ASTM D6324-2011(2017) 9375 Standard Specification for Male Condoms Made from Polyurethane《聚氨酯制成男性避孕套的标准规格》.pdf
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1、Designation: D6324 11 (Reapproved 2017)Standard 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 revisi
2、on. A number in parentheses 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 specificatio
3、n also describes the 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 condo
4、ms of consistent quality. 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 fo
5、rinclusion in the 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 f
6、or anycondom design 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
7、 not purport to address 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.1.8 This international standard was d
8、eveloped in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced
9、Documents2.1 ASTM Standards:2D374 Test Methods for Thickness of Solid Electrical Insu-lation (Metric) D0374_D0374MD412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD618 Practice for Conditioning Plastics for TestingD638 Test Method for Tensile Properties of PlasticsD882 Tes
10、t Method for Tensile Properties of Thin PlasticSheetingD3078 Test 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 Pr
11、ocedures 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 10993 Biological Evaluation of Medical Device
12、s, Part23ISO 23409 Synthetic Condom Standard33. Significance and 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 thede
13、sign and the quality of condoms made of polyurethanematerial.1This specification is under the jurisdiction of Committee D11 on Rubber andRubber-like Materials and is the direct responsibility of Subcommittee D11.40 onConsumer Rubber Products.Current edition approved June 1, 2017. Published July 2017
14、. Originally approvedin 1999. Last previous edition approved in 2011 as D6324 11. DOI: 10.1520/D6324-11R17.2For 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 stand
15、ards Document Summary page onthe ASTM website.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis internati
16、onal standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committ
17、ee.13.2 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
18、male condom with a performance in-use test.3.4 Current products in international commerce at the timeof 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
19、performance user studies will need to beundertaken.4. Materials and Manufacture4.1 Condoms shall be manufactured 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
20、lubricants that contain a spermicide, such as Non-oxynol 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 conform to therequirements listed in Table 1.5.1.2 Sample H
21、andlingTo 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 during the testing procedure.5.1.3 Process ControlsManufacture
22、rs may use processcontrol tests to determine polyurethane condom properties.Finished 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 ti
23、me using the same process, rawmaterials, 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
24、 arerequired for each test method.5.2 LengthThis part of the standard specifies 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 EvaluationMeasure the lengthof the condom, to the nearest 1 mm,
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