ASTM E1115-2011 Standard Test Method for Evaluation of Surgical Hand Scrub Formulations《外科手擦洗规程评估标准试验方法》.pdf

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1、Designation: E1115 11Standard Test Method forEvaluation of Surgical Hand Scrub Formulations1This standard is issued under the fixed designation E1115; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A num

2、ber in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This test method is designed to measure the reduction ofmicrobial flora on the skin. It is intended for determining bothimmediate and pers

3、istent (continuing antimicrobial effect)microbial reductions, after single or repetitive treatments, orboth. It may also be used to measure cumulative antimicrobialactivity after repetitive treatments.1.2 A knowledge of microbiological techniques is requiredfor these procedures.1.3 Performance of th

4、is procedure requires the knowledgeof regulations pertaining to the protection of human subjects(21 CFR, Parts 50 and 56)1.4 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.4.1 In this test method, SI units are used for all ap

5、plica-tions, except for distance, in which case inches are used and SIunits follow in parentheses.1.5 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 safety and health

6、 practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D1193 Specification for Reagent WaterE1054 Test Methods for Evaluation of Inactivators of An-timicrobial AgentsE2180 Test Method for Determining the Activity of Incor-porated

7、AntimicrobialAgent(s) In Polymeric or Hydropho-bic Materials2.2 Other Documents:21 CFR Parts 50 and 563AATCC 1472004 Antibacterial Assessment of Textile Ma-terials: Parallel Streak Method4JIS Z 2801 :2000, Antimicrobial ProductsTest for Anti-microbial Activity and Efficacy5USP32 United States Pharma

8、copeia, Chapter 61 “MicrobialLimits Test”, 200963. Terminology3.1 Definitions:3.1.1 active ingredienta substance added to a formulationspecifically for the inhibition or inactivation of microorgan-isms.3.1.2 cleansing washa non-antimicrobial wash intendedto remove gross soil or residues from the han

9、ds.3.1.3 cleansing wash formulationa liquid castile soap orother liquid soap with neutral pH which does not contain anantimicrobial.3.1.4 cumulative effecta progressive decrease in the num-ber of microorganisms recovered following repeated applica-tions.3.1.5 internal reference formulationa formulat

10、ion withdemonstrated performance characteristics within the labora-tory.3.1.6 neutralizationa process that results in quenching orinactivation of the antimicrobial activity of a formulation. Thismay be achieved through dilution of the formulation or throughthe use of chemical agents called neutraliz

11、ers.3.1.7 persistenceprolonged or extended antimicrobial ac-tivity that prevents or inhibits the proliferation or survival ofmicroorganisms after treatment.1This test method is under the jurisdiction of ASTM Committee E35 onPesticides, Antimicrobials, and Alternative Control Agents and is the direct

12、responsibility of Subcommittee E35.15 on Antimicrobial Agents.Current edition approved Aug. 1, 2011. Published August 2011. Originallyapproved in 1986. Last previous edition approved in 2010 as E1115 10. DOI:10.1520/E1115-11.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcon

13、tact 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 U.S. Government Printing Office, 732 N. Capitol St., Washing-ton, DC 20401, U.S. Government Bookstore, http:/bookstore.g

14、po.gov/baskets/cfr-listing.jsp.4Technical Manual of the American Association of Textile Chemists andColorists (AATCC), 2009, Vol 82, P.O. Box 12215, Research Triangle Park, NC27709, http:/www.aatcc.org.5Available from Japanese Industrial Standards Committee, Divisional Councilon Consumer Life, Japan

15、ese Standards Association (JSA), 4-1-24 Akasaka Minato-Ku, Tokyo, 107-8440, Japan, http:/www.jsa.or.jp.6Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,MD 20852-1790, http:/www.usp.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 1

16、9428-2959, United States.3.1.8 sampling fluida buffered solution that aids in recov-ery of microorganisms from the skin and neutralization of theactive ingredient in test and internal reference formulations.3.1.9 test formulationa formulation containing an activeingredient(s).4. Summary of Test Meth

17、od4.1 This test method is conducted on individuals selectedfrom a group of subjects who have refrained from using anyantimicrobials for at least one week prior to initiation of thetest. Subjects are selected from this group on the basis of highinitial bacterial count,$ 1 3 105CFU/per hand as determi

18、nedby baseline measurements of the bacteria on their hands usingthe recovery techniques in this method.4.2 The selected subjects perform a simulated surgical scrubunder the supervision of an individual competent in aseptictechnique. One hand of each subject is sampled immediatelyafter the scrub (wit

