A-A-53103A
Physical properties. The polyvinyl chloride used in the manufacture of the syringe shall have the properties shown in Table I. A sufficient amount of the raw material, which is representative of the lot or batch, shall be used as a sample for testing.
TABLE I.
|
Property |
Value |
Test Method |
|
Tensile strength, break |
1100-1400 psi |
ASTM D638 |
|
Elongation %, break |
450-500 |
ASTM D538 |
|
Tensile modulus 100% |
350-400 psi |
ASTM D638 |
|
Hardness (shore durometer) |
55-63A |
ASTM D2240 |
Hardness. Using ASTM Designation 1)2240, the gage reading shall be made 10 seconds after application of the instrument.
Vacuum test. When tested as specified, the syringe shall draw a vacuum of not less than 760 mm of mercury. Manually evacuate the syringe by compressing the top of the syringe until it touches the opposite wall. Connect the syringe to a mercury manometer and release the syringe. Take the reading once the manometer reaches equilibrium. The vacuum suction pressure shall be not less than 760 mm of mercury.
Accelerated aging test. Preheat an air oven to 140° +\- 4°F prior to placing the sample in the oven. The sample shall be placed in the oven for seven days. The appearance of the sample before and after the aging test shall be noted. The physical properties listed in Table I shall not decrease by more than 25 percent due to the aging test. The vacuum suction pressure shall not be less than 760mm of mercury as a result of the aging test. The physical properties of the representative polyvinyl chloride sample shall be established prior to performing the accelerated aging test.
Sterilization, safety and freedom from pyrogens. The syringe shall be sterile, free from pyrogens and safe. The syringe shall be tested for sterility, freedom from pyrogens and safety in accordance with the USP.
For Parts Inquires call Parts Hangar, Inc (727) 493-0744
© Copyright 2015 Integrated Publishing, Inc.
A Service Disabled Veteran Owned Small Business