1、A-A-53787 65 W 9999974 0031722 8 W - COMMERCIAL ITEM DESCRIPTION f 3343 A-A-5 3 7 8 7 15 December 1988 COLLECTING TUBING SET, UTERINE, PLASTIC, DISPOSABLE The General Services Administration has authorized the use of this commercial item description. This commercial item description covers a sterile
2、 disposable collecting tubing set suitable for vacuum aspiration of uterine contents. Salient characteristics: General. Shall be a plastic disposable collecting tubing set specifically designed for vacuum aspiration of uterine contents. The collecting tubing set serves to control the suction curette
3、s attached to the distal end and to connect them to the aspiration collection bottle and to the vacuum source. Characteristics. The set shall have a handle which is rotatable and a slip ring for finger tip vacuum control. It shall be 6 feet long and have a tapered fitting on the proximal. end of the
4、 set for connecting to the aspiration collection bottle. On the distal end shall be a female taper fitting to accommodate male taper fitting on the proximal end of the suction curettes. The set shall accommodate suction curettes ranging in size from 4 mm OD to 12 mm OD. The set shall be composed of
5、a handle assembly, flexible tubing and a fitting (to the aspiration collection bottle). The handle assembly shall contain a mechanism to control vacuum, allow the handle to swivel and have a female taper fitting to connect with the suction curettes. The set shall be capable of operating as indicated
6、 at a vacuum of 510 mm Hg. The set shall be in accordance with DPSC Drawing No. 24507. Material. The set shall be fabricated of clear, non- conductive plastic. Sterility. The collecting tubing sets shall be sterile when tested in accordance with applicable portions of the USP. The sterility assuranc
7、e level shall be,0.0001 as a minimum. AMSC N/A FSC-6515 DISTRIBUTION STATEMENT A. Approved for-public release; distribution is unlimited. , THIS DOCUMENT CONTAINS 3 PAGES. Licensed by Information Handling Services- A-A-5377 b5 W 7777774 0033723 T A-A- 5 3 7 8 7 Workmanship. The sets sh 11 be process
8、ed in such a manner to be uniform in quality and free from defects that would affect the life, serviceability, or appearance of the end item. S Product Quality Level. Visual and dimensional examination. Shall be examined to verify that design, construction and workmanship are in accordance with appl
9、icable requirements. Materials. The supplier shall be responsible for performing tests to assure that materials are in accordance with requirements specified. Unit. Package (PG). One package containing ten collecting tubing sets, each set individually packaged sterile in a sealed peel-open type cont
10、ainer capable of maintaining sterility of contents, constitutes one unit. Quality Assu rance Provis ions. the contract or purchase order, the contractor is responsible for the performance of all inspection requirements as specified herein. Except as otherwi.se specified in the contract or purchase o
11、rder, 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 inspections are dee
12、med necessary to assure supplies and services conform to prescribed requirements. Responsibility for inspection. Unless otherwise specified in 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
13、 the Governments request, at any time, or fromtime to time, during the performance of the contract 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 investiga
14、tion without the use of speci.al laboratory appliances or procedures) and testing (determinatron by technical means of physical and chemical properties) of the item. Licensed by Information Handling ServicesI A-A-53707 Tests. Tests shall be cnducted to determine compliance with specification require
15、ments. Where feasible, the same sample shall be used for the determination of two or more test characteristics. Q Operational test. When the set is connected to a suitable vacuum source until a vacuum of 510 mm Hg has been attained the handle shall be able to potate and control the degree of vacuum
16、and the tubing shall not collapse. Sampling for tests. Sampling for tests shall be conducted in accordance with MIL-STD-105 and as specified herein. At an Inspection Level of S-2, dimensional testing shall be at a 2.5% AQL and operational testing shall be at a 1.0 percent AQL. The unit of product fo
17、r test purposes shall be one collecting tubing set. 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 Govern
18、ment 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 be considered on an equal basis with those manufactured using in
19、ch-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. If a product is manufactured to metric dimensions and those dimensions exceed the tolerances
20、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 or rejecting the product. I 3 Licensed by Information Handling Services- _ _- A-A-53747 65 W 7777974 0031725 3 m A-A-5
21、37 07 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 Administration to be under its jurisdiction, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/supplier
22、s, with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. En addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State,
23、and local statutes, ordinances, and regulations. Recovered materials. The offeror/contractor is encouraged to use recovered material in accordance with Public Law 94-580, as amended, and as implemented by Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. Preservation, pack
24、aging, packing, labeling, and marking. 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., involving shipment from the supply source to the recei
25、ving 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. NOTE 1: The following National Stock Number is covered by
26、this document: NSN 6515-01-15 6-2 45 2 ITEM IDENTIFICATION COLLECTING TUBING SET, UTERINE, PLASTIC, -Disposable NOTE 2: The following suction curettes and their corresponding Natianai Stock Numbers (NSNs) fit the tubing collection set described in this specification: NSN - 6515-01-153-4933 6515-01-1
27、85-8836 ITEM IDENTIFICATION Curette, Suction, Uterine, Semi- Rigid, 8 mm Outer Diameter, 10s Curette, Suction, Uterine, Semi- Rigid, Curved, 10 mm Outer Diamet er ,lo s Licensed by Information Handling ServicesA-A-53787 65 m 7777774 0033926 5 A- A- 5 3 7 8 7 NSN 0 6515-01-185-8837 ITEM IDENTIFICATIO
28、N Curette, Suction, Uterine, Semi- Rigid, 12 mm Outer Diameter, 10s Ordering data (Intermediate/exterior package quantities, labeling, and marking must be specified in the contract and/or order). MILITARY INTERESTS: Preparing Activity: Custodians: Army - MD Navy - MS Air Force - 03 DoD-MB Agent: DLA-DM CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS PHS FDA-MPQAS PGC 53323 5 Project No. 6515-3387 w.s. GOVERNMENT PRINITNG omcE: nts - (DcM311wI Licensed by Information Handling Services
