DOD A-A-53535-1988 STAPLER SKIN SURGICAL (DISPOSABLE)《外科皮肤原材料(可任意使用的)》.pdf

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1、9999974 OL580L7 TTT W SIZE DIMENSIONS * “ Regular “ 5.7 mm Crown width “Wide“ 6.9 mm Crown width 3.9 mm Leg length 3.9 mm Leg length 7- s/- 91 A- A-5 3 5 3 5 27 June 1988 COMMERCIAL ITEM DESCRIPTION STAPLER, SKIN, SURGICAL (Disposable) The General Services Administration has approved the use of this

2、 commercial item description. This commercial item description covers four disposable skin staplers used to close surgical incisions. Salien? characteristics: General. Shall be disposable, hand-held, surgical skin staplers designed for “one-handed“ operation (See Note 1). Each stapler covered by thi

3、s document shall be pre-loaded with skin staples. The size and quantity of staples loaded in each stapler shall be as specified herein (See Note 3). Staples shall be supplied in two sizes: Regular and Wide. Dimensions of both skin staple sizes shall be as specified below. Table I. Dimensions of skin

4、 staples Performance. Each stapler covered by this document shall drive and clinch a skin staple into living tissue when the user follows the instructions provided with the stapler. (See “Instructions“). The force needed to fire a single staple into living tissue shall be 5.5 - + 2.5 pounds. AMSC N/

5、A FSC 6515 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. THIS DOCUMENT CONTAINS PAGES. Licensed by Information Handling Services1115 9999974 0358038 93b A-A-5 3 5 3 5 Materials. Staplers shall be fabricated from rigid plastic and corrosion-resisting steel. The mod

6、ulus of elasticity of “rigid“ plastic shall be no less than 100,000 psi when tested in accordance with ASTM Designation D638. Testing of “rigid“ plastic shall be conducted at 23 degrees C (73 degrees FI and 50% relative humidity. Corrosion resisting steel shall meet all requirements of ASTM Designat

7、ion F899. Skin staples shall be fabricated from corrosion-resisting steel wire that complies with ASTM Designation F55, Grade 1 or Grade 2. All materials shall be suitable for their intended purpose. Sterility. The stapler shall be sterile in accordance with the latest edition of the United States P

8、harmacopeia (USP). Instructions. Each package of skin staplers shall be supplied with a “Directions for Use“ manual. Workmanship. Each stapler covered by this document shall be free from defects that detract from its appearance or impair its serviceability. Unit, Package (PG). One package containing

9、 six individually packaged sterile skin staplers of one size only, with instructions for use, as specified, constitutes one unit. The individual package shall be a sealed, peel open type container capable of maintaining sterility of contents unless package is damaged or opened . Oualitv Assurance Pr

10、ovisions. 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 contract or purchase order, the contractor may use his own

11、 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

12、 services 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 the Governments request, at any time, or from time to time, during the performance of the contra

13、ct and for a period of three years after delivery of the supplies to which such records relate. 2 Licensed by Information Handling Services9999974 OL58OL 872 A-A-5 3 53 5 Inspection. Inspection, as used herein, is defined as both examination (such as visual or auditory investigation without the use

14、of special laboratory appliances or procedures) and testing (determination by technical means of physical and chemical properties) of the item. Tests. Tests shall be conducted to determine compliance with spemation requirements. used for the determination of two or more test characteristics. Where f

15、easible, the sanie sample shall be Samplinq for inspection. Sampling for inspection of the end item shall be conducted in accordance with MIL-STD-105 at Level S-2, AQL 0.65%. The unit of product for inspection purposes shall be one skin stapler . Contractor certification. The contractor shall certif

16、y that the product offered meets the salient characteristics of this description and conforms to the producers own drawings, specifications, standards, and quality assurance practices. The Government reserves the right to require proof of such conformance prior to first delivery and thereafter as ma

17、y be otherwise provided for under the provisions of the contract. Metric products. Products manufactured to metric dimensions will be considered on an equal basis with those manufactured using inch- pound units, providing they fall within the tolerances specified using conversion tables contained in

18、 the latest revision of Federal Standard No. 376, and all other requirements of this document are met. - If a product is manufactured to metric 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

19、 the product is acceptable. the product. Regulatory requirements. The Contracting officer has the option of accept-ing or rejecting Federal Food, Drug 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,

20、the oferor/contractor shall comply, and be ,responsible for compliance by its subcontractors/suppliers, with the requirements of the FederaJ. Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for comp

21、liance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations. 3 Licensed by Information Handling Services m 9999974 0158020 594 W I A-A-53535 - I- . -_ - - -_ 6515-01-071-5561 STAPLER, SKIN, SURGICAL, Disposable

22、, 35 Size 6.9 by 3.9 mm Staples, 6s. 6515-01-076-4647 STAPLER, SKIN, SURGICAL, - Disposable, with 30 to 35 Size 5.7 by 3.9 mm Staples, 6s. Disposable, 15 Size 6.9 by 3.9 mm Staples, 6s. Disposable, 15 Size 5.7 by 3.9 mm Staples, 6s. 6515-01-110-4797 STAPLER, SKIN, SURGICAL, 6515-01-162-1957 STAPLER,

23、 SKIN, SURGICAL, Recovered materials. The offeror/contractor is encouraged to use recovered material in accordance with Public Law 94-580 to the maximum extent practical. 4 Licensed by Information Handling ServicesA-A-53 53 5 NOTE 3: The staple charge for each item covered by this document is as fol

24、lows: 1 NSN - STAPLE CHARGE STAPLE SIZE 6515-01-071-5561 30-35 Staples 6515-01-076-4647 30-35 Staples 6515-01-110-4797 12-20 Staples 6515-01-162-1957 12-20 Staples Wide Size Regular Size Wide Size Regular Size Ordering data (Intermediate/exterior package quantities and labeling and marking must be s

25、pecified in the contract and/or order). MILITARY INTERESTS: Preparing Activity: Custodians: Army - MD Navy - MS Air Force - 03 CIVIL COORDINATING ACTIVITIES: VA-OSS PHS FDA-MPQAS DoD-MB Agent: DLA-DM PGC SF030 Project No. 6515-4084 5 Licensed by Information Handling ServicesLicensed by Information Handling Services