ASTM D6324 - 11(2017)

    Standard Specification for Male Condoms Made from Polyurethane

    Active Standard ASTM D6324 | Developed by Subcommittee: D11.40

    Book of Standards Volume: 09.02

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    Significance and Use

    A2.2 Significance and Use

    A2.2.1 Tensile properties determined by this test method are of value for the identification and characterization of materials for control and specification purposes.

    1. Scope

    1.1 This specification covers the minimum requirements for individually packaged male condoms made from polyurethane. This specification also describes the minimum inspection and quality levels that shall be utilized in referee tests. It is not intended to be a routine quality control specification for polyurethane condom manufacturing operations.

    1.2 This specification is intended to assist buyers in obtaining male polyurethane condoms of consistent quality. The safe and proper use of male polyurethane condoms is excluded from the scope of these test methods.

    1.3 The annexes in these test methods include important information, such as that on apparatus or materials, that are a mandatory part of these test methods but too detailed for inclusion in the main text.

    1.4 The appendixes in these test methods contain information intended to provide guidance.

    1.5 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.

    1.6 It shall be the responsibility of the manufacturer for any condom design that falls outside the specifications of this standard to determine testing methodology and substantiate the appropriateness of that methodology to assure the quality of the condoms to the purchaser and to the government regulatory authority having jurisdiction.

    1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

    1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    D374 Test Methods for Thickness of Solid Electrical Insulation (Metric) D0374_D0374M

    D412 Test Methods for Vulcanized Rubber and Thermoplastic ElastomersTension

    D618 Practice for Conditioning Plastics for Testing

    D638 Test Method for Tensile Properties of Plastics

    D882 Test Method for Tensile Properties of Thin Plastic Sheeting

    D3078 Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission

    D3492 Specification for Rubber Contraceptives (Male Condoms)

    D3767 Practice for Rubber--Measurement of Dimensions

    Other Documents

    ANSI/ASQC Z1.4–2003 Sampling Procedures and Tables for Inspection by Attributes Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036,

    ISO 10993 Biological Evaluation of Medical Devices, Part 2

    ISO 23409 Synthetic Condom Standard

    ICS Code

    ICS Number Code 83.140.99 (Other rubber and plastic products)

    UNSPSC Code

    UNSPSC Code 53131622(Condoms)

    Referencing This Standard
    Link Here
    Link to Active (This link will always route to the current Active version of the standard.)

    DOI: 10.1520/D6324-11R17

    Citation Format

    ASTM D6324-11(2017), Standard Specification for Male Condoms Made from Polyurethane, ASTM International, West Conshohocken, PA, 2017,

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