DOD A-A-54435-1991 MASK SURGICAL (NON-WOVEN FABRIC POUCH)《外科面罩(非纺织织物小袋)》.pdf

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1、A-A-54435 b5 9999974 0063834 7 A-A-54435 25 June 1EiQl COMMERCIAL ITEM DESCRIPTION MASK. SUROICAL (Non-Woven Fabpic, Pouch) The Oeneral Services Administration has authorized the use of this Commercial Item Description as a replacement for Type II of MIL-M-36884C, which is cancelled. This Commercial

2、 Item Description covers a lightweight. disposable, surgical mask. Salient Characteristic= The mask shall be a pouch-type. lightweight, disposable, surgical mask, made of non-woven fabric and suitable for use try medical personnel in operating rooms and other areas where it is neceersary to maintain

3、 protective aseptic techniques. The surgical mask shall be fabricated of the following materials: 1. The bacterial filter medium shall consist of a filter mat composed of fibers of appropr1at.e size and material BO as to enable the finished mask to meet a minimum bacterial filtering efficiency of 95

4、 percent when tested IN VIVO and 80 percent when tested IN VITRO. The filter medium shall not contain epicules of glass. 2. The facing material encasing the filter medium shall consist of a non-woven fabric suitable for the intended purpose. The mask shall be rectangular in shape, measuring a minimu

5、m of 4 inches vertical by a minimum of 6-1/2 inches horizontal, and so constructed as to form a pouch that will allow a snug but comfortable fit insuring a minimal amount of air flow around the edges. The filter medium mat shall be completely encased by the non-woven fabric, and the peripheral margi

6、n bound with woven tape or non-woven fabric. The mask AMSC N/A FSC 6515 DISTRIBUTION STATEMENT A: Approved for public release: dietribution is unlimited. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54435 b5 E 9999974 00bL35 9 W A-A-54435 shal

7、l have four suitable ties, one from each corner, extending a minimum of 14 inches from the mask. The mask ehall have a flat malleable metal strip either on the outside top horizontal margin of the mask, or incide the top horizontal edge. which cari be easily farmed to the contours of the nose and fa

8、ce to prevent leakage at the top of the mask and fogging of spectacles. The external metal strip shall be so secuved, that it will not detach during use or when soaked with perspiration. The finished mask shall be non-allergenic, of pastel blue, blue-green or green color that will reduce light glare

9、 and reflection. The mask shall permit free breathing and unrestrained communication. The mask shall meet the requirements of Class I, Commercial Standard 101-53 Irevi8ed) for flammability. Workmanship. The surgical mask shall be free from defects which detract from its appearance or impair its serv

10、iceability. Unit. Package (Pat). One package containing fifty masks, as specified, constitutes one unit. Each mask shall be packaged in asuitable container that permite one-at-a-time removal. Quality Assurance Provisions-, Responsibility for inspection. Unless otherwise specified in the contract or

11、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 own or any facilities suitable far the performance of the inspection requirements specifie

12、d herein, unless dieapproved by the Government. The goverriment reserves the right to perform any of the inepections set forth in the epecification where such inspections ape deemed necessary to assure supplies and services conform to prescribed requirements. Records. Records of examinations and tes

13、ts performed by or for the contractor shall be maintained by the contractor and made available to the Qovernment upon the Qovernments 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 record

14、s relate. 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54435 b5 W 9979974 00b383b O W A-A-54435 Inspection. Inspection, as used herein, is defined as both examination (such as visual or auditory inveEtigation without the use of special labor

15、atory appliances or procedures) and testing (determination by technical means of physical and chemical properties) of the item. SamDlinE 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.

16、The unit of product for examination purposes shall be one package of surgical maks. Sampling for testg. Sampling for tests. including dimensional test, shall be Conducted in accordance with MIL-STD-105. with an AUL of 1.5 percent defective) and an inspection level of 9-52. The unit of product for te

17、et purposes shall be one package of surgical m&sks. Tests. Tests shall be conducted to determine compliance with epeification requirements. Where feasible, the same sample I shall be used for the determination of two or more test characteriStic8. Tests shall include, but shall not be limited to, the

18、 following: 1. Fi1terng.efficiency 2. Flammability 3. Dermatological reactions Metric products. Products manufactured to metric dimensions will be considered on an equal basis with those manufactured using inch-pound units, providing they fall within the tolerances specified using conversion tables

19、contained in the latest revision of Federal Standard 376, and all other requirements of this document are met If a product is manufactured to metric dimensions and thuse unite. a request should be made to the contracting officer to determine if the product le: acceptable. , dimeneions exceed the tol

20、erances specified in the inchipound The contracting officer has the option of accepting or reject,ing the product. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54435 b5 = 9999974 00bI37 2 = A-A-54435 Contractor certification. The contractor

21、ghall 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 Government reserves theright to require proof of such conformance prior to first delivery and there

22、after as may be otherwise provided for under the provisions of the contract. Regulatory recruirements. 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 offerorcontractor shall c

23、omply, and be responsible for compliance by its subcontraCtUFs/sUpplir8, with the requirements of the Federal Food. Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/sup

24、pliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances and regulations. Recovered materials. The offeror/contraetor is encouraged to use recovered mateliia1 in accordance with Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. P

25、reeervationackaging , P acking, labeling, and marking. Unless otherwise specified, preaervation, packaging, and packing shall be to a degree of protection to preclude damage to containers and/or contents thereof undeV normal shipping conditions. handling. etc., involving shipment from the supply our

26、ce to the receiving activity, plus reshipment from receiving activity. and shall conform to applicable carriere rules and regulations. Intermediate and exterior package quantities and labeling and marking shall be as specified in the contract and/or order. OrderinR data. Intermediate/exterior packag

27、e quantities, labeling, and marking must be specified in the contract and/or order. NOTE: The following National Stock Number is covered by this document. 6515-00-782-2621 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-I A-A-54435 65 S 9999974 006

28、3838 4 0 A-A-54435 E *- MILITARY INTERESTS: PREPARINB ACTIVITY: Custodians: POP-ME Army - MD Agent: Navy - MS Aiv Force - 03 PLA-DM CIVIL AaENCY COOHDINATIN ACTIVITIES: VA-OSS USPHS FDA- MPQ AS Project Number: 8515-4935 Location: MASKPCID.15E Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-