DOD A-A-54273-1990 CEMENT ZINC OXIDE AND EUGENOL DENTAL (INTERMEDIATE RESTORATIVE MATERIAL)《牙齿氧化锌和丁子香酚结合剂》.pdf

1、A-A-54273 b5 7777774 0057554 3 W A-A-5427 3 31 October 1990 COMMERCIAL ITEM DESCRIPTION CEMENT, ZINC OXIDE AND EUGENOL, DENTAL (Intermediate Restorative Material) The General Services Administration has authorized the use of this Commercial Item Description as a replacement for Military Specificatio

2、n MIL-C-36757A which is cancelled. This commercial item description covers zinc oxide and eugeno dental cement suitable for use as an intermediate restorative material. Salient characteristics: The cement package shall consist of a minimum of 38.0 grams (9) of ivory colored powder, a minimum of 14.0

3、 milliliters (ml) of liquid, a plastic dropper, a plastic powder scoop, and a set of instructions for use. Powder. The composition of the cement powder shall be essentially zinc oxide, a zinc acetate accelerator, and high molecular weight polymethyl methacrylate. Cement powder shall contain no abras

4、ive fillers such as quartz or alumina. The quality of the materials shall be as follows: a. Zinc oxide shall be in accordance with the U.S.P. for lead and arsenic content only. b. Zinc acetate shall be U.S.P. C. The polymethyl methacrylate shall be nontoxic. The manufacturer shall submit a statement

5、 to the contracting officer that the polymer furnished has no toxic effect on the normal, healthy person, Liquid. The composition of the liquid shall be eugenol, U.S.P. with acetic acid, A.C.S. added as an accelerator. Accessories. The powder scoop shall be fabricated of clear styrene and shall deli

6、ver 0.20 to 0.24 grams of powder. AMSC N/A FSC 6520 DISTRIBUTION STATEMENT A: Approved for public release; distribution is unlimited. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54273 Instructions. Adequate and accurate instructions for using

7、 the dental cement shall accompany each unit package. In addition, the instructions shall include setting time, mixing time, powder-liquid ratio, and methods for proportioning and manipulating the cement, including number of drops of liquid required to mix with one scoop of powder to make a mix of 5

8、.2 to 6.3 powder-liquid ratio by weight. Two copies of the instructions shall be forwarded to the contracting officer for information purposes. The dental cement shall be suitable as a sedative intermediate restorative material which may also be used as a base under amalgam restorations. The cement

9、shall not form lumps, granules, or evolve gas when mixed according to the manufacturers instructions, Physical properties, The cement shall have the following physical properties when tested as specified below. The setting time shall be 7.5 to 9.5 minutes. The compressive strength shall be 9000 poun

10、ds per square inch, minimum. The solubility and disintegration shall be 0.12 percent by weight, maximum. The film thickness shall be 50 to 90 microns (0.0020 to 0.0035 inches). The consistency shall be 16.5 to 19.5 millimeters. Immediate container. Immediate container for the cement powder shall be

11、a plastic bottle. Immediate container for the liquid shall be an amber glass bottle with screw cap closure. Each bottle shall be permanently and legibly marked with the lot number, date of manufacture, and inspection test date. Each bottle shall be further marked with the following legend: “STORE AT

12、 CONTROLLED ROOM TEMPERATURE 15O-3OoC (59O-86OF)“. Shelf life. The shelf life of the cement shall be not less than 24 months from date of manufacture when stored at controlled room temperature (59O to 86F). Delivery schedule. Not more than 4 months shall have elapsed from the date of manufacture of

13、the cement to the date of delivery to the Government. Workmanship. The powder and liquid shall be free from all dirt, foreign materials, and impurities which detract from their appearance or which may impair their serviceability. 2 Provided by IHSNot for ResaleNo reproduction or networking permitted

14、 without license from IHS-,-,-A-A-54273 b5 7779774 0057556 7 A-A-54273 - Unit. Package (PG). One package containing one bottle of powder, one bottle of liquid, a dropper, a powder scoop, and instructions for use, as specified, constitutes one unit. Quality Assurance Provisions. Responsibility for in

15、spection. Unless otherwise specified 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

16、 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 services conform to prescribed

17、 requirements. Records. Records of examinations 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 y

18、ears after delivery of the supplies to which 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

19、 and chemical properties) of the item. Sampling for inspection. Sampling for inspection shall be conducted in accordance with MIL-STD-105. Where feasible, the same sample shall be used for the determination of two or more inspection characteristics. purposes shall be one package of cement. Unless ot