19、hin 1 min), and the other hand, 6 h afterscrubbing. Only one hand of a subject is sampled at a specifiedtime. Optionally, another sampling time, 3 h for example, canbe added between the immediate and 6 h sampling times. If thisis desired, the panel size must be increased by 50 % to obtainthe same nu

20、mber of data points at each designated samplinginterval. Also, a sampling time randomization must be gener-ated such that one-third of the hands are sampled at eachsampling interval with only one hand of a subject beingsampled at a sampling time interval.NOTE 1Data for submission to some regulatory

21、bodies may requirethe addition of a positive and negative control in addition to the testproduct. For the negative control, 0.9 % saline can be used when testingalcohol products and the product vehicle can be used as the negativecontrol when testing non-alcoholic products.4.3 If demonstration of cum

22、ulative activity is desired,eleven additional scrubs are performed over a 5-day period,one additional time on Day 1, three times on Days 2, 3, and 4and once on Day 5. The hands are sampled again after the lastscheduled scrub.5. Significance and Use5.1 The procedure in this test method should be used

23、 toevaluate the activity of the test formulation in reducing thebacterial population of the hands immediately after a single useand to determine persistent activity (inhibition of growth) after6 h. Optionally, measurements of persistent activity after a 3 hperiod and measurements of cumulative activ

24、ity may be madeafter repetitive uses over a five day period.6. Apparatus6.1 Colony CounterUse any of several types.6.2 IncubatorAny incubator capable of maintaining atemperature of 30 6 2C.6.3 SterilizerAny suitable steam sterilizer capable ofproducing the conditions of sterilization.6.4 Timer (stop

25、-clock)one that displays minutes and sec-onds.6.5 Hand Washing SinkA sink of sufficient size to permitsubjects to wash without touching hands to sink surface orother subjects.6.5.1 Water Faucet(s)To be located above the sink at aheight that permits the hands to be held higher than the elbowsduring t

26、he washing procedure. (It is desirable for the height ofthe faucet(s) to be adjustable.)6.6 Tap Water Temperature Regulator and TemperatureMonitorTo monitor and regulate water temperature to 40 62C.7. Reagents and Materials7.1 Petri Dishes100 by 15 mm. Required for performingStandard Plate Count.NOT

27、E 2Pre-sterilized/disposable plastic petri dishes are availablefrom most local laboratory supply houses.7.2 Bacteriological Pipets10.0 and 2.2 or 1.1-mL capac-ity.NOTE 3Pre-sterilized/disposable bacteriological pipets are availablefrom most local laboratory supply houses.7.3 Water-Dilution BottlesAn

28、y sterilizable container hav-ing a 150 to 200-mL capacity and tight closures may be used.NOTE 4Dilution bottles of 160-mL capacity having a screw-capclosure are available from most local laboratory supply houses.7.4 Cleansing Wash FormulationA mild, non-antimicrobial soft soap such as the following

29、or any otherliquid soap with neutral pH which does not contain anantimicrobial:Soft soap, 200 g/LLinseed oil 50 parts by weightPotassium hydroxide 9.5 partsEthanol 7 partsDistilled or high purity water as needed7.4.1 Add linseed oil to a solution of potassium hydroxidein 15 parts water and heat up t

30、o approximately 70C whileconstantly stirring. Add the ethanol and continue heating whilestirring until the saponification process is completed and asample dissolves clearly in water and almost clearly in alcohol.The weight of the soft soap is then brought up to 100 parts byaddition of hot water. Tak

31、e 200 g of the soft soap in 1 L ofwater. Dispense in to appropriate containers and sterilize in anautoclave.7.5 Gloves for SamplingLoose-fitting, unlined, powder-free latex gloves which possess no antimicrobial properties,7orequivalent.NOTE 5A zone of inhibition test such as AATCC 1472004, TestMetho

32、d E2180, or Japanese Standard JIS Z 2801 may be used to evaluateantimicrobial properties of gloves.7.6 Test FormulationDirections for use of active testformulation should be utilized if available. If not available, usedirections provided in this test method (see 11.1.3).7The sole source of supply of

33、 the apparatus (Ansell #579500, sterile, EncoreAcclaim Latex Surgical Gloves) known to the committee at this time is PSSMedical, Inc. (Cat #105613). If you are aware of alternative suppliers, pleaseprovide this information to ASTM International Headquarters. Your comments willreceive careful conside

34、ration at a meeting of the responsible technical committee,1which you may attend.E1115 1127.7 WaterSterile deionized water or equivalent (Specifi-cation D1193, Type III).7.8 Sampling Fluid8Dissolve 0.4 g KH2PO4, 10.1 gNa2HPO4, 1.0 g isooctylphenoxypolyethoxyethanol (for ex-ample, Triton X-100), and

