DOD A-A-54421-1991 SKIN CLOSURE ADHESIVE SURGICAL (POROUS)《外科带粘性皮肤(多孔渗水的)》.pdf

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1、A-A-54421 65 9999974 00bL94 7 A-A-544 2 1 28 June 1991 COMMERCIAL ITEM DESCRIPTION SKIN CLOSURE, ADHESIVE, SURGICAL, (POROUS) The General Services Administration has authorized the use of this Commercial Item Description as a replacement for Military Specification MIL-S-37164 which is cancelled. Sal

2、ient Characteristics: Shall be sterile, hypo-reactive, pre-packaged strips of micro-porous adhesive tape suitable for use in place of skin sutures to hold a skin wound together securely without interfering with healing of the wound margins. closures shall be sterile when tested in accordance with th

3、e USP. The skin closure shall be on a card and the skin closures shall be easily removable from the card. Skin closures shall not extend beyond the card in any direction. Skin Skin closure shall be of the following sizes and of the following quantities of skin closures in one immediate container (en

4、velope). SKIN CLOSURE SKIN CLOSURE QUANTITY OF WIDTH distribution is unlimited. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54421 65 9999974 0061995 9 A-A-54421 . b. Expanded network-like polyproplene film. c. Nonwoven nylon fabric. The adhes

5、ive shall be pressure sensitive, shall be on one side of the skin closures and shall be continuously visible. The adhesive shall be a pure, single component acrylate or acrylic copolymer and shall be hypo-reactive. The facing material (card) shall be smooth and shall be capable of protecting the adh

6、esive and shall resist breaking, cracking or tearing when the skin closures are removed. The facing material shall have a minimum thickness of four mils and shall be chemically inert to the adhesive. The facing material shall be in the form of rectangular cards. Each rectangular card shall be clean

7、cut and each card shall be perforated at least 1/4 inch from each end to permit easy removal of the skin closures by exposing the ends of all skin closures on each card. There shall be visible spaces between the skin closures on each card. The skin closures shall comply with the following requiremen

8、ts.: PROPERTY MINIMUM MAXIMUM TEST METHOD Adhesion to steel (ounces 6 per inch of width) or as an alternate to steel per inch of width) 100 cc of air) (pounds per inch of width) Adhesion to aluminum (ounces 32 Porosity (seconds per - Breaking strength, dry 10 Thickness (inch) 0.0030 Ultimate elongat

9、ion (percent) 5 ASTM-D-1000 L/ 70 ASTM-D-1000 L/ 96 500 ASTM-D-726 a/ Method A Method A a/ Method B 4J Method 36 Method A a/ Method B A/ 50 ASTM-D-882 or - Fed Std No 147 100 ASTM-D-882 or - 1/ Multiple skin closures, parallel to each other, shall be used to make up the one inch width. 2 Provided by

10、 IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54421 65 m 9999974 0061i996 O m A-A-54 4 2 1 - 2/ Testing shall be performed using the following equipment: adapter plate with two parallel orifices 1/16 by 3/4 inch each and a suitable gasket to insure no lea

11、kage. Cover each orifice with a skin closure. Inspect to insure there is a complete bond on all edges and inspect to insure that the skin closures are not damaged. Insert adapter plate in porosity testing apparatus with skin closures up (adhesive down). Tighten porosity testing apparatus firmly. The

12、 time in seconds is the time necessary for transmission of 100 cc of air through the sample. - 3/ Multiple skin closures, parallel to each other, shall be used to make up the one inch width. Jaw separation 1 inch using a cross head speed of 2 inches per minute. - 4/ Multiple skin closures, parallel

13、to each other, shall be used to make up the one inch width. Jaw separation 1 inch using a cross head speed of 12 inches per minute. For all of the property tests above, skin closures shall be removed from their envelopes and conditioned for at least 24 hours at 73+3.5OF and at 50+2 percent relative

14、humidity and shall be tested under these conditions. The skin closures shall remain adhered to skin after the skin is wet and skin closures shall be clean and clean-cut. Manufacturers instructions for the opening of the immediate container (envelope) and for the use of skin closures shall be supplie

15、d in each unit container. Workmanship. The skin closures and their facing (cards) shall be free from defects which detract from their appearance or impair their serviceability. Unit. Package (PG) . For Size 1, shall be supplied 6 skin closures on an easily removed backing packaged in a sealed peel-o

