ASTM E2756-2018 Standard Terminology Relating to Antimicrobial and Antiviral Agents.pdf

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1、Designation: E2756 10E2756 18Standard Terminology Relating toAntimicrobial and Antiviral Agents1This standard is issued under the fixed designation E2756; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A

2、 number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 The purpose of this terminology standard is to establish uniformity in terms used in the field of antimicrobial and antiviralagent tes

3、ting. Terms are adapted from related fields such as regulatory terms defined by law and definitions as supported by testrequirements.1.2 The terms are appropriate to the wide range of interest related to standards developed in the area of antimicrobial andantiviral testing.1.3 This international sta

4、ndard was developed in accordance with internationally recognized principles on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Ter

5、minologyGENERAL ANTIMICROBIAL AND ANTIVIRAL TERMSaccuracy, na measure of the degree of conformity of a value generated by a specific procedure to the assumed or accepted truevalue, and includes both precision and bias.ambient temperature, ntemperature of the environment in which a test method is per

6、formed.antibacterial, adjdescribes an agent that kills bacteria or suppresses their growth or reproduction.antimicrobial, adjdescribes an agent that kills or inactivates microorganisms or suppresses their growth or reproduction.antiseptic, na material for use on living tissue that either destroys mi

7、croorganisms or suppresses their growth.bias, na systematic error that contributes to the difference between the mean of a large number of test results and an acceptedreference value (ASTM Form and Style Manual).DISCUSSIONA statement of bias is not possible because standard reference materials are n

8、ot available for most microbiological methods.biofouling, nthe unwanted accumulation of organisms and/or their products on surfaces.cleaner-sanitizer, na physical or chemical agent that removes soil from an object and reduces numbers of microorganisms onnon-food contact surfaces.carrier, na surrogat

9、e surface or matrix that facilitates the interaction of test microorganisms and treatment(s).cell monolayer, na single layer of eukaryotic cells typically propogated on a glass or plastic surface to which they are securelyattached.cleansing wash, na procedure intended to remove soil or residue.clast

10、ogen, nan agent that reduces chromosomal breakage.1 This terminology is under the jurisdiction of ASTM Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents and is the direct responsibility ofSubcommittee E35.15 on Antimicrobial Agents.Current edition approved May 1, 2010April

11、1, 2018. Published December 2010June 2018. Originally approved in 2010. Last previous edition approved in 2010 asE275610. DOI: 10.1520/E275610.10.1520/E275618.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been ma

12、de to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Cop

13、yright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1composite sample, na series of grab samples integrated into a single sample or samples collected at specific times and integratedinto a single sample.cooling system, nequipment and coolant

14、used for the removal of heat from processes, equipment, or both.cooling water, nany water-based solution that absorbs and transfers heat in cooling systems.a heat exchange system.cumulative effect, na progressively additive reduction in the numbers of viable microorganisms measured from an establish

15、edbaseline following repeated applications of a material or procedure.decontamination, na procedure that eliminates or reduces contaminants. The usual reference is to reduce potentially harmfulor undesirable microorganisms.disinfectant, na physical or chemical agent or process that destroys pathogen

16、ic or potentially pathogenic microorganisms in/onsurfaces or objects.D-value (decimal reduction time/log death time), nthe time or radiation dose required to achieve inactivation of 90 % of onelog10 of a population of the test microorganism under stated exposure conditions.effectiveness, na measure

17、of the performance of a product.efficacy, nthe proven performance of a product established under defined conditions of testing.envelope, na layer of host cell membrane-deprived lipid that surrounds the capsid of some viruses.false negative, adjincorrectly indicating the absence of a finding or condi

18、tion.false positive, adjincorrectly indicating the presence of a finding or condition.fomite (fomes), nan inanimate object that harbors pathogenic microorganisms and may transmit infection.germ, nmicroorganisms pathogenic to humans.glove juice procedure, na process requiring placement of test subjec

19、ts hands into low bioburden plastic bags or sterile glovesthat are powder-free and non-antimicrobial. Stripping solution is added to the glove, the hands are massaged, and the strippingsolution (glove juice) is sampled to recover microorganisms.grab sample, nsingle sample from process stream (flowin

