DOD A-A-54908-1993 CANNULA BRAIN (FRAZIER)《脑套管》.pdf

1、1 INCH-POUND 1 A-A-549 08 31 August 1993 COMMERCIAL ITEM DESCRIPTION CANNULA, BRAIN, (Frazier) The General Services Administration has authorized the use of this Commercial Item Description as a replace- ment for Federal Specification GG-C-121, which is cancelled. This Commercial Item Description co

2、vers an 8 Fr. angled suction tube of the Frazier design suitable for use in general surgical procedures. Salient characteristics: General, The cannula shall consist of the tube, tubing connector with a thumb piece suction control port and a stylet. permanently attached to the tubing connector and ha

3、ve a blunt open tip at the distal end. The tubing connector shall be sized for suction tubing ranging from 1/8 to 3/16 inch inside diameter. a knurled handle or knob and a permanently attached steel wire. The cannula tube at the proximal end shall be The stylet assembly shall consist of Material. Th

4、e cannula tube, thumb piece and stylet assembly shall be manufactured from Class 3, austenitic stainless steel in accordance with ASTM Designation F899. Hardness. The cannula tube, thumb piece and stylet handle shall have a Rockwell Hardness B scale (HRB) of 70 to 95 when tested in accordance with A

5、STM Designations E18 or E92 whichever is applicable. Conversion of hardness values shall be in accordance with ASTM Designation E140. Finish. The finish of components shall be mirror or satin. Style, desiqn and dimensions. Cannulas shall be in accordance with Figure 1. AMSC N/A FSC 6515 DISTRIBUTION

6、 STATEMENT A: Approved for public release; distribution is unlimited. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54908 m 9999974 0353220 T35 A-A-54 9 O 8 Passivation. Cannulas shall be properly passivated. Corrosion resistance. Cannulas shal

7、l show no signs of corrosion when tested for corrosion resistance in accordance with ASTM Designation Fi089. Identification markins and labelinq. Cannulas shall be legibly marked with the contractors name or registered trademark and shall also have the word “stainless“ marked on the thumb piece. Can

8、nulas of foreign manufacture shall bear the name of the country of origin. Workmanship. The cannula and stylet assembly shall be uniform and free from cracks, pits, burrs, sharp edges, scale, rough areas, corrosion, grind or tool marks, and dirt or polishing materials. Visual and dimensional examina

9、tion. Cannula and stylet assembly shall be examined to verify that design, construction and workmanship are in accordance with applicable requirements. Materials. The supplier shall be responsible for performing tests to assure that materials are in accordance with requirements. Unit. Each (EA). One

10、 cannula, as 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

11、 in the contract 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

12、where such inspections are deemed necessary to assure supplies and services conform to prescribed requirements. 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54 9 08 Records. Records of examinations and tests performed by or for the contracto

13、r shall be maintained by the contractor and made O 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 period of three years after delivery of the supplies to which such records relate. Inspection. Inspection,

14、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 of physical and chemical properties) of the item. Examination. Examination shall be conducted to dete

15、rmine compliance with specification requirements. Samplina for examination. Sampling for examination shall be conducted in accordance with MIL-STD-105 and as specified. Unit of product for examination purposes shall be one cannula as specified. Sampling shall be general inspection level II with an A

16、cceptable Quality Level (AQL) of 1.0. Tests. Tests shall be conducted to determine compliance with specification requirements. Where feasible, the same sample shall be used for determination of two or more test characteristics. Samplinq for tests. Sampling for tests shall be conducted in accordance

17、with MIL-STD-105 and as specified. Unit of product for test purposes shall be one cannula. Sampling shall be special inspection level S-2 with an AQL of 1.0. Contractor certification. The contractor shall certify and maintain substantiating evidence that the product offered meets the salient charact

18、eristics of this Commercial Item Description, and that the product 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 may be otherwise pro

19、vided for under the provisions of the contract. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54908 9999974 OL5L222 98 A-A-549 O 8 Metric products. Products manufactured to metric dimensions will be considered on an equal basis with those man

20、ufactured using inch-pound units, providing they fall within the tolerance 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 manufactured to metric dimensions and those dimensions excee

21、d 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 contracting officer has the option of accepting or rejecting the product. Reaulatory requirements. Federal Food, Druq, and Cosmetic Act. If the produ

22、ct 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 Food, Drug and Cosmetic Act, as amended,

23、 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 regulations. to use recovered material in ac

24、cordance with Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. Preservation, packaaina, p ackinq, labelinq, and markinq. Unless otherwise specified, preservation, packaging, and packing shall be to a degree of protection to preclude damage to containers and/or contents th

25、ereof 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 and regulations. Intermediate and exterior package quantities and labeling and marking s

26、hall be as specified in the contract and/or order. Orderina data. Intermediate/exterior package quantities and labeling and marking must be specified in the contract and/or order. Recovered materials. The offeror/contractor is encouraged 4 Provided by IHSNot for ResaleNo reproduction or networking p

27、ermitted without license from IHS-,-,-A-A-54908 9999974 OL5L223 724 A-A-54 9 O 8 NOTE: The following National Stock Number and its respective O - Item Identification is covered by this document: NATIONAL STOCK NUMBER ITEM IDENTIFICATION 6515-00-386-6800 CANNULA, BRAIN, Frazier, 8 Fr., Angular, 5-5/8

28、 inch (14.3 cm) Long MILITARY INTERESTS: Preparing Activity: Custodians: DoD-MB ArXtIy - MD Navy - MS Air Force - 03 CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS USPHS FDA-MPQAS GSA-FSS-FCGC Agent: DLA-DM Project Number: 6515-5619 Location: c:worddocdavidcannula2sg 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-O O cb CD I O E O I Ln Co z v, Z . - -. .- Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-