DOD A-A-53847-1989 SPECIMEN KIT URINE《尿样本工具》.pdf

1、- A-A-53847 65 799797q 0032384 3 = A-A- 53 8 47 24 March 1989 COMMERCIAL ITEM DESCRIPTION SPECIMEN KIT, URINE The General Services Administration has authorized the use of this Commercial Item Description as a replacement for Military Specification MIL-S-37498 which is cancelled. This Commercial Ite

2、m Description covers an integrated set of compatible, non-sterile components suitable for collecting, transporting, and testing of urine specimens. Salient characteristics: The urine specimen kit shall consist of the following integrated set of compatible non-sterile components for urine specimen co

3、llection, transport, and analysis: 500 - Clear plastic calibrated urine specimen tubes. 500 - Snap caps for tubes. 500 - Adhesive labels for tubes. 50Q - Urine specimen collection cups. 4 minimum quantity - Holders for urine specimen tubes. Urine Specimen Tube. The urine specimen tube shall be made

4、of clear plastic and shall have a capacity of 15 plus or minus 1 milliliters (mi). The top of the tube shall be circular and it shall have a lip to accommodate the snap cap. The tube may terminate in a point (may be slightly rounded) at the bottom to facilitate the collection of centrifuged precipit

5、ate. walls of the tube shall be straight, or shall taper inward toward the bottom. approximate dimensions: The The tube shall have the following Diameter of lip - 7/8 inches Outside diameter - 5/8 inches of tube below lip Length of tube - 4-1/8 inches The tube shall have graduated markings at the 1/

6、4 ml, 1/2 ml or 1 ml level and the-12 ml level. Additional graduation marks shall be acceptable. The tube shall have no breaks, holes, cracks, or sharp edges. AMSC N/A DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. FSC 6530 THIS DOCUMENT CONTAINS 7 PAGES. Provided

7、by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-5 3 8 41 Snap Cap. The cap shall be an easy-on, easy-off plastic snap cap. It may have an integral lift tab or rim. It shall snap on and off the lip of the tube without undue effort and shall fit securely ov

8、er the opening of the tube. The cap shall have no breaks, tears, or sharp edges, and shall protect contents of the tube from dust, other contamination, and spillage. The tube and cap shall show no evidence of leakage when tested. Label. The label shall be white and shall measure 1-3/4 plus or minus

9、1/4 inches by 1-1/4 plus or minus 1/4 inches. The label shall be imprinted with at least three lines for recording data. It shall accept and retain writing from a standard ball-point pen. The label shall be coated on one side with an all-purpose, permanent pressure-sensitive adhesive. The adhesive s

10、urface shall be protected by a strip of suitable removable backing material. The label shall peel freely from the backing and shall adhere firmly to the specimen tube. The label shall not lift or separate from the tube when tested. Cup. The cup shall have a capacity of not less than 3 ounces and sha

11、ll be fabricated of a material suitable for the collection of urine. The cup shall have a flat bottom so that it can stand on a level surface when filled, without rock or wobble. Cups may be constructed so that they can be nested to conserve storage space. The cup shall contain no tears or holes. Th

12、e cup shall show no evidence of leakage when tested. Tube Holder. The tube holder shall be fabricated of cardboard, plastic, or other suitable material, free of tears or other deformations. It shall have inserts, approximately 1-1/2 inches deep, or at least two levels of concentric holes, to hold 10

13、 or more specimen tubes in an upright position. It shall be supplied fully assembled, or shall be capable of being assembled, without the use of tools, fasteners, or adhesive in three minutes or less. The holder shall show no evidence of spillage, deformation, or other failure when tested. All compo

14、nents of the kit shall be free of dirt, oil, grease, or other contamination. Workmanship. The urine specimen kit shall be free from defects which detract from its appearance or impair its serviceability. kit, containing 500 tubes, 500 caps, 500 labels, 500 cups, and four holders as specified, consti

15、tutes one unit. Unit. Package (PG). One package consisting of one specimen 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53847 65 7999974 O032186 7 W - A-A-5 3 a 47 Quality Assurance Provisions. the contract or purchase order, the contractor

16、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 by

17、 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. Responsibility for inspection. Unless otherwise specified in Records. Re

18、cords 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 years after delivery of the

19、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 and chemical properties) o

20、f the item. Tests. Tests shall be conducted to determine compliance with specification requirements. shall be used for the determination of two or more test characteristics. Where feasible, the same sample Samplinq for examination. Sampling for examination shall be conducted in accordance with MIL-S

21、TD-105, with an AQL of 1.0 (percent defective) and an inspection level of II. The unit of product for examination purposes shall be one urine specimen kit as specified in this description. Defects Complete Kit Any component is not provided. Count is less than specified. Marking of components and pac

