COMMERCIAL ITEM DESCRIPTION A-A-51887
Table II. Thread Dimensions
|
|
Needle Hub |
Tube Holder |
|
Major Diameter |
0.185 |
0.193 |
|
Minor Diameter |
0.139 |
0.150 |
|
Pitch Diameter |
0.164 |
0.175 |
The needles shall withstand loading without deflecting more than shown in inches in Table III below:
Table III. Stiffness
|
Gage |
Span |
Load (kg) |
Maximum Deflection |
|
22 |
0.62 |
1.42 |
0.023 |
The shut-off sleeve shall reseal against a 40 cm ± 5 cm hydrostatic head of water without more than one drop leakage. The test for effectiveness of the shut-off sleeve shall be accomplished by using a container with a bottom outlet to which is attached a gum rubber tube of the required length. The lower end of the tube shall be plugged. The patient end of the blood collecting needle shall then be inserted into the tubing at the specified distance below the water level in the container. Resealing quality is determined by using the thumb and finger to push the shut-off sleeve against the needle hub and observing its resealing action when it is released. As an alternate, a piece of bond paper can be held taut and pressed over the needle.
The cannula shall be straight and have a bevel length as shown in Table I. The point shall be ground flat or concave and may have a center ridge at the distal end to strengthen the tip. The point shall be ground at the outer edge to enhance the keeness. All edges of the point shall be free from burrs and slivers. The heel of the point shall be dull to prevent coring. The hub shall be securely attached on the cannula. The cannula exterior and interior shall be free from chips or any foreign matter.
The needle shall be free of pyrogens and be non-toxic in accordance with the USP.
All needles shall comply with the sterility requirements shown under Sterility test:
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