ASTM D3492-2008 Standard Specification for Rubber Contraceptives (Male Condoms)《橡胶避孕套(男用避孕套)标准规范》.pdf

1、Designation: D 3492 08Standard Specification forRubber Contraceptives (Male Condoms)1This standard is issued under the fixed designation D 3492; 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

2、 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 Department of Defense.1. Scope1.1 This specification covers the minimum requirements forindividua

3、lly 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

4、 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 manufa

5、c-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 provid

6、e 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 qu

7、ality of thecondoms to the purchaser and to the government regulatoryauthority having jurisdiction.1.7 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:2D 412 Test Methods for Vulcanized

8、 Rubber and Thermo-plastic ElastomersTensionD 573 Test Method for RubberDeterioration in an AirOvenD 1076 Specification for RubberConcentrated, AmmoniaPreserved, Creamed, and Centrifuged Natural LatexD 3078 Test Method for Determination of Leaks in FlexiblePackaging by Bubble EmissionD 3767 Practice

9、 for RubberMeasurement of DimensionsD 4483 Practice for Evaluating Precision for Test MethodStandards in the Rubber and Carbon Black ManufacturingIndustriesE 691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test Method2.2 ISO Standard:3ISO 4074 Natural Latex Rubber

10、 Condoms Requirementsand Test Methods2.3 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 D 1076.3.2 The condoms and any dressing materials ap

11、plied 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.NOTE 1Natural rubber latex products are known to cause irritation orsensitivity in a small proportion of the user popula

12、tion.NOTE 2Condom lubricants that contain Nonoxynol 9 spermicide areknown to cause irritation in a small proportion of the user population.4. Requirements4.1 General:4.1.1 SamplingSamples will be selected randomly fromthe defined “lot.” The sampling plan must conform to therequirements listed in Tab

13、le 1.4.1.2 Sample HandlingTo avoid inadvertent damage, op-erators must wear rubber gloves, finger cots, or other suitable1This specification is under the jurisdiction ofASTM Committee D11 on Rubberand is the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition appr

14、oved June 15, 2008. Published July 2008. Originallyapproved in 1976. Last previous edition approved in 2003 as D 3492 03.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refe

15、r 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 10036.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.hand/finger covers

16、 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 properties. Finished con-doms shall be used for qualification and referee t

17、ests.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 same specifica-tion, common equipment, and packaged with the same lubri-cant and any other additives or dressing in the same type ofind

18、ividual 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, using the method described in Annex A1.4.2.1.2 WidthMeasure to t

19、he 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 with water or isopropanol.Measure the wall thickness at three poi

20、nts, 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 PracticeD 3767, Test Method A with the pressure of the foot thicknessgage at 22 6 5 kPa. When a condom is textured, measure thethickness in the nontextured area. Report the

21、measurements tothe nearest 0.01 mm.4.2.1.4 Precision and BiasThis precision and bias hasbeen prepared in accordance with Practice D 4483. Refer tothis practice for terminology and other statistical details. Theprecision results in this precision and bias give an estimate ofthe precision for this tes

22、t method. The precision parametersshould not be used for acceptance or rejection of the material,as this data is specific to this round robin and may not berepresentative of other lots, materials or laboratories. Users ofthis test method should apply the principles outlined in PracticeD 4483 to thei

23、r laboratory and materials or between specificlaboratories. The principles of 4.2.1.5 would then be valid forsuch data. Tables 3 and 4 are based on an interlaboratory studyconducted in 2001 in accordance with Practice D 4483 involv-ing three male latex condom materials (A“thin”, Bregular,C“thicker”)

24、, ten laboratories, two locations on the condom(open end150 mm from the shoulder, closed end30 mm fromthe shoulder) with two replicates per location taken on thesame day. Therefore, p = 10, q =3,andn = 2. The measurementtechnique as defined in Practice D 3767 was used.4.2.1.5 Concept of r and RIf Sr

25、and SRhave beencalculated from a large enough body of data for test results thatwere averaged (medians/other function) form testing X numberof specimens, the following definitions are applicable:(a) Repeatability (r)Comparing two test methods for thesame material obtained by the same operator using

26、the sameequipment on the same day. The two test results should bejudged not equivalent if they differ by more than the r value ofthat material.(b) Reproducibility (R)Comparing two test results for thesame material obtained by different operators using differentequipment on different days. The two te

27、st results should bejudged not equivalent if they differ by more than the R valuefor that material.(c) Any judgment in accordance with 4.2.1.4 and 4.2.1.5would have an approximate 95 % (0.95) probability of beingcorrect.There are no recognized standards by which to estimate biasof this test method.4

28、.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 force, tensile strength, or elongationrequirements for condoms given in this specification.4.3.1 Procedu

29、res for Tensile Propertiesbreaking force,tensile strength, and ultimate elongation. Test methods arepresented in Appendix X1 and Test Methods D 412.4.3.1.1 As IsCondoms that are less than 12 months oldand have not been subjected to accelerated aging.4.3.1.2 Accelerated AgingHeat condoms to be aged i

30、ntheir primary packages at 70 6 2C for 166 6 2hinaccordance with Test Method D 573. Determine tensile prop-erties not less than 16 h or not more than 96 h after heating.Manufacturers may use process control tests to determineTABLE 1 Quality Inspection RequirementsACharacteristic Inspection Level AQL

