COMMERCIAL ITEM DESCRIPTION A-A-51805
Table I (Cont’d)
MECHANICAL, PHYSICAL, CHEMICAL AND BIOLOGICAL PROPERTIES
Physical Property |
|
Test Method |
Heavy Metals Content (4) |
660 ppm, maximum |
USP, Monograph #231 |
Pyrogenticity |
Non-pyrogenic |
USP, Monograph # 151 |
Toxicity |
Non-Toxic |
USP, See #4 |
(1) 24- hour water absorption.
(2) Use die B for testing.
(3) Represents the total concentration of heavy metals.
(4) Perform the systematic injection test at Class IV testing. See “ Biological Tests Plastics.”
Thermal Stability. The circle band sleeve shall pass the thermal stability test specified herein.
Thermal stability test. Subject sample circle band sleeves to cyclic steam autoclaving in a high speed sterilizer at 2700F and 30 psig for 10 ± 1/2 minutes. Use a total of 10 cycles. After each cycle, examine the samples for blooming, warpage, wrinkles, or tackiness.
As an alternate, ample circling bands may be steam autoclaved in a standard gravity sterilizer at 2500F and 15 psig for 30 ± 1/2 minutes. Complete this version of the test by following the examination and cycling procedure listed above.
Sterility. The circle band sleeve shall be sterile when tested in accordance with accordance with the latest edition of the USP.
Finish. The circle band sleeve shall have a smooth, uniform finish.
Workmanship. The circling band shall be free from blooming, blisters, fish-eyes, frosting, pits, pimples, shorts, warpage, wrinkles, and any other defects which detract from their appearance or impair its serviceability. Definitions of defects listed above shall be in accordance with ASTM D883, “ Standard Definitions of Terms Relating to Plastics.”
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