20、g) or from source of confined geometry (stagnant) withdrawn at aspecific time.inoculum, nthe viable microorganisms used to contaminate a sample, device, or surface, often expressed as to number andtype.in microbiology, a specimen comprised of living spores, bacteria, yeast or the multicellular filam

21、entous fungi, orcombination of two or more types of microorganisms, that are introduced into a test medium or onto a specimen to be testedin order to investigate the ability of the medium or specimen to support microbial growth or to investigate its antimicrobialproperties.intermediate-level disinfe

22、ctant, na disinfectant that inactivates mycobacteria, vegetative bacteria, most fungi, and lipid andnon-lipid viruses.low-level disinfectant, na disinfectant that inactivates vegetative bacteria, lipid viruses, and some fungi.minimum inhibitory concentration (MIC), nthe lowest concentration of an an

23、timicrobial agent that prevents visible growthof a microorganism in an agar or broth dilution susceptibility test.negative control, nmaterial or procedure used to differentiate the effects of specified treatments from the uncontrolled variablesin a test system.neutralization, nthe process for inacti

24、vating or quenching the activity of a microbicide, often achieved through physical (forexample, filtration or dilution) or chemical means.persistent effect, nprolonged antimicrobial activity measured after treatment(s) that prevents or inhibits proliferation or survivalof microorganisms, or both.pos

25、itive control, ntreatment using known material or procedure used to validate a test protocol.precision, nthe closeness of agreement between independent test results obtained under prescribed conditions.preservative, nchemical agent(s) added to a product to reduce or prevent microbial growth.recovery

26、 control, na procedure that validates that initial population(s) meet the criterion of a method.E2756 182reference control, nmaterial or procedure with known performance in a test method.repeatability, nthe precision of test results obtained in the same laboratory under specifically defined conditio

27、ns.reproducibility, nthe precision of test results obtained in different laboratories performing the same test procedure underspecifically defined conditions.resident microbial skin flora, nmicroorganisms that survive and multiply on the skin, forming a stable population.room temperature, ntemperatu

28、re in the range of 20 to 30C (68 to 85F).sanitizer, nchemical or physical agent(s) used to reduce the number of microorganisms to a level judged to be appropriate fora defined purpose and/or claim.slimicide, nchemical agent(s) added to a process to reduce the number of slime-forming microorganisms.s

29、terilant, nchemical or physical agent(s) that kill all forms of microorganisms in the inanimate environment.surrogate microorganism, nmicroorganism that is tested to estimate responses of other microorganism(s) for which directtesting is impractical.transient microbial skin flora, nmicroorganisms th

30、at contaminate the skin but do not form a stable population.treated materials or articles, nplastic, textile, or other pre-formed articles pretreated with antimicrobial products before firstuse. The antimicrobial benefit is limited to the material or article to maintain or preserve its chemical and/

31、or physical integrity.validation, nthe action (or process) or proving that a procedure, process, system, equipment, or method works and achieves itsintended purpose under defined conditions.volar aspect of the forearm, nthe surface of the forearm on the same side as the palm of the hand.E2756 183BIB

32、LIOGRAPHY2(1) E640 Test Method for Preservatives in Water-Containing Cosmetics(2) E645 Test Method Practice for Efficacy of Microbicides Used in Cooling Water Systems(3) E723 Test Method Practice for EfficacyEvaluation of Antimicrobials as Preservatives for Aqueous-Based Products Used in the Paper I

33、ndustry(Bacterial Spoilage)(4) E875 Test Method Practice for EfficacyEvaluation of Fungal Control Agents as Preservatives for Aqueous-Based Products Used in the PaperIndustry(5) E979 Test Method Practice for Evaluation of Antimicrobial Agents as Preservatives for Invert Emulsion and Other Water Cont

34、aining HydraulicFluids(6) E1052 Test Method for Efficacy of Antimicrobial Agents Against to Assess the Activity of Microbicides against Viruses in Suspension(7) E1053 Test Method for Efficacy of Virucidal Agents Intended for Inanimate to Assess Virucidal Activity of Chemicals Intended for Disinfecti

