DOD A-A-54672-1992 ANESTHESIA KIT LARYNGOTRACHEAL DISPOSABLE《可任意试用的喉气管工具》.pdf

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1、A-A-54672 65 = 9999974 0066808 9 W 1 INCH-POUND I 15 June 1992 A-A-54 6 7 2 COMMERCIAL ITEM DESCRIPTION ANESTHESIA KIT, LARYNGOTRACHEAL, DISPOSABLE The General Services Administration has authorized the use of this commercial item description as a replacement for Military Specification MIL-A-37842 (

2、DLA-DM) which is cancelled. This commercial item description covers a disposable laryngotracheal anesthesia kit for the administration of topical anesthesia to the interior of the larynx and trachea. Salient characteristics: General. The laryngotracheal anesthesia kit shall consist of a sterile, pla

3、stic dispensing injector (vial injector) with integral stainless steel cannula, a 5 ml glass vial containing 4 ml of sterile Lidocaine Hydrochloride Solution, United States Pharmacopeia (USP) 4 percent and instructions for use. The stainless cannula shall be ground to a point at the proximal end to

4、facilitate penetration of the rubber stopper. Material. Material of the metal barrel cannula shall be Class 3 corrosion resistant steel in accordance with ASTM Designation F899. The barrel plastic cannula shall be fabricated of polycarbonate resin and the barrel shall be fabricated of polypropylene.

5、 The vial shall be made of USP Type I borosilicate glass and the rubber stopper (plunger) shall be made of rubber inert to the contained medication. Style, desiqn and dimensions. The anesthesia kit shall be in accordance with Figure 1 for style, design and dimensions. Passivation. Corrosion resistan

6、t steel shall be properly passivated. AMSC N/A FSC 6515 DISTRIBUTION STATEMENT A: Approved for public release; distribution is unlimited. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A- 5 4 6 7 2 Corrosion resistance. Corrosion resistant steel c

7、annula shall show no evidence of corrosion or plating of copper when tested in accordance with ASTM Designation F1089. Sterility. The Lidocaine and vial injector shall be sterile in accordance with the USP. Security of assembly. There shall be no separation of the plastic cannula from the vial injec

8、tor when a tensile load of 25 pounds is applied for one minute to the injector. Ease of injection. The cap shall be removed from the vial and the vial screwed into vial injector. The vial shall then be forcefully compressed into the vial injector to discharge the Lidocaine. The Lidocaine shall be co

9、mpletely discharged in three (3) seconds. Instructions. Each kit shall be furnished with a list of the kit contents, assembly instructions and procedural instructions for use. Workmanship. The anesthesia kit shall be free from defects which detract from its appearance or impair its serviceability. E

10、xpiration datinq period. The anesthesia kit expiration dating period shall be not less than 24 months. Not less than 20 months of the expiration dating period shall remain at time of delivery to the Government. Unit. Package (PG). One package containing twenty-four individually packaged sterile anes

11、thesia kits, 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. QUALITY ASSURANCE PROVISIONS. Responsibility for inspection. Unless otherwise specified in the cont

12、ract of 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 or any facilities suitable for the performance of the inspection requirements

13、specified herein, unless disapproved by the Government. The 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54b72 b5 W 9999974 OObbfLO 7 A-A-54 6 7 2 Government reserves the right to perform any of the inspections set forth in the specification

14、 where such inspections are deemed necessary to assure supplies and 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 a

15、ny 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, as used herein, is defined as both examination (such as visual or auditory investigation without the use of speci

16、al laboratory appliances or procedures) and testing (determination by technical means of physical and chemical properties) of the item. Samplinq for examination. Sampling for examination shall be conducted in accordance with MIL-STD-105 and as specified herein. Unit of product for examination purpos

17、es shall be one anesthesia kit. Sampling shall be inspection level II with an Acceptable Quality Level (AQL) of 1.0. Examination. Examination shall be conducted to determine compliance with specification requirements. in accordance with MIL-STD-105 and as specified herein. Unit of product for test p

18、urposes shall be one anesthesia kit. Sampling shall be inspection level S-2 with an AQL of 1.0. Samplinq for tests. Sampling for tests shall be conducted Tests. Tests shall be conducted to determine compliance with specification requirements. Where feasible, the same sample shall be used for the det

19、ermination of two or more test characteristics. 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 tolerance specified using conversion tables contained in the latest revision

20、 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 n the inch-pound units, a request should be made to the contracting officer to determine if the product is accepta

21、ble. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54b72 65 9999974 OObbLl 9 A-A-54 67 2 The contracting officer has the option of accepting or rejecting the product. Contractor certification. The contractor shall certify and maintain substan

22、tiating evidence that the product offered meets the salient characteristics 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 conform

23、ance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract. Requlatory requirements. Federal Food, Druq, 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 juris

24、diction, 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 regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible

25、for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations. Recovered materials. The offeror/contractor is encouraged to use recovered material in accordance with Federal Acquisition Regulation Subpart

26、 23.4 to the maximum extent practical. Preservation, packaqinq, p ackinq, labelins, and markinq. 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, et

27、c:, 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 shall be as specified in the contract and/or order. O

28、rderinq data. Intermediate/exterior package quantities and labeling and marking must be specified in the contract and/or order. NOTE: The following National Stock Number and its respective Item Identification covered by this document: 4 Provided by IHSNot for ResaleNo reproduction or networking perm

29、itted without license from IHS-,-,-A-A-54672 65 7799774 00bbL2 O = A-A-54 6 7 2 NATIONAL STOCK NUMBER ITEM IDENTIFICATION 6515-01-003-9783 ANESTHESIA KIT, LARYNGOTRACHEAL, Disposable, 24s MILITARY INTERESTS: Preparing Activity: Custodians: DoD-MB Army - MD Navy - MS Air Force - 03 CIVIL AGENCY COORD

30、INATING ACTIVITIES: Agent : DLA-DM VA-OSS USPHS FDA-MPQAS Project Number: 6515-5405 Location: c:wordnishanecthcd 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54b72 b5 9999974 00bbL3 2 A-A-5 4 6 7 2 I I ! i I I . . . A- n -+I 8f c 3 3 3 I- z 7 4 t 4 7 I I T d ul 3 Il- d. 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-