1、I INCH-POUND I 29 May 1992 A-A-54 6 64 COMMERCIAL ITEM DESCRIPTION NEEDLE, HYPODERMIC, CARTRIDGE TYPE, Disposable The General Services Administration has authorized the use of this commercial item description as a replacement for Military Specification MIL-N-36319A(l) which is cancelled. This commer
2、cial item description covers a disposable, sterile, cartridge type hypodermic needle suitable for use in anesthetic procedures. Salient Characteristics: General. The needles shall be of the following types and sizes: Type 1 - plastic hub, self-threading or threaded Type II - aluminum hub, threaded S
3、ize 1 - 25 Gage, 13/16 Inch Size 2 - 25 Gage, 1-3/8 Inch Size 3 - 27 Gage, 13/16 Inch ,Size 4 - 27 Gage, 1-3/8 Inch The needle shall be compatible with a thumb ring-handled operating cartridge syringe specifically designed to accept needles of the type and size described (See Note 2 and 3). Material
4、. Cannula. The cannula shall be fabricated from either seamless drawn or welded and drawn Class 3, Type 304 stainless steel in accordance with ASTM Designation F899. m. The Type I hub shall be fabricated from polypropylene plastic. The Type II hub shall be fabricated from aluminum alloy. Insert. fab
5、ricated from aluminum alloy. For Type I hub, with insert, the insert shall be 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-54664 65 = 99
6、99974 0065520 4 A-A-54664 Needle container. The needle container, comprised.of a needle sheath and cap, shall be fabricated from polypropylene or other plastic. o contents unless it is damaged or opened. The container shall be capable of maintaining sterility Style, desiqn and dimensions. Each cartr
7、idge-type needle shall be packaged in an individual sealed container. Each needle container shall consist of a sheath and cap. The needle shall be suitable for use with a thumb ring aspirating cartridge syringe specifically designed to accept needles of the type and size described. The needle shall
8、be in accordance with Defense Personnel Support Center (DPSC) Drawing No. 20467. Corrosion resistance. The cannula shall show no signs of corrosion when boil tested in accordance with ASTM Designation F1089. reaction when immersed in 3% sodium chloride solution at 20-25 degrees C after one hour. nst
9、ructions. Each unit of issue shall contain instructions for use which include proper disposal. The Type II hub shall show no signs of discoloration or Stiffness. When tested as specified, the maximum cannula deflection shall be as follows: for 27 gage 0.022 inch 25 gage 0.026 inch Securitv of stakin
10、q. Upon applying an axial tensile pull of 5 pounds for one minute, the cannula or aluminum insert (for Type I needle) shall not loosen or pull out of the hub. Needle bendinq resistance test. The needle cannula shall not crack or separate from the needle hub when bent 25 degrees from its rest positio
11、n and then bent 25 degrees in the opposite direction. Sterility, PY roqencity, toxicity. The needle shall be sterile in accordance with the USP or AAMI guidelines. The sterility assurance level shall be 0,0001. The needle shall be nonpysogenic and nontoxic when tested in accordance with the USP. 2 P
12、rovided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54 6 64 Identification markinq and labelinq. Each needle container shall be marked with the name or registered trademark of the manufacturer, gage and needle length (i.e. short or long), and “Disposa
13、ble after one use“ or similar legend. Workmanship. Needles shall be free from defects which detract from their appearance or may impair their serviceability. The cannula shall show a smooth finished outer surface free from pits and tool marks, burrs, scale or corrosion, and inner surface free from s
14、cale, deep pits, deep furrows, or die marks. The 1u:nen of the cannula and the hub cavity shall be free from burrs, chips, dirt, slivers or other foreign matter. Needles shall be sharp, not blunt or bent, when examined under 7 power magnification. PRODUCT OUALITY LEVEL Visual and dimensional examina
15、tion. The needle shall be examined to verify that the design, construction and workmanship are in accordance with applicable requirements. I Materials. The supplier shall be responsible for performing tests to assure that materials are in accordance with requirements as specified. Unit. Package (PG)
16、. One package containing one hundred individual needles of the size specified, constitutes one unit. PUALITY ASSURANCE PROVISIONS. * Responsibility for inspection. Unless otherwise specified in the contract or purchase order, the contractor is responsible for the performance of all inspection requir
17、ements 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 specified herein, unless disapproved by the Government. The Government reserves the right to perfo
18、rm any of the inspections set forth in the specification where such inspections are deemed necessary to assure supplies and services conform to prescribed requirements. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- - A-A-54bb4 b5 a 9999974 00b.5
19、522 8 W I A-A-54 6 64 ! 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, at any time, or from time to time, during the performance of the contract and for a period of three years aft
20、er 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 special laboratory appliances or procedures) and testing (determination by technical means of physical and che
21、mical 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 shall be one needle. Sampling shall be inspection level II with an acceptable quality level (AQL) of 1
22、.0. compliance with specification requirements. : Examination. Examination shall be conducted to determine $ 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 needle. Sampling shall be insp
23、ection level S-2 with an AQL of 1.0. Tests. Tests shall be conducted to determine compliance with specification requirements. Where feasible, the same sample shall be used for the determination of two or more test characteristics. Stiffness test. The cannula shall be placed across two test edges (0.
