ASTM D3492-2003 Standard Specification for Rubber Contraceptives (Male Condoms)《橡胶避孕套(男用避孕套)标准规范》.pdf

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1、Designation: D 3492 03Standard 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 (e) 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 forindividu

3、ally 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-in

4、g 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 manuf

5、ac-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 provi

6、de guidance only and are not a mandatory partof the specification.1.6 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:D 412 Test Methods for Vulcanized Rubber and Thermo-plastic Elastom

7、ersTension2D 573 Test Method for RubberDeterioration in an AirOven2D 1076 Specification for RubberConcentrated, AmmoniaPreserved, Creamed, and Centrifuged Natural Latex2D 3078 Test Method for Determination of Leaks in FlexiblePackaging by Bubble Emission3D 3767 Practice for RubberMeasurement of Dime

8、nsions2D 4483 Practice for Determining Precision for Test MethodStandards in the Rubber and Carbon Black Industries2E 691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test Method42.2 Other Document:ANSI/MIL-STD 105E Sampling Procedures and Tables forInspection by A

9、ttributes53. Materials and Manufacture3.1 Condoms shall be manufactured from natural rubberlatex conforming to Specification D 1076.3.2 The condoms and any dressing materials applied tothem shall not liberate substances that are known to be toxic,sensitizing, locally irritating, or otherwise harmful

10、 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.NOTE 2Condom lubricants that contain Nonoxynol 9 spermicide areknown to cause irritation in a small proportion of the

11、user population.4. Requirements 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 oth

12、er 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 properties. Finished con-doms shall be used fo

13、r qualification and referee tests.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 Aug. 10, 2003. Published Septemeber 2003. Originallyapproved in 1976. Last previou

14、s edition approved in 1997 as D 349297.2Annual Book of ASTM Standards, Vol 09.01.3Annual Book of ASTM Standards, Vol 15.09.4Annual Book of ASTM Standards, Vol 14.02.5Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.1Copyright ASTM Internationa

15、l, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.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 w

16、ith the same lubri-cant and any other additives or dressing in the same type ofindividual 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

17、 thenearest 1 mm, 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 h

18、ave been removed 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 PracticeD 3767, Test Method A with the pressure of the foot thicknessgage at 22 6 5 kPa. Wh

19、en a condom is textured, measure thethickness in the nontextured area. Report the 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. Theprecisio

20、n results in this precision and bias give an estimate ofthe precision for this test 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

21、 ofthis test method should apply the principles outlined in PracticeD 4483 to their 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

22、D 4483 involv-ing three male latex condom materials (A“thin”, Bregular,C“thicker”), 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 measureme

23、nttechnique as defined in Practice D 3767 was used.4.2.1.5 Concept of r and RIf Srand 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)Co

24、mparing 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 ofthat material.(b) Reproducibility (R)Comparing two test results for thesame material obta

25、ined 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 judgement in accordance with 4.2.1.4 and 4.2.1.5would have an approximate 95 % (0.95) probability of beingcorre

26、ct.There are no recognized standards by which to estimate biasof this test method.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 force, tensile streng

27、th, 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 D 412.4.3.1.1 As IsCondoms that are less than 12 months oldand have not bee

28、n 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 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 d

29、etermineTABLE 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 RequirementsMinimum Length, mm Maximum Width, mm Minimum Thickness, mm160 54 0.03T

30、ABLE 3 Open End ThicknessNOTE 1All 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).BSris the between-laboratory standard deviation of the aver

31、age (median/otherfunction).Cr is the within-laboratory repeatability limit = 2.8 Sr.DR is the between-laboratory reproducibility limit = 2.8 SR.TABLE 4 Closed End ThicknessNOTE 1All 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

32、3.5 24.3ASRis 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.D3492032

33、suitable shelf life, but accelerated aging at 70C for 166 h shallbe used for qualification 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 Properti

34、esCondoms 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, 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

35、 by thefollowing equation:Vmin5 0.00592w2! (1)where:Vmin= minimum burst volume in dm3, 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 a

36、nd Bias:4.4.3.1 Table 5 and Table 6 are based on an interlaboratorystudy conducted in 1992 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 tha

37、ttested them. Each test result was the average of 80 individualdeterminations. Each lab 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 inTa

38、ble 5 and Table 6 should not be rigorously applied to theacceptance or rejection of condom 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

39、 691 togenerate data specific to their laboratory and materials, orbetween specific laboratories. 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 fu

40、nction) from 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 the sameequipment on the same day. The two test results should bejudged not equivalent if they differ by more t

41、han the r value forthat material.(b) Reproducibility (R)Comparing two test results for 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 jud

42、gement in accordance with 4.4.3.1 and 4.4.3.2would have an approximate 95 % (0.95) probability 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 tes

43、t area, including seepage,microdroplets, squirters, etc., not including leakage at a dis-tance of 25 mm (1 in.) or less from the open end, will beconsidered failures. The test method is described in Annex A3.4.5.2 Precision and BiasNo statement is made concerningthe precision or bias of determining

44、leakage in condoms sincethe result states merely whether there is conformance to thecriteria specified.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 D 3078 wit

45、h the pressure reduced at least 50.8kPa (15 in. of Hg) below atmospheric pressure. The inspectionrequirements of Section 10.2 of Test Method D 3078 are notrequired. Package integrity requirements are stated in Table 1.6. Labeling6.1 Each condom package (individual or retail) shall bemarked legibly a

46、nd include the name or trademark of themanufacturer.6.2 The retail package shall contain either the uncoded dateof manufacture or expiration date, which shall be marked assuch.6.3 The retail package may also contain information regard-ing the description of the condom (for example, nominal width,len

47、gth, texture, shape, etc.).TABLE 5 Burst PressureNOTE 1All values in kPa units.Condom Lots Average SrASRBrCRDA 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 standar

48、d 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 VolumeNOTE 1All values in dm3unit

49、s.Condom Lots Average SrASRBrCRDA 37.3 4.6 5.4 13.0 15.3B 30.5 3.3 3.9 9.3 11.1C 38.4 5.2 6.0 14.7 16.9D 37.9 5.6 6.3 15.7 17.9E 28.4 4.8 5.1 13.7 14.5F 37.8 6.1 6.6 17.2 18.8ASris 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.D34920337. Storage7.1 Condoms shall not be allowed to come into contact withoil-base