1、Designation: E1173 15Standard Test Method forEvaluation of Preoperative, Precatheterization, orPreinjection Skin Preparations1This standard is issued under the fixed designation E1173; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision
2、, 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.1. Scope1.1 The test method is designed to measure the reduction ofthe microflora of the skin.1.2 A knowledge of mic
3、robiological techniques is requiredfor these procedures.1.3 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.3.1 ExceptionIn this test method, metric units are usedfor all applications except for linear measure, in which casein
4、ches are used, and metric units follow in parentheses.1.4 Performance of this procedure requires a knowledge ofregulations pertaining to the protection of human subjects (1).21.5 This standard does not purport to address all of thesafety problems, if any, associated with its use. It is theresponsibi
5、lity of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:3E1054 Test Methods for Evaluation of Inactivators of Anti-microbial AgentsE1874 Test Method for R
6、ecovery of Microorganisms FromSkin using the Cup Scrub TechniqueE2756 Terminology Relating to Antimicrobial and AntiviralAgents3. Terminology3.1 Terms used in this standard are defined in E2756,Standard Terminology Relating to Antimicrobial and AntiviralAgents. Others defined below are specific to t
7、heir use in thisdocument.3.2 Definitions of Terms Specific to This Standard:3.2.1 active ingredient, na substance added to a formula-tion specifically for the inhibition or inactivation of microor-ganisms.3.2.2 inguen, ngroin: the junctional region between theabdomen and thigh; pl. inguina.3.2.3 ing
8、uinal creasethe discrete region of flexure be-tween the abdomen and the thigh.3.2.4 sampling fluida recovery fluid that contains a neu-tralizer demonstrated to inactivate or quench the active ingre-dient(s) in test and reference control formulations. See TestMethod E1054.3.2.5 test formulationa form
9、ulation containing an activeingredient(s).4. Summary of Test Method4.1 These test methods are conducted on human subjectsselected randomly from a group of volunteers who, afterrefraining voluntarily from using topical and oral antimicrobi-als for at least two weeks (14 days), exhibit acceptably high
10、normal flora counts on the skin sites to be used in testing (seeSection 8).4.2 The antimicrobial activity of preoperative, vascularprecatheterization, or preinjection skin preparations is mea-sured by comparing microbial counts, obtained at various timeintervals after application of a test formulati
11、on to skin sites, tocounts obtained from those same sites prior to application ofthe test formulation. Skin sites recommended for use in testingare: (1) the inguinal region and the abdomen for preoperativeskin preparations; (2) the inguinal region, the subclavian(clavicular) region, or the median cu
12、bital region of the arm forvascular precatheterization preparations, or both; and (3) themedian cubital region of the arm for preinjection skin prepa-rations.4.2.1 Preoperative Skin PreparationMicrobial samplesare collected from the test sites a minimum of three (3) times1This test method is under t
13、he jurisdiction of ASTM Committee E35 onPesticides, Antimicrobials, and Alternative Control Agents and is the directresponsibility of Subcommittee E35.15 on Antimicrobial Agents.Current edition approved May 1, 2015. Published July 2015. Originally approvedin 1987. Last previous edition approved in 2
14、009 as E1173 01(2009). DOI:10.1520/E1173-15.2The 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 Service at serviceastm.org. For Annual Book of ASTMStandards volum
15、e 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 States1after treatment application on both moist and dry skin sites.The recommended sample times are 10 min, 30 mi
16、n, and 6 hpost-treatment, but other relevant times may be selected.4.2.2 Vascular Precatheterization PreparationMicrobialsamples are collected from the test sites a minimum of three (3)times after treatment application on both moist and dry skinsites. The recommended sample times are “immediate,” 12
17、 h,and 24 h post-treatment, but other relevant times may beselected. The immediate sample may be 30 s to 10 min,depending on the test material evaluated.4.2.3 Preinjection PreparationA microbial sample is col-lected from the test site 30 s post-treatment.4.3 The fluid used for sampling the test site
18、s must effec-tively quench (neutralize) the antimicrobial action of allformulations tested. The effectiveness of the inactivator mustbe demonstrated prior to initiation of product-testing, asdescribed in Test Method E1054, and using in-vivo techniquesconsistent with the cup-scrub technique (see Sect
