DOD A-A-54876-1993 SPONGE ABSORBABLE GELATIN USP《美国标准吸收凝胶海绵》.pdf

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1、A-A-5487b m 9999974 0344453 OT7 m A-A-54 87 5 21 May 1993 COMMERCIAL ITEM DESCRIPTION SPONGE, ABSORBABLE GELATIN, USP The General Services Administration has authorized the use of this Commercial Item Description as a replacement for Military Specifications MIL-S-37092 which is cancelled. This Comme

2、rcial Item Description covers absorbable gelatin sponges. Salient characteristics: General. Shall be an absorbable gelatin sponge suitable for use as a local hemostatic in oral and dental surgery. Shall be capable of absorbing and holding whole blood within its meshes. Shall be the following types T

3、ype 1 - 20 by 20 by 7mm, 15s Type II - 20 by 60 by 7mm, 12s Type III - 80 by 125 by lOmm, 6s Material. Shall be a light, nearly white, pliable, non- antigenic, non-elastic, tough, porous matrix. Shall be in accordance with the tests, standards, and requirements of the United States Pharmacopeia (USP

4、). Absorbability. When implanted in tissues, the absorbable gelatin sponge shall be completely absorbed in from four to six weeks without including excessive skin tissue formation. AMSC N/A FSC 6510 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. Provided by IHSNot

5、for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-5487b M 9999974 0144454 T33 M A-A-54 8 7 6 Absorbability testing shall be performed on one lot for one contract provided the contractor certifies that the manufacturing procedure for each subsequent lot and contract i

6、s identical to the procedure used to manufacture the one lot subjected to the absorbability test. contracts, the supplier shall submit certification that the lots offered to the Government were manufactured identically as the material subjected to the absorbability test. Heat durability. withstand a

7、 dry heat at 95OC for four hours without showing decomposition. slightly brown of the absorbable gelatin sponge is not considered decomposition of the material. Dimensions. with the measurements specified below for the appropriate type: On subsequent The absorbable gelatin sponge shall The darkening

8、 in color from yellow to Each absorbable gelatin sponge shall comply Width Heisht Thickness Type 1 18 to 22mm 18 to 22mm 5.3 to 9.8mm Type II 18 to 22mm 52.5 to 67.5mm 5.3 to 9.8mm Type III 70 to 9Omm 110 to 150mm 8 to 12.5mm At least ten sponges shall be examined to determine whether the sponges co

9、mply with the above dimensions. one sponge shall deviate from the above by more than & 15% in width, 15% in height, and fi 30% in thickness. Non-toxicitv, p ruaencitv and sterility. non toxic and pyrogen free when tested in accordance with United States Pharmacopeia (USP). The sponge shall be tested

10、 for sterility in accordance with USP or AAMI requirements. Sterility assurance level shall be 0.000001. Not more than The sponge shall be 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54876 m 9999974 0144455 97T m A-A-54 8 7 6 Unit. For Size

11、 1 - Jar (JR). One jar containing 15 absorbable gelatin sponges, as specified, constitutes one unit. Jar shall be capable of maintaining sterility of contents unless damaged or opened. For Size 2 - Box (BX). Each sponge shall be individually packaged in a white paper envelope (inner envelope) and en

12、closed in a sealed, peel-open envelope capable of maintaining sterility of contents unless damaged or opened. One box containing 12 individually packaged sponges, as specified, constitutes one unit. For Size 3 - Box (BX). Each sponge shall be individually packaged in a white paper envelope (inner en

13、velope) and enclosed in a sealed, peel-open envelope capable of maintaining sterility of contents unless damaged or opened. One box containing 6 individually packaged sponges, as specified, constitutes one unit. QUALITY ASSURANCE PROVISIONS. ResDonsibility for inspection. Unless otherwise specified

14、in the contract or purchase 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 re

15、quirements 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 services conform to prescribed requirements. Records. Records of ex

16、aminations 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 to which such reco

17、rds relate. Lot. A lot, batch, or control is that single, uniform, and homogeneous quantity of absorbable gelatin sponge produced from one formulation, subjected to the same compounding and manufacturing operations, and placed into the final containers. 3 Provided by IHSNot for ResaleNo reproduction

18、 or networking permitted without license from IHS-,-,-A-A-5487b m 9999974 OL4445b Ob m A-A- 5 4 8 7 6 Sterility lot. A sterility lot is that single quantity of product subjected to the same manufacturing operation and simultaneously sterilized in the same sterilizer chamber. Each unit package shall

19、be clearly marked with a lot (control) number and expiration date as specified in the labeling requirements. Each sterility lot shall be traceable to the pertinent manufacturing lot (s) . Upon approval of the procuring activity, the assigning of pharmaceutical lot (quality control) numbers without s

20、howing individual load (charge) designation (sterility lot) will be acceptable, provided samples from each sterilizer charge are tested and reserve samples representing each sterilizer charge are retained for future testing, as needed. Inspection. Inspection, as used herein, is defined as both exami

21、nation (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. conducted in accordance with MIL-STD-105 and as specified herein. Unit of product for exami

22、nation purposes shall be one sponge. Sampling shall be Inspection level II with an acceptable quality level (AQL) of 1.0. Samplins for examination. Sampling for examination shall be Examination. Examination shall be conducted to determine compliance with specification requirements. Samplina for test

23、s. Sampling for tests shall be conducted in accordance with MIL-STD-105 and as specified herein. product for test purposes shall be one sponge. Inspection level S-2 with an AQL of 1.0. Unit of Sampling shall be Tests. Tests shall be conducted to determine compliance with specification requirements.

24、shall be used for the determination of two or more test characteristics. Where feasible, the same sample Contractor Certification. maintain substantiating evidence that the product offered meets the salient characteristics of this Commercial Item Description, and that the product conforms to the pro

25、ducers 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. The contractor shall certify and 4 Pro

26、vided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54876 W 7777774 0344457 742 W A-A-54 876 ,tric products. Products manu,actured to metric dimensions will be considered on an equal basis with those manufactured using inch-pound units, providing they f

27、all 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 product is manufactured to metric dimensions and those dimensions exceed the tolerances specified in the inch/pound units

28、, 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. Resulatorv reauirements. Federal Food, Drus, and Cosmetic Act. If the product covered by this document has been determined by

29、 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 amended, and regulations promulgated thereunder. In addi

30、tion, 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. Recovered material. The offeror/contractor is encouraged to use recovered mater

31、ial in accordance with Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. Preservation, packasina. D ackina, labelins, and marking. Unless otherwise specified, preservation, packaging, and packing shall be to a degree of protection to preclude damage to containers and/or co

32、ntents thereof under normal shipping conditions, handling, 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

33、 marking shall be as specified in the contract and/or order. Orderino data. (Intermediate/exterior package quantities and labeling and marking must be specified in the contract and/or order). 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-5487

34、6 9999934 0344458 b89 A-A-54876 NOTE: The following National Stock Numbers are covered by this document : - NSN Item Identification Size 6510-00-064-4858 SPONGE, ABSORBABLE GELATIN, USP, 1 20 by 20 by 7mm, 15s. 6510-00-080-2053 SPONGE, ABSORBABLE GELATIN, USP, 2 20 by 60 by 7mm, 12s. 6510-00-080-205

35、4 SPONGE, ABSORBABLE GELATIN, USP, 3 80 by 125 by lorn, 6s. MILITARY INTERESTS: PREPARING ACTIVITY: Custodians: DoD-MB Amy-MD Navy-MS Air Force-O3 Agent : DU-DM CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS USPHS FDA-MPQAS Project No. 6510-0851 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-