ASTM D1193-2006(2018) Standard Specification for Reagent Water《试剂水标准规范》.pdf

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1、Designation: D1193 06 (Reapproved 2018) 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 U.S. Department of Defense.1. Scope1.1 This specification describes

3、 the required 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 manual, Form and Style for ASTMStandards. These have been assigned in order of historicalprecedence a

4、nd should not be taken as an indication of aprogression in water purity.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 Standa

5、rds are expected to 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 proces

6、s.1.5 Although these 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 specification to ensure that theselected water types or grades are suitable for their intend

7、eduse. Historically, reagent water Types I, II, III, and IV havebeen linked to specific processes for their production. Startingwith this revision, these types of waters may be produced withalternate technologies as long as the appropriate constituentspecifications are met and that water so produced

8、 has beenshown to be appropriate 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 pyrog

9、ens. Suchcontaminants were 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 purificati

10、on systemis provided in Appendix X1 of this specification.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 theres

11、ponsibility 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.1.9 This international standard was developed in accor-dance with internationally recognized principles on standard-i

12、zation 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

13、Resis-tivity of WaterD1129 Terminology Relating to WaterD1293 Test Methods for pH of WaterD4453 Practice for Handling of High Purity Water SamplesD4517 Test Method for Low-Level Total Silica in High-Purity Water by Flameless Atomic Absorption Spectros-copyD5128 Test Method for On-Line pH Measurement

14、 of Waterof Low ConductivityD5173 Guide for On-Line Monitoring of Total OrganicCarbon in Water by Oxidation and Detection of ResultingCarbon Dioxide1This specification is under the jurisdiction of ASTM Committee D19 on Waterand is the responsibility of Subcommittee D19.02 on Quality Systems,Specific

15、ation, and Statistics.Current edition approved March 15, 2018. Published March 2018. Originallyapproved in 1951. Last previous edition approved in 2011 as D1193 06 (2011).DOI: 10.1520/D1193-06R18.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at

16、 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 accorda

17、nce 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.1TABLE 1 Processes for Reagent Wate

18、r ProductionType Grade Production ProcessA,B,C,D S/cmE(max)McmF(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 bymixed bed DI, 0.2 mfiltrationA0.0555 18 50 1 1 3I A Purify to 20 S/cm by dist.or

19、 equiv., followed bymixed 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 bymixed 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 bymixed bed DI, 0.2 mfiltrationA0.0555 18 50 1 1 3 100/10

20、II 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, RO,or a combinationthereof followed by 0.45m filtration.C0.25 4.0 200 10 10 500III A Distillation, DI, EDI,

21、 RO,or a combination thereof,followed by 0.45 mfiltration.C0.25 4.0 200 10 10 500 10/1000 0.03III B Distillation, DI, EDI, RO,or a combinationthereof, followed by0.45 m filtration.C0.25 4.0 200 10 10 500 10/100 0.25III C Distillation, DI, EDI, RO,or a combinationthereof, followed by0.45 m filtration

22、.C0.25 4.0 200 10 10 500 1000/100IV Distillation, DI, EDI, RO,or a combinationthereof.D5.0 0.2 5.0 to 8.0 50 50IV A Distillation, DI, EDI, RO,or a combinationthereof.D5.0 0.2 5.0 to 8.0 50 50 10/1000 0.03IV B Distillation, DI, EDI, RO,or a combinationthereof.D5.0 0.2 5.0 to 8.0 50 50 10/100 0.25IV C

23、 Distillation, DI, EDI, RO,or a combinationthereof.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 s

24、tep 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 s

25、pecified.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 pur

26、ity 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

27、III 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 con

28、stituent 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

29、a combination thereof.Type IV reagent water may be produced with alternate technologies as long as the appropriate constituent specifications are met and that water so produced has beenshown to be appropriate for the application where the use of such water is specified.EElectrical conductivity at 25

30、C.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.D1193 06 (2018)2D5245 Practice for Cleaning Laboratory Glassware,Plasticware, and Equipment Used in

31、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 ChromatographyD5997 Test Method for On-Line Monitoring of TotalCarbon, Inorganic Carbon in Water by Ultraviolet, P

32、ersul-fate Oxidation, and Membrane Conductivity DetectionD6071 Test Method for Low Level Sodium in High PurityWater by Graphite Furnace Atomic Absorption Spectros-copyD6161 Terminology Used for Microfiltration, Ultrafiltration,Nanofiltration and Reverse Osmosis Membrane ProcessesD6529 Test Method fo

33、r Operating Performance of Continu-ous Electrodeionization Systems on Feeds from 501000S/cmF1094 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

34、.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 reagent waterwater that is used specifically as acomponent of an analytical measurement process and meets orexceeds the specifications for these wat

35、ers.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 ionic transport properties of the activemedia are a primary sizing parameter. Electrodeionizationdevices

36、 typically comprise semi-permeable ion-exchangemembranes and permanently charged ion-exchange media (seeTest Method D6529).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 asemipermea

37、ble membrane. RO removes ions based on electro-chemical forces, colloids, and organics down to 150 molecularweight. May also be called hyperfiltration (see TerminologyD6161).4. Composition and Characteristics4.1 The types and grades of water specified in this specifi-cation shall conform to the requ

38、irements 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 SilicaRefer to Test Method D4517.5.4 SodiumRefer to Test Method D6071.5.5 ChloridesRefer to Test Methods D5542.5.6 TOCRefer to Guide D517

39、3 and Test Method D5997.5.7 EndotoxinsRefer to LAL Test Method.35.8 Microbiological ContaminationRefer to Test MethodsF1094.6. Keywords6.1 laboratory analysis; reagent; waterAPPENDIX(Nonmandatory Information)X1. POTENTIAL REAGENT WATER ISSUESINTRODUCTIONThis appendix is provided as a guide to variou

40、s issues in the production, application, storage, andmonitoring of reagent water. These 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

41、 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 waters may beproduced with alternate technologies as long as the appropriateconstituent specifications are met and that water s

42、o 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 influences the limits of impurities. Therefore, theselection of an alternate technology in place of the technologyspecified in t

43、he Table 1 should be made taking into account the3Published in the U.S. Pharmacopeia by The U.S. Pharmacopeial Convention,Inc.D1193 06 (2018)3potential impact of other contaminants such as micro-organismand pyrogens, even if a grade is not specified. Such contami-nants were not necessarily considere

44、d 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 type/quality, quality of the re

45、genera-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 purification media to limitbac

46、teriological (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 or UV (dual wavelengths185 nm and 254 nm), or both, may be u

47、sed in the polishingstages to decrease the level of organic contaminants (to reachType I water specifications), or to reach lower organic levels,or both.X1.2.1.2 The quality of the water produced depends uponthe type, age, and method of regeneration of the ion exchangematerials (if regenerated). Lik

48、ewise, 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 followed.X1.2.1.3 The use of the membrane filter in the preparationof Type I and Type III water may add a small amoun

49、t 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 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 feed waterquality, system usage and cost considerations. Part