ASTM D6976 - 13

    Standard Specification for Rubber Contraceptives—Vaginal Diaphragms

    Active Standard ASTM D6976 | Developed by Subcommittee: D11.40

    Book of Standards Volume: 09.02


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    Abstract

    This specification covers contraceptive vaginal diaphragms but does not cover other vaginal barrier devices such as cervical caps, vaginal sponges, and female condoms. The products are classified into three types according to structure and should be manufactured from elastomeric polymer dome with a metal reinforced peripheral rim or a rim made of other suitable materials. The diaphragms should pass rim and spring compression tests, tensile tests, and elongation at break tests.

    This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

    Significance and Use

    1. Scope

    1.1 This specification covers requirements for contraceptive vaginal diaphragms, hereafter called diaphragms.

    1.2 Vaginal barrier devices known as cervical caps, vaginal sponges and female condoms are not included in this specification.


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

    Federal Regulations

    U.S.CodeofFederalReg Rubber Articles Intended for Repeated Use Available from Standardization Documents Order Desk, DODSSP, Bldg. 4, Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098

    ASTM Standards

    D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers--Tension

    D573 Test Method for Rubber--Deterioration in an Air Oven

    D3767 Practice for Rubber--Measurement of Dimensions

    ISO Standards

    ISO10993 Biological Evaluation of Medical Devices

    ISO2859 Sampling Procedures and Tables for Inspection by Attributes


    ICS Code

    ICS Number Code 11.200 (Birth control. Mechanical contraceptives)

    UNSPSC Code

    UNSPSC Code 51000000(Drugs and Pharmaceutical Products)


    DOI: 10.1520/D6976-13

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