DOD A-A-54923-1993 WAX BONE《骨蜡》.pdf

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1、A-A-5 4 9 2 3 8 October 1993 COMMERCIAL ITEM DESCRIPTION WAX, BONE The General Services Administration has authorized the use of this Commercial Item Description as a replacement for Military Specification MIL-W- 36795(2), which is cancelled. This Commercial Item Description covers sterile bone wax

2、suitable for use in orthopedic surgery and suitable for hemostasis in the treatment of bone cavities. Salient characteristics: Material. The bone wax shall be a mixture of bees wax and almond oil, with 2 percent (f. 0.5 percent) salicylic acid or a mixture of mismo bees wax and isopropyl palmitate.

3、ratio of ingredients shall be such that the melting point of the bone wax shall not Be less than 57.0 degrees centigrade (OC) nor more than 65.0 C. The finished product shall be of such consistency as to be suitable for hemostasis in the treatment of bone cavities. The The bees wax shall be either w

4、hite or yellow as monographed in the USP or NF. All ingredients which are monographed in USP or NF shall comply with those compendia in all respects. If an ingredient is not monographed in the USP or NF, it shall be of a high quality and a purity suitable for the intended use. Packet assembly. Each

5、packet shall contain 2 to 3 grams (gm.) of bone wax. Each packet shall consist of an inner and outer container as specified. Foil inner container. The foil container shall be a combination of plastic and aluminum foil closed by heat sealing, and shall be fabricated in such a manner and of such mater

6、ial as to maintain the sterility of the bone wax. The sealed foil container shall have two free tabs along the top edge capable of being readily peeled back along the edges to expose the bone wax. AMSC N/A FSC 6515 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. Pro

7、vided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-5 4 9 2 3 Tube tvpe inner container. As an alternate, the sterile bone wax shall be contained in a suitable tin or tin-copper alloy tube dispenser. The weight of the wax and dispenser shall not exceed

8、6 grams. The dispenser shall be suitable for dispensing bone wax during surgical procedures. Outer container. The outer container shall be fabricated of a combination of plastic and aluminum foil closed by heat sealing, and shall be fabricated in such a manner and of such material as to maintain the

9、 sterility of the inner container. The sealed outer container shall have two free tabs along the top edge, capable of being readily peeled back along the sealed edges to expose the inner container. The outer container shall be so designed as to permit ready dispensing of the sterile inner container

10、by aseptic techniques. Sterility. The entire contents of the packet assembly shall be sterile when tested as specified. Salicylic acid content determination. The salicylic acid content shall be determined as specified. Meltinq point. less than 57OC nor more than 65.OoC when tested as specified. The

11、melting point of the wax shall be no Item identification. marked with the item name, and name or registered trademark of the manufacturer. The inner container shall be legibly Sterility. The bone wax shall be sterile when tested in accordance with the USP or AAMI guidelines. Assurance Level shall be

12、 0.00001. Sterility Workmanship. The bone wax shall be free from defects which detract from its appearance or impair its serviceability. Unit. Package (PG). One package containing 12 immediate containers of one type only, as specified, constitutes one unit. immediate containers: Bone wax shall be pa

13、ckaged in either of the following Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- - - .I A-A-54923 W 9999974 0355700 3T0 A-A-5 4 9 2 3 Two to 3 grams of bone wax shall be supplied in a heat- sealed peel-open plastic and foil waterproof immediate con

14、tainer capable of maintaining sterility of contents unless package is damaged or opened. As an alternate, 2 to 3 grams of bone wax shall be supplied in a suitable tin or tin-copper alloy tube dispenser suitable for dispensing bone wax during surgical procedures. The immediate container shall be furt

15、her packaged in a heat-sealed peel-open plastic and foil outer container, which shall permit ready dispensing of the sterile inner container by aseptic techniques. Ouality Assurance Provisions. Responsibility for inspection. Unless otherwise specified in the contract or purchase order, the contracto

16、r 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 herein, unless disapproved

17、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 examinations and tests performed by or for the con

18、tractor 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 the delivery- of the supplies to which such records relate. Inspection. ins

19、pection, 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. Examination. Examination shall be conducte

20、d to determine compliance with specification requirements. Samplinq for examination. Sampling for examination shall be conducted in accordance with MIL-STD-105 and as specified. Unit of product for examination purposes shall be one package of bone wax as specified. Sampling shall be inspection level

21、 II with an Acceptable Quality Level (AQL) of 1.0. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54 9 2 3 Tests. Tests shall be conducted to determine compliance with specification requirements. Where feasible, the same sample shall be used f

