ASTM E2312-2011 Standard Practice for Tests of Cleanroom Materials《清结室材料测试的标准操作规程》.pdf

1、Designation: E2312 11Standard Practice forTests of Cleanroom Materials1This standard is issued under the fixed designation E2312; 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 in

2、dicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice identifies test methods used to evaluate theproperties of various materials and products used in clean-rooms and for cleanroom construction.1.2 T

3、his 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. Referenced Docume

4、nts2.1 ASTM Standards:2E595 Test Method for Total Mass Loss and CollectedVolatile Condensable Materials from Outgassing in aVacuum EnvironmentE1216 Practice for Sampling for Particulate Contaminationby Tape LiftE1234 Practice for Handling, Transporting, and InstallingNonvolatile Residue (NVR) Sample

5、 Plates Used in Envi-ronmentally Controlled Areas for SpacecraftE1235 Test Method for Gravimetric Determination of Non-volatile Residue (NVR) in Environmentally ControlledAreas for SpacecraftE1549 Specification for ESD Controlled Garments Re-quired in Cleanrooms and Controlled Environments forSpacec

6、raft for Non-Hazardous and Hazardous OperationsE1559 Test Method for Contamination Outgassing Charac-teristics of Spacecraft MaterialsE1560 Test Method for Gravimetric Determination of Non-volatile Residue From Cleanroom WipersE1731 Test Method for Gravimetric Determination of Non-volatile Residue f

7、rom Cleanroom GlovesE2088 Practice for Selecting, Preparing, Exposing, andAnalyzing Witness Surfaces for Measuring Particle Depo-sition in Cleanrooms and Associated Controlled Environ-mentsE2090 Test Method for Size-Differentiated Counting ofParticles and Fibers Released from Cleanroom WipersUsing O

8、ptical and Scanning Electron MicroscopyE2217 Practice for Design and Construction of AerospaceCleanrooms and Contamination Controlled AreasF25 Test Method for Sizing and Counting Airborne Particu-late Contamination in Cleanrooms and Other Dust-Controlled AreasF51 Test Method for Sizing and Counting

9、Particulate Con-taminant In and On Clean Room GarmentsF739 Test Method for Permeation of Liquids and Gasesthrough Protective Clothing Materials under Conditions ofContinuous Contact2.2 IEST Standards:3IEST RP-CC003 Garment System Considerations forCleanrooms and Other Controlled EnvironmentsIEST RP-

10、CC004 Evaluating Wiping Materials Used inCleanrooms and Other Controlled EnvironmentsIEST RP-CC005 Gloves and Finger Cots Used in Clean-rooms and Other Controlled EnvironmentsIEST RP-CC020 Substrates and Forms for Documentationin CleanroomsIEST RP-CC022 Electrostatic Charge in Cleanrooms andOther Co

11、ntrolled Environments2.3 Others:4ANSI/AAMI/ISO 11137 Sterilization of Health Care Prod-ucts Radiation Part 13. Terminology3.1 Definitions:3.1.1 ESDelectrostatic discharge, the transfer of electro-static charge between bodies that have different electric poten-tial.1This practice is under the jurisdi

12、ction of ASTM Committee E21 on SpaceSimulation and Applications of Space Technology and is the direct responsibility ofSubcommittee E21.05 on Contamination.Current edition approved Jan. 1, 2011. Published February 2011. Originallyapproved in 2004. Last previous edition approved in 2004 as E2312 04.

13、DOI:10.1520/E2312-11.2For 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.3Available from Institute of Environment

14、al Sciences and Technology (IEST),Arlington Place One, 2340 S. Arlington Heights Rd., Suite 100, Arlington Heights,IL 60005-4516, http:/www.iest.org.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.1Copyright ASTM Internat

15、ional, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.1.2 fiberparticle having an aspect (length-to-width) ra-tio of 10 or more.3.1.3 microorganismliving organism of microscopic sizecapable of growth and reproduction. Examples include bacte-ria, yeasts, and mol

16、ds.3.1.4 non-volatile residue (NVR)that quantity of molecu-lar matter remaining after the filtration of a solvent containingcontaminants and evaporation of the solvent at a specifiedtemperature.3.1.5 outgassingevolution of volatile components froman item exposed to elevated temperature, normally in

17、vacuum.3.1.6 particlesmall piece of matter with defined physicalboundaries.4. Summary of Practice4.1 A number of tests for materials and products used incleanrooms or to fabricate cleanrooms have been issued byvarious organizations such as ASTM and IEST. The purpose ofthis practice is to identify te

18、st methods used to determine theproperties of various materials and products used in clean-rooms. A brief description and some of the features of thevarious tests are also given to aid interested users in selectingthe test or groups of tests that have the ability to meet theirneeds for evaluating ex

19、isting and candidate cleanroom prod-ucts.4.2 Table 1 lists the tests suggested to measure specificproperties of various cleanroom materials and products. Whereno test is presently listed it is probable that a test will berequired and must be identified or developed if none exist atpresent.5. Signifi