35、onof Inanimate, Nonporous Environmental Surfaces(8) E1054 Test Methods for Evaluation of Inactivators of Antimicrobial Agents(9) E1115 Test Method for Evaluation of Surgical Hand Scrub Formulations(10) E1153 Test Method for Efficacy of Sanitizers Recommended for Inanimate Non-Food Contact Surfaces(1

36、1) E1173 Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations(12) E1174 Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations(13) E1259 Practice for Evaluation of Antimicrobials in Liquid Fuels Boiling Below 390C(1

37、4) E1326 Guide for Evaluating NonconventionalNon-culture Microbiological Tests Used for Enumerating Bacteria(15) E1327 Test Method for Evaluation of Antimicrobial Handwash Formulations by Utilizing Fingernail Regions(16) E1428 Test Method for Evaluating the Performance of Antimicrobials in or on Pol

38、ymeric Solids Against Staining by Streptoverticillium reticu-lum (A Pink Stain Organism)(17) E1482 Test Method Practice for Neutralization of Virucidal Agents in Virucidal Efficacy EvaluationsUse of Gel Filtration Columns for Cytotox-icity Reduction and Neutralization(18) E1589 Test Method for Evalu

39、ation of First Aid Antiseptic Drug Products(19) E1766 Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices(20) E1837 Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test)(21) E1838 Test Method f

40、or Determining the Virus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads ofAdults(22) E1839 Test Method for Efficacy of Slimicides for the Paper IndustryBacterial and Fungal Slime(23) E1874 Test Method for Recovery of Microorganisms from Skin using the Cup Scru

41、b Technique(24) E1882 Test Method for Evaluation of Antimicrobial Formulations by the Agar Patch Technique(25) E1883 Test Method for Assessment of an Antibacterial Handwash Product by Multiple Basin Wash Technique2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Cus

42、tomer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.E2756 184(26) E1891 Guide for Determination of a Survival Curve for Antimicrobial Agents Against Selected Microorganisms and Calculation of a D-Valu

43、eand Concentration Coefficient(27) E2011 Test Method for Evaluation of Hygienic Handwash and Handrub Formulations for Virus-Eliminating Activity Using the Entire Hand(28) E2111 Quantitative Carrier Test Method to Evaluate the Bactericidal, Fungicidal, Mycobactericidal, and Sporicidal Potencies of Li

44、quid Chemi-cal MicrobicidesChemicals(29) E2149 Test Method for Determining the Antimicrobial Activity of Immobilized Antimicrobial Agents Under Dynamic Contact Conditions(30) E2180 Test Method for Determining the Activity of Incorporated Antimicrobial Agent(s) In Polymeric or Hydrophobic Materials(3

45、1) E2196 Test Method for Quantification of a Pseudomonas aeruginosa Biofilm Grown with Shear and Continuous Flow Using a Rotating DiskReactor(32) E2197 Quantitative Disk Carrier Test Method for Determining the Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activi-ties of Liqui

46、d Chemical GermicidesChemicals(33) E2274 Test Method for Evaluation of Laundry Sanitizers and Disinfectants(34) E2275Practice for Evaluating Water-Miscible Metalworking Fluid Bioresistance and Antimicrobial Pesticide Performance(35) E2276 Test Method for Determining the Bacteria-Eliminating Effectiv

47、eness of Hygienic Handwash and Handrub Agents Using the Fingerpadsof Adults(36) E2314Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method(Simulated Use Test)(37) E2315 Guide for Assessment of Antimicrobial Activity Using a

48、 Time-Kill Procedure(38) E2361 Guide for Testing Leave-On Products Using In-Situ Methods(39) E2362 Practice for Evaluation of Pre-saturated or Impregnated Towelettes for Hard Surface Disinfection(40) E2406 Test Method for Evaluation of Laundry Sanitizers and Disinfectants for Use in High Efficiency

49、Washing Operations(41) E2471 Test Method for Using Seeded-Agar for the Screening Assessment of Antimicrobial Activity In Carpets(42) E2562 Test Method for Quantification of Pseudomonas aeruginosa Biofilm Grown with High Shear and Continuous Flow using CDC BiofilmReactor(43) E2613 Test Method for Determining Fungus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using Fingerpads of Adults(44) E2614 Guide for Evaluation of Cleanroom Disinfectants(45) E2647 Test Method for Quantification of a Pseudomonas