ASTM D3492-2014 Standard Specification for Rubber Contraceptives &40 Male Condoms&41 《橡胶避孕套标准规格 (男用避孕套)》.pdf

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1、Designation: D3492 08D3492 14Standard 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 num

2、ber 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 f

3、or individually packaged male condoms made from natural rubberlatex and intended for single use. This specification does not cover the specifications for lubricants or other dressing materials thatmay be applied to condoms except as noted in 3.2.1.2 This specification is intended to assist buyers in

4、 obtaining 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 design guideline and a reference test specification. It is not intended to be aroutine quality control specification for co

5、ndom manufacturing operations.1.4 The annexes in this specification include important information, such as that on apparatus or materials, that is a mandatorypart of the specification but too detailed for inclusion in the main text.1.5 The appendixes in this specification contain information intende

6、d to provide guidance only and are not a mandatory partof the specification.1.6 It shall be the responsibility of the manufacturer for any condom design that falls outside the specifications of this standardto determine testing methodology and substantiate the appropriateness of that methodology to

7、assure the quality of the condomsto the purchaser and to the government regulatory authority 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 a

8、s the standard. The values given in parentheses are for information only.2. Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplastic ElastomersTensionD573 Test Method for RubberDeterioration in an Air OvenD1076 Specification for RubberConcentrated, Ammonia Pr

9、eserved, Creamed, and Centrifuged Natural LatexD3078 Test Method for Determination of Leaks in Flexible Packaging by Bubble EmissionD3767 Practice for RubberMeasurement of DimensionsD4483 Practice for Evaluating Precision for Test Method Standards in the Rubber and Carbon Black Manufacturing Industr

10、iesE691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method2.2 ISO Standard:3ISO 4074 Natural Latex Rubber Condoms Requirements and Test MethodsISO 10993 Biological Evaluations of Medical Devices2.3 Other Document:3ANSI/MIL-STD 105E Sampling Procedures and Ta

11、bles for Inspection by Attributes1 This specification is under the jurisdiction ofASTM Committee D11 on Rubber and is the direct responsibility of Subcommittee D11.40 on Consumer Rubber Products.Current edition approved June 15, 2008June 1, 2014. Published July 2008September 2014. Originally approve

12、d in 1976. Last previous edition approved in 20032008 asD3492 03.D3492 08. DOI: 10.1520/D3492-08.10.1520/D3492-14.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the

13、 standards Document Summary page on the ASTM website.3 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been

14、 made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.

15、Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13. Materials and Manufacture3.1 Condoms shall be manufactured from natural rubber latex conforming to Specification D1076.3.2 The condoms and any dressing materials applied to them shall

16、 not liberate substances that are known to be toxic, sensitizing,locally irritating, or otherwise harmful to the general population under normal conditions of use.NOTE 1Natural rubber latex products are known to cause irritation or sensitivity in a small proportion of the user population.NOTE 2Condo

17、m lubricants that contain Nonoxynol 9 spermicide are known to cause irritation in a small proportion of the user population.NOTE 3ISO 10993 contains methods to evaluate the biocompatibility of natural rubber latex condoms.4. Requirements4.1 General:4.1.1 SamplingSamples will be selected randomly fro

18、m the defined “lot.” The sampling plan must conform to therequirements listed in Table 1.4.1.2 Sample HandlingTo avoid inadvertent damage, operators must wear rubber gloves, finger cots, or other suitablehand/finger covers and exercise reasonable caution in handling the packet or condom in order to

19、minimize the possibility ofdamage during the testing procedure.4.1.3 Process ControlsManufacturers may use process control tests to determine condom properties. Finished condoms shallbe used for qualification and referee tests.4.1.4 LotA collection of condoms of the same design, color, shape, size,

20、and formulation manufactured continuously, usingthe same process, raw materials, or the same specification, common equipment, and packaged with the same lubricant and anyother additives or dressing in the same type of individual container. The maximum lot size shall be 500 000 condoms.4.2 Dimensions

