A-A-51514B
Examination. Examination shall be conducted to determine compliance with specification requirements.
Tests. Tests shall be conducted to determine compliance with specification requirements. Where feasible, the same sample shall be used for the determination of two or more test characteristics.
Sampling for tests. Sampling for tests shall be conducted in accordance with MIL-STD-105 and as specified herein. Unit of product for test purposes shall be one syringe and needle. Sampling for Leakage, Accuracy and Resistance to separation shall be S-1 with an AQL of 1.0. (See Note 3).
Accuracy of graduations. The graduated scale shall be accurate to within ± 5 percent of the volume indicated at volumes equal to or greater than 0.2 ml. The scale shall be accurate to within 0.007 ml volume less than 0.2 ml. Syringe shall be tested for volumetric accuracy using a calibrated burette.
Resistance to separation. Syringe and needles shall be tested for resistance to separation. The needle shall not separate from the syringe when the needle is subjected to a 5 pound tensile force for on minute. (See Note 2).
Leakage. An amount of water equal to more than 1/2 the capacity shall be drawn into the syringe through the hypodermic needle. The syringe shall then be held vertically (needle up) to allow air to rise above the water and be expelled. Tapping the barrel of the syringe will facilitate removal of trapped air. The plunger shall then be pressed inward to the 50% mark. Either crimp the needle or block the needle with rubber plug so no water may leak from the needle. Apply a 1 (one) pound axial air force for size 1 syringes. Apply the force for 10 seconds minimum. Observe the cannula/hub junction and barrel/hub interface for possible leakage. No water shall pass the cannula/hub junction and barrel/hub interface. No water shall pass the front rib of the plunger tip.
Sterility and pyrogenicity. Syringe and needle units shall be tested for freedom from pyrogens in accordance with the USP. Using either the Bacterial Endotoxin Test or the Pyrogen Test. Sterility testing shall be in accordance with USP or AAMI guidelines.
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