ASTM D5196-2006 Standard Guide for Bio-Applications Grade Water《应用生物学级水的标准指南》.pdf
《ASTM D5196-2006 Standard Guide for Bio-Applications Grade Water《应用生物学级水的标准指南》.pdf》由会员分享,可在线阅读,更多相关《ASTM D5196-2006 Standard Guide for Bio-Applications Grade Water《应用生物学级水的标准指南》.pdf(4页珍藏版)》请在麦多课文档分享上搜索。
1、Designation: D 5196 06Standard Guide forBio-Applications Grade Water1This standard is issued under the fixed designation D 5196; 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 ind
2、icates the year of last reapproval. Asuperscript epsilon (e) 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 l
3、aboratory 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 use
4、of 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
5、.3 For all the other applications linked to anASTM methodand not bio-sensitive that require purified water, it is recom-mended that Specification D 1193 or Test Method D 5127 beconsulted.1.4 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is t
6、heresponsibility 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. Referenced Documents2.1 ASTM Standards:2D 1125 Test Methods for Electrical Conductivity and Re-sistivity of WaterD 1129 Termi
7、nology Relating to WaterD 1193 Specification for Reagent WaterD 4453 Practice for Handling of Ultra-Pure Water SamplesD 5127 Guide for Ultra Pure Water Used in the Electronicsand Semiconductor IndustryD 5173 Test Method for On-Line Monitoring of CarbonCompounds in Water by Chemical Oxidation, by UV
8、LightOxidation, by Both, or by High Temperature CombustionFollowed by Gas 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 Flo
9、wing High Purity Water SampleD 5542 Test Methods for TraceAnions in High Purity Waterby Ion ChromatographyD 5673 Test Method for Elements in Water by InductivelyCoupled PlasmaMass SpectrometryD 5996 Test Method for Measuring Anionic Contaminantsin High-Purity Water by On-Line Ion ChromatographyF 109
10、4 Test Methods for Microbiological Monitoring ofWater Used for Processing Electron and MicroelectronicDevices by Direct Pressure Tap Sampling Valve and by thePresterilized Plastic Bag Method3. Terminology3.1 DefinitionsFor definitions of terms used in this guide,refer to Terminology D 1129.3.2 Defin
11、itions of Terms Specific to This Standard: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 mLtotal numberof viable micro-organisms present in the 100-mL
12、 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 General Specifications,Technical Resources, and Statistical Methods.Current edition approved April 1, 2006. Publishe
13、d April 2006. Originallyapproved in 1991. Last previous edition approved in 1999 as D 5196 91 (1999).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 D
14、ocument Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.2.3 total organic carboncarbon in the form of organiccompounds.3.2.4 waterwater complying with compositions given inTable 1.4. Significance and
15、 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 prepare and handle the water. Section 7mentions the suitable methods for water preparation.5. Composition5.1 Water for Bio-Applications should be prep
16、ared (usingwater purification technologies) starting from water 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 imp
17、ortant 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 of water should conform tothe prope
18、rties and chemical limits given in Table 1; however,the suggested maximum limits and the actual impuritiesconsidered, or both, may be modified by the user based uponthe intended use of the water.5.3 Although these water types and associated grades havebeen defined specifically for use with ASTM Stan
19、dards, 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.6. Reagents6.1 Purity of WaterUnless otherwise indicated, referencesto water shall be understood to mean
20、water types as defined inthis guide.7. Summary of Preparation Methods7.1 The method of preparation used for the water must bedesigned to remove organic, inorganic, volatile, biologicalimpurities and particulates to provide water that meets theconcentration limits in Table 1. These are suggested limi
21、ts,since the actual maximum levels for the individual impuritieswill depend on the end use for which the water is required.More restrictive limits than those suggested in Table 1 may berequired by mutual consent of the parties concerned, provideda suitable test method is agreed upon.7.2 The Bio-Appl
22、ications grade water needs to be preparedfrom tap water complying with U.S. EPA National PrimaryDrinking Water regulations or comparable regulations of theEuropean Union or Japan.7.3 The purification of tap water shall be accomplished by asingle technology or a combination of suitable purificationte
23、chnologies such as distillation, deionization, electrodeioniza-tion, carbon adsorption, reverse osmosis, ultrafiltration, nano-filtration, UV photo-oxidation, and/or screen membrane filtra-tion, to meet the compositions given in Table 1.7.4 The water purification systems containing these tech-nologi
24、es should be constructed from materials shown tocontribute to low contamination to the final product water.7.5 Because quality assurance is key to ensure safety,efficiency and reliability, validation of the water purificationinstallation is highly recommended (see Section 14).8. Monitoring and Trend
- 1.请仔细阅读文档,确保文档完整性,对于不预览、不比对内容而直接下载带来的问题本站不予受理。
- 2.下载的文档,不会出现我们的网址水印。
- 3、该文档所得收入(下载+内容+预览)归上传者、原创作者;如果您是本文档原作者,请点此认领!既往收益都归您。
最后一页预览完了!喜欢就下载吧,查找使用更方便
10000 积分 0人已下载
下载 | 加入VIP,交流精品资源 |
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- ASTMD51962006STANDARDGUIDEFORBIOAPPLICATIONSGRADEWATER 应用 生物学 标准 指南 PDF

链接地址:http://www.mydoc123.com/p-519133.html