DOD A-A-53838-1989 IRRIGATION TIP SURGICAL《外科冲洗》.pdf

1、41 t a COMMERCIAL ITEM DESCRIPTION IRRIGATION TIP, SURGICAL- A-A-53838 bC - 7779774 0032347 3 A-A-53838 24 March 1989 The General Services Administration has authorized the use of this Commercial Item Description. This Commercial Item Description covers a disposable, multiple orifice surgical irriga

2、tion tip suitable for use with surgical irrigators and tubing assemblies. Salient characteristics: The surgical irrigation tip shall be a sterile, disposable, plastic tip with multiple orifices. approximate dimensions of 3/16 inches outside diameter with a length of 4-1/4 inches. The tip shall have

3、The tip shall be free of sharp edges, burrs, or flash. The tip shall be packaged in a suitable container which shall maintain sterility until opened. The container shall be free of grease, oil, dirt, or other foreign matter. Workmanship. The surgical irrigation tip shall be free from defects which d

4、etract from its appearance or impair its serviceability. Unit. Package (PG). One package containing ten individually packaged sterile irrigation tips, as specified, constitutes one unit. Quality Assurance Provisions. Responsibility for inspection. Unless otherwise specified in the contract or purcha

5、se order, the contractor is responsible for the performance of all inspection requirements 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 here

6、in, 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 . AMSC N/A FSC 6530 DISTRIBUTION STATEMENT A. Ap

7、proved for public release; O distribution is unlimited. THIS DOCUMENT CONTAINS 5 PAGES. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-2 A-A-53838 b 0032350 -8 W r A-A-53030 Records. Records of examinations and tests performed by or for the contract

8、or 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 performance of the contract and for a period of three years after delivery of the supplies to which such records relate. Inspection. Inspection, a

9、s 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. specification requirements. Where feasible, the same

10、 sample shall be used for the determination of two or more test characteristics. Samplinq for examination. 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. The unit of product for examination purposes sh

11、all be one surgical irrigation tip as specified in this description. Defects. Tests. Tests shall be conducted to determine compliance with Irrigation tip is not made of a suitable plastic. Irrigation tip does not have multiple orifices. Irrigation tip is not free of sharp edges, burrs, or Irrigation

12、 tip is not packed in bag individually. Bag is not free of grease, oil, dirt, or other foreign Samplinq for tests. Sampling for tests (dimensional) shall be conducted in accordance with MIL-STD-105, with an AQL of 2.5 (percent defective) and an inspection level of S-3. The unit of product for test p

13、urposes shall be one surgical irrigation tip. flash. matter. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53838 b5 W 7777774 0032351 T t a A-A- 5 3 8 3 8 a. First article. Where a first article sample is required, all tests shall be performed

14、on that unit. b. Acceptance testing. When a first article sample has not If a test article sample has successfully been required, one unit shall be subjected to the performance test specified herein. passed all tests, performance test shall not be required at acceptance. Tests Sterility Test. Steril

15、ization testing shall be in accordance with the FDAS current “Guideline on General Principles of Process Validation.“ Metric products. Products manufactured to metric dimensions will be considered on an equal basis with those manufactured using inch/pound units, providing they fall within the tolera

16、nces 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 dimensions exceed the tolerance specified in the inch/pound units, a request shou-ld be ma

17、de 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 this description and conforms to the producers own drawings, specifications, standards, and

18、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. Contractor certification. The contractor shall certify that E- - 3 Provided by IHSNot for

19、ResaleNo reproduction or networking permitted without license from IHS-,-,- A-A-53838 65 qqqqq74 0032352 3 b ? A-A-53838 Requlatory 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 re

20、sponsible for compliance by its subcontractors/suppliers, with 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 th

21、e requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations. use recovered material in accordance with Public Law 94-580, as amended, and as implemented by Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. Preservation, packaqinq,

22、 packinq, labeling, 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, etc., involving shipment from the supply source to the receiving a

23、ctivity, 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. NOTE: The following National Stock Number is covered by this doc

24、ument: NOTE: The surgical irrigation tip shall be suitable for use with surgical irrigator, NSN 6530-01-184-1238, and tubing assembly, 6530-01-184-1239. Ordering data. Intermediate/exterior package quantities, labeling, and marking must be specified in the contract and/or order. Federal Food, Druq a

25、nd Cosmetic Act. If the product covered Recovered materials. The offeror/contractor is encouraged to 6530-01-184-1240 4 . _f .i Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53838 b5 W 797777q 0032353 3 & . 7 A-A-5303 8 MILITARY INTERESTS: Cust

26、odians: 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. 6530-2016 Location: CID/IRRIGATION/TIP/Hl3-32 &US. GOVERNMENT PRINTING OFFICE: 1989 - 604-053l12424 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-