DOD A-A-54491-1991 CANNULA TRACHEOTOMY UNIVERSITY OF KANSAS DESIGN《堪萨斯州大学涉及气管切开术套管》.pdf

1、A-A-54491 65 W 9999974 0062537 O W A-A-5449 1 30 Sepkemker 1991 COMMERCIAL ITEM DESCRIPTION CANNULA, TRACHEQTOMY, UNIVERSITY OF KANSAS DESIGN The eneral Services Administration has authorized the use Qf this Cqmmeriql Icem Pessrigtisp as a replacement for Vilitary Specifisatisn MIL-C-36672(1) which

2、is cancelled, This Commercial Item Pescriptia covers metal tracheotomy cannulae of the University 9f Kansas design for use in performing cricothyroiadomy, Salient characteristics: General. The tracheotamy Qbnnulae shall be of the University of Kansas design, used in performing cricothyreidotomy, Ali

3、 inner tubes and outer sleeves shall be interchangeable with each other within the given size. The tracheotomy cannulae shall be of the following sizes: Size I - Adult Size i1 - Pediatric. Material. b-fabricated fram-types 303 or 304, class 3 stainless steel in accordance with ASTM F899, As an alter

4、nate, inner tube and outer sleeve shall be fabricated from types 316, 317, class 3 stainless steel in accordance with ASTM F899. All compgnenes of the tracheotomy cannulae shall Hardness. The tracheotomy cannulae shall have a Rockwell 1IardneSs of B75 minimum when tested in accordance with ACTM E18

5、or E92 whichever is appliGakle. Conversion of hardness values shall be in accordance with ASTM Eb40. AMSC N/A DISTRIBUTION STATEMENT A. Approved for public release; distributha is unlimited. FSC 6515 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-,

6、A-A-54491 65 W 9999974 0062518 2 W 1 - A-A-5449 1 Style, desisn and dimensions. Each tracheotomy unit shall consist of two components. fits within an outer curved bivalve sleeve member. inner member shall be concentric and secured by either welding or silver-soldering to a metal plate at the proxima

7、l end designed to permit ease of insertion into and removable from the outer member. The outer bivalve member shall also be permanently secured by either welding or silver-soldering to a metal retaining plate at the proximal end. Distal end of inner cannula shall be open and smoothly finished. The c

8、urved cannula (part 1, inner tube shown on drawing) shall be interchangeable with outer sleeve (part 2, on drawing) with other tracheotomy units being of the same size. (See Note 1) Tracheotomy unit shall be in strict accordance with Defense Personnel Support Center (DPSC) Drawing No. 24120. Finish.

9、 All components shall be polished to a smooth bright finish. Definitions of acceptable surface characteristics shall be as described in ASTM F86. Passivation. construction shall be properly passivated after completion of all final finishing operations. Passivation shall be accomplished by the method

10、s described in ASTM F86 or equivalent. Tracheotomy units that are of silver-solder construction shall be passivated before they are silver- soldered. A curved cannula member which The Tracheotomy units that are of welded Resistance to corrosion. The tracheotomy units shall not show evidence of corro

11、sion when tested in accordance with ASTM F1089. As an alternate, the following saline test may be used: water and rinse in hot water followed by immersion in ethyl alcohol (95%) and then dry. Tracheotomy units shall be completely immersed into Normal Saline Solution (USP) and while immersed, placed

12、into an oven at a temperature of 37+ 1 degrees centigrade for a period of seven (7) days, removed from the oven and examined for corrosion while still immersed. Scrub the tracheotomy units with soap and warm Identification markins. The tracheotomy units shall be legibly marked with the contractors n

13、ame or registered trademark, and the word llstainlessll. Foreign manufactured tracheotomy units shall bear the name of the country of origin. 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54491 - 65 9999974 0062539 4 = A-A-54 4 9 1 Workmanshi

14、p. The tracheotomy units shall be free from defects which detract from their appearance or impair their serviceability. Unit. Each (EA). One cannula of the size specified, constitutes one unit. 9UALITY ASSURANCE PROVISIONS. Responsibilitv for inspection. Unless otherwise specified in the contract or