24、002 inch radius, maximum) separated by 0.375 inch 2 0.003 inch for the 27 gage, and 0.500 inch 2 0.003 inch for the 25 gage. A load of 20 ounces f. ounce for the 27 gage, or 25 ounces 5 l/4 ounce for the 25 gage, shall be applied at the center of the span. The resulting maximum deflection of the can
25、nula shall be measured using a gage with graduations of at least 0.001 inch. The force shall be applied though an edge with a maximum radius of 0.036 inch and centered to within t 0.003 inch. 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-5466
26、4 b5 9999974 0065523 T _ _ A-A-54 664 Contractor certification. The contractor shall certify and maintain substantiating evidence that the product of fered meets the salient characteristics of this Commercial Item Description, and that the product conforms to the producers own drawings, specificatio
27、ns, 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 under the provisions of the contract. Metric products. Products manufactured to metric dimensions will be con
28、sidered on an equal basis with those manufactured using inch-pound units, providing they fall within the tolerances 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 met
29、ric dimensions and those dimensions exceed 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. Requlatory requirements. Federal F
30、ood, Drua, 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 of feror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of the Federa
31、l Food, Drug and 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 other applicable Federal, State, and local statutes, ordinances, and re
32、gulations. I) Recovered materials. The offeror/contractor is encouraged to use recovered material in accordance with Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54
33、bb4 65 m 9799774 00b5524 L m A-A-54 664 Preservation, packaqinq, 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 thereof under normal shipping conditions, handling, e
34、tc., 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
35、. NOTE 1: The following National Stock Numbers, their respective Item Identifications, Types and Sizes are covered by this document : _I NSN ITEM IDENTIFICATION 6515-00-181-7403 Needle, Hypodermic, Cartridge Type, Disposable, 25 gage, 13/16 inch long, 100s 6515-00-181-7404 Needle, Hypodermic, Cartri
36、dge Type, Disposable, 25 gage., 1-3/8 inch long, 100s 6515-00-181-7425 Needle, Hypodermic, Cartridge Type, Disposable, 27 gage, 13/16 inch long, 100s 6515-00-181-7412 Needle, Hypodermic, . Cartridge Type, Disposable, 27 gage, 1-3/8 inch long, 100s TYPE .I * I, II I, II I, .II NOTE 2: A National Stoc
37、k Number for such a syr 010-8761, Syringe, Cartridge, Aspirating, Thumb SIZE - 1 .2 4 nge is 515-0 - Ring Handle. NOTE 3: A National Stock Number for a cartridge to be used with the syringe in Note 2 and the needle described in the specification is 6505-01-146-1139, Lidocaine Hydrochloride and Epine
38、phrine Injection, USP. Ordering data (Intermediate/exterior package quantities and labeling and marking must be specified in the contract and/or order) 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54 664 MILITARY INTERESTS: r) Custodians: Army - MD Navy - MS Air Force - 03 Preparing Activity: DoD-MB Agent : DLA-DM CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS PHS FDA-MPQAS . Project No. 6515-5067 Location: PL Disk #2 (NEED-HYP) I 7 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-
