ASTM_E_1173_-_15.pdf

Designation:E117315Standard 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,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 microbiological 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 caseinches 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 theresponsibility 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 Recovery 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 their 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 inguinal 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 formulation 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 highnormal 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 formulation 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 cubital 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 the 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 2009 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 volume 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 States1 after treatment application on both moist and dry skin sites.The recommended sample times are 10 min,30 min,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 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