ASTM E2756-2010 Standard Terminology Relating to Antimicrobial and Antiviral Agents《有关抗菌剂和抗病毒剂的标准术语》.pdf

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1、Designation: E2756 10Standard 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 number

2、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 establishuniformity in terms used in the field of antimicrobial andantiviral agent testing. Ter

3、ms are adapted from related fieldssuch as regulatory terms defined by law and definitions assupported by test requirements.1.2 The terms are appropriate to the wide range of interestrelated to standards developed in the area of antimicrobial andantiviral testing.2. TerminologyGENERAL ANTIMICROBIAL A

4、ND ANTIVIRALTERMSaccuracy, na measure of the degree of conformity of a valuegenerated by a specific procedure to the assumed or acceptedtrue value, and includes both precision and bias.ambient temperature, ntemperature of the environment inwhich a test method is performed.antibacterial, adjdescribes

5、 an agent that kills bacteria orsuppresses their growth or reproduction.antimicrobial, adjdescribes an agent that kills or inactivatesmicroorganisms or suppresses their growth or reproduction.antiseptic, na material for use on living tissue that eitherdestroys microorganisms or suppresses their grow

6、th.bias, na systematic error that contributes to the differencebetween the mean of a large number of test results and anaccepted reference value (ASTM Form and Style Manual).DISCUSSIONA statement of bias is not possible because standardreference materials are not available for most microbiological m

7、ethods.biofouling, nthe unwanted accumulation of organismsand/or their products on surfaces.cleaner-sanitizer, na physical or chemical agent that re-moves soil from an object and reduces numbers of microor-ganisms on non-food contact surfaces.carrier, na surrogate surface or matrix that facilitates

8、theinteraction of test microorganisms and treatment(s).cell monolayer, na single layer of eukaryotic cells typicallypropogated on a glass or plastic surface to which they aresecurely attached.cleansing wash, na procedure intended to remove soil orresidue.clastogen, nan agent that reduces chromosomal

9、 posite sample, na series of grab samples integrated intoa single sample or samples collected at specific times andintegrated into a single sample.cooling system, nequipment and coolant used for the re-moval of heat from processes, equipment, or both.cooling water, nany water-based solution that abs

10、orbs andtransfers heat in cooling systems.cumulative effect, na progressively additive reduction in thenumbers of viable microorganisms measured from an estab-lished baseline following repeated applications of a materialor procedure.decontamination, na procedure that eliminates or reducescontaminant

11、s. The usual reference is to reduce potentiallyharmful or undesirable microorganisms.disinfectant, na physical or chemical agent or process thatdestroys pathogenic or potentially pathogenic microorgan-isms in/on surfaces or objects.D-value (decimal reduction time/log death time), nthetime or radiati

12、on dose required to achieve inactivation of90 % of one log10of a population of the test microorganismunder stated exposure conditions.effectiveness, na measure of the performance of a product.efficacy, nthe proven performance of a product establishedunder defined conditions of testing.envelope, na l

13、ayer of host cell membrane-deprived lipid thatsurrounds the capsid of some viruses.false negative, adjincorrectly indicating the absence of afinding or condition.false positive, adjincorrectly indicating the presence of afinding or condition.fomite (fomes), nan inanimate object that harbors patho-ge

14、nic microorganisms and may transmit infection.germ, nmicroorganisms pathogenic to humans.1This terminology is under the jurisdiction of ASTM Committee E35 onPesticides and Alternative Control Agents and is the direct responsibility ofSubcommittee E35.15 on Antimicrobial Agents.Current edition approv

15、ed May 1, 2010. Published December 2010. DOI:10.1520/E275610.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.glove juice procedure, na process requiring placement oftest subjectshands into low bioburden plastic bags or sterilegloves

16、that are powder-free and non-antimicrobial. Strippingsolution is added to the glove, the hands are massaged, andthe stripping solution (glove juice) is sampled to recovermicroorganisms.grab sample, nsingle sample from process stream (flowing)or from source of confined geometry (stagnant) withdrawn a

17、ta specific time.inoculum, nthe viable microorganisms used to contaminatea sample, device, or surface, often expressed as to numberand type.intermediate-level disinfectant, na disinfectant that inacti-vates mycobacteria, vegetative bacteria, most fungi, andlipid and non-lipid viruses.low-level disin

