DOD A-A-53483-1988 STAPLER SURGICAL (GASTRO-INTESTINAL)《外科原材料(胃与肠的)》.pdf

1、A-A-53483 65 7777774 0030873 5 p-3)- 91 A-A-53 48 3 8 May 1988 COMMERCIAL ITEM DESCRIPTION STAPLER, SURGICAL (Gastro-intestinal) The General Services Administration has authorized the use of this commercial item description. This commercial item description covers a gastro-intestinal surgical staple

2、r. Salient characteristics: Style and design. Shall be a gastro-intestinal surgical stapler. The stapler shall consist of a cartridge half and an anvil half. Style and design of the cartridge half shall be in accordance with Figure 1. The cartridge half shall consist of a handle and channeled cartri

3、dge fork, Both components shall be attached by means of a distal pivot (see Figure 1). The handle shall have a proximal snap-anchor and transverse bar. The snap-anchor shall be designed to hold the cartridge fork in place until manually detached. The cartridge fork shall contain four alignment slots

4、; two on each side, identically spaced on both sides of the fork. This arrangement shall permit the fork to accept a compatible staple unit . Style and design of the anvil half shall be in accordance with Figure 2. The anvil half shall consist of an anvil fork and lock lever. The proximal end of the

5、 lock lever shall be joined to the mid-point of the anvil by means of the lock-lever pivot. The anvil fork shall have a distal engagement hook and a proximal anvil. The anvil shall contain 52 staple-clinching pockets arranged in two double-staggered rows. The pocket pattern shall match the staple- c

6、hannel pattern contained in the compatible staple unit. Performance. The stapler shall be capable of undergoing repeated assembly and disassembly cycles without jamming or breakage. When the user loads a compatible staple unit and follows the operating manual, the stapler shall place 52 surgical sta

7、ples, arranged in two duble-staggered rows, into tissue and split the tissue between the staples. AMSC N/A FSC 6515 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. THIS DOCUMENT CONTAINS PAGES. Provided by IHSNot for ResaleNo reproduction or networking permitted wit

8、hout license from IHS-,-,-A-A-53483 65 qqqqlq 0030874 ? e A-A-53 48 3 I Materials. The stapler shall be fabricated rom rigid plastic and corrosion-resisting steel, to ASTMDesignation F899. All materials shall be suitable for the purpose intended, Corrosion-resisting steel shall conform Instructions.

9、 The stapler shall be supplied with a “Directions for fEGPTKual . Workmanship. The stapler shall be free from defects that detract grorri fts appearance or impair its serviceability, - Unit. Each (EA). One stapler, as specified, constitutes one unit. Quality Assurance Provisions. Unless otherwise sp

10、ecified in the contract or purchase order, the contractor is responsible for the performance of all inspection requirements as specified herein, Except ar; otherwise specified in the contract or purchase order, the contractor may use hic own or any facilities suitable for the performance of the insp

11、ection requirements specified herein, unless disapproved by the Government. The Government reserves the right to perform any o the inspections set forth in the specification where such inspections are deemed necessary to assure supplies and services conrorm to prescribed requirements. Records o exam

12、inations and tests performed by or or the 6ontaactoT 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 contract and or a period of three years after delivery of the supplies to whi

13、ch such records relate. Re8ponsibility or inspection. Recorde. Ins oction. Inspection, as used herein, is defined as both examination + such as visual or auditory investigation without the use o special laboratory appliances or procedures) and testing (determination by technical means o physical and

14、 chemical properties) of the item. Teet&. Tests shall be conducted to determine compliance with specification requirements. Where feasible, the same sample shall be used or the determination of two or more test characteristics. Sampling or inspection, Sampling for inspection shall be conducted in ac

15、cordance with MIL-STD-105 at level 5-2, AQL 1.0%. The unit of product for inspection purposes shall be one surgical stapler. As an alternate, staplers may be 100% inspected for compliance with this specification and the manufacturers own blueprints and performance speciications. 2 Provided by IHSNot

16、 for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53483 65 9949974 0030875 7 A-A-53 48 3 f Contractor certification. The contractor shall certify that the product offered meets the salient characteristics of this description and conforms to the producers own drawing

17、s, specifications, 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. Metric products. Products manufactured to metric dimensi

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

19、ufactured 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 the product is acceptable. the product. The contracting officer has the option of accepting or rejecting Regulatory require

20、ments. 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 Food, Drug and Cosmetic Act, as amended, and re

21、gulations 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 regulations. Federal Food, Drug and Cosmetic Act. I

22、f the product covered by Recovered materials. The offerorLcontractor is encouraged to use recovered material in accordance with Public Law 94-580 to the maximum extent practical. Preservation, packaging, packing, labeling, and marking. Unless otherwise specified, preservation, packaging, and packing

23、 shall be to a degree of protection to preclude damage to containers and/or contents thereof under normal shipping conditions, handling, etc., involving shipment from the supply source to the receiving activity, plus reshipment from receiving activity, and shall conform to applicable carriers rules

24、and regulations. Intermediate and exterior package quantities and labeling and marking shall be as specified in the contract and/or order. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53 4 8 3 i ROTE 1: This document covers the following Nat

25、ional Stock Number: NSN 6515-01-204-5363 - ITEM IDENTIFICATION STAPLER, SURGICAL, Gastrointestinal, 53 mm NOTE 2: The following NSN is gor use with the NSN listed above: NSN - ITEM IDENTIFICATION 6515-01-207-8226 STAPLE UNIT, SURGICAL, Gastrointestinal, 53 nun, Disposable, 12s: Sterile, Individually

26、 Wrapped, Includes: Built-In Knife Blade Ordering data. (Interrnediate/exterior package quantities and labeling and marking must be specified in the contract: and/or order). MILXTARY INTERESTS: Preparing Activity: CU8tOdianS: Army - MD Navy MS Air Force - 03 DoD-MB Agent: DLA-DM CIVIL COORDXNATING A

27、CTIVITIES: VA-OSS PHS FDA-MPQRS Project No , 6515-4036 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53483 65 m 7777774 0030877 2 m A- A- 5 3 4 8 3 Ca m -4 n r m l e. r m % O I 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53 4 83 N A-A-53Y83 65 7?7777q 0030878 4 z i 31: r O o X r m e m 33 r O o % r m m a3 e I r / 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-