DOD A-A-54746-1992 STOPCOCK INTRAVENOUS THERAPY 3-WAY PLASTIC《塑料三方式静脉治疗活塞》.pdf

1、A-A-5474b 65 9999974 0087703 73T D I INCH-POUND I A-A-54 7 4 6 25 September 1992 COMMERCIAL ITEM DESCRIPTION STOPCOCK, INTRAVENOUS THERAPY, 3-WAY, PLASTIC The General Services Administration has authorized the use of this Commercial Item Description as a replacement for Military Specification MIL-S-

2、37434 which is cancelled. This Commercial Item Description covers a sterile, disposable, stopcock with three separate fluid paths and attached tubing. Salient characteristics: Material. fabricated from a rigid or semi-rigid plastic. The rotating spigot shall be of a color contrasting to the stopcock

3、 body. The stopcock and male Luer connector shall be The plastic tubing shall be fabricated from transparent, pliant plastic. Tubing shall be flexible, but shall be rigid enough to prevent collapse during normal use. The plastic shall be inert to blood and common IV fluids and meet the requirements

4、of the USP for Class II plastics. The total combined quantity of barium, cadmium, and lead for each component (excluding end protectors) shall not exceed 5 parts per million (ppm). Style. desian. and dimensions. The stopcock set shall be of the styles shown in accordance with Figure 1: Style 1: w/20

5、 inch extension tubing Style 2: w/33 inch extension tubing 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-5474b 65 = 9999974 0087704 b7b A-A-54 7

6、 4 6 The set shall consist of a stopcock with a rotating spigot and a secured length of tubing to the stopcock body. Luer connector (needle adapter) shall be secured to the distal end of the tubing. assembled to the rotating spigot. enable piercing and immediate resealing characteristics when punctu

7、red with needles of 18 gage or smaller. The stopcock proper shall have two side ports, 180 apart, each having internal female Luer tapers. The cavity of the rotating spigot that contains the rubber injection site shall also possess a female Luer taper. Luer fittings shall be in accordance with IS0 S

8、tandard 594 and may be female Luer Lock. The rubber plug of the injection site shall be attached by means of a retainer which allows for removal of the injection site. Once removed, the rubber plug shall not be reattached. The rotating spigot shall have an arrow-type handle to indicate which female

9、side Luer port will be part of the fluid path. A male The injection site shall be The injection site shall The two stopcock open ports and male Luer connector shall be covered with readily removable plastic protectors. protectors shall maintain cleanliness and freedom from particle infiltration and

10、shall maintain sterility of the fluid paths until manually removed. The end Performance. The stopcock set shall be a unit suitable for use in administering the direction of flow of blood and solutions for simultaneous and/or alternate intravenous therapy. Stopcocks shall be tested for freedom from l

11、eakage, clear passage of fluid, and security of assembly. Storase. The stopcock set shall be tested to ensure freedom from tackiness, brittleness, or other evidence of deterioration when stored in an elevated temperature. Sterility. with USP or AAMI guidelines. shall be .000001. The stopcock set sha

12、ll be sterile in accordance Sterility Assurance Level Instructions for use. A detailed instruction sheet for proper use of the stopcocks shall be provided with each individual stopcock or with each unit package. Workmanshin. free from parting lines. any defects which affect its appearance or utility

13、. The Luer tapers and rotating spigot shall be The stopcock shall be free from 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54746 65 = 9999974 0087705 502 A-A-5 4 7 4 6 Unit. Package (PG). One package containing fifty individually packaged s

14、terile stopcocks, with instructions, 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 otherw

15、ise specified in the contract or 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 in

16、spection requirements specified 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. for the con

17、tractor shall be maintained by the contractor and made available to the Government upon request, at any 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

18、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. I Records. Records of examinations and tests performed by or t Tests. Tests shall be c

19、onducted to determine compliance with specification requirements. Where feasible, the same sample shall be used for the determination of two or more test characteristics. Samplina for tests. accordance with MIL-STD-105, with an inspection level of S-4. Unit of product for test purposes shall be one

20、set. failure shall be cause for rejection. Sampling for tests shall be conducted in A test 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-5474b 65 m 9999974 0087706 449 m A-A-5474 6 Clear passase of fluid. The stopcock set shall be tested with

21、 an appropriate testing fluid applied internally to the stopcock body with the stopcock body placed in a horizontal position. Each fluid path as shown in Figure 2 shall be tested, in turn, using testing assembly fixtures in accordance with IS0 Standard 594 except that the male connector shall not be

22、 plugged and that the female Luer cavity of the rotating spigot shall be tested by removal of the rubber injection site. allow free passage of the testing fluid within five (5) seconds after an internal pressure of 3 psi maximum has been applied to each female Luer cavity. The set shall Leakaae. The

