DOD A-A-54351-1991 SPECULUM VAGINAL (PLASTIC)《阴道诊视器》.pdf

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1、/ ,= A-A-54351 65 W 9999974 0060395 2 W I. A-A-54 3 5 1 15 March 1991 COMMERCIAL ITEM DESCRIPTION SPECULUM, VAGINAL (Plastic) The General Services Administration has authorized the use of this commercial item description as a replacement for Military Specification MIL-S-37392A which is cancelled. Th

2、is commercial item description covers one type of disposable, adjustable, vaginal speculum suitable for use in gynecological procedures. Salient Characteristics: General. The speculum shall be size 1- small 3-5/8 inch long blade, size 2-medium-4.inch long blade or size 3-large- 5 inch long blade. Th

3、e speculum shall be designed to adjust and hold any one of a minimum of 4 different open positions. The speculum shall be designed for one-handed operation and shall be siliconized for increased lubricity. The manufacturer shall supply instructions for use with each unit package. Material. Material

4、of the speculum shall be fabricated from clear, rigid plastic. The outer surface of the speculum blades shall be coated with a thin layer of siliconized lubricant. Stvle, desiqn and dimensions. The speculum shall be in accordance with Defense Personnel Support Center (DPSC) Drawing No. 24366 for sty

5、le, design and dimensions. Performance. The speculum shall not crack, break, or unlock at any point when tested as specified. be found biologically suitable when tested in accordance with the requirements of the USP for Class II plastics (See Note 2). The speculum shall Identification markins and la

6、belins. Each speculum shall clearly and legibly bear the name of the manufacturers name or registered trademark. AMSC N/A FSC 6515 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. Provided by IHSNot for ResaleNo reproduction or networking permitted without license fr

7、om IHS-,-,- A-A-54351 65 9997974 0060396 4 A-A-54 3 5 1 WorkmanshiD. Workmanship shall be first class throughout. The speculum shall show a smooth finish outer surface free from pits, flash, scale and holes. All edges shall be smooth. Visual and dimensional examination. Speculums shall be examined t

8、o verify that design, construction and workmanship are in accordance with applicable requirements. Materials. tests to assure that materials are in accordance with requirements. The supplier shall be responsible for performing Unit. Package (PG). One package containing one hundred speculums of the s

9、ize specified, constitutes one unit. OUALITY ASSURANCE PROVISIONS. Responsibilitv for inspection. Unless otherwise specified in the contract or purchase order, the contractor is responsible for the performance of all inspection requirements as specified herein. Except otherwise specified in the cont

10、ract 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 the Government. The Government reserves the right to perform any of the inspections set forth in the specification where such i

11、nspections are deemed necessary to assure supplies and services conform to prescribed requirements. Records of examinations 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

12、the performance of the contract and for a period of three years after delivery of the supplies to which such records relate. Records. Inspection. Inspection, as used herein, is defined as both examination (such as visual or auditory investigation without the use of special laboratory appliances or p

13、rocedures) and testing (determination by technical means and chemical properties) of the item. SamDlinq 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 speculum. Sampling shall

14、be inspection level II with an acceptable quality level (AQL) of 1.0. 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54351 65 W 9999974 0060397 6 W A-A-54 3 5 1 Examination. Examination shall be conducted to determine compliance with specifica

15、tion requirements. in accordance with MIL-STD-105 and as specified herein. product for test purposes shall be one speculum. be inspection level S-2 with an AQL of 1.0. Samplins for tests. Sampling for tests shall be conducted Unit of Sampling shall Breakins test for lock and blades. Open and lock th

16、e speculum blades in the fully open position. Support the bottom blade securely on a flat, firm surface and gradually apply a force to the upper blade 1/2 +/- 1/8 inch from the distal end. For the small speculum, apply a weight of 8.0 pounds, the medium speculum, 7.0 pounds, for the large speculum,

17、6.0 pounds. 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 the product offered meets the sali

18、ent characteristics of this description and conforms to the producersown 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 prov

19、isions of the contract. 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 ot

20、her requirements of this document are met. Metric Droducts. a 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

21、 officer has the option.of accepting or rejecting the product. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54 3 51 Resulatorv requirements. Federal Food, Drus, and Cosmetic Act. If the product covered by this document has been determined by

22、 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 Cosmetic Act, as amended, and regulations promulgated thereunder. In addition,

23、 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 recovered material i

24、n accordance with Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. Preservation, Dackaqins, D ackins, labelins, and markins. Unless otherwise specified, preservation, packaging, and packing shall be to a degree of protection to preclude damage to containers and/or content

25、s 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 mark

26、ing shall be as specified in the contract and /or order. NOTE 1: The following National Stock Numbers are covered by this document : ” ITEM IDENTIFICATION SIZE 6515-00-149-1606 SPECULUM, VAGINAL, Plastic 3-Large Large, Disposable, 5 Inch Blade, 100s. 6515-00-149-1607 SPECULUM, VAGINAL, Plastic l-Sma

27、ll Small, Disposable, 3-5/8 Inch Blade, 100s 6515-00-914-1543 SPECULUM, VAGINAL, Plastic 2-Medium Medium, Disposable, 4 Inch Blade, 100s. 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-/ A-A-54351 65 m 9999974 O060399 T m A-A-54 3 5 1 NOTE 2: Each

28、 lot need not be biologically tested provided evidence is furnished that samples for the formulation and identical method of processing has previously been tested, that they comply with USP requirements for Class II plastics and that they are the same as being offered in this contract. Ordering data

29、 (Intermediate/exterior package quantities and labeling and marking must be specified in the contract and/or order). 0 MILITARY INTERESTS: Custodians: Army - MD Navy - MS Air Force - 03 Preparing Activity: DoD-MB Agent : DLA-DM CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS PHS FDA-MPQAS Project No. 6515-4794 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-