ASTM D6324-2008 809 Standard Test Methods for Male Condoms Made from Polyurethane《聚氨酯造男用避孕套的标准试验方法》.pdf

1、Designation: D 6324 08Standard Test Methods forMale Condoms Made from Polyurethane1This standard is issued under the fixed designation D 6324; 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.1. Scope1.1 These test methods cover and shall be used to evaluatemale condoms made only of polyurethane. These test methodsalso describe the minimum inspecti

3、on and quality levels thatshall be utilized in referee tests. It is not intended to be aroutine quality control specification for polyurethane condommanufacturing operations.1.2 These test methods are intended to assist buyers inobtaining polyurethane condoms of consistent quality. The safeand prope

4、r use of polyurethane condoms is excluded from thescope of these test methods.1.3 The annexes in these test methods include importantinformation, such as that on apparatus or materials, that is amandatory part of these test methods but too detailed forinclusion in the main text.1.4 The appendixes in

5、 these test methods contain informa-tion intended to provide guidance.1.5 The values stated in SI units are to be regarded as thestandard. The values given in parentheses are for informationonly.1.6 This standard does not purport to address all of thesafety concerns, if any, associated with its use.

6、 It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D 374 Test Methods for Thickness of Solid Electrical Insu-lationD 618 Practic

7、e for Conditioning Plastics for TestingD 638 Test Method for Tensile Properties of PlasticsD 882 Test Method for Tensile Properties of Thin PlasticSheetingD 3078 Test Method for Determination of Leaks in FlexiblePackaging by Bubble EmissionD 3767 Practice for RubberMeasurement of Dimensions2.2 Other

8、 Documents:ANSI/ASQC Z1.42003 Sampling Procedures and Tablesfor Inspection by Attributes3ISO 37 Rubber, Vulcanized or ThermoplasticDetermination of Tensile Stress-Stain Properties Preclini-cal and Clinical Requirements for Approval to MarketNon-latex Condoms, World Health Organization, 19973ISO 1099

9、3 Biological Evaluation of Medical Devices, Part233. Significance and Use3.1 New polymer materials for male condoms are beingdeveloped. This standard is intended to describe the testmethods whose results shall adequately describe the design andthe quality of condoms made of polyurethane material.3.2

10、 These test methods are not intended to be designrestrictive. The condom design shall be validated prior to use.4. Materials and Manufacture4.1 Condoms shall be manufactured from polyurethanematerials.4.2 The biocompatibility of the finished product, includingany dressing materials, shall be assesse

11、d in accordance withISO 10993 or its equivalent.NOTE 1Condom lubricants that contain spermicides, such as Nonox-ynol 9, cause irritation in a small proportion of the user population.5. Requirements5.1 General:5.1.1 SamplingSamples will be selected randomly fromthe defined lot. The sampling plan must

12、 conform to therequirements listed in Table 1.5.1.2 Sample HandlingTo avoid inadvertent damage, op-erators must wear gloves, finger cots, or other suitable hand/finger covers and exercise reasonable caution in handling thepacket or polyurethane condom in order to minimize thepossibility of damage du

13、ring the testing procedure.1These test methods are under the jurisdiction of Committee D11 on Rubber andare the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition approved Nov. 1, 2008. Published November 2008. Originallyapproved in 1999. Last previous edition ap

14、proved in 2005 as D 6324 05.2For 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

15、 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.5.1.3 Process ControlsManufacturers may use processcontrol tests to determine polyurethane condom properties.Fi

16、nished polyurethane condoms shall be used for qualificationsand referee tests.5.1.4 LotA collection of condoms of the same design,color, shape, size, and formulation manufactured continuously,and at essentially the same time using the same process, rawmaterials, or the same specification, common equ

17、ipment, andpackaged with the same lubricant and any other additives ordressing in the same type of individual container. The maxi-mum lot size shall be 500 000 condoms.5.1.5 TrainingProperly trained and qualified operators arerequired for each test method.5.2 LengthThis part of the standard specifie

18、s a method formeasuring the length of a polyurethane condom. The inspec-tion level, AQL, and a minimum length are given in Table 1.5.2.1 Procedure for Length Evaluation:5.2.1.1 LengthMeasure the length of the condom, to thenearest 1 mm, using the test method described in Annex A1.5.3 WidthThis part

19、of the standard specifies a method formeasuring the width of a polyurethane condom. The inspectionlevel, AQL, and a width requirement are given in Table 1.5.3.1 Procedure for Width EvaluationMeasure, to thenearest 0.5 mm, the width of the condom laid flat at a distanceless than 30 mm from the open e

