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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.
Область применения1.1 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.