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
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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
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