22、or the determination of two or more test characteristics. Sterility test. Each sterility lot shall be sterile when tested for sterility in accordance with the sampling and sterility test methods of the USP for ointments. Methods for determination of salicylic acid in bone wax. The determination of s

23、alicylic acid for compliance with requirements of this specification shall be performed as specified. Reaqents. Reagents to be used in determination of salicylic acid shall be as follows: (1) Benzene-Methanol Solution: Benzene, U.S.P. Reagent, 3 Volumes, plus Methanol, U.S.P. Reagent, 1 Volume. (2)

24、Ferric nitrate solution: 1.0 gm. Fe (N03)3. 9H20 in 100 cubic centimeters (cc.) of 1.0% “O3. (3) Standard solutions. Accurately weigh exactly 0.500 gm. of salicylic acid and dissolve in water to make 500 cc. Four standard solutions shall be prepared by diluting each of 0.5 cc., 1.0 cc., 1.5 cc., and

25、 2.0 ccI portions of the salicylic acid solution, described above, with distilled water to make 50 cc. Procedure. Dissolve approximately 50 milligrams (mg.) of bone wax, accurately weighed, in 3 cc. of Benzene-Methanol Solution contained in a 50 cc. volumetric flask, warming gently, if necessary. To

26、 the cooled solution add exactly 5.0 cc. of ferric nitrate solution. Then add enough water to make approximately 45 cc. and shake vigorously for 1 minute. Allow the two immiscible liquids to separate, and then add water to bring the aqueous layer to the 50 cc. mark. Draw off the benzene layer by mea

27、ns of a medicine dropper, pipette, or other suitable means. Centrifuge a portion of the aqueous solution to free the solution from suspended benzene droplets. Determine the absorbance of this aqueous solution by use of a suitable spectrophotometer, at wave length 525 millimicrons. Use a solution, pr

28、epared with the same quantities of the same reagents in a similar manner as a blank. Prepare a calibration curve of the standard solutions employing the above method and reagents. Determine the concentration of the sample solution from this curve. I e O e 4 Provided by IHSNot for ResaleNo reproducti

29、on or networking permitted without license from IHS-,-,- -_. A-A-54923 m 9999974 0355702 373 m A-A- 5 4 9 2 3 Method for determination of meltins point. The melting point determination shall be conducted in accordance with procedure for class II or III as specified, under “Melting Range or Temperatu

30、re“, inthe current edition of the Pharmacopeia of the United States. Three samples from each lot shall be tested. If the variation among the three determinations is less than 1 degree, their arithmetical average shall be considered as the melting point of the lot represented. three determinations is

31、 greater than 1 degree, two additional determinations shall be made and the arithmetical average of the five determinations shall be considered as the melting point of the lot represented. a If the variation among the Samplinq for tests. Sampling for tests shall be conducted in accordance with MIL-S

32、TD-105 and as specified. Unit of product for test purposes shall be one package of bone wax. Sampling shall be inspection level S-2 with an AQL of 1.0. Contractor certification. maintain substantiating evidence that the product offered meets the salient characteristics of this Commercial Item Descri

33、ption, and that the product 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 otherwise provided for under the provisions of the c

34、ontract. 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 tolerances specified using conversion tables contained in the latest revision of Federal Standard No. 376, and all

35、other requirements of this document are met. The contractor shall certify and 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.

36、 The contracting officer has the option of accepting or rejecting the product. 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54 92 3 Requlatory requirements. Federal Food, Druq and Cosmetic Act. If the product covered by this document has bee

37、n 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 amended, and regulations promulgated thereu

38、nder. 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. Recovered materials. The offeror/contractor is encouraged to use r

39、ecovered material in accordance with Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. Preservation, packaqinq, p ackinq, labelins, and markinq. Unless otherwise specified, preservation, packaging and packing shall be to a degree of protection to preclude damage to contain

40、ers and/or contents 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

41、 labeling and marking shall be as specified in the contract and/or order. Orderinq data. Intermediate/exterior package quantities, labeling, and marking must be as specified in the contract and/or order. . NOTE: The following National Stock Number and its respective Item Identification is covered by

42、 this document: National Stock Number Item Identification 6515-00-965-2511 6 Wax, Bone, Sterile, 12 Packets Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-_ _ % A-A-54923 9999974 0155704 T4b A-A-54 92 3 MILITARY INTERESTS: Preparing 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. 6515-5433 Location: c:wordpaulwax 7 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-