16、pen envelope capable of maintaining sterility of contents unless package is damaged or opened. One package containing 50 sealed envelopes (300 skin closures), as specified, constitutes one unit. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- A-A9

17、54421 65 I 9999974 00bL997 2 M A-A-54 4 2 1 e For Size 2, shall be supplied 10 skin closures on an easily removed backing packaged in a sealed peel-open envelope capable of maintaining sterility of contents unless package is damaged or opened. One package containing 50 sealed envelopes (500 skin clo

18、sures), as specified, constitutes one unit. For Size 3, shall be supplied 5 skin closures on an easily removed backing packaged in a sealed peel-open envelope capable of maintaining sterility of contents unless package is damaged or opened. One package containing 50 sealed envelopes (250 skin closur

19、e), as specified, constitutes one unit. For Size 4, shall be supplied 3 skin closures on an easily removed backing packaged in a sealed peel-open envelope capable of maintaining sterility of contents unless packaged is damaged or opened. One package containing 50 sealed envelopes (150 skin closures)

20、, as specified, constitutes one unit. Quality Assurance Provisions Responsibility 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 as otherwise specified in the c

21、ontract 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 suc

22、h 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, at any time, o

23、r from time 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 investigation without the use of special laborat

24、ory appliances or procedures) and testing (determination by technical means of physical and chemical properties) of the item. 4 a Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Samolins for examination. Sampling for examination shall be conducted in

25、 accordance with MIL-STD-105 and as specified herein. Unit of product for examination purposes shall be one skin closure. Sampling shall be Inspection level II with an acceptable quality level (AQL) of 2.5 (percent defective). 0 Examination. Examination shall be conducted to determine compliance wit

26、h specification requirements. in accordance with MIL-STD-105 and as specified herein. Unit of product for test purposes shall be one skin closure. Sampling shall be Inspection level S-1 with an AQL of 2.5 (percent defective). Samolins for tests. Sampling for tests shall be conducted Tests. Tests sha

27、ll 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 salient characteristics of this

28、description and conforms to the producers 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. Met

29、ric Products. Products manufactured to metric dimensions will be considered on an equal basic with those manufactured using inch-pound units, providing they fall within the tolerance specified using conversion tables contained in the latest revision of Federal Standard No. 376, and all other require

30、ments of this document are met. If a product is manufactured to metric dimensions and those dimensions exceed the tolerance 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 acc

31、epting or rejecting the product. 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54421 65 U 9999974 0063999 b W A-A-54 4 2 1 Requlatorv reauirements. Federal Food, Druq and Cosmetic Act. If the product covered by this document has been determin

32、ed 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 Cosmetic Act, as amended, and regulations promulgated thereunder. In a

33、ddition, 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 m

34、aterial in accordance with Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. Preservation, gackaqinq, _ackinq, p labelins and markinq. Unless otherwise specified, preservation, packaging, and packing shall be to a degree of protection to preclude damage to containers and/o

35、r 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 labeling

36、 and marking shall be as specified in the contract and/or order. NOTE: The following National Stock Numbers are covered by this document : “ ITEM IDENTIFICATION SIZE 6510-00-054-7254 SKIN CLOSURE, ADHESIVE, SURGICAL, 1 POROUS, 1/2 by 4 Inches, 300s 6510-00-054-7255 SKIN CLOSURE, ADHESIVE, SURGICAL,

37、2 POROUS, 1/4 by 4 Inches, 500s 6510-00-054-7256 SKIN CLOSURE, ADHESIVE, SURGICAL, 3 POROUS, 1/8 by 3 Inches, 250s 6510-00-913-5874 SKIN CLOSURE,ADHESIVE, SURGICAL, 4 POROUS, 1/4 by 3 Inches, 150s Ordering data. Inspection/Test dating period, intermediate/exterior package quantities and labeling and

38、 marking must be specified in the contract and/or order. 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54421 65 9 9999974 O062000 7 9 8-8-54 4 2 1 MILITARY INTERESTS: PREPARING ACTIVITY: Custodians: Army - MD Navy - MS Air Force - 03 DoD - MB CIVIL AGENCY COORDINATING ACTIVITY: VA-OSS PHS FDA-MPQAS PGC 05194 7 Agent: DU-DM Project No. 6510-0793 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-