19、ion 10).4.4 To ensure the internal validity of the test, a referencecontrol formulation having performance characteristics knownto the laboratory should be tested in parallel with the testformulation.5. Significance and Use5.1 These procedures should be used to test topicalantimicrobial-containing p
20、reparations that are intended to befast-acting in reducing significantly the number of organismson intact skin immediately and, for preoperative and vascularprecatheterization preparations, to maintain reductions for anextended time.6. Apparatus6.1 Colony CounterAny of several types may be used; for
21、example, Quebec colony counters and similar devices, orautomated, computerized plater/counter systems.6.2 IncubatorAny incubator that can maintain a tempera-ture of 30 6 2C may be used.6.3 SterilizerAny steam sterilizer that can produce theconditions of sterilization is acceptable.6.4 Timer (stopwat
22、ch)One that displays hours, minutes,and seconds.6.5 Examining TableAny elevated surface, such as a3-by-6-ft (0.9-by-1.8-meter) table with mattress or similarpadding to allow the subject to recline.7. Reagents and Materials7.1 Bacteriological Pipettes10.0 and 2.2-mL or 1.1-mLcapacity, available from
23、most laboratory supply houses.7.2 Petri Dishes100 mm by 15 mm, for performingstandard plate counts, available from most laboratory supplyhouses.7.3 Scrubbing CupsAutoclavable cylinders, height ap-proximately 1 in (2.5 cm), inside diameter of a size convenientto placement on the skin of the anatomica
24、l area to be sampled.Useful diameters range from approximately 0.5 to 1.5 in (1.3 to3.8 cm), depending on sites to be sampled.7.4 Rubber Policeman, TFE-fluorocarbon Scrubbers, orother appropriate adviceCan be fashioned in the laboratoryor purchased from most laboratory supply houses. Whichevertype i
25、s selected, it should be used throughout the course oftesting.7.5 Testing Formulation, including directions for use.7.6 Sterile Gauge PadsUsed to cover treated skin sites.7.7 Sterile Dressings4Used to cover treated skin sites.7.8 Sampling FluidDissolve 0.4 g KH2PO4, 10.1 gNa2HPO4, and 1.0 g isooctyl
26、phenoxypolyethoxyethanol in 1 Lof distilled water. Inactivator(s) specific for the antimicrobialactive(s) in the test and reference control formulations must beincluded (See Test Method E1054). Adjust to pH 7.8. Dispensein appropriate volumes and sterilize.7.9 Dilution FluidButterfields (2) phosphat
27、e-bufferedwater adjusted to pH 7.2, or other suitable diluent, which mustcontain antimicrobial inactivators specific for the test andreference control formulations (see Test Method E1054).7.10 Plating MediumSoybean-casein digest agar (3), withor without antimicrobial inactivators.7.11 Sterile Templa
28、te MaterialUsed to demarcate the skinsites; made from paper, plastic, or cloth, for example.7.12 Surgical Skin MarkerUsed to delineate mark the skinsites to be used in testing.NOTE 1Because some markers contain crystal violet or other fluidsthat are inhibitory to many skin microflora, a marker shoul
29、d be provennon-antimicrobial prior to use in testing.8. Skin Sites to be Used in Testing8.1 Preoperative Skin Preparations:8.1.1 The skin sites selected for evaluation of the effective-ness of preoperative skin preparations should include bothmoist and dry skin areas. Bacterial baseline populations
30、shouldbe at least 3.0 log10/cm2greater on moist skin sites than thedetection limit of the sampling procedure, and at least 2.0 log10/cm2greater than the detection limit on dry skin sites. Thepreferred moist-skin areas are the inguina, in which skin-to-skin contact results in a moist environment cond
31、ucive to higherpopulations of microflora. The preferred dry-skin area is thelower abdomen below the umbilicus. These areas are illus-trated in Fig. 1.8.1.2 Using a 1.5-by-5-in (3.8-by-12.7-cm) sterile template(for example, paper, plastic, cloth), treatment sites in theinguina are delineated on the u
32、ppermost inner aspects of boththighs, centering the long axis of the template along theinguinal crease, and marking the corners using a surgical skinmarker. If, due to a subjects anatomy, the treatment site cannotbe centered along the inguinal crease, the site should be4The sole source of supply of
33、the apparatus (TELFA non-adherent dressing, No.3279) known to the committee at this time is Kendall Co.; Hospital Products;Boston, MA 02101. This product is not sterile, but can be steam-sterilized prior touse. If you are aware of alternative suppliers of appropriate dressings, please providethis in
34、formation to ASTM International Headquarters. Your comments will receivecareful consideration at a meeting of the responsible technical committee,1whichyou may attend.E1173 152positioned on the upper, inner thigh as close to the crease aspossible. In no instance should testing be performed on areasn
