ASTM D6976-03 - 1.11.2003
 
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

U.S. Code of Federal Regulations, Title 21, Food and Drug Administration, Section 177.2600,

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

ISO 2859

Sampling Procedures and Tables for Inspection by Attributes

ISO 10993

Biological Evaluation of Medical Devices

D412-16(2021)

Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension

D573-04(2025)

Standard Test Method for Rubber—Deterioration in an Air Oven

D3767-03(2020)

Standard Practice for Rubber´Measurement of Dimensions