18、fectant, na disinfectant that inactivates veg-etative bacteria, lipid viruses, and some fungi.minimum inhibitory concentration (MIC), nthe lowestconcentration of an antimicrobial agent that prevents visiblegrowth of a microorganism in an agar or broth dilutionsusceptibility test.negative control, nm

19、aterial or procedure used to differenti-ate the effects of specified treatments from the uncontrolledvariables in a test system.neutralization, nthe process for inactivating or quenchingthe activity of a microbicide, often achieved through physi-cal (for example, filtration or dilution) or chemical

20、means.persistent effect, nprolonged antimicrobial activity mea-sured after treatment(s) that prevents or inhibits proliferationor survival of microorganisms, or both.positive control, ntreatment using known material or pro-cedure used to validate a test protocol.precision, nthe closeness of agreemen

21、t between independenttest results obtained under prescribed conditions.preservative, nchemical agent(s) added to a product toreduce or prevent microbial growth.recovery control, na procedure that validates that initialpopulation(s) meet the criterion of a method.reference control, nmaterial or proce

22、dure with knownperformance in a test method.repeatability, nthe precision of test results obtained in thesame laboratory under specifically defined conditions.reproducibility, nthe precision of test results obtained indifferent laboratories performing the same test procedureunder specifically define

23、d conditions.resident microbial skin flora, nmicroorganisms that sur-vive and multiply on the skin, forming a stable population.room temperature, ntemperature in the range of 20 to 30C(68 to 85F).sanitizer, nchemical or physical agent(s) used to reduce thenumber of microorganisms to a level judged t

24、o be appropri-ate for a defined purpose and/or claim.slimicide, nchemical agent(s) added to a process to reducethe number of slime-forming microorganisms.sterilant, nchemical or physical agent(s) that kill all formsof microorganisms in the inanimate environment.surrogate microorganism, nmicroorganis

25、m that is tested toestimate responses of other microorganism(s) for whichdirect testing is impractical.transient microbial skin flora, nmicroorganisms that con-taminate the skin but do not form a stable population.treated materials or articles, nplastic, textile, or otherpre-formed articles pretreat

26、ed with antimicrobial productsbefore first use. The antimicrobial benefit is limited to thematerial or article to maintain or preserve its chemical and/orphysical integrity.validation, nthe action (or process) or proving that aprocedure, process, system, equipment, or method worksand achieves its in

27、tended purpose under defined conditions.volar aspect of the forearm, nthe surface of the forearm onthe same side as the palm of the hand.E2756 102BIBLIOGRAPHY2(1) E640 Test Method for Preservatives in Water-Containing Cosmetics(2) E645 Test Method for Efficacy of Microbicides Used in CoolingWater Sy

28、stems(3) E723 Test Method for Efficacy of Antimicrobials as Preservativesfor Aqueous-Based Products Used in the Paper Industry (BacterialSpoilage)(4) E875 Test Method for Efficacy of Fungal Control Agents asPreservatives for Aqueous-Based Products Used in the PaperIndustry(5) E979 Test Method for Ev

29、aluation of Antimicrobial Agents asPreservatives for Invert Emulsion and Other Water ContainingHydraulic Fluids(6) E1052 Test Method for Efficacy of Antimicrobial Agents AgainstViruses in Suspension(7) E1053 Test Method for Efficacy of Virucidal Agents Intended forInanimate Environmental Surfaces(8)

30、 E1054 Test Methods for Evaluation of Inactivators ofAntimicrobialAgents(9) E1115 Test Method for Evaluation of Surgical Hand Scrub Formu-lations(10) E1153 Test Method for Efficacy of Sanitizers Recommended forInanimate Non-Food Contact Surfaces(11) E1173 Test Method for Evaluation of Preoperative,

31、Precatheteriza-tion, or Preinjection Skin Preparations(12) E1174 Test Method for Evaluation of the Effectiveness of HealthCare Personnel Handwash Formulations(13) E1259 Practice for Evaluation of Antimicrobials in Liquid FuelsBoiling Below 390C(14) E1326 Guide for Evaluating Nonconventional Microbio

32、logicalTests Used for Enumerating Bacteria(15) E1327 Test Method for Evaluation of Antimicrobial HandwashFormulations by Utilizing Fingernail Regions(16) E1428 Test Method for Evaluating the Performance of Antimicro-bials in or on Polymeric Solids Against Staining by Streptoverti-cillium reticulum (

