ASTM D3492-2015 Standard Specification for Rubber Contraceptives (Male Condoms)《橡胶避孕套标准规格 (男用避孕套)》.pdf

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1、Designation: D3492 15Standard 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 p

2、arentheses 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 forindivi

3、dually 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-

4、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 man

5、ufac-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 pro

6、vide 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

7、 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 thestandar

8、d. 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, Creame

9、d, 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 f

10、or 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 D

11、ocument: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 a

12、re known to be toxic,sensitizing, locally irritating, or otherwise harmful to thegeneral population under normal conditions of use.NOTE 1Natural rubber latex products are known to cause irritation orsensitivity in a small proportion of the user population.1This specification is under the jurisdictio

13、n ofASTM Committee D11 on Rubberand is the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition approved June 1, 2015. Published October 2015. Originallyapproved in 1976. Last previous edition approved in 2014 as D3492 14. DOI:10.1520/D3492-15.2For referenced ASTM

14、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 F

15、loor, New York, NY 10036.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1NOTE 2Condom lubricants that contain Nonoxynol 9 spermicide areknown to cause irritation in a small proportion of the user population.NOTE 3ISO 10993 contains me

16、thods 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 mus

17、t 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 processcontrol tests to determine condom prope

18、rties. Finished con-doms shall be used for qualification and referee tests.4.1.4 LotA collection of condoms of the same design,color, shape, size, and formulation manufactured continuously,using the same process, raw materials, or the samespecification, common equipment, and packaged with the samelu

19、bricant and any other additives or dressing in the same typeof individual container. The maximum lot size shall be 500 000condoms.4.2 DimensionsCondoms shall meet the requirementslisted in Table 2.4.2.1 Procedures for Dimensional Test:4.2.1.1 LengthMeasure the length of the condom to thenearest 1 mm

20、, using the method described in Annex A1.4.2.1.2 WidthMeasure to the nearest 0.5 mm the width ofthe condom laid flat at a distance 30 6 5 mm from the openend.4.2.1.3 ThicknessMeasure the thickness of condoms driedat room temperature for a minimum of 16 h after any dressingmaterials have been removed

21、 with water or isopropanol.Measure the wall thickness at three points, 30 6 5 mm, 90 65 mm, and 150 6 5 mm from the closed end. The thicknessmeasuring device shall conform to that specified in PracticeD3767, Test Method A with the pressure of the foot thicknessgage at 22 6 5 kPa. When a condom is te

22、xtured, measure thethickness in the nontextured area. Report the measurements tothe nearest 0.01 mm.4.3 Tensile PropertiesThis part of the specification speci-fies a method for determining the breaking force, tensilestrength, and ultimate elongation of rubber contraceptives.There are no breaking for

23、ce, tensile strength, or elongationrequirements for condoms given in this specification.4.3.1 Procedures for Tensile PropertiesBreaking force,tensile strength, and ultimate elongation. Test methods arepresented in Appendix X1 and Test Methods D412.4.3.1.1 As IsCondoms that are less than 12 months ol

24、dand have not been subjected to accelerated aging.4.3.1.2 Accelerated AgingHeat condoms to be aged intheir primary packages at 70 6 2C for 166 6 2hinaccordance with Test Method D573. Determine tensile prop-erties not less than 16 h or not more than 96 h after heating.Manufacturers may use process co

25、ntrol tests to determinesuitable shelf life, but accelerated aging at 70C for 166 h shallbe used for qualification tests and referee tests.4.4 Air Burst PropertiesCondoms shall conform to therequirements of 4.4.1 for pressure and 4.4.2 for volume.4.4.1 PressureWhen tested as described in Annex A2, t

26、hebursting pressure shall not be less than 1.0 kPa.4.4.2 VolumeWhen tested as described in Annex A2, thebursting volume shall not be less than that as calculated by thefollowing equation:Vmin5 0.00592w2! (1)where:Vmin= minimum burst volume in dm3, rounded to thenearest 1 dm3, andw = nominal flat wid

27、th in millimetres of the shank portionof the condom measured 70 6 5 mm from the openend.NOTE 4Cubic decimetre (dm3) is equivalent to litre (L).4.5 Leakage:4.5.1 CriteriaCondoms that burst during the test or showany evidence of leakage in the test area, including seepage,microdroplets, squirters, etc

28、., not including leakage at a dis-tance of 25 mm (1 in.) or less from the open end, will beconsidered failures.4.5.2 The “Hang-and-Squeeze” test method described inAnnex A3 is recommended; however, when the purchaserspecifies by the contract or purchase order, the “Hang-and-Roll” test method describ

29、ed in ISO 4074 may be used by themanufacturer in place of the method described in Annex A3.5. Packaging5.1 Unless otherwise specified, packaging shall be in accor-dance with the manufacturers commercial practice.5.2 Condom packages shall be tested in accordance withTest Method D3078 with the pressur

30、e reduced at least 50.8 kPa(15 in. of Hg) below atmospheric pressure. The inspectionTABLE 1 Quality Inspection RequirementsACharacteristic Inspection Level AQLCondomDimensions S-2 4.0Air burst properties I 1.5Leakage I 0.25PackagePackage integrity S-3 2.5AANSI MIL-STD 105E.TABLE 2 Dimensional Requir

31、ementsNominal Length(mm)A,BNominal FlatWidth (mm)C,DThickness(mm)Minimum 170 47 0.03Maximum 210 57 N/AAThe length of the condom shall be measured excluding the reservoir tip if any.BNo length measurement shall deviate from the nominal length stated by themanufacturer by more than 10 mm.CNo width mea