35、ot having skin-to-skin contact. The site is then divided on thelong axis into 1-by-1.5-in (2.5-by-3.8-cm) sampling areas,allowing for spaces of about 0.25 (about 0.6 cm) between eachof the four areas.8.1.2.1 Sampling areas are numbered from anterior toposterior, beginning with 1 and proceeding perin
36、eally to 4, andthen are randomized to sampling for baseline and the threepost-treatment sampling times (see Note 2).NOTE 2Bacterial populations in the inguina are known to beheterogeneous, with counts tending to increase proceeding from the upperreaches of the inguinal crease perineally toward conve
37、rgence of theinguina at the gluteal fold, and to decrease proceeding laterally from theinguinal crease onto the (dry) surface of the upper thigh. Hence, samplingareas must be confined to skin immediately adjacent to the inguinal creasewhere skin-to-skin contact provides the moist environment conduci
38、ve tobacterial growth. Note that the large variance in the count data that resultsfrom randomization of the sampling areas likely will require testing of arelatively large number of subjects in order to demonstrate statisticalsignificance of post-treatment reductions.8.1.2.2 Because of constraints i
39、mposed by the anatomicalarea, sampling cylinders used for the inguinal sites must be 1in( 2.54 cm) in diameter.8.1.2.3 The test formulation and reference control materialare then randomized bilaterally to the treatment sites.8.1.3 Abdominal treatment sites are to be located within5-by-5-in (12.7-by-
40、12.7-cm) sites below and to the right or leftof the umbilicus, approximately midway between the umbili-cus and the pubis. Using a 5-by-5-in (12.7-by-12.7-cm) steriletemplate (for example, paper, plastic, cloth), the corners ofeach site are numbered 1, 2, 3, and 4 directly on the skin, usinga surgica
41、l skin marker. Numbering is to be the same for allabdominal sites: number 1 is placed at the top corner to thesubjects right, and numbers 2, 3, and 4 are assigned in orderclockwise from 1. Three quadrants of each site are used for thethree different treatment exposure times, and the remainingquadran
42、t is used for a baseline count. The test formulation andreference control material are then randomized to the treatmentsites, right and left, and baseline and the three post-treatmentsampling times are randomized to the four sampling areaswithin each site.8.2 Vascular Precatheterization Skin Prepara
43、tions:8.2.1 The skin sites selected for evaluation of the effective-ness of vascular precatheterization skin preparations shouldinclude body areas that may be catheterization sites and shouldinclude both moist and dry skin areas. Bacterial baselinepopulations should be at least 3.0 log10/cm2greater
44、on moistskin sites than the detection limit of the sampling procedure,and at least 1.0 log10/cm2greater than the detection limit on dryskin sites. The preferred moist-skin areas are the inguina, andthe preferred dry-skin areas are the clavicular region and themedian cubital region of the arm.8.2.2 T
45、est sites in the inguina are to be located and evaluatedas specified for testing of preoperative skin preparations (see8.1.2.1, Note 2, and Fig. 1).8.2.3 The dry skin sites and sampling configurations used intesting vascular precatheterization preparations are illustratedFIG. 1 Illustration of Appro
46、ximate Sampling Locations on Treatment Sites: Inguen, Abdomen, Clavicular Region, and Median CubitalRegion of ArmE1173 153in Fig. 1 and Fig. 1 Detail A. Sterile templates (for example,paper, plastic, cloth) are fashioned for the sampling configu-ration such that they accommodate the diameter of the
47、sam-pling cylinder, plus at least 0.5 in (1.25 cm) between the 4sampling areas. The template is applied to the treatment site,and a surgical skin marker is used to demarcate the samplingareas. These are numbered 1 through four at outside corners,beginning at the subjects upper right and proceeding c
48、lock-wise in the clavicular region, and beginning proximally andproceeding distally on the arm. Three sampling areas of the siteare used for different treatment exposure times of “immediate”(30 s to 10 min, depending on test product), 12 h, or 24 h, andthe remaining sampling area is used for a basel
49、ine count. Thetest formulation and reference material should be randomizedto the treatment sites, right or left, and exposure times andbaseline should be randomized to the four quadrants of eachsite.8.3 Preinjection Skin Preparations:8.3.1 The skin site selected for use in evaluating theeffectiveness of preinjection skin preparations should representa body area that is commonly used for transepidermal injectionor phlebotomy. Bacterial baseline populations should be atleast 1.0 log10/cm2greater than the detection limit of thesampling procedure. A
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