33、A Pink Stain Organism)(17) E1482 Test Method for Neutralization of Virucidal Agents inVirucidal Efficacy Evaluations(18) E1589 Test Method for Evaluation of First Aid Antiseptic DrugProducts(19) E1766 Test Method for Determination of Effectiveness of Steril-ization Processes for Reusable Medical Dev

34、ices(20) E1837 Test Method to Determine Efficacy of Disinfection Pro-cesses for Reusable Medical Devices (Simulated Use Test)(21) E1838 Test Method for Determining the Virus-Eliminating Effec-tiveness of Hygienic Handwash and Handrub Agents Using theFingerpads of Adults(22) E1839 Test Method for Eff

35、icacy of Slimicides for the PaperIndustryBacterial and Fungal Slime(23) E1874 Test Method for Recovery of Microorganisms from Skinusing the Cup Scrub Technique(24) E1882 Test Method for Evaluation of Antimicrobial Formulationsby the Agar Patch Technique(25) E1883 Test Method for Assessment of an Ant

36、ibacterial HandwashProduct by Multiple Basin Wash Technique(26) E1891 Guide for Determination of a Survival Curve for Antimi-crobialAgentsAgainst Selected Microorganisms and Calculation ofa D-Value and Concentration Coefficient(27) E2011 Test Method for Evaluation of Hygienic Handwash andHandrub For

37、mulations for Virus-Eliminating Activity Using theEntire Hand(28) E2111 Quantitative Carrier Test Method to Evaluate the Bacteri-cidal, Fungicidal, Mycobactericidal, and Sporicidal Potencies ofLiquid Chemical Microbicides(29) E2149 Test Method for Determining the Antimicrobial Activity ofImmobilized

38、 Antimicrobial Agents Under Dynamic Contact Con-ditions(30) E2180 Test Method for Determining the Activity of IncorporatedAntimicrobial Agent(s) In Polymeric or Hydrophobic Materials(31) E2196 Test Method for Quantification of a Pseudomonas aerugi-nosa Biofilm Grown with Shear and Continuous Flow Us

39、ing aRotating Disk Reactor(32) E2197 Quantitative Disk Carrier Test Method for Determining theBactericidal, Virucidal, Fungicidal, Mycobactericidal and Spori-cidal Activities of Liquid Chemical Germicides(33) E2274 Test Method for Evaluation of Laundry Sanitizers andDisinfectants(34) E2275 Practice

40、for Evaluating Water-Miscible Metalworking FluidBioresistance and Antimicrobial Pesticide Performance(35) E2276 Test Method for Determining the Bacteria-EliminatingEffectiveness of Hygienic Handwash and Handrub Agents Usingthe Fingerpads of Adults(36) E2314 Test Method for Determination of Effective

41、ness of CleaningProcesses for Reusable Medical Instruments Using a MicrobiologicMethod (Simulated Use Test)(37) E2315 Guide for Assessment of Antimicrobial Activity Using aTime-Kill Procedure(38) E2361 Guide for Testing Leave-On Products Using In-Situ Meth-ods(39) E2362 Practice for Evaluation of Pr

42、e-saturated or ImpregnatedTowelettes for Hard Surface Disinfection(40) E2406 Test Method for Evaluation of Laundry Sanitizers andDisinfectants for Use in High Efficiency Washing Operations(41) E2471 Test Method for Using Seeded-Agar for the ScreeningAssessment of Antimicrobial Activity In Carpets(42

43、) E2562 Test Method for Quantification of Pseudomonas aeruginosaBiofilm Grown with High Shear and Continuous Flow using CDCBiofilm Reactor(43) E2613 Test Method for Determining Fungus-Eliminating Effective-ness of Hygienic Handwash and Handrub Agents Using Fingerpadsof Adults(44) E2614 Guide for Eva

44、luation of Cleanroom Disinfectants(45) E2647 Test Method for Quantification of a Pseudomonas aerugi-nosa Biofilm Grown Using a Drip Flow Biofilm Reactor with LowShear and Continuous Flow2For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at servicea

45、stm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.E2756 103This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved o

46、r 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 theresponsible technical committee, which you may attend. If you feel th

47、at 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 C700, West Conshohocken, PA 19428-2959,United States. Individual reprints

48、 (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/).E2756 104