DOD A-A-53450-1988 WRAPPER STERILIZATION《杀菌包装材料》.pdf

《DOD A-A-53450-1988 WRAPPER STERILIZATION《杀菌包装材料》.pdf》由会员分享，可在线阅读，更多相关《DOD A-A-53450-1988 WRAPPER STERILIZATION《杀菌包装材料》.pdf（5页珍藏版）》请在麦多课文档分享上搜索。

1、A-A-5 3 4 50 29 April 1988 AMSC N/A FSC 6530 DISTRIBUTION STATEMENT A. distribution is unlimited. Approved for public release; 0- /- THIS DOCUMENT CONTAINS 5 PAGES. y I. COMMERCIAL ITEM DESCRIPTION WRAPPER, STERILIZATION The General Services Administration has authorized the use of this Commercial I

2、tem Description. This Commercial Item Description covers a disposable wrapper suitable for wrapping surgical supplies for sterilization by autoclaving. Salient characteristics: The sterilization wrapper shall be a clean, disposable, polypropylene, regular weight wrapper, fabricated of a non- woven m

3、aterial, suitable for wrapping and processing surgical supplies for sterilization. The wrapper shall be supplied in the following approximate sizes: Size 1 - 18 inches (45.7 cm) square Size 2 - 24 inches (61.0 cm) square Size 3 - 36 inches (91.4 cm) square Size 4 - 54 inches (137.2 cm) square The wr

4、apper shall be fluid repellent, memory-free, low linting, and puncture and abrasion resistant. The wrapper shall have bacterial barrier properties. The weight of the wrapper shall be approximately 1.3 ounces per square yard. The wrapper shall be freely permeable to steam and ethylene oxide penetrati

5、on. The wrapper shall assure efficient concentration of steam to guarantee sterilization of the contents when used as a double wrapper. The wrapper shall insure adequate air removal for drying efficacy. The wrapper shall not have more than a three percent weight gain during steam sterilization. Lice

6、nsed by Information Handling ServicesA-A-53450 b5 U 9999974 0030733 O M A-A-5 3 450 The wEapper shall maintain the supplies in a stexile manner or 30 days without: a “dust cover“ in a clean, temperature controlled, humidity controlled environment if the item has not been opened or tampered with. The

7、 wmpper shall meet Electrical Surface Conductivity Standard, NFPA 99, and Flame Resistance Standard, NFPA 702, class I. no primary Irritation or sensitization as evaluated by the U.S. Public Health Service, Dermatosis Section. The wrapper shall be nonallergenic as evidenced by The wEapper shall be s

8、uitable for use with a standard eterilization indicator tape, The wrapper shall maintain its resiliency after exposure to the high temperature of sterilization, not becoming hard or brittle. It shall be resistant: to tearing 01: puncturing ater sterilization, and shall be easy to open safely while t

9、echnique. The wieapper shall be free of tears, cuts, holes, perforations, grease, dirt, or foreign matter. observing aseptic WorkmanshiE. The sterilization wrapper shall be free from defects which detract: rom its appeacance or impair its serviceability. Unit. Package (PG), One package containing on

10、e thousand warns of size 1 only, as specified, constitutes one unit. - Unit, Package (PG). One package containing five hundred wrappers sf size 2 only, as specified, constitutes one unit, - Unit. Package &GI. One package containing three hundred wiappel=s o size 3 only, as specified, constitutes one

11、 unit. _. Unit. Package GI. One package containing one hundred wrappers of size 4 only, as speclied, constitutes one unit, The wrappers shall maintain sterility for 30 days without a “dust coverfi in a clean, temprature controlled, humidity controlled environment if the item has not been opened or t

12、ampered with. 2 Licensed by Information Handling ServicesA-A-5 3 4 50 Oualitv Assurance Provisions. Defects. Responsibility for inspection. Unless otherwise specified in the contract or purchase order, the contractor is responsible for the performance f all inspection requirements as specified herei

13、n. Except as otherwise specified in the contract 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

14、 set forth in the specification 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 upo

15、n the Governments 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. Inspection. Inspection, as used herein, is defined as both examination (such as visual or auditory investi

16、gation without the use of special laboratory appliances or procedures) and testing (determination by technical means of physical and chemical properties) of the item. 0 Tests. Tests shall be conducted to determine compliance. with specification requirements. Where feasible, the same sample shall be

17、used for the determination 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 steril

18、ization wrapper as specified in this description. Wrapper not made of polypropylene. Wrapper not free of tears, cuts, holes, or perforations. Weight of wrapper not correct. Wrapper not free of grease, dirt, or foreign material 3 Licensed by Information Handling ServicesA-Am53450 b5 74 030735 4 M A-A

19、-5 3 450 Sampling for tests. Sampling for tests including dimensional test, shall be conducted in accordance with MIL-STD-LOS, with an AQL of 23 (percent deeective) and inspection level o S-1, The unit of product or test purposes shall be one sterilization wrapper Tests - Sterilization test Typical

20、surgical supplies shall be placed inside the sterlization wrapper, sealed with sterilizer indicator tape, and autoclaved with steam at 25OOF. and 15 pounds pressuie for 30 minutes, brittleness, and resistance to puncturing or tearing. excessive haidness, brittleness, or tendency to puncture or tear,

21、 shall constitute a deect. The wrapper shall then be inspected for haxdness, Any Contractor certification. The contractor shall certify that the product offered meets the salient characteristics o this description and conforms to the producers own drawings, specifications, standards, and quality ass

22、urance practices. The Government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided or under the provisions of the contract. sulatory requirements. by this document has been determined by the U.S. Food and Drug Administration t

23、o be under its jurisdiction, the offerorcontractor shall comply, and be responsible or compziance by its subcontractors/suppliers, with the requirements of the FedeEal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeEor/conttactor shall comply, a

24、nd be responsible or compliance by its subcontractorssuppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations, Federal Food, Drug and Cosmetic Act. If the product covered Recovered materials. The offerorcontractor is encouraged to uee r

25、ecovered 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. 4 Licensed by Information Handling ServicesA-A-53450 65 m 997797LI 0030736 b m A-A-5 34 5 O Preservation, packaging, packing, labelin

26、g, and marking. Unless otherwise 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 res

27、hipment from receiving activity, 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. NOTE: document: The following National Stock Numbers are covered by this 6530-01-

28、049-1829 (Size 1) 6530-01-029-8764 (Size 2) 6530-01-049-1830 (Size 3) 6530-01-086-2464 (Size 4) Ordering data. Intermediate/exterior package quantities, labeling, and marking must be specified in the contract and/or order . MILITARY INTERESTS: PREPARING ACTIVITY: 0 Custodians: Army - MD Navy - MS Air Force - 03 CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS PHS FDA-MPQAS PGC 05942 DoD - MB Agent: DLA-DM Project No. 6530-1975 Location: CID/WRAPPER/H13-28 Licensed by Information Handling Services