ASTM_D_3492_-_16.pdf

Designation:D349216Standard Specification forRubber Contraceptives(Male Condoms)1This standard is issued under the fixed designation D3492;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.This standard has been approved for use by agencies of the U.S.Department of Defense.1.Scope1.1 This specification covers the minimum requirements forindividually packaged male condoms made from natural rubberlatex and intended for single use.This specification does notcover the specifications for lubricants or other dressing mate-rials that may be applied to condoms except as noted in 3.2.1.2 This specification is intended to assist buyers in obtain-ing condoms of consistent quality.The safe and proper use ofcondoms is excluded from the scope of this specification.1.3 The applicability of this specification is as a designguideline and a reference test specification.It is not intended tobe a routine quality control specification for condom manufac-turing operations.1.4 The annexes in this specification include importantinformation,such as that on apparatus or materials,that is amandatory part of the specification but too detailed for inclu-sion in the main text.1.5 The appendixes in this specification contain informationintended to provide guidance only and are not a mandatory partof the specification.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 Regulatory bodies may require additional information,such as clinical data,to support the condom sizes subject to thisstandard.1.8 The values stated in SI units are to be regarded as thestandard.The values given in parentheses are for informationonly.2.Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD573 Test Method for RubberDeterioration in an AirOvenD1076 Specification for RubberConcentrated,AmmoniaPreserved,Creamed,and Centrifuged Natural LatexD3078 Test Method for Determination of Leaks in FlexiblePackaging by Bubble EmissionD3767 Practice for RubberMeasurement of DimensionsD4483 Practice for Evaluating Precision for Test MethodStandards in the Rubber and Carbon Black ManufacturingIndustriesE177 Practice for Use of the Terms Precision and Bias inASTM Test MethodsE691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test Method2.2 ISO Standard:3ISO 4074 Natural Latex Rubber Condoms Requirementsand Test MethodsISO 10993 Biological Evaluations of Medical Devices2.3 Other Document:3ANSI/MIL-STD 105E Sampling Procedures and Tables forInspection by Attributes3.Materials and Manufacture3.1 Condoms shall be manufactured from natural rubberlatex conforming to Specification D1076.3.2 The condoms and any dressing materials applied tothem shall not liberate substances that are known to be toxic,sensitizing,locally irritating,or otherwise harmful to thegeneral population under normal conditions of use.NOTE1Natural rubber latex products are known to cause irritation orsensitivity in a small proportion of the user population.1This specification is under the jurisdiction ofASTM Committee D11 on Rubberand is the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition approved July 1,2016.Published August 2016.Originallyapproved in 1976.Last previous edition approved in 2015 as D3492 15.DOI:10.1520/D3492-16.2For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 NOTE2Condom lubricants that contain Nonoxynol 9 spermicide areknown to cause irritation in a small proportion of the user population.NOTE3ISO 10993 contains methods to evaluate the biocompatibilityof natural rubber latex condoms.4.Requirements4.1 General:4.1.1 SamplingSamples will be selected randomly fromthe defined“lot.”The sampling plan must conform to therequirements listed in Table 1.4.1.2 Sample HandlingTo avoid inadvertent damage,op-erators must wear rubber gloves,finger cots,or other suitablehand/finger covers and exercise reasonable caution in handlingthe packet or condom in order to minimize the possibility ofdamage during the testing procedure.4.1.3 Process ControlsManufacturers may use p