A-A-51218B
These procedures are in agreement with the protocol of the “AAMI, Recommended Practice for Steam Sterilization and Sterility Assurance”. (The above referenced documents are available from the Association for the Advancement of Medical Instrumentation, Suite 417, 1500 Wilson Blvd., Arlington, VA 22209).
This item is intended to replace the Bowie-Dick hand-assembled test pack. Therefore any device that effectively mimics the Bowie-Dick test pack is acceptable provided the dimensions of 9 inches (22.9 cm) by 12 inches (30.5 cm) by 2 inches (51. cm) per test and total exterior shipping container weight per unit of issue of 34 pounds are not exceeded.
Instructions.
An instruction sheet shall be included in each box of 30 packs.
Workmanship. Workmanship shall be first quality throughout. Sheets shall be free from performance and cosmetic defects.
Unit. Package (PG). One package containing 30 test packs and instructions, as specified, constitutes one unit.
Quality Assurance Provisions.
Responsibility 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 contact 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 set forth in the specification where such inspections are deemed necessary to assure supplies and services conform to prescribed requirements.
Contractor certification. The contractor shall certify and maintain substantiating evidence that the product offered meets the salient characteristics of this Commercial Item Description, 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 contract.
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