1、Designation: D6324 11Standard Specification forMale Condoms Made from Polyurethane1This standard is issued under the fixed designation D6324; 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 pa
2、rentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers the minimum requirements forindividually packaged male condoms made from polyurethane.This specification also describes t
3、he minimum inspection andquality levels that shall be utilized in referee tests. It is notintended to be a routine quality control specification forpolyurethane condom manufacturing operations.1.2 This specification is intended to assist buyers in obtain-ing male polyurethane condoms of consistent q
4、uality. The safeand proper use of male polyurethane condoms is excluded fromthe scope of these test methods.1.3 The annexes in these test methods include importantinformation, such as that on apparatus or materials, that are amandatory part of these test methods but too detailed forinclusion in the
5、main text.1.4 The appendixes 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 It shall be the responsibility of the manufacturer for anycondom desig
6、n that falls outside the specifications of thisstandard to determine testing methodology and substantiate theappropriateness of that methodology to assure the quality of thecondoms to the purchaser and to the government regulatoryauthority having jurisdiction.1.7 This standard does not purport to ad
7、dress all of thesafety concerns, if any, associated with 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:2D374 Test Me
8、thods for Thickness of Solid Electrical Insu-lationD412 Test Methods for Vulcanized Rubber and Thermo-plastic ElastomersTensionD618 Practice for Conditioning Plastics for TestingD638 Test Method for Tensile Properties of PlasticsD882 Test Method for Tensile Properties of Thin PlasticSheetingD3078 Te
9、st Method for Determination of Leaks in FlexiblePackaging by Bubble EmissionD3492 Specification for Rubber Contraceptives (Male Con-doms)D3767 Practice for RubberMeasurement of Dimensions2.2 Other Documents:ANSI/ASQC Z1.42003 Sampling Procedures and Tablesfor Inspection by Attributes3ISO 37 Rubber,
10、Vulcanized or ThermoplasticDetermination of Tensile Stress-Stain Properties Preclini-cal and Clinical Requirements for Approval to MarketNon-latex Condoms, World Health Organization, 19973ISO 10993 Biological Evaluation of Medical Devices, Part23ISO 23409 Synthetic Condom Standard33. Significance an
11、d Use3.1 New polymer materials for male condoms are beingdeveloped. Several products have been developed and arecurrently marketed in international commerce. This standard isintended to provide specifications to adequately describe thedesign and the quality of condoms made of polyurethanematerial.3.
12、2 This standard is not intended to be design restrictive.The condom design shall be validated prior to use.3.3 This standard will provide test methods to validate thematerial of construction for a polyurethane condom character-izing this material and then confirm the material as suitable fora male c
13、ondom with a performance in-use test.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, 2011. Published December 2011. Originallyapproved in 1999. Last previous
14、edition approved in 2008 as D6324 08. DOI:10.1520/D6324-11.2For 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.3A
15、vailable from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.4 Current products in international commerce at the timeof
16、 publication shall be considered in compliance with thisstandard. The use of a polyurethane condom material valida-tion for line extension will still need to be undertaken oralternately individual performance user studies will need to beundertaken.4. Materials and Manufacture4.1 Condoms shall be man
17、ufactured from polyurethanematerials.4.2 The biocompatibility of the finished product, includingany dressing materials, shall be assessed in accordance withISO 10993 or its equivalent.NOTE 1Condom lubricants that contain a spermicide, such as Non-oxynol 9, cause irritation in a small proportion of t
18、he user population.5. Requirements5.1 General:5.1.1 SamplingSamples will be selected randomly 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/fi
19、nger covers and exercise reasonable caution in handling thepacket or polyurethane condom in order to minimize thepossibility of damage during the testing procedure.5.1.3 Process ControlsManufacturers may use processcontrol tests to determine polyurethane condom properties.Finished polyurethane condo
20、ms 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 equipment, andpackaged with
21、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 specifies a method formeasuring t
22、he 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 EvaluationMeasure the lengthof the condom, to the nearest 1 mm, using the test methoddescribed in Annex A1.5.2.2 Precision and bias for measuring the length can befoun
23、d in Specification D3492.5.3 WidthThis part 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
24、at a distanceless than 30 mm from the open end using the test methoddescribed in Annex A4.5.3.2 Precision and bias for measuring the width can befound in Specification D3492.5.4 ThicknessMeasure the thickness of condoms afterbeing dried at room temperature for a minimum of 16 h. Anydressing material
25、s (lubricant) should be removed carefully withabsorbent paper.5.4.1 Procedure for Thickness EvaluationMeasure thewall thickness at three points, 30 6 5 mm, 90 6 5 mm, and 1506 5 mm from the closed end of the condom, excludingreservoir tip. The thickness measuring device shall conform tothat specifie
26、d in Practice D3767. Use the test method in AnnexA6. When a condom is textured, measure the thickness in thenontextured area. Report the measurements to the nearest 0.01mm.5.4.2 Precision and bias for measuring the thickness can befound in Specification D3492.5.5 Leakage:5.5.1 CriteriaPolyurethane c
27、ondoms that burst during thetest or show any evidence of leakage in the test area, includingseepage, micro-droplets, squirters, and so forth, not includingleakage at a distance of 25 mm (1 in.) or less from the openend, will be considered failures. The test method is described inAnnex A5 with the qu
28、ality inspection level and AQL given inTable 1.5.5.2 Precision and BiasNo statement is made concerningthe precision or bias of determining leakage in condoms sincethe result states merely whether there is conformance to thecriteria specified.5.6 Strength Requirements for Polyurethane Condoms:5.6.1 T
