DOD A-A-54210-1990 SCISSORS EYE (IRIS STRABISMUS TENOTOMY AND ENUCLEATION)《眼状物剪刀(割腱术和剜出器斜视)》.pdf

1、I I A-A-54210 b5 7777774 0058280 8 m A-A-54 2 10 7 November 1990 COMMERCIAL ITEM DESCRIPTION SCISSORS, EYE (Iris, Strabismus, Tenotomy and Enucleation) The General Services Administration has authorized the use of this commercial item description as a replacement for Federal Specification GG-S-167A

2、which is cancelled. This commercial item description covers ophthalmic scissors of the iris, strabismus, tenotomy and enucleation design for use in surgical procedures on the eye. Commercial Item Description Sheet. Scissors shall be in accordance with all requirements specified herein and the applic

3、able Commercial Item Description Sheet (slash sheet- See Note). Salient characteristics: General. Eye scissors shall be of the following types and classes. Type I. Iris. Class 1. -Straight, 4-1/4 inches. Class 2. -Full Curved, 4-1/4 inches. Class 3. -Angular, 4-1/2 inches. Type II. Strabismus, 4-1/4

4、 inches. Type III. Tenotomy. Class 1. -Straight, 4-1/4 inches. Class 2. -Curved, 4-1/4 inches. Type IV. Enucleation, 5 inches. Material. The material shall be Class 4 corrosion resistant steel in accordance with ASTM F899. Style, desisn and dimensions. Types and classes shall be in accordance with a

5、pplicable Commercial Item Description Specification Sheet and as specified herein (See Note). 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 from IHS-,-,-A-A-5 4

6、2 1 O Hardness. Scissor blades shall have a Rockwell Hardness C scale (HRC) of 50 to 55 when tested in accordance with ASTM Designations E18 or E92 whichever is applicable. of hardness values shall be in accordance with ASTM Designation E140. Conversion Finish. The finish of the instrument shall be

7、mirror, satin or matte. The matte finish shall exhibit a uniform nondirectional surface texture equivalent to that produced by lightly blasting the prepared surface with fine abrasives under pressure. Passivation. Corrosion resistance. corrosion or plating of copper when tested for corrosion resista

8、nce in accordance with ASTM Designation F1089. Performance. Scissors shall be tested in accordance with scissors performance requirements of ASTM Designation F1079. Identification markinq. with the contractors name or registered trademark and the word ltstainlesst1. bear the name of the country of o

9、rigin. Workmanship. Scissors shall meet the workmanship, finish, and appearance requirements in ASTM Designation F1079 as applicable. Scissors shall be properly passivated. Scissors shall show no signs of Scissors shall be legibly marked Scissors of foreign manufacture shall PRODUCT QUALITY LEVEL. V

10、isual and dimensional examination. Scissors shall be examined to verify that design, construction and workmanship are in accordance with applicable requirements. Materials. The supplier shall be responsible for performing tests to assure that materials are in accordance with requirements. Unit. Each

11、 (EA). One scissor of the type and class specified, constitutes one unit. 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54210 b5 m 7777774 0058282 L A-A-54 2 10 Quality Assurance Provisions. Responsibility for inspection. Unless otherwise spe

12、cified 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 inspec

13、tion requirements specified herein, unless disapproved by the Government. The Government reserves the right to perform any of the inspections cet forth in the specification where such inspections are deemed necessary to assure supplies and services conform to prescribed requirements. Records. Record

14、s 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 the performance of the contract and for a period of three years after delivery of the supplies to which suc

15、h 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) of the item. conducted

16、 in accordance with MIL-STD-105, and as specified herein. Unit of product for examination purpose shall be one scissor. Sampling shall be inspection level II with an acceptable quality level (AQL) of 1.0. Samplins for examination. Sampling for examination shall be Examination. Scissors shall be exam

17、ined to determine compliance with all specification requirements. Samplins for tests. Sampling for tests shall be conducted in accordance with MIL-STD-105 and as specified herein. The unit of product for test purposes shall be one scissor. Sampling shall be inspection level S-2 with an AQL of 1.0. T

18、ests. 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. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-542

19、10 b5 M 7777734 0058283 3 A-A-54 2 1 O Contractor certification. The contractor shall certify that the product offered meets the salient characteristics of this description and conforms to the practices. The Government reserves the right to require proof of such conformance prior to first delivery a

20、nd there-after as may be otherwise provided for under the provisions of the contract. 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,

21、 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, a request should be made to the contracting offic

22、er to determine if the product is acceptable. The contracting officer has the option of accepting or rejecting the product. Regulatory requirements. Federal Food, Druq and Cosmetic Act. If the product covered by this document has been determined by the U.S. Food and Drug Administration to be under i

23、ts 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 shall comply, and be resp

24、onsible 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

25、 Subpart 23.4 to the maximum extent practical. 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-542LO 65 W 7799774 0058284 5 = A-A-5 4 2 1 O Preservation, packasins, 13 ackins, labelins and markinq. Unless otherwise specified, preservation. pack

26、aging 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 receiving activity, and shall conform to applicabl

27、e carriers rules and regulations. Intermediate and exterior package quantities, labels and markings shall be as specified in the contract and/or order. NOTE : Ordering data. Purchasers should select the preferred options permitted herein and include the following information in the procurement docum

28、ents: (a) Title, number and date of this specification. (b) Title, number and date of the applicable specification sheet which shall include this specification letter and number, and the slash number. Examples: A-A-54210/1 Scissors, Iris A-A-54210/2 Scissors, Strabismus A-A-54210/3 Scissors, Tenotom

29、y A-A-54210/4 Scissors, Enucleation 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. 6515-4606 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-