21、Condoms shall meet the requirements listed in Table 2.4.2.1 Procedures for Dimensional Test:4.2.1.1 LengthMeasure the length of the condom to the nearest 1 mm, using the method described in Annex A1.4.2.1.2 WidthMeasure to the nearest 0.5 mm the width of the condom laid flat at a distance 30 6 5 mm

22、from the open end.4.2.1.3 ThicknessMeasure the thickness of condoms dried at room temperature for a minimum of 16 h after any dressingmaterials have been removed with water or isopropanol. Measure the wall thickness at three points, 30 6 5 mm, 90 6 5 mm, and150 6 5 mm from the closed end. The thickn

23、ess measuring device shall conform to that specified in Practice D3767, Test MethodAwith the pressure of the foot thickness gage at 22 6 5 kPa. When a condom is textured, measure the thickness in the nontexturedarea. Report the measurements to the nearest 0.01 mm.4.2.1.4 Precision and BiasThis preci

24、sion and bias has been prepared in accordance with Practice D4483. Refer to this practicefor terminology and other statistical details. The precision results in this precision and bias give an estimate of the precision forthis test method. The precision parameters should not be used for acceptance o

25、r rejection of the material, as this data is specificto this round robin and may not be representative of other lots, materials or laboratories. Users of this test method should applythe principles outlined in Practice D4483 to their laboratory and materials or between specific laboratories.The prin

26、ciples of 4.2.1.5would then be valid for such data. Tables 3 and 4 are based on an interlaboratory study conducted in 2001 in accordance withPractice D4483 involving three male latex condom materials (A“thin”, Bregular, C“thicker”), ten laboratories, two locationson the condom (open end150 mm from t

27、he shoulder, closed end30 mm from the shoulder) with two replicates per location takenon the same day. Therefore, p = 10, q = 3, and n = 2. The measurement technique as defined in Practice D3767 was used.4.2.1.5 Concept of r and RIf Sr and SR have been calculated from a large enough body of data for

28、 test results that wereaveraged (medians/other function) form testing X number of specimens, the following definitions are applicable:(a) Repeatability (r)Comparing two test methods for the same material obtained by the same operator using the sameequipment on the same day. The two test results shou

29、ld be judged not equivalent if they differ by more than the r value of thatmaterial.(b) Reproducibility (R)Comparing two test results for the same material obtained by different operators using differentequipment on different days. The two test results should be judged not equivalent if they differ

30、by more than the R value for thatmaterial.(c) Any judgment in accordance with 4.2.1.4 and 4.2.1.5 would have an approximate 95 % (0.95) probability of being correct.There are no recognized standards by which to estimate bias of this test method.TABLE 1 Quality Inspection RequirementsACharacteristic

31、Inspection Level AQLCondomDimensions S-2 4.0Air burst properties I 1.5Leakage I 0.25PackagePackage integrity S-3 2.5A ANSI MIL-STD 105E.D3492 1424.3 Tensile PropertiesThis part of the specification specifies a method for determining the breaking force, tensile strength, andultimate elongation of rub

32、ber contraceptives. There are no breaking force, tensile strength, or elongation requirements for condomsgiven in this specification.4.3.1 Procedures for Tensile Propertiesbreaking force, tensile strength, and ultimate elongation. Test methods are presentedin Appendix X1 and Test Methods D412.4.3.1.

33、1 As IsCondoms that are less than 12 months old and have not been subjected to accelerated aging.4.3.1.2 Accelerated AgingHeat condoms to be aged in their primary packages at 70 6 2C for 166 6 2 h in accordance withTest Method D573. Determine tensile properties not less than 16 h or not more than 96

34、 h after heating. Manufacturers may useprocess control tests to determine suitable shelf life, but accelerated aging at 70C for 166 h shall be used for qualification testsand referee tests.4.3.2 Precision and BiasThe precision and bias associated with the tensile strength and ultimate elongation of

