ASTM_E_2361_-_13.pdf

Designation:E236113Standard Guide forTesting Leave-On Products Using In-Situ Methods1This standard is issued under the fixed designation E2361;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 This guide covers test methods and sampling procedureoptions for leave-on products for consumer and hospitalpersonnel.Leave-on products,such as alcohol hand rubs andlotions containing antimicrobial ingredients,are increasinglymarketed and used by consumers and health care personnel.These products are distinguished from conventional washingand scrubbing preparations in that they do not rely on therinsing,physical removal,and antimicrobial action in deter-mining their effectiveness.Although agitation and friction mayserve to release organisms from the skin and folds and crevices,organisms are then killed in situ and are not rinsed from theskin surface before sampling.Appropriate test methods for thehands have been published,while other sampling methods willbe needed for testing body areas other than the hands.1.1.1 Researchers have described techniques to identify theexpanded flora we now know can be present on the skin.It isimpractical,if not prohibitive to attempt to recover and identifythese varieties of organisms with each test.At some point in thedesign of a test,a decision is necessary for defining the targetorganisms.Should the sampling be designed to recover asmuch of the microflora as possible or a particular portion of it?Consideration of transient and resident,superficial and deep,oraerobic and anaerobic flora must be included in defining theobjective in testing products.The recovery methods selectedfor any testing must be based on the projected use of theproduct type being tested.1.2 Methods of recovery after application of the contami-nating organisms to a part of the body other than by theagitation/rubbing of the hands against a glass petri plate alsoneed examination.Consideration should be given to contactplating,controlled swabbing with a template,and cup scrub-bing(detergent/agitation used)since the target organisms forrecovery are likely to be on the superficial layers of skin.1.3 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.4 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 requirements prior to use.2.Referenced Documents2.1 ASTM Standards:2E1174 Test Method for Evaluation of the Effectiveness ofHealth Care Personnel Handwash FormulationsE1327 Test Method for Evaluation of Antimicrobial Hand-wash Formulations by Utilizing Fingernail RegionsE2755 TestMethodforDeterminingtheBacteria-Eliminating Effectiveness of Hand Sanitizer FormulationsUsing Hands of Adults2.2 European Standard:3EN1500 Chemical Disinfectants and Antiseptics-HygienicHandrub-Test Method Requirements(phase 2/step 2)approved by CEN(Comit Europen de Normalisation)3.Summary of Guide3.1 In this guide,choices of recovery techniques after theuse of antimicrobial products will be considered.By the natureof the distribution of the skin flora,these sampling techniquesestimate the flora remaining after antimicrobial use;some of itis superficial and some hidden.An appropriate samplingmethod can be selected depending on product use and theimportance of superficial(transient)and hidden or deep(mostly resident)flora.Recent publications have revealed agreater variety of organisms that populate the skin and com-prise the skin microbiome(1,2).4This information requires alarger selection of recovery media.For certain applications,such as acne studies or when recovery of the greatest diversityof organisms is desired,specific anaerobic/microaerophilicmedia should be used.1This guide is under the jurisdiction of ASTM Committee E35 on Pesticides,Antimicrobials,and Alternative Control Agents and is the direct responsibility ofSubcommittee E35.15 on Antimicrobial Agents.Current edition approved April 1,2013.Published June 2013.Originallyapproved in 2004.Last previous edition approved in 2007 as E2361 04(2007).DOI:10.1520/E2361-13.2For 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 British Standards Institute(BSI),389 Chiswick High Rd.,London W4 4AL,U.K.4The boldface numbers in parentheses refer to the list of references at the end ofthis standard.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.Uni