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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.
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.
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ISO StandardsISO 10993 Biological Evaluation of Medical Devices
D412 Test Methods for Vulcanized Rubber and Thermoplastic ElastomersTension
D573 Test Method for RubberDeterioration in an Air Oven
D3767 Practice for Rubber--Measurement of Dimensions
Federal RegulationsU.S. Code of Federal Regulations, Title 21, Food a Rubber Articles Intended for Repeated Use Available from Standardization Documents Order Desk, DODSSP, Bldg. 4, Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098
ICS Number Code 11.200 (Birth control. Mechanical contraceptives)
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ASTM D6976-13(2018), Standard Specification for Rubber Contraceptives—Vaginal Diaphragms, ASTM International, West Conshohocken, PA, 2018, www.astm.orgBack to Top