A-A-30056E
Sampling for examination. Sampling for examination shall be conducted in accordance with MIL-STD-105, with an AQL of 4.0 (percent defective) and an inspection level of S-2. The unit of product for examination purposes shall be one specimen container as specified in this description.
Defects
Cup or cap not free of any deformation.
Scale numerals or lines not cleanly defined and easily read.
Cup not free from waviness that obliterates the lines or numerals.
Cup or cap not free from holes, pits, scratches, burrs and abrasions.
Cup not stable when placed on a flat surface.
Individual package not properly sealed to maintain sterility of contents.
Cup or cap not free from objectionable odor, water drops or dried stains, oil or grease smears, or dirt or loose particles, on either inside or outside.
Sampling for test. Sampling for tests including dimensional test, shall be conducted in accordance with MIL-STD-105, with an AQL OF 2.5 (percent defective) and an inspection level of S-2) The unit of product for test purposes shall be one specimen cup.
Tests.
Sterility. Sterilization testing shall be in accordance with FDA’s current “Guideline on General Principles of Process Validation”. Failure to be in accordance shall constitute a defect.
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