ASTM_D_7661_-_18.pdf

Designation:D766118Standard Test Method forDetermining Compatibility of Personal Lubricants withNatural Rubber Latex Condoms1This standard is issued under the fixed designation D7661;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 test method covers procedures used to detect a shiftin physical properties of natural rubber latex(NRL)condomsafter immersion in a personal lubricant.“Personal lubricants”are lubricants such as liquids or gels that are applied by theconsumer at the time of condom use.1.2 This test method does not attempt to address compat-ibility of lubricants applied to a condom at the time ofmanufacture(“manufacturer lubricants”).It shall be the re-sponsibility of the condom manufacturer to verify the long-term stability(shelf life)of any manufacturer lubricant that ispackaged within the individual condom wrapper.Other regu-latory requirements may apply.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,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2D3492 Specification for Rubber Contraceptives(Male Con-doms)E177 Practice for Use of the Terms Precision and Bias inASTM Test MethodsE691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test Method3.Summary of Test Method3.1 This test method measures the change in tensile andairburst properties,specifically force at break,percent elonga-tion at break,airburst pressure,and airburst volume,of NRLcondoms and condom rings after 60 min of immersion in aliquid or gel lubricant.Condoms(up to the open end)and ringscut from condoms are immersed in personal lubricant,heatedto body temperature,cleaned of excess lubricant,and tested forboth tensile and airburst properties.Those properties are thencompared to control condoms and rings that are subjected tothe same procedures without adding lubricant.For comparisonpurposes,baseline testing is also performed on condomsdirectly from their packages.A final group exposed to mineraloil is also included to validate the laboratorys test technique.3.2 A flow chart of the lubricant compatibility tensile testcomponent is shown in Fig.1.A flow chart of the lubricantcompatibility airburst test component is shown in Fig.2.Eachstep of the process shall be performed immediately after theconclusion of the previous step.4.Significance and Use4.1 Weakening of natural rubber latex is known to occurafter contact with certain lubricants,particularly petroleum-based products.3,4This procedure was developed as a screeningmethod for lubricant manufacturers to determine whether ornot a particular personal lubricant has a significant effect on thetensile and airburst properties of an NRL condom.4.2 This test method is designed for use on NRL condomsthat meet the criteria of Specification D3492 and can:(1)havea ring specimen cut in compliance with Appendix X1 of1This test method is under the jurisdiction of ASTM Committee D11 on Rubberand Rubber-like Materials and is the direct responsibility of Subcommittee D11.40on Consumer Rubber Products.Current edition approved Sept.1,2018.Published December 2018.Originallyapproved in 2010.Last previous edition approved in 2017 as D7661 10(2017).DOI:10.1520/D7661-18.2For 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.3White,N.,Taylor,K.,Lyszkowski,A.,Tullett,J.,and Morris,C.,Dangers oflubricants used with condoms,Nature,1988,Sep 1;335(6185):19.4Voeller,B.,Coulson,A.,Bernstein,G.,and Nakamura,R.,Mineral oillubricants cause rapid deterioration of latex condoms,Contraception,1989,Jan;39(1):95-102.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 theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization