ASTM_D_7907_-_14.pdf

Designation:D790714Standard Test Methods forDetermination of Bactericidal Efficacy on the Surface ofMedical Examination Gloves1This standard is issued under the fixed designation D7907;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 methods herein specify two analytical tests forquantitatively evaluating surface bactericidal efficacy of medi-cal examination gloves incorporated with bactericidal proper-ties.They may be used for the determination of bactericidalactivity on either the outer or inner glove surface.The methodsincorporate bacterial challenges in two different formats:Method(A)a saline or buffered saline solution,and Method(B)a saline or buffered saline solution containing an organicload.Each method represents a different means of microbialcontamination that can be expected in the healthcare environ-ment.1.2 Methods described herein are not appropriate forvirucidal,fungicidal,tuberculocidal or sporicidal evaluationsas each of these categories require unique culture techniquesand testing conditions.Results of the test methods described inthis document are limited to bactericidal efficacy againstvegetative bacteria.1.3 A more expansive glove description,such as broadspectrum antimicrobial efficacy,would require testing of abroader list of microbial species than vegetative bacteria alone.It is recommended that interested manufacturers discuss spe-cies and strain selections with appropriate regulatory agenciesbefore testing is commenced.1.4 Testing is to be performed by individuals trained inmicrobiological techniques under appropriate controlled con-ditions to ensure integrity of results and personnel safety.1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 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 practices and determine the applica-bility of regulatory limitations prior to use.Most regulatoryagencies require compliance with Biocompatibility guidelinesunder ISO 10993.2.Referenced Documents2.1 ASTM Standards:2D7160 Practice for Determination of Expiration Dating forMedical GlovesE178 Practice for Dealing With Outlying ObservationsE1054 Test Methods for Evaluation of Inactivators of Anti-microbial Agents2.2 Other References:U.S.Pharmacopeia General Notices in U.S.Pharmacopeia26th rev.Rockville,MD:U.S.Pharmacopeia;2003.2ndSupplement3.Terminology3.1 Definitions:3.1.1 active side,nrefers to the inside or outside surface ofthe glove on which the antimicrobial agent has been placed.This may be both sides if the active agent is placed on both theinside and outside surfaces or if the actives agent is incorpo-rated during compounding and is expressed onto both surfaces.3.1.2 aliquot,na portion of a total amount of a solution orsuspension.3.1.3 bactericide(or bacteriocide),na substance that killsor destroys bacteria.3.1.4 bacteriostat,nchemical or biological material thatstops the growth(reproduction)of bacteria,but does NOT killthem.3.1.5 challenge inoculum,nthe viable microorganismsused to contaminate a specimen,device,or surface,oftenexpressed as to number and type.3.1.6 colony forming unit(CFU),na bacterial colonypresumed to have originated from a single bacterium.1This test method is under the jurisdiction of ASTM Committee D11 on Rubberand is the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition approved May 1,2014.Published May 2014.DOI:10.1520/D7907-14.2For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.7 control glove,nthe same glove formulation as thetest glove in every aspect,but without the addition of thebactericidal agent(s).3.1.8 coverslip(cover glass),na small,very thin piece ofglass used to cover a specimen or smear on a microscope slideor,in this case,to cover the bacterial inoculum on the surfaceof the glove specimen being tested.3.1.9 fastidious bacteria,nbacteria that are difficult togrow and keep stable often requiring complex nutritional orenvironmental factors to survive.3.1.10 inoculated,nindicates that the challenge inoculumhas been delivered to the test specimen or control.3.1.11 kill rate,nthe rate at which microorganisms arekilled.3.1.12 minimum effective concentration(MEC),nthe low-est concentration of antibacterial agent per surface unit areawhich still kills the specifi