35、appropriately validated neutralizersin 1 L distilled water. Adjust pH to 7.8 6 1 with 0.1 N HCl or01. N NaOH. Dispense to achieve a final volume of 75 6 1mLand sterilize.7.9 Dilution FluidSterile Butterfields buffer9or othersuitable diluent adjusted to pH 7.2 6 0.1 with effectiveneutralizer for the

36、test material. Adjust pH with 0.1 N HCl or0.1 N NaOH. See Test Methods E1054.7.10 AgarSoybean-casein Digest agar (USP 32) or othersolid media appropriately validated to support growth of thetest organism with appropriate neutralizers if needed.NOTE 6Inadequate neutralization may result in false inte

37、rpretation ofthe test data. The use of excess chemical neutralizers may exert a toxiceffect on the recovery of bacterial cells. The goal, therefore, is to stopantimicrobial activity as early as possible in the sampling/plating process.If it can be demonstrated that antimicrobial activity is quenched

38、 orinactivated in the sampling fluid then, to reduce the chance of possibletoxic effects, inactivators should not be added to the dilution fluid orplating media.7.11 Scrub Sponge and Nail Cleaner StickSuch as E-ZScrub 16010or any equivalent may be used.8. Subjects8.1 Recruit a sufficient number (see

39、 X1.1) of healthy sub-jects who have no clinical evidence of dermatoses, openwounds, or other skin disorders. Exclude any individualreceiving antibiotic therapy and any individual sensitive tonatural rubber or latex or to a component of the formulation(s)being tested.8.2 Instruct the subjects to avo

40、id contact with antimicrobialproducts (other than the test formulation(s) as dispensed foreach scrub) for the duration of the test and for at least one weekprior to the test. This restriction includes antimicrobial-containing antiperspirants, deodorants, shampoos, lotions,dishwashing liquids and soa

41、ps, and also such materials asacids, bases, and solvents. Bathing in biocide treated pools, hottubs, or spas should be avoided. Subjects are provided with akit of non-antimicrobial personal care products for exclusiveuse during the test and rubber gloves to be worn when contactwith antimicrobials ag

42、ents cannot be avoided.9. Procedure9.1 After subjects have refrained from using antimicrobialsfor at least one week, perform wash with cleansing washformulation (see 7.4) using methodology outlined in 10.1-10.4.Subjects are not to have washed their hands on this day 2 hprior to baseline determinatio

43、n. After washing, determine firstestimate of baseline bacterial population by sampling handsand enumerating the bacteria in the sampling fluid. This is Day1 of “Baseline Period.” Repeat this baseline determinationprocedure on Days 3 and 7, Days 3 and 5, or Days 5 and 7 of“Baseline Period” to obtain

44、three estimates of baseline popu-lation. After obtaining the first and second estimates of thebaseline populations, select subjects who exhibited at eachsampling time counts $1 3 105per hand. The three estimatesof the baseline population obtained for each of the selectedsubjects are averaged to obta

45、in the mean baseline counts.9.2 Abasic random bacterial recovery sampling plan shouldbe followed. The number of subjects and sampling timesdepend on the test formulation but must establish the onset andextent of the bacterial suppression and the duration of suppres-sion below the baseline counts. Eq

46、ual numbers of subjectsshould be assigned per sampling time, test formulation andhand.Atypical balanced randomization plan for testing a blockof six subjects follows with sampling at 0 h, 3 h (optional), and6h.Subject No. Post Scrub Sampling Time, h0-h 3-h 6-h1 left hand right hand2 left hand right

47、hand3 right hand left hand4 right hand left hand5 left hand right hand6 right hand left handIf only 0 h and 6 h post scrub samples are collected the 0 hwill be randomized to the right or left hand.9.2.1 The number of subjects per block may vary but mustbe divisible by two and by the number of sampli

48、ng times inorder to assign equal number of left and right hands to eachsampling time.9.3 No sooner than 24 h and no longer than 96 h aftercompletion of the baseline determination, subjects performscrub with the test formulation. The starting interval should besame for all subjects participating in t

49、he study. According tothe random sampling plan, determine the bacterial populationson the subjects hands at the assigned sampling times afterscrubbing. Determine bacterial population by sampling handsand enumerating the bacteria in the sampling fluid as specifiedin Sections 13 and 14.9.4 If measurement of cumulative effect is desired, thehands are sampled one more time after performing 11 addi-tional scrubs with the active test formulation overa5dayperiod. Repeat the treatment procedure with the test formula-tion one additional time after