DOD A-A-54859-1993 TUBE EXTENSION INJECTION SET《注射装置扩展管》.pdf

1、*#- A-A-54859 D 9999974 0344492 847 A-A-54 8 5 9 21 May 1993 COMMERCIAL ITEM DESCRIPTION TUBE, EXTENSION, INJECTION SET The General Services Administration has authorized the use of this Commercial Item Description as a replacement for Military Specifications MIL-T-36673B and MIL-T-36192A(4) which a

2、re cancelled. This Commercial Item Description covers three types of sterile, disposable, plastic, intravenous extension sets, suitable for the administration of intravenous medications and for the introduction of diagnostic dyes into the circulatory system. Salient characteristics: General. suitabl

3、e for the administration of intravenous medications and for the introduction of diagnostic dyes into the circulatory system. The units shall be disposable extension sets Material. All rubber and plastic components shall be sterile, free from pyrogens, compatible, safe (non-toxic), and shall be in ac

4、cordance with the Pharmacopeia of the United States (USP) for Class VI plastics and for transfusion and infusion assemblies. The transparent PVC tubing shall be flexible and pliable, but be sufficiently rigid to prevent collapse during normal use. shall be free from all liquid additive substances wh

5、ich oxidize, exude or sweat-out onto the surface of the tubing. The tubing The adapters and clamps shall be fabricated from a rigid, dimensionally stable plastic. AMSC N/A FSC 6515 DISTRIBUTION STATEMENT A. distribution is unlimited. Approved for public release; Provided by IHSNot for ResaleNo repro

6、duction or networking permitted without license from IHS-,-,-A-A-54 8 5 9 Stvle. desiun and dimensions. The dimensions for the tubing of the three types of sets shall be as follows (dimensions are in inches): Overall Internal External TYPE Lensth Diameter Diameter I II 30 & 4 0.100 & .O03 0.138 & .O

7、05 120 2 5 0.120 k .O03 0.170 & .O05 III 30 & 4 0.100 2 .O03 0.138 & .O05 IV 20 f. 3 0.100 2 .O05 0.138 & .O05 V 30 & 4 0.100 & .O05 0.138 & .O05 The extension sets shall have permanently attached female Luer adapters at one end and male slip-fit Luer adapters at the other end. The adapters shall ea

8、ch be fitted with a tight but readily removable end protector which shall maintain the sterility of the fluid path and adapters after sterilization. The Types I and II extension sets shall have a regulating roller clamp or a slide type shut-off clamp present to control the flow rate from complete sh

9、ut-off to full flow. The extension sets shall be supplied with the clamps positioned on the tubing in the open position. The Type III extension set shall have two Y injection sites present 6 and 26 inches from the distal luer. A slotted slide clamp shall be present between the female Luer adapter an

10、d the Y injection site and a slide or regulating roller clamp between the two Y injection sites. The open end of the Y shall face the female adapter. The Types IV and V extension sets do not require a flow regulator. Descrbtion of ComDonents. The male slip-fit adapter shall be approximately 1-1/2 in

11、ches in overall length. The female adapter shall be 3/4 inch to 1-3/4 inches in overall length. The tapers shall be in accordance with IS0 594/1. The adapters shall not separate or loosen from the plastic tubing. 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license

12、from IHS-,-,-A-A-54859 m 9999974 0144494 b1T m A-A-54059 The flow regulator shall be a roller or slotted slide-type clamp and shall be permanently attached to the plastic tubing. removable. Slide clamps shall be rigid, smooth and free from burrs. It shall be moveable, and shall be capable of one-han

13、ded operation. The regulator shall be capable of accomplishing a complete quick shut-off, with no falling drop apparent in 5 minutes. of maintaining a constant flow rate of liquid at any point between complete shut-off and maximum flow. Each injection site shall be a rigid, transparent iiYi with a p

14、ermanently attached puncturable, self-sealing rubber diaphragm. Performance and Construction Reauirements. Flow rate. Flow rate for Types I, III, IV and V sets shall be 100 ml of water in no more than 120 seconds when connected to a regular administration set. The flow rate for the Type II set shall

15、 be 1 liter in less than 16 minutes when connected to a 1 liter bottle of water. The roller of the roller clamp shall not be The regulator shall be capable Leakaae and separation of set. The adapter shall be permanently attached to the plastic tubing such that with the opening-blocked, it shall not

16、leak or separate when subjected to an internal hydrostatic pressure of 45 psig for 5 minutes. 0 Deformation of tubins. While held in the same position on the tubing, the flow regulator shall be operated from its fully open position to complete shut-off ten times. tubing shall not be cut, pierced, or

17、 damaged in any manner which would cause leakage or restriction of the flow of solut ion. The DiaDhraqm reseal test. The rubber diaphragm shall reseal without a falling drop within 10 seconds after puncture with a dry nonlubricated 18 gage needle when subjected to an internal (hydrostatic) pressure

18、of 4 psig for 60 seconds. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54859 W 9999974 0144495 556 D A-A-54859 Security of roller in clamp body. When the flow regulator is of the roller type, the roller shall not be removed from the roller c

19、lamp under a 3.65 kilogram load when tested as follows: The roller clamp shall be removed from the set together with a piece of tubing approximately one inch longer than the clamp body. The tubing shall be present in the roller clamp in its normal position with a 1/2 inch length extending from each