32、surement shall deviate from the nominal width stated by themanufacturer by more than 2 mm.DFor condoms having a shaped profile about the closed end, the width of theprofile, when laid flat, shall be not more than 75 mm.D3492 152requirements of Section 10.2 of Test Method D3078 are notrequired. Packa

33、ge integrity requirements are stated in Table 1.6. Labeling6.1 Each condom package (individual primary package andretail package) shall be marked legibly.6.1.1 Each condom package (individual primary packageand retail package) shall include the name or trademark of theproduct.6.1.2 Each condom packa

34、ge (individual and retail) shallinclude the statement, “Caution: This Product Contains NaturalRubber Latex Which May Cause Allergic Reactions.”6.2 The condom primary package (a.k.a. “wrapper” or“foil”) and the retail package shall display the expiration date,which shall be marked as such, for exampl

35、e, “Exp.”6.2.1 The expiration date, which shall be interpreted as thelast day of the month indicated, shall be displayed as the monthand year of expiry using either a numeric or alphabetic month,preceded or followed by the numeric year designation, forexample: 01/2010 or Jan 2010 or 2010/01 or 2010

36、Jan.6.2.2 The expiration date shall be determined as specified inAnnex A4.6.2.3 Each condom package shall also include the name andplace of business of manufacturer, packer, or distributor;statement of identity (“latex condom”); lot number and expi-ration date; and, if appropriate, country of origin

37、 (for example,“Made in _”).6.3 The retail package label shall include the intended uses,appropriate warning statements, and declaration of net quantityof contents.6.3.1 The retail package label may also contain informationregarding the description of the condom (for example, nominalwidth, length, te

38、xture, shape, etc.).6.3.2 Appropriate directions for use shall be included on theretail package or separately in a package insert.6.3.3 For packaged condoms intended for export from theUSA, each condom package (individual and retail) shall accordto the specifications of the foreign purchaser and not

39、 be inconflict with the laws of the country to which it is intended forexport.7. Storage7.1 During production, processing, and packaging, condomsshall not be allowed to come into contact with oil-basedantiseptics, phenols and their derivatives, petroleum-basedproducts, or other material harmful to r

40、ubber.7.2 In-process bulk unpackaged latex condoms should bestored in appropriate closed containers in dry areas at atemperature below 40C (104F). Storage for short periods oftime above this temperature will not be harmful to product.They should be kept away from direct sources of heat andultraviole

41、t light.8. Quality Assurance8.1 When specified in the contract or purchase order, thesupplier is responsible for the performance of all inspectionrequirements.9. Keywords9.1 condoms; contraceptives; prophylactic; rubberANNEXES(Mandatory Information)A1. DETERMINATION OF LENGTHA1.1 PurposeA1.1.1 Annex

42、 A1 specifies a method of determining thelength of rubber condoms.A1.2 PrincipleA1.2.1 Free hanging of the unrolled condom over a gradu-ated mandrel (Fig. A1.1) and observation of its length, the teatexcluded.A1.3 EquipmentA1.3.1 A mandrel with a scale divided into millimetres andhaving the dimensio

43、ns shown in Fig. A1.1.A1.4 ProcedureA1.4.1 Unroll the condom and smooth out the wrinklesresulting from the condom having been rolled up.A1.4.2 Put the condom over the mandrel and let it hangfreely, stretched only by its own mass.A1.4.3 Note, to the nearest millimetre, the length of thecondom as indi

44、cated on the scale outside the open end of thecondom.A1.5 Test ReportA1.5.1 Report the following information:A1.5.1.1 Identification of the sample,A1.5.1.2 Length noted in accordance with A1.4.3, andA1.5.1.3 Date of testing.D3492 153FIG. A1.1 Mandrel for Determining Length of CondomD3492 154A2. AIR

45、BURST TESTING OF CONDOMSA2.1 PrincipleA2.1.1 A constant length of condom is inflated with air, andthe volume and pressure at the moment of bursting is recorded.A2.2 EquipmentA2.2.1 Apparatus capable of inflating the condom withclean, oil-free air at a specified rate and provided withequipment for me

46、asuring volume inside the condom to anaccuracy of 5 % and pressure inside the condom to an accuracyof 2 %, respectively. It must be configured to measure thepressure within the condom and not at the air inlet linepressure, which may be different.A2.2.2 Suitable mount for clamping the condom to theap

47、paratus without damaging or stretching the condom. Themount shall be equipped with a rod of sufficient length toensure that the length of condom tested, excluding reservoir (ifany), is 150 6 3 mm. The rod shall terminate in a smoothsphere 25 mm in diameter for hanging the unrolled condomwhen fixed t

48、o the apparatus. Examples of suitable mounts areshown in Fig. A2.1 and Fig. A2.2. Additional informationNOTE 1Other designs for a mechanical clamp system are feasible. This drawing is intended only as an example of one of the possibilities. In anydesign of this type of system the important criteria

49、are:(1) Pressure tap configured such that there is no pressure drop between the condom and the pressure tap.(2) Length of condom that is free to expand is 150 6 3 mm.(3) Sphere at top of length limiter is 25.0 6 0.2 mm diameter.(4) Clamping ring does not pull condom down the cylinder as it is lowered.FIG. A2.1 Example of Condom Mount for Air Inflation TestingMechanical ClampD3492 155related to the validation of the air burst testing apparatus isprovided in Appendix X2.A2.3 ProcedureA2.3.1 Carry out the test under controlled conditions o