20、herwise specified, sampling for examination shall be conducted at inspection level II, AQL 2.5, and sampling for tests shall be conducted at inspection level S-1, AQL 1.0. The unit of product for inspection 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from I

21、HS-,-,-9, A-A-5q273 b5 7777774 0057557 7 A-A-5427 3 a Examination. The dental cement shall be examined for defects including, but not limited to, those listed below: Defects. Package does not contain all specified components. Powder not homogeneous or free of extraneous material. Liquid not clear or

22、 has significant color. Bottle for liquid not amber or does not have screw cap Loose caps, broken bottles, leaks, etc. present. Marking of immediate containers not as specified. instructions missing, incorrect, incomplete, or closure. illegible. Tests. Tests shall be conducted to determine complianc

23、e with specification requirements. Preparation of test specimens. The preparation of test specimens shall be conducted at a temperature of 70 to 75“F, and 45 to 55 percent relative humidity with a powder-liquid ratio of 5.2 to 6.3 by weight (standard consistency). Consistency. The procedure for the

24、consistency test shall be as described in American Dental Association (ADA) Specification No. 30 for Dental Zinc Oxide-Eugenol Type Restorative Materials, except that a 520 gram load (500 gram weight and 20 gram glass plate) shall be applied 2 minutes after the mix is started. The load shall be appl

25、ied for 8 minutes. Then consistency shall be measured. O Settinq time. A mix of cement using 0.25 ml of liquid and an amount of powder in proportion shall be loaded into a polyethylene crown form cap with approximate internal dimensions of 9.5 mm diameter by 7 mm deep. Type A durometer hardness shal

26、l be determined as described in ASTM designation D2240. Readings shall be taken at 0.5 minute intervals. Hardness shall be plotted against time, and the setting time in minutes shall be the interpolated value of time when durometer reading equals 50. Setting time shall be reported to the nearest 0.5

27、 minute. 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54273 b5 9 9999974 0057558 O e. r, A-A-54273 Compressive strenqth. Procedure for compressive strength test shall be as described in ADA Specification No. 30. Test equipment used for deter

28、mining compressive strength shall be the Instron Corporations Test Machine, or other suitable equipment, provided prior approval is received from the contracting officer. Testing conditions on the Instron test machine shall be as follows: a. Crosshead speed of 0.2 inch per minute. b. Force range of

29、1000 pounds. c. Chart speed of 10 inches per minute. The value for compressive strength shall be reported as the average of three or more from a group of five specimens and shall be rounded off to the nearest 50 pounds. If the values for individual specimens fall more than 15 percent below the avera

30、ge of the five, they shall be discarded and the average of the remaining specimens shall be reported. In case more than two of the specimens are eliminated, the test shall be repeated. Solubility and disintesration. Procedure for solubility and disintegration test shall be as described in ADA Specif

31、ication NO. 30, Film thickness. Procedure for film thickness test shall be as described in ADA Specification No. 30. Contractor certification. The contractor shall certify that O the product offered meets the salient characteristics of this description and conforms to the producers own drawings, spe

32、cifications 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. Metric products. Products manufactured to metric dimensions will

33、 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 other requirements of this document are met. 5 Provided by IHSNot for Res

34、aleNo reproduction or networking permitted without license from IHS-,-,-A-A-54273 65 7777774 0057559 2 A-A-54273 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 dete

35、rmine if the product is acceptable. The contracting officer has the option of accepting or rejecting the product. Resulatorv requirements. Federal Food, Drug and Cosmetic Act. If the product covered by this document has been determined by the U.S. Food and Drug Administration to be under its jurisdi

36、ction, 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 of regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible

37、 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 recovered material in accordance with Federal Acquisition Regulation Subpar

38、t 23.4 to the maximum extent practical. Preservation, packaging, packinq, labelins, 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

39、., 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. 6

40、 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54273 NOTE: The following National Stock Number is covered by this document: National Stock Number Item Identification 6520-00-181-7732 CEMENT, ZINC OXIDE AND EUGENOL, DENTAL, intermediate Restor

41、ative, Ivory, 38 Gram Orderinq data. (ntermediate/exterior package quantities, labeling, and marking must be as specified in the contract and/or order). MILITARY INTERESTS: Custodians: Army - MD Navy - MS AIR FORCE - 03 PREPARING ACTIVITY: DoD-MB AGENT : DLA-DM crvm AGENCY COORDINATING ACTIVITIES: VA-OSS PHS FDA-MPQAS PROJECT NO. 6520-2362 LOCATION: WORD/CEMENTPAUL 7 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-