DOD A-A-53501-1988 STAPLE UNIT SURGICAL THORACIC-ABDOMINAL《胸腹部的外科原材料》.pdf

1、A-A-535 O 1 11 May 1988 AMSC N/A FSC 6515 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited, - COMMERCIAL ITEM DESCRIPTION STAPLE UNIT, SURGICAL, THORACIC-ABDOMINAL The General Services Administration has authorized the use of this commercial item description. This com

2、mercial item description covers seven styles of Thoracic -abdominal surgical staple units. Salient characteristics: Style and design. Style and design of staple units shall conform to Figure 1. Staple units shall consist of the following: Staple cartridge. The staple cartridge shall contain staple c

3、hannels, a drive mechanism designed to engage the compatible stapler and drive the staples toward the anvil, a spring-loaded alignment pin, and a slotted alignment pin spring. The number of staple channels (staples) shall be as specified in Table II. Except as specified in the “Notes“ section, the c

4、hannels shall be arranged in a double-staggered row (See Figure 1). Each channel shall be loaded with a surgical staple. Anvil. The anvil shall contain a mated set of staple- clinching pockets.and an engagement hook and detent stop, as shown in Figure 1. Hinge. the anvil and cartridge. The hinge sha

5、ll be a spring-loaded hinge connecting Dimensions. For each NSN, staple dimensions shall be as indicated in Table I. The length of the staple-channel pattern and the number of channels shall be as indicated in Table II. 1 , THIS DOCUMENT CONTAINS 7 PAGES. p. Provided by IHSNot for ResaleNo reproduct

6、ion or networking permitted without license from IHS-,-,-A-A-53501 NSN -No.taples Stase-Pattern (1) (2) 6 !5-L50-1T0-7=819 1 31 6515-01-209-8220 11 31.5 6515-01-207-8222 33 91.5 Length 6m-0ig2o-822i 11 31.5 Table I. Surgical Staple Dimensions NCN (a) Staple- 515-01-207-8220 4.8 4.0 0.28 515-01-207-8

7、221 3.5 4.0 0.23 515-81-207-8222 4.8 4.0 0.28 515-01-207-8223 3.5 4.0 0.23 515-01-207-8224 3.5 4.0 0.23 515-01-207-8225 4.8 4.0 9.28 (a) All dimensions in mm. (1) Tolerance: .E 0.05 mm. (2) Tolerance: 0.005 mm. Table II, Staple Unit Dimensions 5515-01-207-8225 19 53 E _.I_ (1) Length in mm. (2) Tole

8、rance: 0.05 rnm. Matsialc. Staples shall be fabricated from corrosion-resisting stsol wire that coneorms to ACTM Designation F138, Grads 2 or ASTM Desagnation F55, Grade 2. Staple units ahall be Eabricate from a suitable corrosion-resisting steel and a suitable r igfd plastic. Performance. Staple un

9、it shall be compatible with the stapler indicated in Table III. Staple units shall be suitable for use in abdominalt gynecologicall pediatric, and thoracic surgical pmceduxec. 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53501 b5 m 7777774 0

10、030748 T m A-A-535 O 1 * I c 0 TABLE III. Stapler - Staple Unit Compatibility 1 NSN: Staple Unit NSN: Stapler 6515-01-207-8219 6515-01-204-5365 6515-01-207-8220 6515-01-204-5365 6515-01-207-8221 6515-01-204-5365 6515-01-207-8222 6515-01-204-5362 6515-01-207-8223 6515-01-204-5362 6515-01-207-8224 651

11、5-01-204-5364 b 6515-01-207-8224 6515-01-204-5364 Sterility. Staple units shall be sterile in accordance with the latest edition of the United States Pharmacopiea (USP). Workmanship. from their appearance or impair their serviceability. - Unit. Each (PG) . One package containing tweIve individually

12、packaged sterile stapling units, as specified, constitutes one unit. The individual package shall be a sealed peel-open type container capable of maintaining sterility of contents unless the package is damaged or opened. Staple units shall be free from defects that detract Quality Assurance Provisio

13、ns. Responsibility for inspection. Unless otherwise specified in the contract or purchase order, the contractor is responsible for the performance of al1 inspection requirements as specified herein. Except as otherwise specified in the contract or purchase order, the contractor may use his own or an

14、y 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 servi

15、ces conform to prescribed requirements. 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 contract and for a pe