22、kages is not complete or not present. 3 x _- u Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A- 5 3 8 4 7 Cap Defects (continued) Not free of grease, oil, and dirt. Not free of sharp edges. Not free of breaks and tears. Does not fit securely on s

23、pecimen tube. Tube - Not free of grease, oil, and dirt. Not free of sharp edges. Not free of breaks, holes, and cracks. Plastic cloudy; not clear. Tube does not have specified graduation marks. Tube is not free of waviness, water marks, excessive scratches, or surface cracks greater than 1/4 inch lo

24、ng. Label Backing material cannot be p.eeled freely or is Does not adhere firmly to tube. otherwise inadequate. cup Not free of grease, oil and dirt. Cup is not free from tears or holes. Cup crushed or deformed. Holder Does not support tubes in an upright position. Not free of tears. Not capable of

25、being assembled. Does not accept tubes. Samplinq for tests. test 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 purposes shall be one urine specimen kit. Sampling for tests including dimensional 4

26、 E Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-P A-A-538V7 b5 W 7997774 00321188 O W A-A-53 8 47 a. First article. Where a first article sample is required, b. Acceptance testinq. When a first article sample has not all tests shall be performed o

27、n that unit. been required, one unit shall be subjected to the performance test specified herein. If a test article sample has successfully passed all tests, performance test shall not be required at acceptance. Centrifuqe test. Tubes shall be filled with water to the 12 ml. graduation and placed in

28、 a centrifuge. The centrifuge shall be operated at 2200 revolutions per minute for a 10 minute period. The tubes shall then be removed from the centrifuge and examined for evidence of leakage or breakage. Any evidence of leakage or breakage shall constitute a defect. Tube leakaqe test. Tubes shall b

29、e filled with water to the 12 ml. level. The caps shall be fastened on and all traces of water removed from the exterior of the tubes and caps. The tubes shall be held upside down for two minutes, and then placed lengthwise on a horizontal surface in a vacuum chamber and subjected to a negative pres

30、sure of 6 inches of mercury for one hour at normal room temperature (650 F to 900 F), At the end of the hour the tubes shall be examined for any evidence of leakage, Any evidence of leakage shall constitute a defect. Cup leakaqe test. Cups shall be filled with 2-1/2 fluid ounces of water and left st

31、anding upon a level surface for 2 hours at room temperature. Cups shall then be examined for any evidence of leakage. Any evidence of leakage shall constitute a defect. Tube holder test. Ten tubes shall be filled to the 12 ml. level and placed in the holder. Each tube shall be removed and replaced t

32、wice, and allowed to remain in the holder for 2 hours. After 2 hours, the tube holder shall be examined for any evidence of failure to support the tubes upright without spillage. Any evidence of failure shall constitute a defect. Label adhesion. Specimen tubes shall be filled with 12 ml. of water at

33、 room temperature and capped. A label shall be applied firmly to each tube. The tubes shall be refrigerated at 40 F or less for a period of a-t least 10 hours. Tubes shall then be centrifuged at 2200 revolutions per minute for a 10 minute period. The tubes shall then be removed from the centrifuge a

34、nd examined for any evidence of labels lifting from the tube surface. Any evidence of label lifting from the tube surface shall constitute a defect. 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- A-A-53897 65 7779979 0032187 2 A-A-53 8 47 Metric

35、products. Products manufactured to metric dimensions will be considered on an equal basis with those manufactured using ir.ch/pound units, providing they fall within the tolerances specified using conversion tables contained in the latest revision of Federal Standard 376, and all other requirements

36、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, a request should be made to the contracting officer to determine if the product is acceptable. The contracting officer has the option of accepting

37、 or rejecting the product. Contractor certification. The contractor shall certify that the 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 t

38、o require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract. Regulatory requirements. Federal Food, Drug and Cosmetic Act. If the product covered by this document has been determined by the U.S. Food and Drug Admini

39、stration 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 addition, the offeror/contractor sha

40、ll 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 recovered material in accordance with Public L

41、aw 94-580, as amended, and as implemented by Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-i A-A- 5 3 8 47 Preservation, packaqinq, packinq, labeling, and markinq. Unles

42、s 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 activity, plus reshipment from receivin

43、g 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: document: The following National Stock Number is covered by this 6530-00-075-6636 Orderinq data.

44、 Intermediate/exterior package quantities, labeling, and marking must be specified in the contract and/or order. MILITARY INTERESTS: PREPARING ACTIVITY: Custodians: DoD - MB Army - MD Navy - MS Air Force - 03 Agent: DLA-DM CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS PHS FDA-MPQAS Project No. 6530-2008 Location: CID/SPECIMEN/CUP/Hl3-32 O 7 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-