A-A-51514B
The size 1 syringe shall have subgraduations every two units and main graduation every 10 units. The scale shall be 5.5 cm (minimum) in length.
Type II- Dual scale graduations. Dual scale syringes shall have the single scale described above, except that main graduations shall be a minimum of 12.5 percent longer than subgraduations. In addition, dual scale syringes shall have an odd-numbered scale adjacent to the even-numbered scale. The main graduations of the odd-numbered scale shall be numbered.
The size 1 odd-numbered scale shall have subgraduations every 2 units and main graduations every 10 units. Subgraduations shall range from 1 to 99 units and main graduations shall range from 5 to 95 units.
Dual scale syringes may be substituted for single scale syringes only if all single scale requirements (including the 33 percent longer main graduations) are met.
Markings. Syringes shall bear the legend “For Use with U-100 Insulin Only” or words to that effect. Syringes shall bear the manufacturer’s name or registered trademark.
Dead space. Dead space shall not exceed one (1) unit in the syringe and needle.
Materials. The syringe barrel and plunger shall be manufactured from polypropylene plastic. As an alternate, the plunger may be manufactured from impact-modified polystyrene have having an impact strength (Izod) of 0.5 ft.- lbs/inch of notch (min) when tested in accordance with ASTM Designation D256. The plunger tip shall be manufactured from rubber. The needle shall be manufactured from austenitic Class 3 stainless steel in accordance with ASTM Designation F899. The syringe shall be properly annealed and passivated.
Toxicity, pyrogenicity, and sterility. Shall be non-toxic and pyrogenic in accordance with USP. Shall be sterile in accordance with USP or AAMI guidelines.
Workmanship. The syringe and needle shall contain no defects which detract from appearance or impair the serviceability of the unit.
Instructions. Each unit package shall contain complete instructions for use and disposable of the syringes.
For Parts Inquires call Parts Hangar, Inc (727) 493-0744
© Copyright 2015 Integrated Publishing, Inc.
A Service Disabled Veteran Owned Small Business