16、riod of three years after delivery of the supplies to which such records relate. Records. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53SOI b5 qq74 0030944 I A-A-5 3 5 O 1 Ins ectfon. Enspection, as used herein, is defined as both examinati

17、on + such as visual or auditory investigation without the use of special laboratory appliances or procedures) and testing (determination by technical means o physical and chemical properties) of the item. Tests. Testrii shall be conducted to determine compliance with specification requirements. Wher

18、e feasible, the same sample shall be used or the determination of two or more test characteristics. Sampling for inspection. Sampling for inspection shall be conducted in accordance with MIL-STD-105 and as specified herein, The unit of product or test purposes shall be one package of staple unite. A

19、r; an alternate, staplers may be inspected for compliance with this specification and the manufacturers own blueprints and performance specifications. Contractor certification, The contractor shall certify that the sroduct: offered meets the salient characteristics of this description - - an conform

20、a to the producers own drawings, specifications, standaids, and quality assurance practices. The Government reserves the Eight to require proof of such conformance prior to first deliveKy and thereafter as may be otherwise provided for under the provisions of the contract. Regulatory requirements. t

21、his 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 regulation

22、s promulgated thereunder. In addition, the offeror/contractor shall comply, and be reapsnsible for compliance by its subcontractors/suppliers, with the requirements o all other applicable Federal, State, and local statutes, ordinances, and regulations. Federal Food, Drug and Cosmetic Act. If the pro

23、duct covered by Recovered materials. The oferor/contractor is encouraged to use KeCOVered material in accordance with Public Law 94-580 to the maximum extent practical. 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-5350L 65 7777774 0030750 B

24、A-A-53501 . Preservation, packaging, packing, labeling, and marking. 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:, involving shipment from

25、the supply source to the receiving activity, plus reshipment from receiving activity, and shall conform to applicable carriers rules and regulations. Intermediate and exterioi package quantities and labeling and marking shall be as specified in the contract and/or order. NOTE: document: The followin

26、g National Stock Numbers are covered by this NS N - 6515-01-207-8219 6515-01-207-8220 6515-01-207-8221 6515-01-207-8222 6515-01-207-8223 6515-01-207-8224 6515-01-207-8225 ITEM IDENTIFICATION Staple Unit, Surgical, Thoracic- Abdominal, 31 mm, Disposable, 12s Sterile, Individually Wrapped Staple Unit,

27、 Surgical, Thoracic- Abdominal, 31.5 mm, Disposable, 12s Sterile, Individually Wrapped Staple Unit, Surgical, Thoracic- 4.0 mm Wide, 31.5 mm, Disposable, 12s Sterile, Individually Wrapped Staple Unit, Surgical, Thoracic- 4,O mm Wide, 91.5 mm, Disposable, 12s Sterile, Individually Wrapped Staple Unit

28、, Surgical, Thoracic- 4.0 mm Wide, 91.5 mm, Disposable, 12s Sterile, Individually Wrapped Staple Unit, Surgical, Thoracis- 4.0 mm Wide, 53 mm, Disposable, 12s Sterile, Individually Wrapped Staple Unit, Surgical, Thoracic- 4.0 mm Wide, 53 mm, Disposable, 12s Sterile, Individually Wrapped NOTE: NSN 65

29、15-01-207-8219 shall have 23 staple-channels arranged in a triple-staggered row. document shall conform to the requirements specified herein. All other staple units covered by this 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-t A-A-53501 bS qqq7

30、74 0030751 T W A-A-53501 Orderng data, (Pntermediate/exterioL package quantities and labeling and marking must: be specified in the contract and/or order). HILITARY INTERESTS: Preparing Activity: Custodians : Army - MD Navy - RS Air Force - O3 ROD-MB Agent: DLA-DM CIVIL COQRDINATXNG ACTIVITIES: VA-O

31、SC PHS FDA-MPQAC Project No, 6515-3979 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-w I W 8 A-A-5 35 O 1 FIGURE 1 STAPLE UNIT, SURGICAL 1 STAPLE CARTRIDGE ASSEMBLY 2 ANVIL ASSEMBLY 3 ALIGNMENT PIN SPRING 4 ALIGNMENT PIN 5 SPRING-LOADED HINGE 6 DETENT STOP 7 STAPLE CHANNELS 8 ANVIL 9 ENGAGEMENT HOOK 10 ACTUATOR ROD SLOT (FOR GENERAL STYLE ANO OESIGN) 7 *US. GOVERNMENT PRIMING OFFICE r)88 - 55-33/9ZSM Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-