35、male condomsare as specified in Test Methods D412.4.4 Air Burst PropertiesCondoms shall conform to the requirements of 4.4.1 for pressure and 4.4.2 for volume.4.4.1 PressureWhen tested as described in Annex A2, the bursting pressure shall not be less than 1.0 kPa.4.4.2 VolumeWhen tested as described

36、 in Annex A2, the bursting volume shall not be less than that as calculated by thefollowing equation:Vmin50.00592w 2! (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 the condom measured 70 6 5 mm from the ope

37、n end.NOTE 4Cubic 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 interlaboratory study conducted in 1992 in accordance with Practice E691 involvingsix condom lots tested by six laboratories. For each lot, all the samples were prepared

38、at one source but the individual specimenswere prepared at the laboratories that tested them. Each test result was the average of 80 individual determinations. Each labobtained two test results for each condom lot. (WarningThe explanations of r and R in 4.4.3.2 are only intended to present ameaningf

39、ul way of considering the approximate precision of this test method. The data in Table 5 and Table 6 should not berigorously applied to the acceptance or rejection of condom lot, as those data are specific to the round robin and may not berepresentative of other lots, conditions, materials, or labor

40、atories. Users of this test method should apply the principles outlinedin Practice E691 to generate data specific to their laboratory and materials, or between specific laboratories. The principles of4.4.3.2 would then be valid for such data.)4.4.3.2 Concept of r and RIf Sr and SR have been calculat

41、ed from a large enough body of data for test results that wereaverages (medians/other function) from testing X number of specimens, the following definitions are applicable:(a) Repeatability (r)Comparing two test methods for the same material obtained by the same operator using the sameequipment on

42、the same day. The two test results should be judged not equivalent if they differ by more than the r value for thatmaterial.(b) Reproducibility (R)Comparing two test results for the same material obtained by different operators using differentequipment on different days. The two test results should

43、be judged not equivalent if they differ by more than the R value for thatmaterial.(c) Any judgment in accordance with 4.4.3.1 and 4.4.3.2 would have an approximate 95 % (0.95) probability of being correct.4.4.3.3 There are no recognized standards by which to estimate bias of this test method.4.5 Lea

44、kage:4.5.1 CriteriaCondoms that burst during the test or show any evidence of leakage in the test area, including seepage,microdroplets, squirters, etc., not including leakage at a distance of 25 mm (1 in.) or less from the open end, will be consideredfailures.TABLE 2 Dimensional RequirementsNominal

45、 Length(mm)A,BNominal FlatWidth (mm)C,DThickness(mm)Minimum 170 47 0.03Maximum 210 57 N/AA The length of the condom shall be measured excluding the reservoir tip if any.B No length measurement shall deviate from the nominal length stated by themanufacturer by more than 10 mm.C No width measurement s

46、hall deviate from the nominal width stated by themanufacturer by more than 2 mm.D For condoms having a shaped profile about the closed end, the width of theprofile, when laid flat, shall be not more than 75 mm.D3492 1434.5.2 The “Hang-and-Squeeze” test method described in AnnexA3 is recommended; how

47、ever, when the purchaser specifies bythe contract or purchase order, the “Hang-and-Roll” test method described in ISO 4074 may be used by the manufacturer in placeof the method described in Annex A3.4.5.3 Precision and BiasNo statement is made concerning the precision or bias of determining leakage

48、in condoms since theresult states merely whether there is conformance to the criteria specified.5. Packaging5.1 Unless otherwise specified, packaging shall be in accordance with the manufacturers commercial practice.5.2 Condom packages shall be tested in accordance with Test Method D3078 with the pr

49、essure reduced at least 50.8 kPa (15in. of Hg) below atmospheric pressure. The inspection requirements of Section 10.2 of Test Method D3078 are not required.Package integrity requirements are stated in Table 1.6. Labeling6.1 Each condom package (individual primary package and retail package) shall be marked legibly.6.1.1 Each condom package (individual primary package and retail package) shall include the name or trademark of the product.6.1.2 Each condom package (individual and retail) shall include the statement, “Caution: This