DOD A-A-54526-1991 INDICATOR STERILIZATION《消毒指示器》.pdf

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1、A-A-54526 65 9999974 0063009 -i A-A-54526 23 November IS91 COMMERCIAL ITEM DESCRIPTION INDICATOR, STERILIZATION The General Services Administration has authorized the use of this Commercial Item Description as a replacement for MIL-1-38789, which is cancelled. This Commercial Item Description covers

2、 one type of sensitized paper or fabric test record for determination of air elimination from within a prevacuum erteam sterilizer during the pre-vacuum stage of a high vacuum sterilizer. Salient Characteristics: The air removal indicator shall consist of a sensitized sheet of paper having a light b

3、ackground overprinted with a darker colored uniformly applied steam-heat sensitive ink. The ink shall undergo a significant uniform color change in the presence of a vacuum, or absence of air, with subsequent exposure to steam heat during the vacuum portion of the Strilization Cycle. Each air remova

4、l indicator sheet shall have minimum dimensions of 8-1/2 inches by 11 inches and shall be sufficiently flexible to conform to the irregular contours in surgical packs. The steam-heat sensitive ink shall be applied in et repetitive or concentric pattern within an area not less than 7 inehes by 11 inc

5、hes and in such a manneyi that there shall be no area greater than 1/2 inch diameter within the pattern without the indicating ink. Areas with printing that identifies the product or manufactuper shall be excluded from the 1/2 inch diameter requirement. Once the ink has changed, the chemical process

6、 shall be irreversible providing a permanent record. When subjected to a complete vacuum-steam sterilization cycle, at 270F for 3-1/2 minutes, the indicators steam-heat sensitive ink shall exhibit a complete and uniform color change as explained in the instructions to indicate complete air removal.

7、When subjected to a sterilization cycle with AMSC N/A FSC 6530 DISTRIBUTION STATEMENT A: Approved for public release; distribution is unlimited. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-1 A-A-54526 65 D 9999974 O063010 4 8 A-A-54526 partial va

8、cuum and steam at 270F or at 25“F, the ink color shall remain unchanged or shall only slightly change to indicate incomplete sterilization. The following information shall be printed on each indicator sheet: * Name or registered trademark of.the manufacturer % Piloduct identif ication or tradename X

9、 Far record keeping purposes: DATE AUTOCLAVE or STERILIZER NO. OPERATOR Full instructions for use shall accompany each unit of thirty- one (31) indicators. Workmanship. The indicator sheets shall be free from defects which detract from their appearance or impair their eerviceability. Sheets shall be

10、 free of cuts, tears and holes in the area with the indicating ink pattern and shall Le clean. Unit. Package (Pa). One package containing thirty-one indicators with instruetion eheet, as specified, constitutes one uni t. O Quality Assurance Provisions. Respongibility for inspection. Unless otherwise

11、 specified in the contract or purchase order, the contractor is responsible for the performance of all inspection requirements as specified hei3eii-i. Except. as otherwiee specified in the contract or purchase oi?der, the contractor may use his own or any facilities guitable for the performance of t

12、he inspection requirementg specified herein, unlesa disapproved by the Government. The rfovernment reserves the right to perforin any of the inspections set forth in the specification where such inspections are deemed necessary to assure supplies and services conform to prescribed requirements. Reco

13、rds. 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 rfovernments request, at any time, or from time to time, during the performance of the coi-ltract and foi. a period of three years after deliv

14、ery of the 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-5452b 65 W 9999974 OOb30LL b W A-A- 54526 supplies to which such records relate. O Inspection. Inspection, as used herein, is defined as both examination (such as visual or auditory inv

15、estigation without the use of special 1aboratol.y appliances or procedures) and testing (determination by technical means of physical and chemical properties) of the item. SamplinE for examination. Sampling for examination shall be Conducted in accordance with MIL-STD-105, with an AQL of 2.5 (percen

