1、A-A-5 4957 9999974 0164945 331 I NCH-POU N D A-A-5 4 9 5 7 10 June 1994 COMMERCIAL ITEM DESCRIPTION BAG, OSTOMY The General Services Administration has authorized the use of this Commercial Item Description. This Commercial Item Description covers stoma bags suitable for post-operative wear over an
2、artificial opening related to the colon or ileum for containing and disposing of ostomy discharge. Salient character ist ic : Classification. The ostomy bags shall be furnished in the following sizes: 1 2 inches 2 2-1/2 inches -_. Material. The bag shall be fabricated of polyethylene. The Karaya sea
3、l shall consist of karaya powder, glycerine, and mold and bacteria inhibitors. The clamp bottom closure shall be fabricated of polypropylene. Bag material shall be non-toxic and non-irritating to body skin surfaces. - Style _ and . design. The bag shall be a drainable disposable stoma bag of medium
4、length with the body fabricated of co- extruded polyethylene. The polyethylene shall have a minimum thickness of 2 mils. The bag shall have approximate dimensions of 15-1/2 inches long by 6-1/2 inches width at the top and 2-1/2 inches at the bottom. The bottom edge of the bag shall be open to permit
5、 drainage of contents. The bag shall be provided with a polyethylene gasket with a Karaya seal attached on the top center back surface for AMSC N/A FSC 6515 _ DISTRIBUTION STATEMENTTA: Approved for public release; distribution is unlimited. Provided by IHSNot for ResaleNo reproduction or networking
6、permitted without license from IHS-,-,-A-A-54957 - 9999974 0164946 278 A-A- 5 4 9 5 7 sealing to the body. The gasket shall have a tab, with a hole, on each side for attachment of a ostomy bag belt. A clamp fabricated of polypropylene shall be provided to seal the bottom opening. The clamp shall be
7、one piece, having a smooth surface with an integral hinge and easy-open latch. The clamp length shall be approximately 3-1/4 inches. The bag component dimensions shall be as follows: Gasket (Inches) Seal (Inches) Size . I.D. . - - O.!? L Le-xLt_ I.D2- O.D. Thickness 1 2 2-3/4 4-1/2 1-5/8 2-3/4 13/64
8、 2 2-1/2 3-1/4 5-1/4 2-1/8 3-1/4 13/64 Leakaqe. Bags shall be completely filled with cold tap water. The bags shall not leak when suspended from a suitable support for eight (8)hours. Instructions. Each ostomy package shall contain instructions for use. Workmanship. The bags shall be free from defec
9、ts which detract from their appearance or may impair their serviceability. Bags shall be free from tears, cuts, weak areas, foreign material or other defects. Identification markinq. Each bag shall be legibly and permanently marked with the manufactures name or registered trademark. gnit. Package (P
10、G). One package containing 30 bags of one size only, together with instruction for use, as specified, constitutes one unit. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54957 9999974 O1b4947 104 A-A-54 95 7 Quality Assurance Provisions. Respon
11、sibility 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 contract or purchase order, the contractor may use his own or any faciliti
12、es 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 deemed necessary to assure supplies and services confor
13、m 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, or from time to time, during the performance of the contract and for a per
14、iod 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 laboratory appliances or procedures) and testing (determination by technical mea
15、ns of physical and chemical properties) of the item. Examinati-. Examination shall be conducted to determine compliance with specification requirements. Sampling-.f-or examination. Sampling for examination shall be conducted in accordance with MIL-STD-105 and as specified. Unit of product for examin
16、ation purposes shall be one package of ostomy bags. Samplinq shall be inspection level S-2 with an Acceptable Quality Level (AQL) of 1.0. _- Tests. Tests shall be conducted to determine compliance with specification requirements. Where feasible, the same sample shall be used for the determination of
17、 two or more test characteristics. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54957 = 9999974 OLb494B O40 = SampJ-ing .for-p_test-s. Sampling for tests shall be conducted in accordance with MIL-STD-105 and as specified. Unit of product for
18、 test purposes shall be one package of ostomy bags. Sampling shall be inspection level S-2 with an AQL of 1.0. Contractor - certification. The contractor shall certify and maintain substantiating evidence that the product offered meets the salient characteristics of this Commercial Item Description,
19、 and that the product 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 contrac
20、t. Eet-ric products. p 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 contained in the latest revision of Federal Standard 376, and all other r
21、equirements of this document are met. If a product is manufactured to metric dimensions and those dimensions exceed the tolerances specified in the inch-pound determine if the product is acceptable. a units, a request should be made to the contracting officer to The contracting officer has the optio
22、n of accepting or rejecting the product. -. Requlatory_-requirements . Federal Foo& Drug,. -and Cosmetic- Ac-t. 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 f
23、or compliance by its subcontractors/suppliers, 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/suppliers, with the requirem
24、ents of all other applicable Federal, State, and local statutes, ordinances, and regulations. 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54757 c174 01164947 TB? = A-A-54 95 7 Recovered materials. The offeror/contractor is encouraged to use
25、 recovered 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 cont
26、ainers 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
27、and labeling and marking shall be as specified in the contract and/or order. Orderinq data. Intermediate/exterior package quantities, labeling, and marking must be specified in the contract and/or order. NOTE: The following National Stock Numbers and their respective Item Identifications and Sizes a
28、re covered by this document: NATIONAL STOCK NUMBER ITEM IDENTIFICATION SIZE _ 6515-00-915-4143 BAG, OSTOMY, Karaya Seal, 1 Drainable, Disposable, 2 inch size, 30s 6515-00-828-2469 BAG, OSTOMY, Karaya Seal, 2 Drainable, Disposable, 2-1/2 inch size, 30s 5 Provided by IHSNot for ResaleNo reproduction o
29、r networking permitted without license from IHS-,-,-m 74 03b4944 4T5 m * “ A-A-54957 A-A-5 4 9 5 7 Custodians: Army - MD Navy - MS Air Force - 03 Preparing Activity: DOD-MB Agent: DLA-DM CIVIL AGENCY COORDINATING ACTIVIT IES : VA-OSS USPHS FDA-MPQAS Project Number: 6515-5716 Location: bag/Intergraph/vb 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-