20、end of the roller clamp. vertically, with the large end down, over a supporting gap so that the roller if forced out of the body is free to fall. roller, so that the roller shall be able to rotate in the course of the test, and the vertical downward force required to separate the roller from the cla

21、mp body is measured. an alternate, any position of the clamp is acceptable providing the clamp body is not distorted and the load measurement is accurate. The clamp shall be held A polished steel rod is applied to the top of the As Safety (non-toxicity) and freedom from Dvroaens The extension tube s

22、hall be nontoxic (safe) and pyrogen-free when tested in accordance with the USP for Transfusion and Infusion Assemblies. Sterility. The extension tube shall be sterile in accordance with the USP or AAMI requirements. assurance level shall be 0.000001. Sterility Instructions. be provided with each Ce

23、rtificates of sterility. freedom from twroaens, and safety tests. A certificate listing all lot or control numbers shall state that representative samples from each lot or control have been tested and found to be sterile, free from pyrogens, and safe. This certificate shall include the specific test

24、s performed and the test results. inspection, certificates shall be furnished to the procuring activity via the government inspector. For destination inspection, certificates shall be submitted by the contractor directly to Defense Personnel Support Center, directorate of Medical Materiel, Technical

25、 Operations Division, 2800 South 20th Street, Philadelphia, PA 19102, ATTN: Quality Assurance Branch, and one copy of each shall be forwarded with each shipment to the consignee. Instruction for proper use of the sets shall unit package. For source 4 Provided by IHSNot for ResaleNo reproduction or n

26、etworking permitted without license from IHS-,-,-A-A-54859 D 9999974 034449b 492 D A-A-54 8 59 Manufacturers records of tests. The manufacturer shall place a code or lot number on the paper label, or on the printed carton, which can be verified against the manufacturers records of all tests made on

27、nontoxic, sterile, pyrogen-free sets. These records shall be made available for inspection by any duly authorized Government representative. No shipment shall be made until all tests have been completed, verified, and recorded in the permanent records of the manufacturer, O Individual container. Eac

28、h extension tube shall be coiled in such a manner as to prevent kinking, shall be packaged sterile in a sealed peel-open type container capable of maintaining sterility of contents. an alternate, the coiled tubes shall be supplied in a paperboard box wrapped with polyester capable of maintaining ste

29、rility of contents. The coiled tube As WorkmanshiD. The sets shall be free from defects which detract from their appearance or impair their serviceability. . Unit. For Size 1 - Package (PG). One package containing twenty individually packaged sterile extension tubes, as specified, constitutes one un

30、it. Each tube shall be individually packaged in a suitable container capable of maintaining sterility of contents unless package is damaged or opened. e For Size 2 - Each (EA). One individually packaged sterile extension tube, as specified, constitutes one unit. The tube shall be individually packag

31、ed in a suitable sealed container capable of maintaining sterility of contents unless package is damaged or opened. For Size 3 - Package (PG). One package containing either 48 or 50 individually packaged sterile extension tubes, as specified, constitutes one unit. Each tube shall be individually pac

32、kaged in a suitable sealed container capable of maintaining sterility of contents unless package is damaged or opened. For Size 4 - Each (EA). One individually packaged sterile extension tube, as specified, constitutes one unit. The tube shall be individually packaged in a suitable sealed container

33、capable of maintaining sterility of contents unless package is damaged or opened. 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54859 m 9999974 0344497 329 m A-A-5 4 8 59 PUALITY ASSURANCE PROVISIONS. Responsibility for inspection. Unless oth

34、erwise specified in the contract or purchase order, the contractor is responsible for the performance of all inspection requirements as specified herein. purchase order, the contractor may use his own or any facilities suitable for the performance of the inspection requirements specified herein, unl

35、ess 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. Except as otherwise specified in the contract or Recor

36、ds. 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 after delivery of the supplies t

37、o 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 chemical properties) of the item

38、. SamDlins 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 extension tube. Sampling shall be Inspection level II with an acceptable quality level (AQL) of 1.0. Examination. Exte

39、nsion tubes shall be conducted to determine Samplins for tests. Sampling for tests shall be conducted in Sampling compliance with specification requirements. accordance with MIL-STD-105 and as specified herein. product for test purposes shall be one extension tube. shall be Inspection level S-2 with

40、 an AQL of 1.0. Unit of 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. 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without lic

41、ense from IHS-,-,-. A-A-54859 W 9999974 0144498 2b5 A-A- 5 4 8 5 9 0 Contractor Certification. The contractor shall certify and maintain substantiating evidence that the product offered meets the salient characteristics of this Commercial Item Description, and that the product conforms to the produc

42、ers 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 under the provisions of the contract. Metric Products. Products manufactured to

43、 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 of Federal Standard No. 376, and all other requirements of this document are met. If a p

44、roduct is manufactured to metric 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. Reaul

45、atorv reuuirements. O Federal Food, Drus, 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 compliance by its subcontractors/suppliers, with

46、 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 for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and lo

47、cal statutes, ordinances, and regulations. Recovered material. The offeror/contractor is encouraged to use recovered material in accordance with Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. 7 Provided by IHSNot for ResaleNo reproduction or networking permitted without

48、 license from IHS-,-,-A-A-54859 Preservation. xackaains. D ackina, labelins, and markins. 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, etc., inv

49、olving 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. Orderina data. (Intermediate/exterior package quantities and labeling and marking must be specified in the contract and/or order). NOTE 1: document : The