16、t defective) and an inspection level of II. The unit of product for examination purposes shall be one indicator sheet. SamDlinE for tests. Sampling for tests, including dimensional test, shall be conducted in accordance with MIL-STD-105, with an AQL of 1 (percent defective) and ai1 inspection level

17、of S-l. The unit of product for test purposes shall be one indicator sheet. Tests. Tests shall be conducted to determine compliance with specification requirements. Where feasible, the same sample shall be used for the detePmik1ation of two or more test characteristics. Tests shall include, but shal

18、l not be limited to, the following: 1. Physical tests. Physical tests shall be conducted in accordance with this specification and applicable methods of TAPPI, as listed below: Property TAPPI Method Thickness Tearing resistance Porosity T-411 T-414 T-460 2. Complete sterilization. A single sheet of

19、the I indicator shall be placed in the center of a stack of towels 10 to 11 inches high (2 to 3 dozen towels1 and folded flat to t2 by 12 inches. The towels shall be wrapped a= an ordinary ,surgical bundle and autoclaved in a pre-vacuum type sterilizer at 280F for 12 minutes. Repeat the test, using

20、a fresh indicator, at 272F for 3-1/2 minutes. At the conclusion of the sterilization cycle, the indicators shall be examined. 3. Incomplete sterilization. The test shall be aonducted at the same time and in the game sterilizer as the test in 2. (above). A t2 inah strip cut from one side of the indic

21、ator 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54526 b5 m 9999974 00b3012 m A- A- 54 526 paper shall be placed in a Mason jar, or equivalent tight seal container, in such a manner that half of the strip protrudes from the jar. The portion

22、 of the strip inside the jar shall be taped to the inner wall so that. the temperature outside the jar reaehes the strip while air is trapped in the jar. Before sealing, the jar and strip shall be heated in a 250F oven for 5 minutes in order to eliminate moisture from the sample and jar. The jar sha

23、ll be tightly sealed, placed in the sterilizer and the two sterilization cycles eompleted as speeified in 2. (above). At- the conclusion of each test, the test gtrip shall be exaniined. Metric products. Products manufactured to metria dimensions will be considered on an equal basis with those manufa

24、ctured using inch-pound units , providing t.hey fall within the tolerances specified using conversion tables contained in the latest revision of Federal Standard 378, and all other requirements of this doriuntent are met. If a product is manufactured to metpic dimensions and those dimensions exceed

25、the toleranees specified in the inchipound units, a request should be made t.o the contracting officer to determine if the produet ir: acceptable. The contracting officer has the option of accepting or rejecting the product. Contractor certification. The contractor shall certify that the product off

26、ered meets the salient characteristics of this description and conforms to the producers? own drawings, specifications, standarde, and quality assurance practices. The CTovernment reserves the right to require proof of such conformance prior to firBt delivery and thereafter as niay be otherwise prov

27、ided for under the provisions of the contract. Regulatory reauirements. 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 offeror/contractor shall comply, and be responsible for

28、compliance by its subcontraetors/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 subcontraetors/suppliers, with the requirements

29、 of all other applicable Federal, State, and local statutes, 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54526 65 9999974 0063013 T m A-A- 54526 ordinances and regulations. O Recovered materials. The offeroricontractor is enaouraged to use

30、recovered material in accordance with Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. Preservation. packaging, P acking. labeling, and marking. Unless otherwise specified, preservation, packaging, and packing ehall be to a degree of protection to preclude damage to conta

31、iners 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 a

32、nd labeling and marking shall be as specified in the contract and/or arder. OrderinE data. Intermediate/exterior package quantities, labeling, and marking must be specified in the contract and/or order. NOTE: The following National Stock Number is covered by this document. 6530-00-181-7770 MILITARY

33、INTERESTS: e PREPARING ACTIVITY: Custodians: DoD-Mb Army - MD Na.vy - MS Air Force - 03 Agent: DLA-DM CIVIL AaENCY COORDINATING ACTIVITIES: VA-OSS USPHS FDA-MPQAS Project Number: 6530-2257 Location: STER3CID.lBC 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-