A-A-51922 Diaphragm, Vaginal (Arcing)

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A-A-51922A

The diaphragm shall include a reusable rigid plastic carrying case.

Material. Diaphragm shall be fabricated from silicone or other suitable synthetic rubber.

Contraceptive jelly. Only type II diaphragms shall be supplied with a minimum of 26 grams of contraceptive jelly.

Instructions. Each diaphragm shall be provided with an instruction booklet detailing function of the diaphragm, when the diaphragm should be inserted and removed, techniques for correct insertion and removal with appropriate anatomy illustrations, and instructions for proper care of the diaphragm.

Tests and examinations. Diaphragms shall be tested and examined in accordance with all applicable inspections and sampling levels of ASTM Designation D3899.

In addition, rubber material shall be tested in accordance with the Muscle Implatation Test and Intracutaneous Tests of the United States Pharmacopeia (See certificate of biocompatibility). Diaphragm shall be non-toxic and non-pyrogenic in accordance with United States Pharmacopeia (USP) requirements.

Workmanship. The diaphragm shall be free from defects which detract from its appearance or impair its serviceability.

Unit. Each (EA). One diaphragm of the type and millimeter (mm) specified, constitutes one unit.

Quality Assurance Provisions.

Responsibility for inspection. Unless otherwise specified in the contract or purchase order, the contractor is responsible for the performance of all inspection requirements as specified herein. Except as otherwise specified in the contact or purchase order, the contractor may use his own or any facilities suitable for the performance of the inspection requirements specified herein, unless disapproved by the Government. The Government reserves the right to perform any of the inspections set forth in the specification where such inspections are deemed necessary to assure supplies and services conform to prescribed requirements.