DOD A-A-54031-1989 INDICATOR STERILIZATION STEAM《蒸汽消毒指示器》.pdf

1、A-A-5 40 3 1 24 November 1989 COMMERCIAL ITEM DESCRIPTION INDICATOR, STERILIZATION, STEAM The General Services Administration has authorized the use of this Commercial item Description. This Commercial Item Description covers a steam sterilization indicator strip. Salient characteristics: The steril

2、ization indicator strip shall provide visual indication of exposure to steam sterilization conditions by a distinctive color change on the strip. The indicator area shall change color when used as directed incide a surgical pack and sublected to stean at 250 F for 15 minutes or at 2700 F for 3 minut

3、es. Other tnan the color change, the entire indicator shall be totally unaffected by autoclaving conditions. Smudging, flaking, or any form of physical damage to the indicator shall De unaccegtable. Tne color change and original color must be distinctive enough for the end-user to easily differentia

4、te between gas or steam sterilization indicators. Indicator strips shall not be less than 6-1/2 inches long and 1/2 inch wide. Each strip shall be imprinted with instructions for use and for posicive determination of complete6 exposures. Workmanship. The steam sterilization indicator shall be free f

5、ror defect which detract from its appearance or impair its serviceability. Unit. PacKage (PG) . One package containing two hundred and fifty (250) ineicators, witr: Instruczion for use, as specified, ConsLitutes one unit. AMSC N/A FSC 6530 DISTRIBTION STATEMENT A. Approved for public release; distri

6、bution is unlimited. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A- 5 4 O 31 Quality Assurance Provisions. Responsibility for inspection. Unless otnerwise specified in the contract or purchase order, the contractor is responsible for the perfor

7、mance of all inspection requirements as Specified herein. Except as otherwise specified in the contract or purchase order, the contractor may use hic own or any facilities suitable for the performance of the inspection requirements specified herein, unless disapproved by the Government. The Governme

8、nt reserves the right to perform any of the inspections set forch in the specification wnere 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

9、the contractor and made available to the Government upon the Governments request, at any time, or from time to tirne, 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 use nerein, is defined

10、as both examination (such as visual or auditory investlgation witnout the use of special laboratory appliances or procedures) and testing (determination by technical means of pnycical and chemical properties! of the item. Tests. Tests shall be conucte to determine compliance with specification requi

11、rements. Where feasible, the same sample shall be used for the determination of two or more test characteristics. Samplinq for examination. Sampling for examination shall be conuctec 11: accordance with MIL-STD-105, wrth an AQL of 2 (percent defective) and an Inspectior, level of S-2. The unit of pr

12、oduct for examination purposes shall be one package of 250 indicators, as specified in tnis description. 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54 O 3 1 Contractor certification. The contractor shall certify that the product offered me

13、ets the salient characteristics of this 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 u

14、nder the provisions of the contract. Regulatory requirements. Federal Food, Drug and Cosmetic Act. If the product covered by this document has been derermined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/contractor shall comply, and De responsible for compliance

15、 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 requirements of all ot

16、her applicable Federal, State, and local statutes, ordinances, and regulations. 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 exten

17、t practical. Preservation, packaging, packAng, labeling, and marking. Unless otnerwise specified, preservation, packaging, and packing shall be to a degree of protection to preclude damage to containezs and/or contents thereof under normal shipping conditions, handling, etc., involving shipment from

18、 the supply source to the receiving activity, plur resnipment from receiving activity, and shail coniorrr, to applicable carriers rules and regulations. Intermediate and exterioc package quantities and labeling and marking shall be as specified in the contract and/or order. N3TE: The foilowing Satio

19、nai Stack Number is covered by tnis ocument : 6530-00-074-7039 Orering data. nLermediate/exterior package quantities, labeling, and marking must be specified in the contract and/or order. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54031 MI

20、LITARY INTERESTS: PREPARING ACTIVITY: Custodians: Army - MD Navy - MS kir Force - 03 DD - MB Agent: DLA-DM CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS PHS FDA-MPQAS Project No. 6530-1932 Location: CID/INDICATOR/HlB-33 -1 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-