DOD A-A-54620-1992 ARTHROSCOPIC SYSTEM SURGICAL 4 MM《4MM外科关节(内窥)镜检查系统》.pdf

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1、. A A-A-54620 65 U 9999974 00871133 724 A-A-54 620 21 August 1992 COMMERCIAL ITEM DESCRIPTION ARTHROSCOPIC SYSTEM, SURGICAL, 4 mm The General Services Administration has authorized the use of this commercial item description. This commercial item description covers an arthroscopic surgical system su

2、itable for use in athroscopic surgical procedures. Salient characteristics: The system shall be a 4 millimeter (mm) arthroscopic surgical system, suitable for use during joint visualization or during arthroscopic surgery procedures. The system shall consist of the following components: Component Qua

3、ntity Telescope 1 Pyromidal Trocar 1 Conical Obturator 1 Trocar Sleeve, Self-Locking with Stopcock 1 Cable, Fiberoptic 1 Fiberoptic Telescope. Fiberoptic Arthroscopic telescope with a 25O viewing angle, providing for a panoramic view without loss of contrast. The telescope shall be fabricated of a s

4、uitable corrosion resisting steel, properly hardened and passivated and in accordance with ASTM F899. The proximal eyepiece shall be of bakelite material and shall not crack during ethylene oxide or steam sterilization. The system shall contain a 4 mm The fiber bundles width shall be a minimum of 3.

5、8 mm. Illumination and brightness through the lens shall produce true to life reproduction of color in both video and still photography. The telescope shall have an overall nominal length of 23.5 centimeter (cm) and a working length of 17.7 cm. Shall fit smoothly and securely lock into a 5 mm self-

6、locking trocar sleeve. AMSC N/A FSC 6515 DISTRIBUTION STATEMENT A: distribution is unlimited. Approved for public release; Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54620 b5 = 9999974 0087434 bbO & A-A-5 4 6 2 O A fiberoptic light cord adap

7、ter shall be an integral part of the proximal portion of the telescope and shall be located immediately distal to the bakelite eyepiece. The proximal end of the telescope shall be color coded to match other component parts of the arthroscopic system in use. Either the millimeter size or the company

8、stock number shall be clearly imprinted somewhere on the proximal end of the telescope. The telescope shall be approximately 23.5 cm and shall have a working length of approximately 17.7 cm. Pyromidal trocar. The system shall contain a 4 mm corrosion-resisting steel trocar. The trocar shall fit smoo

9、thly into the 5 mm trocar sleeve with no gaping between the sleeve and the trocar at the distal end. When inserted into the 5 mm trocar sleeve the trocar tip shall protrude from the sleeve. The distal tip shall be beveled on two aspects to form a sharp trocar. The trocar shall have an overall length

10、 of 21 cm and a working length of 18.6 cm. The trocar shall have an integral collar with lateral metal projections for a secure fit into the collar of the 5 mm self-locking arthroscopic trocar sleeve. The extreme proximal end of the trocar shall be color coded to match other component parts of the a

11、rthoscopic system in use. Either the millimeter size or the company stock number shall be clearly imprinted on the proximal end of the trocar. Conical obturator. The system shall contain a 4 mm corrosion-resisting steel obturator properly hardened and passivated. Shall be fabricated from stainless s

12、teel Type 303 or 304 in accordance with ASTM F899. When inserted into the 5 mm trocar sleeve the obturator shall fit smoothly without gaping between the sleeve and the obturator at the distal end. When inserted into the 5 mm trocar sleeve the conical end shall protrude. The distal tip shall be blunt

13、 and conical in shape. The obturator shall have an overall length of 21 cm and a working length of 18.6 cm. The obturator shall have an integral collar with lateral metal projections for a secure fit into the collar of a 5 mm self locking arthroscopic trocar sleeve. 2 . a a a Provided by IHSNot for

14、ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54620 65 9999974 0087435 5T7 H A-A-54 62 O The extreme proximal end shall be color coded to match other component parts of the arthroscopic system in use. Either the millimeter size or the company stock number shall be cl

15、early imprinted on the proximal end of the obturator. Trocar sleeve, self lockins with stopcock. The system shall contain a corrosion-resisting steel trocar fabricated from stainless Type 303 or 304. The sleeve diameter shall be 5 mm and be specifically designed for accommodating a 4 mm arthroscopic

16、 trocar and telescope. The overall length of the trocar sleeve shall be a nominal 17.7 cm and the working length shall be 13.1 cm. The proximal end shall have a self locking collar which prevents the telescope from disengaging. The distal end shall be slightly angulated with smooth edges for decreas

17、ing the possibility of tissue damage. Several smooth edged holes shall be located on the lateral aspect of the distal tip. The trocar sleeve shall have a single integral luer-lock stopcock on the proximal portion of the sleeve shaft. The self locking collar shall be color coded to match other compon

