ASTM E1115-2011(2017) Standard Test Method for Evaluation of Surgical Hand Scrub Formulations《外科手擦洗剂配方评估的标准试验方法》.pdf

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1、Designation: E1115 11 (Reapproved 2017)Standard 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 la

2、st revision. A number 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 both

3、immediate and persistent (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

4、 Performance of this 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 a

5、re used for allapplications, except for distance, in which case inches are usedand SI units 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 s

6、afety, health, and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment

7、of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2D1193 Specification for Reagent WaterE1054 Test Methods for Evaluation of Inactivators of Anti-microbial AgentsE2180 Te

8、st Method for Determining the Activity of Incor-porated Antimicrobial Agent(s) In Polymeric or Hydro-phobic 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 Antimi

9、-crobial Activity and Efficacy5USP 32 United States Pharmacopeia, 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

10、wash intendedto remove gross soil or residues from the hands.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 ap

11、plica-tions.3.1.5 internal reference formulationa formulation withdemonstrated performance characteristics within the labora-tory.3.1.6 neutralizationa process that results in quenching orinactivation of the antimicrobial activity of a formulation. This1This test method is under the jurisdiction of

12、ASTM Committee E35 onPesticides, Antimicrobials, and Alternative Control Agents and is the directresponsibility of Subcommittee E35.15 on Antimicrobial Agents.Current edition approved Nov. 1, 2017. Published December 2017. Originallyapproved in 1986. Last previous edition approved in 2011 as E1115 1

13、1. DOI:10.1520/E1115-11R17.2For 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 U.S. Government Pr

14、inting Office, 732 N. Capitol St.,Washington, DC 20401, U.S. Government Bookstore, http:/bookstore.gpo.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.or

15、g.5Available from Japanese Industrial Standards Committee, Divisional Councilon Consumer Life, Japanese 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:/ww

16、w.usp.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopmen

17、t of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1may be achieved through dilution of the formulation or throughthe use of chemical agents called neutralizers.3.1.7 persistenceprolonged or extended antimicrobi

18、al ac-tivity that prevents or inhibits the proliferation or survival ofmicroorganisms after treatment.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 formu

19、lationa formulation containing an activeingredient(s).4. Summary of Test Method4.1 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

20、 on the basis of highinitial bacterial count, 1105CFU/per hand as determinedby 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 aseptictechn

21、ique. One hand of each subject is sampled immediatelyafter the scrub (within 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 this

22、is desired, the panel size must be increased by 50 % to obtainthe same number 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

23、at a sampling time interval.NOTE 1Data for submission to some regulatory 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 negati

24、vecontrol when testing non-alcoholic products.4.3 If demonstration of cumulative 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.

25、 Significance and Use5.1 The procedure in this test method should be used 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 p

26、ersistent activity after a 3 hperiod and measurements of cumulative activity 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 steri

27、lizer capable of pro-ducing the conditions of sterilization.6.4 Timer (stop-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

28、at aheight that permits the hands to be held higher than the elbowsduring the 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.

29、1 Petri Dishes100 by 15 mm. Required for performingStandard Plate Count.NOTE 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 ava

30、ilablefrom most local laboratory supply houses.7.3 Water-Dilution BottlesAny 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

31、 Wash FormulationA mild, non-antimicrobial soft soap such as the following 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 lins

32、eed oil to a solution of potassium hydroxidein 15 parts water and heat up to 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

33、the soft soap is then brought up to 100 parts byaddition of hot water. Take 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,7ore

34、quivalent.NOTE 5A zone of inhibition test such as AATCC 1472004, TestMethod E2180, or Japanese Standard JIS Z 2801 may be used to evaluate7The sole source of supply of the apparatus (Ansell #579500, sterile, EncoreAcclaim Latex Surgical Gloves) known to the committee at this time is PSSMedical, Inc.

35、 (Cat #105613). If you are aware of alternative suppliers, pleaseprovide this information to ASTM International Headquarters. Your comments willreceive careful consideration at a meeting of the responsible technical committee,1which you may attend.E1115 11 (2017)2antimicrobial properties of gloves.7

36、.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).7.7 WaterSterile deionized water or equivalent (Specifi-cation D1193, Type III).7.8 Sampling Fluid8Dissolve 0.4 g KH2PO4, 10.1 gN

37、a2HPO4, 1.0 g isooctylphenoxypolyethoxyethanol (forexample, Triton X-100), and appropriately validated neutraliz-ers in 1 L distilled water. Adjust pH to 7.8 6 1 with 0.1 N HClor 01. N NaOH. Dispense to achieve a final volume of 75 6 1mL and sterilize.7.9 Dilution FluidSterile Butterfields buffer9or

38、 othersuitable diluent adjusted to pH 7.2 6 0.1 with effectiveneutralizer for the 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 appropria

39、te neutralizers if needed.NOTE 6Inadequate neutralization may result in false interpretation 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

40、/plating process.If it can be demonstrated that antimicrobial activity is quenched 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

41、16010or any equivalent may be used.8. Subjects8.1 Recruit a sufficient number (see 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

42、 to a component of the formulation(s)being tested.8.2 Instruct the subjects to avoid 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-con

43、taining antiperspirants, deodorants, shampoos, lotions,dishwashing liquids and soaps, 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 exclusiveu

44、se during the test and rubber gloves to be worn when contactwith antimicrobials agents 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. Subjec

45、ts are not to have washed their hands on this day2 h prior to baseline determination. After washing, determinefirst estimate of baseline bacterial population by samplinghands and enumerating the bacteria in the sampling fluid. Thisis Day 1 of “Baseline Period.” Repeat this baseline determi-nation pr

46、ocedure on Days 3 and 7, Days 3 and 5, or Days 5 and7 of “Baseline Period” to obtain three estimates of baselinepopulation.After obtaining the first and second estimates of thebaseline populations, select subjects who exhibited at eachsampling time counts 1105per hand. The three estimates ofthe base

47、line population obtained for each of the selectedsubjects are averaged to obtain 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 bacter

48、ial suppression and the duration of suppres-sion below the baseline counts. Equal 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.

49、Post Scrub Sampling Time, h0-h 3-h 6-h1 left hand right hand2 left hand right 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 sampling 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 basel