DOD A-A-54403-1991 INTRAUTERINE DEVICE CONTRACEPTIVE《子宫内避孕器》.pdf

1、A-A-54 4 03 22 May 1991 COMMERCIAL ITEM DESCRIPTION INTRAUTERINE DEVICE, CONTRACEPTIVE The General Administration has authorized the use of this commercial item description. This commercial item description covers an intrauterine device suitable of use in intrauterine contraception. Salient characte

2、ristics: General. The system shall be a sterile, T-shaped, copper and polyethylene intrauterine device with an inserter and plunger. Materials. The T-shaped body shall be fabricated of Alathon 20 polyethylene. Copper wire shall be Grade 1 copper wire. Copper collars shall be Grade 1 copper 99.99% pu

3、re. The polyethylene IITIl shall contain 22% barium sulfate added to render it radiopaque. Strings shall be fabricated of polyethylene containing up to 1% titanium dioxide for visibility. Style and desisn. The system shall be a T-shaped polyethylene body with approximately 176 mg of copper wire woun

4、d around the vertical portion of the l1Tl1. Copper collars each weighing 66.5 mg shall be provided on each arm of the horizontal sections of the IlTIl. The bottom of the T shall be bulb shaped with a monofilament polythylene thread tied through the bulb. The thread shall allow protrusion through the

5、 os for conformation checks that the intrauterine device is insitu. An insertion tube and plunger shall be furnished with each device. The insertion tube shall be equipped with a moveable flange to aid in gauging the depth to which the insertion tube is inserted through the cervical canal and uterin

6、e cavity. The inserter shall be 8-1/8 distribution is unlimited. . Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- - - A-A-54403 b5 9999974 00bL51b 4 - A-A-54 4 O 3 Plunger shall be 7.5 f 0.1 inches long from handle brace to tip with a body diameter

7、 of 0.10 inches and a distal end diameter of 0.11 inches. Plunger shall have a finger ring on the proximal end for use in manipulating the plunger. The IUD shall be 1.245 to 1.270 inches wide by 1.405 to 1.425 inches high with at least 4-1/2 inches of polyethylene string attached to the bulb. The pl

8、astic body shall be 0.064 inches in diameter. The copper bands shall be 0.198 inches wide each located 7/32 inches from the vertical portion of the Instructions. Instructions for use shall be provided with each IUD which shall also contain a minimum of one patient information brochure and one patien

9、t wallet card. Shall also contain additional pertinent information on the item for physicians use. BiocomDatibility. The IUD shall meet the requirements of the USP for Class II plastics. Sterility. The set components and inside surfaces of the containing envelope shall be sterile and have a minimum

10、quality assurance level of 0.000001 in accordance with AAMI guidelines. Shelf life. A minimum of 40 months shelf life shall remain on shipment of the IUD to the Government. WorkmanshiD. The IUD shall be free from defects which detract from its appearance or impair its serviceability. Shall be free f

11、rom pits, cracks, distortion, corrosion, burrs, sharp edges or foreign material. Unit. Package (PG). One package containing five individually packaged sterile intrauterine devices, with instruction for use, as specified, constitutes one unit. Each device shall be packaged in a peel back container fo

12、r aseptic removal. The individual package shall be a sealed peel-open container capable of maintaining sterility of contents unless the package is damaged or opened. 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54 4 O 3 QUALITY ASSURANCE PRO

13、VISIONS. - Remonsibilitv for inspec-ion. Unless otherwise specified in the contract or purchase order, the contractor is responsible for the performance of all inspection requirements as specified herein. Except otherwise specified in the contract or purchase order, the contractor may use his own or

14、 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 se

15、rvices conform to prescribed requirements. Records. Records of examinations and tests performed by or for the contractor shall be maintained by the contractor and made available to the Government upon request, at any time, or from time to time, during the performance of the contract and for a period

16、 of three years after delivery of the supplies to which such records relate. Inspection. Inspection, as used herein, is defined as both examination (such as visual or auditory investigation without the use of special laboratory appliances or procedures) and testing (determination by technical means

17、and chemical properties) of the item. SamPlins for examination. Sampling for examination shall be conducted in accordance with MIL-STD-205, and as specified herein. Unit of product for examination purposes shall be one intrauterine device. Sampling shall be Inspection level II with an acceptable qua

18、lity level (AQL) of 1.0. Examination. Examination shall be conducted to determine compliance with specification requirements. in accordance with MIL-STD-105 and as specified herein. product for test purposes shall be one intrauterine device. Sampling shall be inspection level S-2 with an AQL of 1.0.

19、 Camplins for tests. Sampling for tests shall be conducted Unit of Tests. Tests shall be conducted to determine compliance with specification requirements. Where feasible, the same sample shall be used for the determination of two or more test characteristics. 3 Provided by IHSNot for ResaleNo repro

20、duction or networking permitted without license from IHS-,-,- _. _- A-A-54403 b5 9999974 0061518 A-A-54 4 O 3 Contractor certification. The contractor shall certify that the product offered meets the salient characteristics of this description and conforms to the producersown drawings, specification

21、s, standards, and quality assurance practices. The Government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract. Products manufactured to metric dimensions will be considered on an equa

22、l basis with those manufactured using inch-pound units, providing they fall within the tolerances specified using conversion tables contained in the latest revision of Federal Standard No. 376, and all other requirements of this document are met. Metric products. If a product is manufactured to metr

23、ic dimensions and those dimensions exceed the tolerances specified in the inch/pound units, a request should be made to the contracting officer to determine if the products is acceptable. The contracting officer has the option of accepting or rejecting the product. Requlatory reauirements. Federal F

24、ood, Druq, and Cosmetic Act. If the product covered by this document has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of the Federal

25、 Food, Drug Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal State, and local statutes, ordinances, and regulati

26、ons. Recovered materials. The offeror/contractor is encouraged to use recovered material in accordance with Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54403 b5 m

27、9999974 00bL5I19 T m A-A-5 4 4 O 3 Preservation, packasins, acking, labelins, and markina. unless otherwise specified, preservation, packaging, and packing shall be to a degree of protection to preclude damage to containers and/or contents thereof under normal shipping conditions, handling, etc:, in

28、volving shipment from the supply source to the receiving activity, plus reshipment from receiving activity, and shall conform to applicable carriers rules and regulations. Intermediate and exterior package quantities and labeling and marking shall be as specified in the contract and /or order. NOTE:

29、 The following National Stock Number is covered by this document : “ ITEM IDENTIFICATION 6515-01-283-5192 INTRAUTERINE DEVICE, CONTRACEPTIVE, Sterile, T-shaped, copper and Plastic Ordering data (Intermediate/exterior package quantities and labeling and marking must be specified in the contract and/or order). MILITARY INTERESTS: Custodians: Army - MD Navy - MS Air Force - 03 CIVIL AGENCY COORDINATING ACTIVITIES: Preparing Activity: DoD-MB Agent: DLA-DM VA-OSS PHS FDA-MPQAS Project No. 6515-5015 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-