ASTM_D_6324_-_11_2017.pdf

Designation:D632411(Reapproved 2017)Standard 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.1.8 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:2D374 Test Methods for Thickness of Solid Electrical Insu-lation(Metric)D0374_D0374MD412 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.1This specification is under the jurisdiction of Committee D11 on Rubber andRubber-like Materials and is the direct responsibility of Subcommittee D11.40 onConsumer Rubber Products.Current edition approved June 1,2017.Published July 2017.Originally approvedin 1999.Last previous edition approved in 2011 as D6324 11.DOI:10.1520/D6324-11R17.2For 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 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 Technical Barriers to Trade(TBT)Committee.1 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 the