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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.
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.
1.3 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.
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