18、ent parts of the arthroscopic lens system. The millimeter size or the company stock number shall be clearly imprinted on the locking collar. Fiberoptic cable. The system shall contain a fiberoptic cable having minimum length of 1.8 meters with a 4 mm bundle diameter. The cable ends shall be specific

19、ally designed for adapting into a 4 mm arthroscope and a fiberoptic light source without an adapter. Both ends shall have a strain relief sleeve for protection against sharp bending. The fiber light cables shall be covered with medical grade silastic rubber tubing. The metal portions of the cable sh

20、all be fabricated from a corrosion resistant stainless steel Class 3, Type 302 or equal in accordance with ASTM F899. Compatibility. All components of the arthroscope shall be compatible, one with the other. Sterilization. All components shall be capable of withstanding repeated sterilization via st

21、eam at 275OF or ethylene oxide or long term 10 hour soaking in cold sterilization solution procedures. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-5 4 6 2 O Finish. The system shall be fabricated from materials which are inherently resistan

22、t to corrosion or which are treated to render them corrosion-resistant. Where painting or plating is used, appropriate cleaning and priming shall be performed prior to finishing. Unless otherwise specified, finish shall be equivalent or superior to that of comparable commercial equipment and shall b

23、e free of gaps, scratches, chips, and other imperfections. Workmanship. The arthroscopic surgical system shall be free from defects which detract from its appearance or impair its serviceability. Unit. Each (EA). One arthroscopic surgical system, as specified, constitutes one unit. QUALITY ASSURANCE

24、 PROVISIONS. Responsibility for inspection. Unless otherwise specified in the contract of 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

25、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 inspections are deemed necessary to assure supplies

26、and services conform to prescribed 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 con

27、tract and for a period of three years 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 (determinati

28、on by technical means of physical and chemical properties) of the item. Samplinq for tests. Sampling for tests shall be conducted in accordance with MIL-STD-105 and as specified herein. product for test purposes shall be one arthroscopic. surgical system. 1.0. Unit of Sampling shall be inspection le

29、vel S-2 with an AQL of 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54620 65 m 9999974 0087437 37T m A-A-5 4 6 2 O Tests, Tests shall be conducted to determine compliance with specification requirements. Where feasible, the same sample shall

30、 be used for the determination of two or more test characteristics. Contractor certification. The contractor shall certify and maintain substantiating evidence that the product offered meets the salient characteristics of this Commercial Item Description, and that the product conforms to the produce

31、rs 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 contract, Requlatory requirements. Federal Food, Dru

32、q, 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 jurisdiction, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of the Federal Food, D

33、rug and Cosmetic Act, as amended, and regulations promulgated thereunder. 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

34、. Recovered materials. The offeror/contractor is encouraged to use recovered material in accordance with Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. Preservation, packaqinq, p ackinq, labelinq, and markinq. Unless otherwise specified, preservation, packaging, and pac

35、king 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 applicable carriers rul

36、es and regulations, Intermediate and exterior package quantities and labeling and marking shall be as specified in the contract and/or order. Orderins data. Intermediate/exterior package quantities and labeling and marking must be specified in the contract and/or order. NOTE 1: The following Nationa

37、l Stock Number and its respective Item Identification is covered.by this document: 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54 6 2 O NATIONAL STOCK NUMBER ITEM IDENTIFICATION 6515-01-206-5971 ARTHROSCOPIC SYSTEM, SURGICAL, 4 mm NOTE 2: T

38、he following National Stock Numbers, and Item Identifications are applicable for this Commercial Item Description: NATIONAL STOCK NUMBER ITEM IDENTIFICATION 6515-01-171-6050 TELESCOPE, ARTHROSCOPIC, PANORAMIC, 25O Viewing Angle, 4 mm Outside Diameter 6515-01-166-3528 TROCAR, PYROMIDAL TIP, 1 mm, Out

39、side Diameter 6515-01-166-3504 OBTURATOR, ARTHROSCOPE, 4 mm Diameter, Color Coded, Conical Tip 6515-01-173-2452 ARTHROSCOPIC, TROCAR SLEEVE, Self- Locking Collar with Stopcock, 5 mm Diameter 6515-01-139-8567 CABLE, Assembly, Fiberoptic, 4 mm, 6 feet (1.83 m) Long 6515-01-181-8711 LIGHT, Endoscope In

40、strument Fiber Optic, 120/240 Volt, 50/60 Hz, AC, Portable MILITARY INTERESTS: Preparing Activity: Custodians: DoD-MB Army - MD Navy - MS Air Force - 03 Agent: DLA-DM CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS USPHS FDA-MPQAS Project Number: 6515-4600 Location: c:wordericarthrocd 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-