20、cance and Use5.1 This practice is not intended to advocate or discourageuse of any particular test method. It is intended for informationonly, and to provide a useful guide for further detailed study,test, and evaluation of cleanroom materials and products.6. Hazards6.1 Hazards can be present when u

21、sing many of the refer-enced tests. Each of the referenced test methods warn ofpossible hazards and suggest means to minimize them. If toxicor other hazardous materials are identified, they must behandled properly per the reference documents.7. Procedure7.1 Table 1 lists the types of materials and c

22、leanroomproducts of present interest and recommends the test methodsto be used to evaluate these materials. Where several tests arelisted, it is suggested that all of them be considered at leastinitially to evaluate the product and allow properties to beevaluated. Test results will provide relative

23、values for theproperties tested such as particle count per unit area, NVR perTABLE 1 Test MethodsTests of Cleanroom Materials and ProductsTests Garments Wipers Gloves Swabs Documents Tote BoxCleanrooms,SurfacesParticles IEST RP003Sect. 10.1-10.3IEST RP004Sect. 5.1-5.2ASTM E1216ASTM E2090ASTM F51IEST

24、 RP005Sect. 7ASTM E1216IEST RP004Sect. 5, 5.1-5.2IEST RP020Sect. 6, 7ASTM E1216ASTM E1216 ASTM F25ASTM E1216ASTM E2088ASTM E1234ASTM E1235Extractable,NVRIEST RP003Sect. 10.4ASTM E1549IEST RP004Sect. 6, 6.2ASTM E1560ASTM E1731IEST RP005Sect. 8ASTM E1560ASTM E1731IEST RP004Sect. 6-6.2ASTM E1560IEST RP

25、020Sect. 7.2ASTM E1560 ASTM E1560Microorganisms NoneAIEST RP004Sect. 11, 13NoneANoneANA NA NoneChemicalCompatibilityASTM E1549ASTM F739None IEST RP005Sect. 6.3None NA None NoneBarrier ASTM E1549 None IEST RP005Sect. 6.4NA NA NA NonePermeability ASTM E1549 NA IEST RP005Sect. 6.6NA NA NA NAStatic, ESD

26、 IEST RP003Sect. 10.7ASTM E1549IEST RP004Sect. 8IEST RP005Sect. 8NA NA None IEST RP022Outgassing IEST RP003Sect. 9ASTM E595ASTM E1559ASTM E595ASTM E1559ASTM E595ASTM E1559NA NA ASTM E595ASTM E1559ASTM E595ASTM E1559Heat Resistance ASTM E1549 NA IEST RP005Sect. 6.1NA NA NA NAAcceleratedAgingNA NA IES

27、T RP005Sect. 6.2NA NA NA NADesign,ConstructionIEST RP003Sect. 9ASTM E1549NA None NA None None ASTM E2217Filter Efficiency IEST RP003Sect. 7.3NA NA NA NA NA ASTM E2217Sorbancy None IEST RP004Sect. 7None None NA NA NAAIf microorganisms must be limited or controlled on garments, wipers, or gloves those

28、 products must be procured from a source that certifies cleanliness such asvendors and garment laundries that supply pharmaceutical cleanrooms (reference ANSI/AAMI/ISO 11137 Sterilization of Health Care Products Radiation Part 1:Requirements for development, validation and routine control of a steri

29、lization process for medical devices).E2312 112unit area or mass, or outgassing at a given temperature,typically at 125C. No pass/fail values or minimum require-ments are specified because there are no established values forcleanliness for any of the products that are listed. Users shouldrank materi

30、als for contamination generation potential andsuitability for cleanroom use based upon test results and addedfactors such as conditions of use, consistency of test results,testing bias, and cost and availability of the products as-used incleanrooms. It is normal for properties to vary somewhat froml

31、ot to lot, so it is important to test several lots to evaluatereproducibility of results and product consistency.NOTE 1If there is a specific interest in identifying or developing testmethods for areas shown as having no tests at present, or that the test isNot Applicable, Committee E21 will conside

32、r any such suggestions.7.2 Test methods as noted in the table are available fromASTM or IEST.8. Report8.1 The report should identify the material or product tested,the vendor, supplier or source, any part number or otheridentifying specification, the test or tests performed, and theactual test resul

33、ts.8.2 The report also may compare test results for differentlots from the same manufacturer or supplier, or for differenttypes of products, and rank performance and test results. It alsois useful to identify specific products or materials as beingacceptable for use in particular types of facility o

34、r for specificuses or applications.9. Precision and Bias9.1 There is no precision or bias value possible for thispractice. Many of the referenced documents do include preci-sion and bias statements. They should be considered on anindividual basis for each test method.10. Keywords10.1 cleanroom produ

35、cts; contamination control; gloves;materials evaluation; materials properties; material testing;product evaluation; product properties; product testing; testmethods; wipersASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentioned

36、in this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and m

37、ust be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of t

38、heresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C7

39、00, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).E2312 113