DOD A-A-54974-1994 SUTURE NONABSORBABLE SURGICAL NYLON《外科尼龙不吸水缝合处》.pdf

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1、A-A- 5 4 9 7 4 9 September 1994 COMMERCIAL ITEM DESCRIPTION SUTURE, NONABSORBABLE, SURGICAL, Nylon The General Services Administration has authorized the use of this Commercial Item Description as a replacement for Federal Specification GG-S-O0816C, which is cancelled. This Commercial Item Descripti

2、on covers two surgical nylon sutures suitable for use in surgery, Salient characteristics: General. Shall be black, monofilament, nylon surgical sutures. The size, length, and arming of every suture covered by this document shall be as specified below. The type of needle(s) specified below shall be

3、attached to the suture. The shape and length of the needle(s) shall be as specified below. Sutures shall comply with the latest United States Pharmacopeia (USP) requirements for “Class I Nonabsorbable Surgical Suture“. (See note 1) * a) RCN - Reverse-Cutting Needle b) SPN - Spatula-Point Needle c) S

4、-A - Single Armed d) D-A - Double-Armed AMSC N/A FSC 6515 DISTRIBUTION STATEMENT A. distribution is unljmited. Approved for public release; Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54374 M 3337774 0365229 70T A-A-5 4 9 7 4 Material. Suture

5、s shall be made of surgical-grade nylon. A non- leachable black dye shall be used to color the sutures. Sutures shall comply with the requirements for “Extractable Color“ specified in the USP monograph entitled “Nonabsorbable Surgical Suture“ . Suture needles shall be made of a corrosion resistant s

6、teel that complies with all requirements of American Society for Testing and Materials (ASTM) F899. Stvle and desicrn. Suture needles shall have a flattened needle body, a minimum of 4 longitudinal ribs on the inside and outside curvatures of the needle body, and a seamless swage. Finish. Sutures sh

7、all have a smooth finish. Suture needles shall be stress-relieved and passivated. Suture needles shall have a bright, smooth finish. WorkmanshiD. Sutures shall be free from kinks, splinters, cuts, knots and any other defects that detract from their appearance or impair their serviceability. Suture n

8、eedles shall be free from dull points, dulled edges, feathered edges, burrs, cracks, nicks, pits, corrosion, and any other defects that detract from their apperance or impair their serviceability. Sterilitv. Sutures shall be sterile. The sterility assurance level shall be minimum. Sterile packaainq.

9、 Sutures shall be sealed in peel-open, heat-sealed, leak-resistant double-packets. The packets shall maintain the sterility of their contents until they are opened or damaged. The packets shall comply with the requirements of ASTM D3078. The packets shall be marked with the following: suture materia

10、l, suture size, suture length, suture arming ( “Single Armed“ , or “Double Armed“ ) , needle type, needle style, and the legend “Sterile“. All packet markings shall be permanent and legible. Instructions. Sutures shall be supplied with printed instructions conc8rning cautions, contraindications, and

11、 aseptic dispensing from sterile packaging. 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54974 9999974 02b5230 421 Unit. Package (PG). For suture I, each suture shall be individually packaged in a sealed-peel-open, leak-resistant double pack

12、et capable of maintaining sterility of contents unless packet is damaged or opened. One package containing 36 individually packaged sutures, as specified, constitutes one unit. For suture 2, each suture shall be individually packaged in a sealed-peel-open, leak-resistant double packet capable of mai

13、ntaining sterility of contents unless packet is damaged or opened. One package containing 12 individually packaged sutures, as specified, constitutes one unit. gualitv Assurance Provisions, the contract or purchase order, the contractor is responsible for the performance of all inspection requiremen

14、ts as specified herein. 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 specificat

15、ion where such inspections are deemed necessary to assure supplies 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, a

16、t any time, or from time to time, during the performance of the contract and for a period of three years after the delivery of the supplies to which such records relate. the examination and testing of an item. defined as unaided visual, auditory, tactile, or olfactory investigation. Testing shall be

17、 defined as the use of laboratory equipment and procedures to determine various properties of an item. Inspections shall be conducted to determine compliance with specification requirements. Where feasible, the same sample shall be used for the determination of two or more inspection characteristics

18、. For inspection purposes, the unit of product shall be one suture, except when inspecting suture packets. When inspecting suture packets, the unit of product shall be one packet of sutures. Responsibilitv for inspection. Unless otherwise specified in Except as otherwise specified in the contract or

19、 Inspection. Inspection, as used herein, shall be defined as Examination shall be Camplins for inspection. Sampling for inspection shall be 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- A-A-54974 m 9999974 OLb523L 3b8 m A-A-54 9 7 4 conducted in

20、 accordance with MIL-STD-105. performed for each salient characteristic specified herein. For each sampling, inspection level S-2 shall be used; the Acceptable Quality Level (AQL) shall be 2.5 percent. A sampling shall- be Suture material shall be divided into samples in accordance with section 12.2

21、 of American Society for Testing and Materials (ASTM) D1898. Needle material shall be divided into samples in accordance with section 13.4 of ASTM D1898. Ten-power magnification shall be used during the examination of sutures and suture needles. Contractor certification. The contractor shall certify

22、 and maintain substantiating evidence that the product offered meets the salient characteristics of this Commercial Item Description, and that the product conforms to the producers own drawings, specifications, standards, and quality assurance practices. The government reserves the right to require

23、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 inch-pound units, providing they fall

24、 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 specified in the inch-pound units,

25、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. 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54974 W 9999974 OLb5232

26、 2T4 = . Requlatory reauirements. 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, Drug and Co

27、smetic 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. use reco

28、vered 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 packing shall be to a degree of protection to preclude damage to containers

29、 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 rules and regulations. Intermediate and exterior package quantities and la

30、beling and marking shall be as specified in the contract and/or order. Orderina data. Intermediate/exterior package quantities, labeling, and marking must be as specified in the contract and/or order. Federal Food, Druq and Cosmetic Act, If the product covered Recovered materials. The offeror/contra

31、ctor is encouraged to NOTE 1: To differentiate the sutures, each one is assigned a “Suture Number”; however suture numbers shall be used only for this purpose. The National Stock Number (NSN) assigned to each suture shall be the primary reference number. NSNs and suture numbers are cross-referenced

32、below. NOTE 2: The following Suture Numbers, National Stock Numbers and their respective Item Identifications are covered by this document : SUTURE NO. NATIONAL STOCK NUMBER 1 ITEM IDENTIFICATION 6515-00-227-7897 SUTURE, NON-ABSORBABLE SURGICAL, Nylon, Mono- filament, Size 3-0, Single-Armed, 36s 5 P

33、rovided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- A-A-54974 W 9999974 O365233 i130 A-A-54 9 74 SUTURE NO. NATIONAL STOCK NUMBER ITEM IDENTIFICATION 2 6515-01-169-0246 SUTURE, NON-ABSORBABLE SURGICAL, Nylon, Mono- filament, Size 8-0, Double-Armed, 12s M

34、ILITARY INTERESTS: Custodians: Army-MD Navy-MS Air Force-O3 Preparing Activity: DoD-MB Agent: DLA-DM CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS USPHS F DA-MPQAS GSA-FSS-FCGC Project No. 6515-5711 Location: john/nylon/dawne 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-