ASTM_D_6324_-_11.pdf

Designation:D632411Standard Specification forMale Condoms Made from Polyurethane1This standard is issued under the fixed designation D6324;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 specification covers the minimum requirements forindividually packaged male condoms made from polyurethane.This specification also describes the minimum inspection andquality levels that shall be utilized in referee tests.It is notintended to be a routine quality control specification forpolyurethane condom manufacturing operations.1.2 This specification is intended to assist buyers in obtain-ing male polyurethane condoms of consistent quality.The safeand proper use of male polyurethane condoms is excluded fromthe scope of these test methods.1.3 The annexes in these test methods include importantinformation,such as that on apparatus or materials,that are amandatory part of these test methods but too detailed forinclusion in the main text.1.4 The appendixes in these test methods contain informa-tion intended to provide guidance.1.5 The values stated in SI units are to be regarded as thestandard.The values given in parentheses are for informationonly.1.6 It shall be the responsibility of the manufacturer for anycondom design that falls outside the specifications of thisstandard to determine testing methodology and substantiate theappropriateness of that methodology to assure the quality of thecondoms to the purchaser and to the government regulatoryauthority having jurisdiction.1.7 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:2D374 Test Methods for Thickness of Solid Electrical Insu-lationD412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD618 Practice for Conditioning Plastics for TestingD638 Test Method for Tensile Properties of PlasticsD882 Test Method for Tensile Properties of Thin PlasticSheetingD3078 Test Method for Determination of Leaks in FlexiblePackaging by Bubble EmissionD3492 Specification for Rubber Contraceptives(Male Con-doms)D3767 Practice for RubberMeasurement of Dimensions2.2 Other Documents:ANSI/ASQC Z1.42003 Sampling Procedures and Tablesfor Inspection by Attributes3ISO37 Rubber,VulcanizedorThermoplasticDetermination of Tensile Stress-Stain Properties Preclini-cal and Clinical Requirements for Approval to MarketNon-latex Condoms,World Health Organization,19973ISO 10993 Biological Evaluation of Medical Devices,Part23ISO 23409 Synthetic Condom Standard33.Significance and Use3.1 New polymer materials for male condoms are beingdeveloped.Several products have been developed and arecurrently marketed in international commerce.This standard isintended to provide specifications to adequately describe thedesign and the quality of condoms made of polyurethanematerial.1These test methods are under the jurisdiction of Committee D11 on Rubber andare the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition approved Nov.1,2011.Published December 2011.Originallyapproved in 1999.Last previous edition approved in 2008 as D6324 08.DOI:10.1520/D6324-11.2For 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 American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.2 This standard is not intended to be design restrictive.The condom design shall be validated prior to use.3.3 This standard will provide test methods to validate thematerial of construction for a polyurethane condom character-izing this material and then confirm the material as suitable fora male condom with a performance in-use test.3.4 Current products in international commerce at the timeof publication shall be considered in compliance with thisstandard.The use of a polyurethane condom material valida-tion for line extension will still need to be undertaken oralternately individual performance user studies will need to beundertaken.4.Materials and Manufacture4.1 Condoms shall be manufactured from polyurethanematerials.4.2 The biocompatibility of the finished product,includingany dressing materials,shall be assessed in accordance withISO 10993 or its equivalent.NOTE1Condom lubricants that contain a spermicide,such as Non-oxynol 9,ca