ASTM D6324-2005 Standard Test Methods for Male Condoms Made from Synthetic Materials《合成材料制男性避孕套的标准试验方法》.pdf

1、Designation: D 6324 05Standard Test Methods forMale Condoms Made from Synthetic Materials1This 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 numb

2、er in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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 of various synthetic materials. These testmethods also describe th

3、e minimum inspection and qualitylevels that shall be utilized in referee tests. It is not intended tobe a routine quality control specification for synthetic condommanufacturing operations.1.2 These test methods are intended to assist buyers inobtaining synthetic condoms of consistent quality. The s

4、afe andproper use of synthetic condoms is excluded from the scope ofthese 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 appe

5、ndixes in 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

6、 its use. 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 61

7、8 Practice 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 Dimensions

8、2.2 Other 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, 1997

9、3ISO 10993 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 the condoms.3.2 These test metho

10、ds are not intended to be design ormaterial restrictive. The design requirements for each materialare unique to that material and shall be validated prior to use.4. Materials and Manufacture4.1 Condoms shall be manufactured from synthetic materi-als.4.2 The biocompatibility of the finished product,

11、includingany dressing materials, shall be assessed 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 ran

12、domly fromthe defined lot. The sampling plan must 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 the1These test methods are under

13、 the jurisdiction of Committee D11 on Rubber andare the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition approved Dec. 15, 2005. Published January 2006. Originallyapproved in 1999. Last previous edition approved in 2004 as D 6324 99a (2004).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

15、Floor, New York, NY 10036.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.packet or synthetic condom in order to minimize the possibilityof damage during the testing procedure.5.1.3 Process ControlsManufacturers may use processcontro

16、l tests to determine synthetic condom properties. Fin-ished synthetic condoms shall be used for qualifications andreferee 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, r

17、awmaterials, or the same specification, common equipment, 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 m

18、ethod.5.2 LengthThis part of the standard specifies a method formeasuring the length of a synthetic condom. The inspectionlevel, 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 met

19、hod described in Annex A1.5.3 WidthThis part of the standard specifies a method formeasuring the width of a synthetic 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

20、 a distanceless than 30 mm from the open end using the test methoddescribed in Annex A2.5.4 Leakage:5.4.1 CriteriaSynthetic condoms that burst during the testor show any evidence of leakage in the test area, includingseepage, microdroplets, squirters, and so forth, not includingleakage at a distance

21、 of 25 mm (1 in.) or less from the openend, 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 st

22、ates merely whether there is conformance to thecriteria specified.5.5 Strength Requirements for Synthetic 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 m

23、ethod for sample preparation for this 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 thesynthetic condom has been determined, the condom will beclassified in

24、to either Type A, Type B, or Type 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 5

25、00 %.NOTE 2Requirement is the minimum 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

26、 50 kPa (380 mmHg or 15 in. Hg) below atmospheric pressure. The inspectionlevel and AQL are given in Table 1.5.7 Design RequirementsWhile the rapid proliferation ofnew materials and development in synthetic condoms makestandardization difficult, the design tests included in thisstandard shall be use

27、d as a guide in the development orassessment, or both, of synthetic condoms. Rather than de-scribe a list of requirements and tests that might be soonoutdated, Appendix X4 consists of what is required to validatethe design of synthetic condoms.6. Test Methods6.1 DimensionsThicknessThis part of the s

28、tandard speci-fies a test method for measuring the thickness of a syntheticcondom. 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 lubrica

29、ntdressing materials have 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 thesynthetic condom, excluding reservoir tip, using the methoddescribed in Appendix X1.6.1.1.2 Precision and bias for measur

30、ing the thickness of asynthetic 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 synthetic condoms. There are no volume or pressurerequirements for a synthetic condom in this standard.6.2.1 Pr

31、ocedures for Air Burst Properties: Volume andPressureA test method is presented in Appendix X2.6.2.2 Precision and bias for the air burst testing of asynthetic condom have not been determined.6.3 Tensile PropertiesThis part of the standard specifies amethod for determining the breaking force, tensil

32、e strength,and ultimate elongation of synthetic condoms. There are noTABLE 1 Quality Inspection RequirementsACharacteristic InspectionLevelAQL SpecificationMinimumSynthetic Condom:Length S-2 4.0 160 mmWidth S-2 4.0 62 mm nominalwidth permanufacturerLeakage GI 0.25 not applicableStrength (see Note 2)

33、 S2 Mean Type A15 MPaType B35 MPaType C50 MPaPackage:Package integrity S-3 2.5 not applicableAANSI/ASQC Z1.4 - 2003.D6324052breaking force or elongation requirements for synthetic con-doms in this standard.6.3.1 Procedure for Tensile Properties: Breaking Force,Tensile Strength, and Ultimate Elongati

34、onA test method ispresented in Annex A2.6.3.2 Precision and bias for the tensile properties of syn-thetic materials have not been determined.6.4 Weld Strength PropertyThis part of the standardspecifies a test method for measuring the weld strength of asynthetic condom. There is no weld strength requ

35、irement forsynthetic 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 syntheticcondoms 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 synthetic 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 Ap

39、paratusA1.3.1 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 the

40、 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 th

41、e 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 Identif

42、ication 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.D6324053FIG.

43、A1.1 Mandrel for Determining Length of CondomD6324054A2. TEST METHOD FOR TENSILE PROPERTIES OF SYNTHETIC CONDOMS BY THE DUMBBELL METHODA2.1 ScopeA2.1.1 This appendix covers the test method for determin-ing the tensile properties of synthetic condoms. Specimenelongation may be measured by extension i

44、ndicators 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 grip sep

45、ara-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 stress.A2.

46、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 % relative hum

47、idity 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 Test Meth

48、od 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 lay it on

49、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.A2.5.3 Measure