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ASTM_E_2967_-_15.pdf

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1、Designation:E296715Standard Test Method forAssessing the Ability of Pre-wetted Towelettes to Removeand Transfer Bacterial Contamination on Hard,Non-PorousEnvironmental Surfaces Using the Wiperator1This standard is issued under the fixed designation E2967;the number immediately following the designat

2、ion indicates the year oforiginal adoption or,in the case of revision,the year 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.INTRODUCTIONHigh-touch environmental surfaces(HITES)

3、are increasingly being recognized as potentialvehicles for infectious agents(1-3).2Decontamination of such surfaces is almost always by either adisinfectant-spray-and-wipe procedure or,more commonly,by wiping with an applicator or toweletteprewetted with a disinfectant(4).In either case,the microbic

4、idal action of the disinfectant is combinedwith the physical action of wiping(mechanical removal).This standard,formulated after a criticalreview of available wipe test methods(5-8)and published standards,is based on the use of amechanical device(the Wiperator;Appendix X1)designed to wipe HITES unde

5、r controlled conditionsand also to test the transfer of acquired microbial contamination to clean surfaces.1.Scope1.1 This standard is designed for use with a mechanizeddevice(the Wiperator;Appendix X1)to test pre-wetted tow-elettes.1.2 Two species of vegetative bacteria,one Gram-positivecoccus(Stap

6、hylococcus aureus)and one Gram-negative bacil-lus(Acinetobacter baumannii),representing important nosoco-mial pathogens,are used to separately contaminate disks ofmagnetized and brushed stainless steel in order to test thetowelettes for their relative ability to:1.2.1 Decontaminate non-porous enviro

7、nmental surfacesexperimentally-contaminated with vegetative bacteria;and1.2.2 Transfer any acquired bacterial contamination on thetowelettes to clean surfaces.1.3 This test method is not meant for use with towelettes fordecontamination of skin.1.4 The values stated in SI units are to be regarded as

8、thestandard.The values given in parentheses,if any,are forinformation only.1.5 This test method should be performed by persons withtraining in microbiology in facilities designed and equipped forwork with infectious agents at the appropriate biosafety level.1.6 It is the responsibility of the invest

9、igator to determinewhether Good Laboratory Practice(GLP)regulations arerequired and to follow them where appropriate.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 s

10、afety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:3D1129 Terminology Relating to WaterD1193 Specification for Reagent WaterE1054 Test Methods for Evaluation of Inactivators of Anti-microbial AgentsE2197 Quantit

11、ative Disk Carrier Test Method for Determin-ing Bactericidal,Virucidal,Fungicidal,Mycobactericidal,and Sporicidal Activities of ChemicalsE2362 Practice for Evaluation of Pre-saturated or Impreg-nated Towelettes for Hard Surface DisinfectionE2756 Terminology Relating to Antimicrobial and AntiviralAge

12、ntsE2896 Test Method for Quantitative Petri Plate Method(QPM)for Determining the Effectiveness of Antimicro-bial Towelettes1This test method is under the jurisdiction of ASTM Committee E35 onPesticides,Antimicrobials,and Alternative Control Agents and is the directresponsibility of Subcommittee E35.

13、15 on Antimicrobial Agents.Current edition approved May 1,2015.Published February 2016.DOI:10.1520/E2967-15.2The boldface numbers in parentheses refer to the list of references at the end ofthis standard.3For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Servi

14、ce at 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 States1 2.2 AOAC Standard:4AOAC Standards Method 961.02 Germ

15、icidal Spray Prod-ucts as Disinfectants.Official Methods of Analysis2.3 CFR Standards:540 CFR 160 Good Laboratory Practice Standards21 CFR 58 Good Laboratory Practice Regulations2.4 Other Reference:Organization for Economic Cooperation and Development(OECD)Guideline No.187;2013 Guidance Document onQ

16、uantitative Methods for Evaluating the Activity of Mi-crobicides used on Hard,Non-Porous Surfaces63.Terminology3.1 For definitions of standard terms,please refer to Termi-nology E2756.3.2 Definitions of Terms Specific to This Standard:3.2.1 boss,na Teflon cylinder designed to hold the testtowelette in place with the help of an O ring.3.2.2 eluate,nrecovered eluent that may contain the testorganism(s).3.2.3 eluent,nany liquid that is harmless to the testorganism and that is added to a carrier to

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