20、nd using the test methoddescribed in Annex A2.5.4 Leakage:5.4.1 CriteriaPolyurethane condoms that burst during thetest or show any evidence of leakage in the test area, includingseepage, microdroplets, squirters, and so forth, not includingleakage at a distance of 25 mm (1 in.) or less from the open

21、end, will be considered failures. The test method is described inAnnex A4 with the quality inspection level and AQL given inTable 1.5.4.2 Precision and BiasNo statement is made concerningthe precision or bias of determining leakage in condoms sincethe result states merely whether there is conformanc

22、e to thecriteria specified.5.5 Strength Requirements for Polyurethane Condoms:5.5.1 For the strength requirement to be determined andvalidated, the condom shall be type tested for its ultimateelongation to determine its minimum equivalent strengthparameters. The method for sample preparation for thi

23、s test isfound in Annex A2. The dumbbell specimen for this test shallinclude the weld of the condom in the test area, if any ispresent.5.5.2 Once the type test for the ultimate elongation for thepolyurethane condom has been determined, the condom will beclassified into either Type A, Type B, or Type

24、 C.5.5.2.1 Type AThis condom shall have an ultimate elon-gation of greater than 675 %.5.5.2.2 Type BThis condom shall have an ultimate elon-gation of no more than 675 % and no less than 500 %.5.5.2.3 Type CThis condom shall have an ultimate elon-gation of less than 500 %.NOTE 2Requirement is the min

25、imum level based on an “as-manufactured” basis.5.6 Packaging:5.6.1 Unless otherwise specified, packaging shall be inaccordance with the manufacturers commercial practice.5.6.2 Packaging shall be tested in accordance with TestMethod D 3078 with the pressure reduced to 50 kPa (380 mmHg or 15 in. Hg) b

26、elow atmospheric pressure. The inspectionlevel and AQL are given in Table 1.5.7 Design RequirementsWhile the rapid proliferation ofnew materials and development in polyurethane condomsmake standardization difficult, the design tests included in thisstandard shall be used as a guide in the developmen

27、t orassessment, or both, of polyurethane condoms. Rather thandescribe a list of requirements and tests that might be soonoutdated, Appendix X4 consists of what is required to validatethe design of polyurethane condoms.6. Test Methods6.1 DimensionsThicknessThis part of the standard speci-fies a test

28、method for measuring the thickness of a polyurethanecondom. There are no thickness requirements given in thisstandard.6.1.1 Procedures for Measuring the Thickness:6.1.1.1 ThicknessMeasure the thickness of condoms driedat room temperature for a minimum of 16 h after any lubricantdressing materials ha

29、ve been removed, if applicable. Measurethe wall thickness at the following three points: 30 6 5 mm, 906 5 mm, and 150 6 5 mm, all from the closed end of thecondom, excluding reservoir tip, using the method described inAppendix X1.6.1.1.2 Precision and bias for measuring the thickness of apolyurethan

30、e condom have not been determined.6.2 Air Burst PropertiesThis part of the standard specifiesa test method for determining the volume and pressure at breakfor polyurethane condoms. There are no volume or pressurerequirements for a polyurethane condom in this standard.6.2.1 Procedures for Air Burst P

31、roperties: Volume andPressureA test method is presented in Appendix X2.6.2.2 Precision and bias for the air burst testing of apolyurethane condom have not been determined.6.3 Tensile PropertiesThis part of the standard specifies amethod for determining the breaking force, tensile strength,and ultima

32、te elongation of polyurethane condoms. There are nobreaking force or elongation requirements for polyurethanecondoms in this standard.TABLE 1 Quality Inspection RequirementsACharacteristic InspectionLevelAQL SpecificationMinimumPolyurethane Condom:Length S-2 4.0 160 mmWidth S-2 4.0 62 mm nominalwidt

33、h permanufacturerLeakage GI 0.25 not applicableStrength (see Note 2) S2 Mean Type A15 MPaType B35 MPaType C50 MPaPackage:Package integrity S-3 2.5 not applicableAANSI/ASQC Z1.4 - 2003.D63240826.3.1 Procedure for Tensile Properties: Breaking Force,Tensile Strength, and Ultimate ElongationA test metho

34、d ispresented in Annex A2.6.3.2 Precision and bias for the tensile properties of poly-urethane materials have not been determined.6.4 Weld Strength PropertyThis part of the standardspecifies a test method for measuring the weld strength of apolyurethane condom. There is no weld strength requirementf

35、or polyurethane condoms given in this standard.6.4.1 Procedure for Measuring Weld StrengthA testmethod for determining the strength of a welded seam ispresented in Appendix X3.6.4.2 Precision and bias for the weld strength of polyure-thane condoms have not been determined.7. Labeling7.1 Condom Ident

36、ificationEach condom individual pack-age or retail package shall be marked legibly to include thename or trademark of the marketer, and the condom type asdefined in 5.5.2.7.2 The retail package and the individual package shallcontain a lot number and an expiration date, which shall bemarked as such.