31、CondomDimensions S-2 4.0Air burst properties I 1.5Leakage I 0.25PackagePackage integrity S-3 2.5AANSI/MIL-STD 105E.TABLE 2 Dimensional RequirementsNominal 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

32、 reservoir tip if any.BNo length measurement shall deviate from the nominal length stated by themanufacturer by more than 610 mm.CNo width measurement shall deviate from the nominal width stated by themanufacturer by more than 62 mm.DFor condoms having a shaped profile about the closed end, the widt

33、h of theprofile, when laid flat, shall be not more than 75 mm.TABLE 3 Open End ThicknessNOTEAll values in microns (0.001 mm).Material Average SrASRBrCRDA 61.8 0.8 5.3 2.3 14.8B 62.2 0.8 4.6 2.3 12.8C 80.8 1.0 7.0 2.7 19.6ASRis within-laboratory standard deviation of the average (median/otherfunction

34、).BSris the between-laboratory standard deviation of the average (median/otherfunction).Cr is the within-laboratory repeatability limit = 2.8 Sr.DR is the between-laboratory reproducibility limit = 2.8 SR.D3492082suitable shelf life, but accelerated aging at 70C for 166 h shallbe used for qualificat

35、ion tests and referee tests.4.3.2 Precision and BiasThe precision and bias associ-ated with the tensile strength and ultimate elongation of malecondoms are as specified in Test Methods D 412.4.4 Air Burst PropertiesCondoms shall conform to therequirements of 4.4.1 for pressure and 4.4.2 for volume.4

36、.4.1 PressureWhen tested as described in Annex A2, thebursting 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,

37、rounded to the nearest 1 dm3,andw = nominal flat width in millimetres of the shank portion of thecondom measured 70 6 5 mm from the open end.NOTE 3Cubic decimetre (dm3) is equivalent to litre (L).4.4.3 Precision and Bias:4.4.3.1 Table 5 and Table 6 are based on an interlaboratorystudy conducted in 1

38、992 in accordance with Practice E 691involving six condom lots tested by six laboratories. For eachlot, all the samples were prepared at one source but theindividual specimens were prepared at the laboratories thattested them. Each test result was the average of 80 individualdeterminations. Each lab

39、 obtained two test results for eachcondom lot. (WarningThe explanations of r and R in 4.4.3.2are only intended to present a meaningful way of consideringthe approximate precision of this test method. The data inTable 5 and Table 6 should not be rigorously applied to theacceptance or rejection of con

40、dom lot, as those data are specificto the round robin and may not be representative of other lots,conditions, materials, or laboratories. Users of this test methodshould apply the principles outlined in Practice E 691 togenerate data specific to their laboratory and materials, orbetween specific lab

41、oratories. The principles of 4.4.3.2 wouldthen be valid for such data.)4.4.3.2 Concept of r and RIf Srand SRhave beencalculated from a large enough body of data for test results thatwere averages (medians/other function) from testing X numberof specimens, the following definitions are applicable:(a)

42、 Repeatability (r)Comparing two test methods for thesame material obtained by the same operator using the sameequipment on the same day. The two test results should bejudged not equivalent if they differ by more than the r value forthat material.(b) Reproducibility (R)Comparing two test results for

43、thesame material obtained by different operators using differentequipment on different days. The two test results should bejudged not equivalent if they differ by more than the R valuefor that material.(c) Any judgment in accordance with 4.4.3.1 and 4.4.3.2would have an approximate 95 % (0.95) proba

44、bility of beingcorrect.4.4.3.3 There are no recognized standards by which toestimate bias of this test method.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., not including leakage at a dis

45、-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 described in ISO 4074 may be used by the

46、manufacturer in place of the method described in Annex A3.4.5.3 Precision and BiasNo statement is made concerningthe precision or bias of determining leakage in condoms sincethe result states merely whether there is conformance to thecriteria specified.5. Packaging5.1 Unless otherwise specified, pac

47、kaging shall be in accor-dance with the manufacturers commercial practice.TABLE 4 Closed End ThicknessNOTEAll values in microns (0.001 mm).Material Average SrASRBrCRDA 77.2 0.4 3.9 1.1 11.0B 82.2 0.7 6.0 2.1 16.7C 114.4 1.3 8.7 3.5 24.3ASRis within-laboratory standard deviation of the average (media

48、n/otherfunction).BSris the between-laboratory standard deviation of the average (median/otherfunction).Cr is the within-laboratory repeatability limit = 2.8 Sr.DR is the between-laboratory reproducibility limit = 2.8 SR.TABLE 5 Burst PressureNOTEAll values in kPa units.Condom Lots Average SrASRBrCRD

49、A 1.86 0.19 0.20 0.53 0.56B 1.87 0.24 0.25 0.63 0.72C 1.76 0.18 0.19 0.50 0.53D 1.75 0.20 0.21 0.56 0.60E 1.84 0.26 0.26 0.73 0.75F 1.71 0.19 0.20 0.53 0.56ASris the within-laboratory standard deviation of the average (median/otherfunction).BSRis the between-laboratory standard deviation of the average (median/otherfunction).Cr is the within-laboratory repeatability limit = 2.8 Sr.DR is the between-laboratory reproducibility limit = 2.8 SR.TABLE 6 Burst VolumeNOTEAll values in dm3units.Condom Lots Average SrASRBrCRDA 37.3 4.6 5.4 13.0 1