29、he strength of the condom can be determined usingeither ring or dumbbell test pieces. If the condom is manufac-tured with a welded seam, then it is required that the weld ofthe condom be in the test area.5.6.2 Procedure for Tensile Properties: Breaking Force,Tensile Strength, and Ultimate Elongation
30、Test methods arepresented in Annex A2 (dumbbell testing) and Annex A3 (ringtesting).5.6.3 Precision and bias for the tensile properties can befound in Test Methods D412.5.6.4 Weld Strength PropertyThis part of the standardspecifies a test method for measuring the weld strength of apolyurethane condo
31、m. There is no weld strength requirementfor polyurethane condoms given in this standard.TABLE 1 Quality Inspection RequirementsACharacteristicInspectionLevelAQLSpecificationMinimumPolyurethane Condom:Length S-2 4.0 160 mmWidth S-2 4.0 62 mm nominalwidth permanufacturerLeakage GI 0.25 not applicableA
32、ir Burst Properties GI 1.5 Defined by materialvalidation protocolStrengthBS2 Mean Type A15 MPaType B30 MPaType C50 MPaStrength (ring ordumbbell testing)S2 2.5 Defined by materialvalidation protocolPackage:Package integrity S-3 2.5 not applicableAANSI/ASQC Z1.4-2003.BRequirement is the minimum level
33、based on an “as-manufactured” basis withdumbbell testing only and without the completion of a material validation protocol.D6324 1125.6.5 Procedure for Measuring Weld StrengthA testmethod for determining the strength of a welded seam ispresented in Appendix X1.5.6.6 Precision and bias for the weld s
34、trength can be foundin Test Methods D412.5.6.7 To maintain this standard as a basis for currentlymarketed products after the type dumbbell test for the ultimateelongation for the synthetic condom has been determined, thecondom can be classified into either Type A, Type B, or TypeC.5.6.7.1 Type AThis
35、 condom shall have an ultimate elon-gation of greater than 675 %.5.6.7.2 Type BThis condom shall have an ultimate elon-gation of no more than 675 % and no less than 400 %.5.6.7.3 Type CThis condom shall have an ultimate elon-gation of less than 400 %.5.6.8 The tensile strength specifications in Tabl
36、e 1 for TypesA, B, and C can then be utilized without the need forcompletion of a material validation protocol but only for thatproductdefined by the specific shape, thickness and lubricantsystem. A slippage and breakage user study could be necessaryto achieve local regulatory approval.5.7 Packaging
37、:5.7.1 Unless otherwise specified, packaging shall be inaccordance with the manufacturers commercial practice.5.7.2 Packaging shall be tested in accordance with TestMethod D3078 with the pressure reduced to 50 kPa (380 mmHg or 15 in. Hg) below atmospheric pressure. The inspectionlevel and AQL are gi
38、ven in Table 1.5.8 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 development orassessment, or both, of polyurethane condoms. Rather than
39、describe a list of requirements and tests that might be soonoutdated, Annex A9 consists of what is required to validate thedesign of polyurethane condoms.5.9 Air Burst PropertiesThis part of the standard specifiesa test method for determining the volume and pressure at breakfor polyurethane condoms.
40、 The specifications for the airbursttesting of volume and pressure will be derived from thematerial validation exercise in Section 8 and Annex A9.5.9.1 Procedures for Air Burst Properties: Volume andPressureA test method is presented in Annex A7.5.9.2 Precision and bias for the air burst testing can
41、 be foundin Specification D3492.6. Labeling6.1 Each condom package (individual primary package andretail package) shall be legibly marked.6.1.1 The name or trademark of the product shall beincluded on each condom package (individual primary packageand retail package).6.2 The expiration date, which s
42、hall be marked as such, forexample, “Exp.,” shall be displayed on the condom primarypackage (a.k.a. “wrapper” or “foil”) and the retail package.6.2.1 The expiration date, which shall be interpreted as thelast day of the month indicated, shall be displayed as the monthand year of expiry using either
43、a numeric or alphabetic month,preceded or followed by the numeric year designation, forexample: 01/2010 or Jan 2010 or 2010/01 or 2010 Jan.6.2.2 The expiration date shall be determined as specified inAnnex A8.6.3 Each condom primary package and retail package shallalso include the name and place of
44、business of manufacturer,packer or distributor; statement of identity (“polyurethanecondom”); lot number and expiration date; the intended uses;appropriate warning statements; and declaration of net quantityof contents.6.4 The retail package label shall, if appropriate, indicatethe country of origin
45、 (for example, “Made in -”) and mayalso contain information regarding the description of thecondom (for example, nominal width, length, texture, shape,etc.).6.5 Appropriate directions for use shall be included on theretail package or separately in a package insert.6.6 For packaged condoms intended f
46、or export from theUSA, each condom package (individual and retail) shall accordto the specifications of the foreign purchaser and not be inconflict with the laws of the country to which it is intended forexport.7. Storage7.1 During production, processing, and packaging, condomsshall not be allowed t
47、o come into contact with materials thatwill degrade the condom.7.2 In-process bulk unpackaged condoms should be storedin appropriate closed containers in dry areas at a temperaturebelow 40C (104F). Storage for short periods of time abovethis temperature will not be harmful to product. They should be
48、kept away from direct sources of heat and ultraviolet light.8. Condom Material and Clinical Validation8.1 The manufacturing process used to make the condomlots will have completed a documented validation process.8.2 Full production lots will be sampled to complete thecondom material validation.8.3 A
49、 material characterization protocol shall be under-taken. Examples of useful testing techniques are outlined inAnnex A9, Note A9.1. Airburst testing and tensile strengthtesting shall be the minimum physical testing required.8.4 Once the validated process used for the manufacture ofthe condom has been determined to be in control, i.e. produc-ing condoms with stable and predictable physical properties,three production lots should be sampled using statistically validsample sizes to produce a baseline distribution of the airburstand tensile strengt
