A-A-53490
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 hygroscopic humidifier as specified in this description.
Defects
Connectors on patient or equipment side not correct internal diameter, or not meeting ISO standards.
Individual sterile package punctured or torn, voiding sterility.
Sampling for tests. Sampling for tests including dimensional test, shall be conducted in accordance with MIL-STD-105, with an AQL of 2.5 (percent defective) and inspection level of S-1. The unit of product for tests purposes shall be one hygroscopic humidifier.
Tests.
Sterilization test. Sterilization testing shall be in accordance with the FDA’s current “Guideline on General Principles of Process Validation”
Contractor certification. The contractor shall certify that the product offered meets 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 under the provisions of the contract.
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