ASTM_D_7661_-_10.pdf

Designation:D766110Standard 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 non-lubricated natural rubber latex(NRL)condoms after immersion in a personal lubricant.“Personal lubricants”are lubricants such as liquids or gels thatare applied by the consumer 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 and health practices and determine the applica-bility of regulatory limitations prior to use.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,ofnon-lubricated NRL condoms and condom rings after 60 minof immersion in a liquid or gel lubricant.Condoms(up to theopen end)and rings cut from condoms are immersed inpersonal lubricant,heated to body temperature,cleaned ofexcess lubricant,and tested for both tensile and airburstproperties.Those properties are then compared to controlcondoms and rings that are subjected to the same procedureswithout adding lubricant.For comparison purposes,baselinetesting is also performed on condoms directly from theirpackages.A final group exposed to mineral oil is also includedto 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 ofSpecification D3492 and(2)be tested for burst properties incompliance with Annex A2 of Specification D3492.4.3 This test method is not to be used to determine the safetyof either the test lubricant or NRL condom.This test method isto be used only to determine if the tensile or airburst propertiesof the NRL condom have been significantly affected by the testlubricant.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 Oct.1,2010.Published November 2010.DOI:10.1520/D7661-10.2For 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 oil lubricantscause 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 States1 FIG.1 Flow Chart for the Tensile Test Component of the Lubricant Compatibility TestD7661 102 FIG.2 Flow Chart for the Airburst Test Component of the Lubricant Compatibility TestD7661 103 5.Apparatus5.1 Environmental chamber or oven,capable of maintaining40 6 2C.5.2 Airburst tester and clamping mount,capable of inflatinga co