DOD A-A-54538-1991 INJECTOR TUBE PLASTIC REUSABLE《可再度使用塑料管注射器》.pdf

1、A-A-5453 65 9999974 O063734 7 I A-A-5 4 5 3 8 20 December 1991 COMMERCIAL ITEM DESCRIPTION INJECTOR, TUBE, Plastic, Reusable The General Services Administration has authorized the use of this commercial item description. This commercial item description covers a plastic medical cartridge injector su

2、itable for use with 1 or 2 ml cartridge- needle units. Salient characteristics: General. The injector shall be a cartridge injector which is top-loading and clamps to the proximal end of the cartridge-needle unit by means of a collet mechanism comprised of a ribbed collar and splines attached to a f

3、inger guard. By unscrewing the collar, the cartridge- needle unit can be discarded without touching it. Material. The injector shall be made of polycarbonate or Acrylonitrile Butadiene Styrene (ABS) plastic or combinations of the two plastics. The type of the plunger shall be made of austenitic stai

4、nless steel type 303, 304, or 316 in accordance with ASTM Designation F899 or brass which has been nickel or chromium-over-nickel plated. Style, desiqn and dimensions. The cartridge injector shall consist of a plunger with threaded tip and round thumb - rest, a ribbed collar, and a threaded finger g

5、rip. The injector shall accommodate 1 or 2 ml cartridge-needle units having an 11/32 inch outside diameter (See Note 2). The injector shall be designed so that the plunger can not be withdrawn completely. The plunger tip shall be attachable to the screw of the rubber piston or plug in the cartridge-

6、 needle unit. The finger grip shall be threaded to allow the cartridge-needle unit to be clamped within the collar. Inside the splines shall be a band of elastomeric material to enhance grip on the cartridge-needle unit. The overall length of the injector shall be 4-1/2 to 5 inches. The injector ass

7、embly shall have adequate mechanical strength to move the cartridge piston or plug without undergoing any distortion. The ribbed collar shall have iopeni and “close“ and the appropriate directional arrow printed on it. The injector shall be in accordance with Figure I. AMSC N/A FSC 6515 DISTRIBUTION

8、 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 5 3 8 Instructions. The injector shall be provided with instructions for use. Workmanship. Workmanship shall be first class

9、througho t. The injector shall be free from incorrect thread size, in- operable plunger, crazing or cracking, non-rigid construction, presence of rough or sharp edges, presence of foreign matter, lack of instructions and any defects which detract from its appearance or impairs its serviceability. Un

10、it. Each (EA). One injector tube, as specified, constitutes one unit. OUALITY 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. Excep

11、t 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 herein, unless disapproved by the Government. The Government reserves the right to perform any of the inspections set forth

12、in the specification 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 request,

13、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, as used herein, is defined as both examination (such as visual or auditory investigation without the use of s

14、pecial laboratory applicances or procedures) and testing (determination by technical means 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 purposes sha

15、ll be one injector. Sampling shall be Inspection level II with an Acceptable Quality Level (AQL) of 1.0. Examination. Zxamination shall be conducted to determine compliance with specification requirements. 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IH

16、S-,-,-A-A-54538 6.5 = 9999974 08b37Lb O E A-A-5 4 5 3 8 Samplinq for tests. Sampling for tests shall be conducted in accordance with MIL-STD-105 and as specified herein. Unit of product for test purposes shall be one injector. Sampling shall be Inspection level S-2 with an AQL of 1.0. e Tests. Tests

17、 shall be conducted to determine compliance with specification requirements. Where feasible, the same sample shall be used for the determination of two or more text characteristics. Metric products. Products manufactured to metric dimensions will be considered on an equal basis with those manufactur

18、ed using inch-pound units, providing they fall within the tolerance specified using conversion tables contained in the lastet 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 exceed the t

19、olerances specified in the inch/pound units, a request should be made to the contracting officer to determine if the products is acceptable. The contracting officer has the option of accepting or rejecting the product. Contractor certification. The contractor shall certify that the product offered m

20、eets the salient characteristics of this description and 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 provided for

21、under the provisions of the contract. 8 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 jurisdiction , the offeror/contractor shall comply, and be responsible for compl

22、iance by its subcontractors/suppliers, with the. requirements of the Federal Food, Drug Cosmetic Act, as amended, 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

23、other applicable Federal State, and local statutes, ordinances, and regulations. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54538 65 E 9799974 0063717 2 I I o l i l 1 I A-A-54 5 38 I Recovered materials. The offeror/contractor is encourage

24、d to use recovered material in accordance with Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. Preservation, packaqinq, p ackinq, labelinq, and markinq. Unless otherwise specified, preservation, packaging, and packing shall be to a degree of protection to preclude damage

25、 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 and regulations. Intermediate and exterior package qua

26、ntities and labeling and marking shall be as specified in the contract and /or order. Orderinq data. labeling and marking must be specified in the contract and/or order. Intermediate/exterior package quantities and NOTE 1: The following National Stock Number and its Item Identification is covered by

27、 this document: ” 6515-01-344-8487 ITEM IDENTIFICATION INJECTOR, TUBE, Plastic Reusable, Each NOTE 2: The National Stock Number for one such cartridge-needle unit is 6505-00-058-6590 (Heparin, Sodium, Injection, USP). MILITARY INTERESTS: PREPARING ACTIVITY: Custodians: DoD-MB Army-MD Navy-MS Air For

28、ce-O3 Agent: DLA-DM CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS USPHS FDA-MPQAS FGC 62535 Project No. 6515-4778 Location: AA54538/S11 Disk 1 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-e 3/16 f 1/64 DIA. -T - A-A-54538 65 E 9999974 0063718 4 A-A-5 45 3 8 %URE I. iNJECTOR TUBE, PLAST IC, REUSABLE Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-