15、 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 any facilities suitable for the performance of the inspection requirements specified

16、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 services conform to prescribed requirements. Records. Records of examinations and tests

17、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 of three years after delivery of the supplies to which such records relate. Inspectio

18、n. 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 and chemical properties) ofthe item. Samplins for examination. Sampling for examinatio

19、n shall be conducted in accordance with MIL-STD-105 and as specified herein. Unit of product for examination purposes shall be one cannula. Sampling shall be Inspection level II with an acceptable quality level (AQL) of 1.0. Examination. Examination shall be conducted to determine Samplins for tests

20、. Sampling for tests shall be conducted compliance with specification requirements. in accordance with MIL-STD-105 and as specified herein. product for test purposes shall be one cannula. be Inspection level S-2 with an AQL of 1.0. Unit of Sampling shall 3 Provided by IHSNot for ResaleNo reproductio

21、n or networking permitted without license from IHS-,-,-A-A-54491 65 W 9999974 0062520 O A-A-5449 1 Tests. Tests shall be Goildiicted to determine compliance with specification requirements, Wherg feasible, the same sample shall be used for th determination of two or more test characteristics. Contra

22、ctor certification. The contractor shall certify that the product offered Meets the salient characteristics of this description and cnforms to the producers I awn drawings, specifications, standards, ahd quality assumme practices. The Government reserves the right to require pf06f of sueh conformanc

23、e prior to first delivery and thereafter as may be otherwise provided far under the provisions af the contract, Metric groduGtsc, Products manufactured to nietric dimehsions will be considered on an equal basis With those manufactured using inch-pound units, providing they fall within the tolerance

24、specified using conversion tables esntained in the Utest revision of Federal Standard No6 37e1 nd all other requirements of this document are met. If a product is manufactured to metrio dimerisions and those dimensions exceed the tolerances specified in the inch/pound units, a request should be made

25、 ta the contracting officer to determine if the product is acceptabl, The contracting officer hac the option of accepting or rejecting the product. Reaulatorv reauirements. Federal Fsdd, Drilq, and Cosmetic Act. If the product cavered by this document has been detrmined by the .Sa Food and Drug Admi

26、nistration to be under its jurisdistfon , the offerar/contractor shall comply, arid be responsible for compliance by its subcontractors/suppliers, With the rewirements of the Federal Food, brucj Cosmetic Act, s amended, arid regulations promulgated thereunder. In additian, the offeror/contractor sha

27、ll comply, and be responsible for compliance by its subconractsrs/uppliers/ with the requirements of all other applicable Federal State, and local statutes, ordinances, and regulations. Recovered matrial. .The fferor/contractor is encouraged to use recovered material in ace dance with Federal Acquis

28、ition Regulation Subpart 23.4 ta Lhe maximum extent practical. 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54471 65 9977774 00b252L 2 W A-A-54 4 9 1 Preservation, packaains, P ackins, labelins, and markins. Unless otherwise specified, prese

29、rvation, packaging, and packing shall be tu 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 confor

30、m 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. Orderins data. (Intermediate/xterior package quantities and labeling and marking must be specified Ln the contract and/or order).

31、Note 1: The tracheotomy uit shall be suitable for use with National Stock Numbers (NSN) 6515-00-935-7091 and NSN 6515-00-935-7092. NOT 2: document : The following National Stock Numbers are covered by this Item Identification 6515-00-935-7089 CANNULA, TRACHEOTOMY, UNIVERSITY OF KANSAS DESIGN, Metal,

32、 Pediatric. 6515-00-935-7090 CANNULA, TRACHEOTOMY, UNIVERSITY OF KANSAS DESIGN, Metal, Adult. MIQITARY INTERESTS: PREPARING ACTIVITY: Custodians: DoD-MB Amy-MD Agent t Navy-MS Air Force-03 DLA-DM CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS USPHS FDA-MPQAS Project No. 6515-4981 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-