DOD A-A-53446-1988 SYRINGE FOUNTAIN《喷射注射器》.pdf

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1、I I I l l 1 I I t I I I I i I I I l I I I I I I I I I I I I I I I A-A-53qqb 65 7977Li 00307LL L c-92- 57 a A-A-5 3 44 6 29 April 1988 COMMERCIAL ITEM DESCRIPTION SYRINGE, FOUNTAIN The General Services Administration has authorized the use of this Commercial Item Description as a replacement for Inte

2、rim Federal Specification GG-S-001015a (DSA-DM) which is cancelled. This Commercial Item Description covers a completely assembled, disposable, enema fountain syringe. Salient characteristics: The fountain syringe shall be a disposable enema unit, bag or bucket type, with tubing, soap, underpad and

3、lubricant, suitable for instilling fluids rectally. The bag type enema unit shall hold a minimum of 1200 ml of fluid; the bucket type enema unit shall hold a minimum of 1400 rnl of fluid. The bag or bucket unit shall be leakproof and shall include a filling spout and outlet. The filling spout at the

4、 top shall have a suitable leakproof mechanical or self- a sealing type closure. The enema unit shall have graduation markings at not less than 3 points. Markings shall be accurate to + 25 ml. The unit shall be supplied with a suitable, securemethod to permit suspension of the filled unit from an in

5、travenous stand or other support. The enema unit outlet tubing shall be permanently attached at one end to the bottom opening of the bag or bucket, and there shall be no constriction of the opening as the result of the attachment of the tubing. The tubing shall be not less than 60 inches (152.4cm) l

6、ong, shall be approximately 7-8 millimeters in outside diameter, and shall be marked approximately 5 inches (12.7cm) from the distal end to indicate tube depth of penetration. The mark shall not wash off with soap, water, or washcloth. There shall be not less than one opening approximately 1/8 inch

7、in diameter, approximately 1/2 inch from the distal end of the tube. The tubing shall be flexible, non-toxic, and non-kinking. AMSC N/A FSC 6530 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. , THIS DOCUMENT CONTAINS 5 PAGES. Provided by IHSNot for ResaleNo reprodu

8、ction or networking permitted without license from IHS-,-,-A-A-5 3 4 46 The enema unit shall be provided with a positive acting shut- o clamp, attached to the tubing, which by compression of the tubing shall be capable of accomplishing complete shut-off. The shut-oEE clamp shall be made of a suitabl

9、e corrosion- resistant metal ox a suitable plastic, such as polypropyene or polyethyene, of sufficient thickness that the tubing will not be cut: when the clamp has closed of the path. Two-thrds of a fluid ounce of liquid castile soap shall be supplied in each enema unit. The enema unit shall contai

10、n one disposable, absorbent underpad, approximately 17 inches by 19 inches, folded to approximately 5 inches by 8-112 inches. The undexpad shall have a three-ply thickness of wet strength facial tissue especially embossed to give softnem and high absorbency. The pad shall be backed with a layer of s

11、oft pliable plastic film providing complete moistuce barrier protection. The enema unit shall contain a sterile lubricant which shall be supplied in a vial, a oil package, 01: a plastic package. Each enema unit shall contain one set o instructions or use. Woxkmanshi3. The enema unit fountain syringe

12、 shaLl be free from + efects which detract from its appearance or impair its serviceability. - Unit. Each (EA), One syringe, with instructions for use, as sspeeifie, constitutes one unit. Qualitmururance Provisions. the contract or purchase order, the contractor is responsible for the performance o

13、all inspection requirements as specified hemin. Except as otherwise specified in the contract or purchase order, the contractor may use his own or any facilities suitable or the pexfsrmanee of the inspection requirements specified herein, unless disapproved by the Government. The Gsveiznment reserve

14、s the rght to perform any of the inspections stet forth in the specification where such inspections are deemed necessary to amuie supplies and services conform to prescribed xeyuirements 8 Resgonaibility for inspection, Unless otherwise specified in 2 Provided by IHSNot for ResaleNo reproduction or

15、networking permitted without license from IHS-,-,-I. I l I I i i I I I I I 1 l I I A-A-53qVb 65 m 999997q 0030713 5 m A-A-5 344 6 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 Governme

16、nts 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 such records relate. Ins ection. Inspection, as used herein, is defined as both examination + such as visual or auditory investigation withou

17、t the use of special laboratory appliances or procedures) and testing (determination by technical means of physical and chemical properties) of the item. Tests. Tests shall be conducted to determine compliance with specification requirements. Where feasible, the same sample shall be used for the det

18、ermination of two or more test characteristics. Sampling for examination. Sampling for examination shall be conducted in accordance with MIL-STD-105, with an AQL of 1.0 (percent defective) and an inspection level of II. The unit of product for examination purposes shall be one fountain syringe as sp

19、ecified in this description. Defects . Any component missing or incomplete. Sealing device at filler spout does not function pr Oper ly . Enema unit has no suitable means for suspension. Tubing not permanently attached to bag. Tubing not reasonably round; not free from obstruction throughout its len

20、gth. Tubing does not have smooth rounded tip integral. Lubricant missing or not of proper consistency. Opening in tip not in proper place, proper diameter or missing. Graduations missing or illegible. Instructions for use not included. 3 Provided by IHSNot for ResaleNo reproduction or networking per

21、mitted without license from IHS-,-,-A-A-534Yb 65 U 494937Y 003Q71iY 7 A-A-5344 6 Sampling for tests. Sampling for tests including dimensional test, shall be conducted in accordance with MIL-STD-105, with an AQL o 2.5 (percent defective) and inspection level of S-3. The unit: of product or test purpo

22、ses shall be one fountain syringe. Twits. - =Test:. A sample enema unit, with shut-off clamp closed, shall be filled to its nominal capacity with water at 129oF by it6 suspension device for 60 minutes. The unit shall then be examined for evidence of leakage and suspension failure. Any leakage or sus

23、pension failure shall constitute a deeect. Dlsp Pest. A sample enema unit, with shut-off clamp and filling spout closed, shall be filled to its nominal capacity with warm water at 1200F and dropped from a height of two feet onto a hard xegulai surface. Any rupture or leak shall constitute a defect.

24、Contractor certification. The contractor shall certify that the product oEfered meets the salient characteristics of this description and conforms to the producers own drawings, specifications, standards, and quality assurance practices. The Government reserves the rght to require proof of such conf

25、ormance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract. c- Rogulatory requirements. by iqyis document has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the oQEaror/contmctor shall comply, and be re

26、sponsible for compliance by its subcontractorsVsuppliers, with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, and ioyulations promulgated thereunder. In addition, the oEferor/contractor shal comply, and be responsible for compliance by ita subcontractors/suppliers, with the

27、 requirements of all other applicable Federal, State, and local statutes, ordinnnceci, and regulations. Federal Food, Drug and Cosmetic Act. If the product covered 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53Llib 65 7777774 0030735 7 W A-

28、A-5344 6 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, packaging, packing, labeling, and marking. o

29、therwise 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 receiving activity, plus reshipment from receiving a

30、ctivity, 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. Unless NOTE: document: The following National Stock Number is covered by this 6530-00-073-6264 Ordering d

31、ata. Intermediate/exterior package quantities, labeling, and marking must be specified in the contract and/or order. 0 MILITARY INTERESTS: Custodians: Army - MD Navy - MS Air Force - 03 PREPARING ACTIVITY: DoD - MB Agent: DLA-DM CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS PHS FDA-MPQAS PGC 49947 Project No. 6530-1970 Location: CID/SYRINGE/H13-25 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-