1、e A-A-54785 = 9999974 03235bO b4T A-A-54 7 8 5 8 January 1993 COMMERCIAL ITEM DESCRIPTION MANOMETER, SPINAL FWID The General Services Administration has authorized the use of this Commercial Item Description as a replacement for Military Specification MIL-M-36958 which is cancelled. This Commercial
2、Item Description covers one type of a sterile disposable spinal fluid manometer suitable for measuring spinal fluid pressure. t characteristics: piaterial. The manometer set shall be manufactured from a rigid or semi-rigid plastic. The plastic shall be inert to blood and common IV fluids and meet th
3、e requirements of the USP for class II plastics. Stvle. desian and dimensions. The manometer set shall be in accordance with Figure 1. The stopcock shall be Type I (3-Way) or Type II (4-Way) as shown in Figure 1. The capillary tube shall be calibrated from 3 cm (30 mm) to 55.0 cm (550 mm) minimum. T
4、he scale shall be marked in 2 millimeter graduations with main graduations every 3, centimeter (10 mm). The stopcock and capillary tube shall be furnished with plastic protectors on each connector which shall maintain sterility of the fluid path until removed. Eerformaance, The manometer set shall b
5、e suitable for use in measuring spinal fluid pressure during spinal anesthesia procedures. Manometer sets shall be tested for freedom from pyrogens, leakage, clear passage of fluid, and security of assembly . AMSC N/A FSC 6515 DISTRI BUTION STATEMENT A. distribution is unlimited. Approved for public
6、 release; Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-5 4785 = 9999974 OL2L5bl 58b = A-A- 5 4 7 8 5 Ster ilitv. The manometer set shall be sterile in accordance with USP or AAMI guidelines. shall be 0.000001. Sterility Assurance Level Freedom
7、 fr om Dvr ouens. The manometer set shall be free from pyrogens when tested in accordance with the USP. alternate to the USP Pyrogen Test, the USP Bacterial Endotoxin Test (LAL) may be used. As an Instructions f or use. proper use of the manometer set shall be provided with each individual manometer
8、. A detailed instruction sheet for yorknian chi D. free from parting lines. The manometer set shall be free from flash, pitting, cracks, holes or any foreign matter. The stopcock shall be free from any defects which affects its appearance or utility. mt. Package (PG). One package containing ten indi
9、vidually packaged sterile spinal fluid manometers, 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. use shall be supplied with each unit. The Luer tapers and rot
10、ating plug shall be Complete and detailed instructions for 9UALITY ASSURANCE PRO VISIONS. JtesDonsibili tv for in sDection Unless otherwise specified in the contract or purchase order, the contractor is responsible for the performance of all inspection requirements as specified herein. Except otherw
11、ise 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 in the s
12、pecification where such inspections are deemed necessary to assure supplies and services conform to prescribed requirements. for the contractor shall be maintained by the contractor and made available to the Government upon the Governments request, at any time, or from time to time, during the perfo
13、rmance of the contract and for a period of three years after delivery of the supplies to which such records relate. Records. Records of examinations and tests performed by or 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54785 m 9999974 01215
14、62 412 m A-A-54 7 8 5 mriection. Inspec ion, 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. Tests.
15、 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. mnlina for tests. Sampling for tests shall be conducted in accordance with MIL-STD-105 and as specified herein.
16、Unit of product for test purposes shall be one manometer set. Sampling shall be Inspection level S-l. A test failure shall be cause for rejection. Clear ria ssaae of fl uid. The manometer set shall be tested as an assembly. Each of the three or four fluid paths shall be tested using water or another
17、 suitable test fluid. shall be applied to the fluid path at a pressure of 3-1/2 & 1/2 psig .and shall pass freely through all of the ports within three (3) seconds of application utilizing the gages specified in IS0 Standard 594. Test fluid mue. The manometer set assembly shall be tested for leakage
18、 in accordance with IS0 Standard 594. the testing may consist of an pneumatic circuit equivalent to IS0 Standard 594 except that air shall be applied at a pressure of 10 psi. As an alternate, Any leakage shall be a test failure. Security of Assemblv of stoDcock. The stopcock body shall be secured. A
19、 25 lb. axial force shall be applied to the rotating plug arm for one (1) minute. Any stopcock which breaks or in which any component separates shall be considered a test failure. 3 c1 I Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54785 W 999
20、9974 0121563 359 A-A-54 78 5 Metric Drodu cts . 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 of Federal Stand
21、ard 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 in the inch/pound units, a request should be made to the contracting officer to determine if the product is acceptable. The contrac
22、ting officer has the option of accepting or rejecting the product. Contractor Certifbtion. 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 producers
23、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. Reaulatorv reuuirements. Federal Fo od. Drua.
24、 and Cosmetic Act. If the product covereL 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 the requirements of the Federal Food, Dr
25、ug, 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 regulations
26、. use recovered material in accordance with Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. Pecover ed material. The offeror/contractor is encouraged to 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54 7 8 5 prese
27、rvation. packauina. packing. Weling. and markina. 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:, involving shipment from the supply source t
28、o 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 dat a. (Intermediate/exterior package
29、quantities and labeling and marking must be specified in the contract and/or order . ) NOTE 1: document : The following National Stock Number is covered by this ” Item Identificata 6515-00-782-2620 MANOMETER, SPINAL FLUID, WATER TYPE, Disposable. NOTE 2: through the American National Standards Insti
30、tute (ANSI), 11 West 42nd Street, New York, NY 10036. Copies of IS0 Standards 594/1 and 594/2 may be obtained MILITARY INTERESTS: PREPARZNG ACTIVITY: Custodians: DoD-MB Army-MD Navy-MS Air Force-O3 Agent: DLA-DM CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS USPHS FDA-MPQAS Project No. 6515-5333 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A- 54785 A-A-54785 I 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-
