Active Standard ASTM D6976 | Developed by Subcommittee: D11.40
Book of Standards Volume: 09.02
Historical (view previous versions of standard)
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.
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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 RegulationsU.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
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 StandardsISO10993 Biological Evaluation of Medical Devices ISO2859 Sampling Procedures and Tables for Inspection by Attributes
ICS Number Code 11.200 (Birth control. Mechanical contraceptives)
UNSPSC Code 51000000(Drugs and Pharmaceutical Products)