23、 stopcock set shall be tested for leakage initially with the rubber injection site assembled and then with the rubber injection site removed. shall be removed and the rubber injection site shall be left intact. The end protectors of the set Using test fittings in accordance with IS0 Standard 594 eac

24、h port shall be tested hydrostatically at a pressure of 45 psi for a period of 30 seconds. The connection between the rotating spigot and the stopcock body shall be tested in the same manner except that a pressure of 20 psi shall be applied for a period of 30 seconds. As an alternate, the testing ma

25、y consist of an pneumatic circuit equivalent to the one above except that air shall be applied at a pressure of 10 psi. Any leakage shall be a test failure. Leakage exceeding one clinging water drop shall be cause for failure. The rubber injection site shall then be removed and the ports tested in t

26、he same manner as above except that the female Luer cavity under the injection site shall be plugged. Elevated TemDerature. Samples of the packaged set shall be placed into an oven for seven days at 145O t 2OF. then be observed for signs of deterioration. The set shall 4 Provided by IHSNot for Resal

27、eNo reproduction or networking permitted without license from IHS-,-,-A-A-5474b 65 9999974 0087707 385 M A-A-5 4 7 4 6 Securitv of assemblv. The sample set shall be subjected to the security of assembly test after completion of the elevated temperature test. O The security of the stopcock injection

28、site is to be tested for blow off. testing fluid applied internally to the stopcock. One of the female ports of the stopcock shall be tested by attaching the female port to a fitting in accordance with IS0 Standard 594. The tubing port and the opposite female port are to be plugged. A continuous inc

29、reasing fluid pressure is applied until the injection site is blown off or leaks fluid. The injection site must hold a minimum pressure of 100 psi before blow off. The stopcock shall be tested with an appropriate The security of the tubing connections shall be tested. The connection being tested is

30、to be held and a continuous increasing pull force applied to the tubing until the tubing connection separates. A minimum force of 10 lbs. is required before separation. The security between the stopcock body and rotating spigot shall be tested. increasing pull force applied to the rotating spigot un

31、til the rotating spigot separates from the body. A minimum force of 5 lbs. is required before separation. Metric Droducts. 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 specifie

32、d using conversion tables contained in the latest revision of Federal Standard No. 376, and all other requirements of this document are met. The stopcock body is to be held and a continuous 0 If a product is manufactured to metric dimensions and those dimensions exceed the tolerances specified in th

33、e 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. Contractor Certification. maintain substantiating evidence that the product offered meets the salient chara

34、cteristics 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 p

35、rovided for under the provisions of the contract. The contractor shall certify and 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54 7 4 6 Reaulatorv remirements. Federal Food, Drus. and Cosmetic Act. If the product covered by this document ha

36、s 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, and regulations promulgated

37、 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. Recovered material. The offeror/contractor is encouraged to

38、 use recovered material in accordance with Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. Preservation, Dackaaina. D ackins, labelina. and markins. Unless otherwise specified, preservation, packaging, and packing shall be to a degree of protection to preclude damage to

39、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 quantit

40、ies and labeling and marking shall be as specified in the contract and/or order. Orderins data. (Intermediate/exterior package quantities and labeling and marking must be specified in the contract and/or order). NOTE 1: document : The following National Stock Numbers are covered by this - NSN Item I

41、dentification STYLE 6515-00-864-8864 STOPCOCK, Intravenous Therapy, 1 Disposable, 50s. 6515-01-307-3946 STOPCOCK, Intravenous Therapy, 2 3-Way, with 33 Inch Extension Tube, Plastic, Disposable, 50s. NOTE 2: through the American National Standards Institute (ANSI), 11 West 42nd Street, New York, NY 1

42、0036. Copies of IS0 Standards 594/1 and 594-2 may be obtained 6 Y Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-* A-A-5474b b5 D 9999974 0087709 158 D A-A-547 4 6 MILITARY INTERESTS: Custodians: Amy-MD Navy-MS Air Force-O3 CIVIL AGENCY COORDINATING

43、 ACTIVITIES: VA-OSS USPHS FDA-MPQAS PREPARING ACTIVITY: DoD-MB Agent : DLA-DM Project No. 6515-5398 7 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54746 65 m 9999974 0087710 97T m A- A-5 4 7 4 6 -N W I t- Y o O o a O I- cn Y Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-b A-A-5474b 65 m 9999974 00877LL BOb m A-A- 54746 FP3 NSN 65 15-00-864-8864 F IGURE 2 FLU ID PATHS OF STOPCOCK 9 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-