37、7.3 Storage information and directions for use shall becontained in the labeling.8. Storage8.1 Condoms shall not be allowed to come into contact withmaterials that will degrade the condom.8.2 Condoms shall be protected from exposure to excessiveheat and light in storage.ANNEXES(Mandatory Information

38、)A1. DETERMINATION OF LENGTHA1.1 ScopeA1.1.1 This annex covers the method for determining thelength of polyurethane male condoms.A1.2 PrinciplesA1.2.1 LengthFree hanging of the unrolled condom overa graduated mandrel (Fig.A1.1) and measurement of its length,the reservoir excluded, if one exists.A1.3

39、 ApparatusA1.3.1 Mandrel, with a scale divided into millimetres andhaving the dimensions shown in Fig. A1.1 with the zerobeginning at the rounded end.A1.4 ProcedureA1.4.1 Move the condom inside the package such that it isaway from the area where the package is to be torn. Tear thepackage and remove

40、the condom. In no circumstances usescissors or other sharp instruments to open the package.A1.4.2 Unroll the condom and stretch is slightly twice butby no more than 20 mm to smooth out any wrinkles.NOTE A1.1Lubricants may be removed and suitable powders may beadded to avoid sticking.A1.4.3 LengthPut

41、 the condom over the mandrel and let ithang freely, stretched only by the force of gravity. Record, tothe nearest millimetre, the smallest value of the length of thecondom that can be read on the scale outside the open end ofthe condom.A1.5 ReportA1.5.1 Report the following information:A1.5.1.1 Iden

42、tification of the sample, for example, batchnumber,A1.5.1.2 The length measured in accordance with A1.4.3,andA1.5.1.3 The date of the test.A1.6 Condom DisposalA1.6.1 Condoms subjected to this test may also be used fordetermination of width and thickness but shall be destroyedafter testing.D6324083FI

43、G. A1.1 Mandrel for Determining Length of CondomD6324084A2. TEST METHOD FOR TENSILE PROPERTIES OF POLYURETHANE CONDOMS BY THE DUMBBELL METHODA2.1 ScopeA2.1.1 This appendix covers the test method for determin-ing the tensile properties of polyurethane condoms. Specimenelongation may be measured by ex

44、tension indicators or dis-placement of gauge marks.A2.2 Significance and UseA2.2.1 Tensile properties determined by this test method areof value for the identification and characterization of materialsfor control and specification purposes.A2.3 ApparatusA2.3.1 Tensile Tester, with a constant rate of

45、 grip separa-tion, and capable of measuring the applied load to an accuracyof within 62 %. The maximum force is to be recorded.A2.3.2 ASTM Die, D-412, Type “C”, DIN 53 504, S3A, orISO 37: 1994(E) Type 3.A2.3.3 Gripping System, that will exert uniform pressure tominimize slippage and prevent uneven s

46、tress.A2.3.4 Thickness Measuring Device, reading to 0.001 mmand in accordance with Test Methods D 374 or a method ofequivalent accuracy.A2.3.5 Stereo Microscope (recommended).A2.3.6 Conditioning ApparatusCondition the test speci-mens in their primary packages at 23 6 2C (73.4 6 3.6F)and 50 6 5 % rel

47、ative humidity for not less than 16 h prior totesting in accordance with Procedure A of Practice D 618.Conduct the tests in a standard laboratory atmosphere of 23 62C (73.4 6 3.6F) and 50 6 5 % relative humidity.A2.4 Speed of TestingA2.4.1 The crosshead speed shall be determined in accor-dance with

48、Test Method D 882.A2.4.2 The gauge length shall be 45 mm or 10 mm if Die 53505, S3A, or ISO 37: 1994(E) Type 3 is used.A2.5 ProcedureA2.5.1 Remove the closed end of the condom by making acut perpendicular to the length, followed by a lengthwise cut ofthe side. Open the condom into a flat sheet and l

49、ay it on asmooth, flat surface suitable for cutting thin films. Cut thespecimens with a single impact of the die. The cutting edges ofthe die shall be free of nicks. After cutting, the specimensshould be visually examined, preferably using a stereo micro-scope to look for flaws. Record the direction orientation of thespecimens. Report separately data from specimens cut atdifferent orientations.A2.5.2 If dressing materials are present, remove by care-fully wiping the sample with a clean dry cloth or tissue beforemeasuring the thickness.A2.5.