DOD A-A-53843-1989 TUBING ASSEMBLY SURGICAL IRRIGATOR《外科注射器试管组装》.pdf

1、A-A-53843 65 7777779 0032357 4 = 3 A-A-53 8 43 24 March 1989 COMMERCIAL ITEM DESCRIPTION TUBING ASSEMBLY, SURGICAL IRRIGATOR The General Services Administration has authorized the use of this Commercial Item Description. This Commercial Item Description covers a sterile, disposable tubing assembly s

2、uitable for concurrent pulsed irrigation and suction in both trauma and surgery. Salient characteristics: The surgical irrigator tubing assembly shall be specifically designed for concurrent pulsed irrigation and suction in both trauma and surgery. set and a large handpiece with.three lumens: an irr

3、igation lumen, a control lumen, and a suction lumen, The assembly shall consist of a tubing The irrigation lumen shall be fabricated of polyvinylchloride tubing having approximate dimensions of 13 feet long, with a 3/16 inch I.D. and a 5/16 inch O.D. The lumen shall be fitted with an unvented pierci

4、ng spike for use with collapsible irrigation bags or bottles with vented caps. The control lumen shall be fabricated of polyvinylchloride tubing having approximate dimensions of 13 feet long, with an 1/8 inch I.D. and a 1/4 inch O.D. The suction lumen shall be fabricated of polyvinylchloride tubing

5、having approximate dimensions of 13 feet long, with a 5/16 inch I.D. and a 7/16 inch O.D. The suction tubing shall withstand 27 inches of mercury vacuum. An easily operated fingertip control for both suction and irrigation shall be provided on the handpiece. shall save time and shall not compromise

6、technique. Irrigation on demand via a closed, sterile, fluid path shall be provided. The design All tubing shall be non-kinking and drapable. AMSC N/A FSC 6530 DISTRIBUTION STATEMENT A. Approved for public release: distribution is unlimited. - THIS DOCUMENT CONTAINS d PAGES. - Provided by IHSNot for

7、 ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53843 b5 7777974 0032Lb0 O m e A-A-5 3 8 43 Each assembly shall be furnished with a .I set . of instructions for use . The assembly shall be packaged in a suitable peel-open container which shall maintain sterility unles

8、s the package is damaged or opened. The assembly shall coinply with FDA requirements for sterility. The peel-open container shall be free of oil, grease, dirt, or other contamination on the outside surface. Workmanship. The surgical irrigator tubing assembly shall be free from defects which detract

9、from its appearance or impair its serviceability. Unit. Package (PG). One package containing ten individually packaged sterile tubing assemblies, as specified, constitutes one unit. Quality Assurance Provisions. the contract or purchase order, the contractor is responsible for the performance of all

10、 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, unless disapproved by the Government. Government reserves the right to perform any of the inspections set forth

11、 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 or the contractor shall be maintained by the contractor and made available to the Government upon the Gover

12、nments 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 to which such records relate. Responsibility for inspection. Unless otherwise specified in Except as otherwise specified in the contract or The Ins

13、pection. 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. 2 Provided by IHSNot for Resal

14、eNo reproduction or networking permitted without license from IHS-,-,-A-A-53 8 43 . Tests. Tests shall be Conducted to determine compliance with specification requirements: shall be used for the determination of two or more test characteristics, Where feasible, the same sample Samplinq for examinati

15、on. Sampling for examination shall be conducted in accordance with MIL-STD-105, with an AQL of 1.0 (percent defective) and an inspection level of II. product for examination purposes shall be one surgical irrigator tubing assembly as specified in this description. The unit of Defects . Assembly is n

16、ot complete with all components. Assembly components are broken or non-functioning. Irrigation lumen, control lumen, or suction lumen are not Tubing is not non-kinking and drapable. Assembly is not supplied sterile. fabricated of polyvinylchloride. Assembly is not packaged in a suitable peel-open Pe

17、el-open container is not free of oil, grease, dirt, or container. other contamination on the outside surface. Samplinq for tests. Sampling for tests, including dimensional test, shall be conducted in accordance with MIL-STD-105, with an AQL of 2.5 (percent defective) and an inspection level of S-3.

18、The unit of product for test purposes shall be one surgical irrigator tubing assembly. a. First article. Where a first article sample is required, b. Acceptance testinq. When a first article sample has not all tests shall be performed on that unit. been required, one unit shall be subjected to the p

19、erformance test specified herein. passed all tests, performance test shall not be required at acceptance. If a test article sample has successfully 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-c F A- A- 5 3 8 43 Tests Suction Lumen Vacuum Test.

20、The suction lumen shall be securely connected to a suitable vaeuum pump. drawn down to 27 inches of mercury vacuum and held for a period of 30 minutes. defect. Sterility Test. with the FDAs current “Guideline on General Principles of Process Validation“. Metric products. be considered on an equal ba

21、sis 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 376, and all other requirements of this document are met. If a product is manufactured to metric dimensions and those d

22、imensions 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. the product offered meets the salient characteristics of thi

23、s description and conforms to the producers own drawings, specifications, standards, and quality assurance practices. 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. Requl

24、atory requirements. 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, Drug and Cosmetic Act, as

25、 amended, and regulations promulgated thereunder. offeror/contractor shall comply, and be responsible for compliance by its subaontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations. The lumen shall then be Any evidence of

26、 lumen collapse shall constitute a Sterilization testing shall be in accordance Products manufactured to metric dimensions will Contractor certification. The contractor shall certify that The Federal Food, Drug and Cosmetic Act. If the product covered In addition, the 4 Provided by IHSNot for Resale

27、No reproduction or networking permitted without license from IHS-,-,-A-A-53V3 b5 999997V 0032163 b W F A-A-5 3 8 43 Recovered materials. The offeror/contractor is encouraged to use recovered material in accordance with Public Law 94-550, as amended, and as implemented by Federal Acquisition Regulati

28、on Subpart 23.4 to the maximum extent practical. Preservation, packaginq, packinq, labelinq, and markinq. 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,

29、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 quantities and labeling and marking shall be as specified in the contract and/or order

30、. Unless NOTE: document : The following National Stock Number is covered by this 6530-01-184-1239 NOTE: Surgical Irrigator, NSN 6530-01-184-1238. The tubing assembly shall be suitable for use with Orderinq data. Intermediate/exterior package quantities, labeling, and marking must be specified in the

31、 contract and/or order . MILITARY INTERESTS: 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. 6530-2014 .- -. .- Location: CID/TUBING/H13-32 *&S. GOVERNMENT IRINNG OFFICE: 1989 - 6M-033li2425 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-