car-bon, Inorganic Carbon in Water by Ultraviolet, PersulfateOxidation, and Membrane Conductivity DetectionD6071 Test Me

18、thod for Low Level Sodium in High PurityWater by Graphite Furnace Atomic Absorption Spectros-copyD6161 Terminology Used for Microfiltration, Ultrafiltra-tion, Nanofiltration and Reverse Osmosis Membrane Pro-cessesD6529 Test Method for Operating Performance of Continu-ous Electrodeionization Systems

19、on Feeds from 501000S/cm4F1094 Test Methods for Microbiological Monitoring ofWater Used for Processing Electron and MicroelectronicDevices by Direct Pressure Tap Sampling Valve and by the4Withdrawn. The last approved version of this historical standard is referencedon www.astm.org.TABLE 1 Processes

20、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 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 2

21、0 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 mfiltrationA0.0555 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 mfiltrationA0.055

22、5 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 3 100/10III Distillation, DI, EDI, and/or RO,followed by 0.45 m filtration.C0.25 4.0 200 10 10 500III A Distillation, DI,

23、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 0.25III C Distillation, DI, EDI, and/or RO,followed by 0.45 m filtration.C0.25 4.0 200 10 10 500 1000/100IV Distillatio

24、n, 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 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 s

25、hall 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 step must have a maximum conductivity of 20 S/cm at 298K (25C). Type I reagent water may be produced with alternatet

26、echnologies 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 specified.BType II grade of reagent water shall be prepared by distillation using a still designed to produce a dist

27、illate 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 purity cannot be attained by single distillation. Type II reagentwater may be produced with alternate technologies as

28、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 III grade of reagent water shall be prepared by distillation, ion exchange, continuous electrodeionization, reverse

29、 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 constituent specifications are metand that water so produced has been shown to be appropriate for the application wher

30、e 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 combinationthereof. Type IV reagent water may be produced with alternate technologies as long as the appropriate

31、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.FElectrical resistivity at 25C.GpH at 25C, not applicable to higher resistivity waters.HTotal organic carbon.ISod

32、ium.JChloride ion.KHeterotrophic bacteria count.LEndotoxin in endotoxin units per mL.D1193 06 (2011)2Presterilized Plastic Bag Method3. Terminology3.1 Definitions For definitions used in this specificationrefer to Terminology D1129.3.2 Definitions of Terms Specific to This Standard:3.2.1 reagent wat

33、erwater that is used specifically as 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 i

34、nfluence iontransport, where the ionic transport properties of the activemedia are a primary sizing parameter. Electrodeionizationdevices typically comprise semi-permeable ion-exchangemembranes and permanently charged ion-exchange media (seeTest Method D6529).3.2.3 reverse osmosis (RO)the separation

35、 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 down to 150 molecularweight. May also be called hyperfiltration (see Termino

36、logyD6161)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 TestMethods D1125 and D5391.5.2 pHRefer to Test Methods D1293 and D5128.5.3 SilicaRe

37、fer to Test Method D4517.5.4 SodiumRefer to Test Methods D6071.5.5 ChloridesRefer to Test Method D5542.5.6 TOCRefer to Test Methods D5173 and D5997.5.7 EndotoxinsRefer to LAL Test Method.55.8 Microbiological ContaminationRefer to Test MethodsF1094.6. Keywords6.1 laboratory analysis; reagent; waterAP

38、PENDIX(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 issues are very complex and extensive. This guidance is notintended to be comprehensive

39、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 to specific process for their production.Starting with this revision, these types of wat

40、ers 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 water is specified.X1.1.2 The preparation methods of the various grades ofreagent water infl

41、uences 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 such as micro-organismand pyrogens, even if a grade is not specified. Such contami-nants

42、 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 maycause an addition of organic contaminants to the water. Thiswill depend on the resin

43、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 be put inplace to decrease the risk or organic contamination:(1) Periodic rinsing of the

44、 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 for the recommended volume.(3) Synthetic activated carbon and/or UV (dual wave-lengths

45、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 produced depends uponthe type, age, and method of regeneration of the ion exchange5Publishe

46、d in the U.S. Pharmacopeia by The U.S. Pharmacopeial Convention,Inc.D1193 06 (2011)3materials (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 fo

47、llowed.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 sho

48、uld be rinsed according to the manufacturersinstructions. 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 purification technologies. Thechoice of technologies can vary depending on the fe

49、ed 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 final 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 (s