DOD A-A-54419-1991 GAUZE PETROLATUM《矿脂薄纱》.pdf

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1、- A-A-54419 65 E 9999974 0062012 3 1 - Y I, *: 0 A-A-544 19 28 June 1991 COMMERCIAL ITEM DESCRIPTION GAUZE, PETROLATUM The General Services Administration has authorized the use of this Commercial Item Description as a replacement for Federal Specification DDD-G-l38B, which is cancelled. Salient Cha

2、racteristics: Shall be sterile, petrolaturn impregnated gauze dressings suitable for medical and surgical use. The dressings shall be sterile when tested in accordance with the USP. The impregnated dressings shall be of the following sizes and shall contain the following minimum weight of petrolatum

3、 after removal of the dressings from their immediate container when determined in accordance with Petrolatum Gauze, USP, UNFOLDED DRESSING MINIMUM WEIGHT OF (INCHES) PETROLATUM SIZE LENGTH WIDTH (GRAMS 1 1 36 3 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license fr

4、om IHS-,-,- A-A-54Yl 65 m 9999974 00b2013 5 A-A-5 4 4 19 Residual Ethylene Oxide. If ethylene oxide is used as a sterilization agent, the finished gauze shall contain not more than 250 ppm of Ethylene Oxide, 250 ppm, Ethylene Chlorohydrin and 5000 ppm Ethylene Glycol_. Gauze shall be tested by metho

5、ds 54, 55, or 56 published in the Federal Register, Volume 43, No, 122, Part V, 22 June 1978, Ethylene Oxide, Ethylene chlorohydrine, and Ethylene Glycol, Proposed Maximum Limits and Maximum Levels of Exposure, he has the capability to meet specification requirements for residual testing for the pro

6、duct, report from a recognized independent testing laboratory shall be considered as an acceptable means for demonstrating hic capability, Note: A manufacturer who has demonstrated his ability to use Ethylene Oxide sterilization without excessive residuals present Ln the final product may confirm hi

7、s sterilization method on the basis OE an approved auditing scheiiule in lieu of lot-by=J.ot testing. Prior approval shall be obtained from the contracting officer, Workmanship. The dressings shall be free rom defects which detract from their appearance or impair their serviceability. Petrolatum Con

8、tractor shall satisfactorily demonstrate that A satisfactory test Unit, Package (PG), Each dressing shall be individually packaged in a peel-open type container capable o maintaining sterility of contents unless package is damaged or opened. One package containing 12 individually packaged dressings

9、of one size only, as specified, constitutes one unit. Quality Assurance Provisions. Unless otherwise specified Ln 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 an

10、y 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 specification where such inspections are deemed necessary to assure supplies and servi

11、ces conform to prescribed requirements. ResDonsibilitv for inspection Except as otherwise specified in the contract or 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-: A-A-54439 65 9999974 0062034 7 j c A-A-54 4 19 fF Records. Records of examinati

12、ons and tests performed by or 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 performance of the contract and for a period of three years after delivery of the supplies to which

13、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. Sampli

14、nq 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 dressing. Sampling shall be Inpsection level II with an acceptable quality level (AQL) of 2.5 (percent defective). Examination

15、. Examination shall be conducted to determine compliance with specification requirements. Samplinq for tests. Sampling for tests shall be conducted in accordance with MIL-STD-105 and as specified herein. product for test purposes shall be one dressing. be Inspection level S-1 with an AQL of 2.5 (per

16、cent defective). Unit of Sampling shall e 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. Contractor certification. The contractor shall certify that th

17、e product offered meets the salient characteristics of this description and 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 othe

18、rwise provided for under the provisions of the contract. 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 tolerance specified using conversion tables contained in the latest

19、 revision of Federal Standard No. 376, and all other requirements of this document are met. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-u A-A-54 4 19 If a product is manufactured to metric dimensions and those dimensions exceed the tolerance sp

20、ecified 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, Requlatorv requirements, Federal Food, Druq and Cosmetic Act. If the product covered by this d

21、ocument 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/suppliersI with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, and regulations pro

22、mulgated thereunder. In addition, the offeror/contraetor 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 materials, The offeror/contractor is enc

23、ouraged to use recovered material in accordance with Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. Preservation, packaqinq, D ackincr, labelincr and markinq. Unless otherwise specified, preservation, packaging, and packing shall be to a degree of protection to preclude

24、 damage to containers and/or contents thereof under normal shipping conditions, handling, etc., involving shipment from the supply source ta the receiving activity, plus reshipment from receiving activity, and shall conform to applicable carriers rules and regulations. Intermediate and exterior pack

25、age quantities and labeling and marking shall be as specified in the contract and/or order. NOTE: document : The following National Stock Numbers are covered by this - NSN ITEM IDENTFICATXN SIZE; 6510-00-202-0800 GAUZE, PETROLATUMI 3 By 18 Inches, 12s 6510-01-112-6414 GAUZE, PETROLATUM, 3 By 36 Inch

26、es, 12s 2 1 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-c A-A-54419 65 9999974 00b201b O i A-A-54 4 19 Ordering data. labeling and marking must be specified in the contract and/or order. Intermediate/exterior package quantities and MILITARY INTERESTS: Custodians: Army - MD Navy - MS Air Force - 03 PREPARING ACTIVITY: DoD - MB CIVIL AGENCY COORDINATING ACTIVITY: Agent: DLA-DM VA-OSS PHS FDA-MPQAS PGC 05087 Project No. 6510-0777 I 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-