A-A-51951
28 April 1987
COMMERCIAL ITEM DESCRIPTION
TIRE, RETINAL IMPLANT, (SILICONE)
The General Services Administration has authorized the use of this commercial item description.
This commercial item description covers one type of ophthalmic retinal implant tire.
Salient characteristics:
Style and design. Shall be an asymmetrical, retinal implant tire conforming to Figure 1. The retinal implant tire shall contain a single groove on its outer perimeter. The retinal implant tire shall be suitable for use in retinal re-attachment surgery by facilitating the scleral buckling technique.
Material. The retinal implant tire shall be fabricated from RTV or thermally cured silicone elastomer. This material shall comply with the physical, mechanical, biological, and chemical properties listed in Table I. Samples of the material shall be subjected to the test specified for each property.
Table I
Mechanical, Physical, Chemical and Biological Properties
|
Property |
Test Method |
|
|
Specific Gravity |
1.11 – 1.15 |
ASTM D792 |
|
Durometer Hardness |
A23 – A34 |
ASTM D2240 |
|
Tensile Strength |
1000, psi minimum |
ASTM D412 |
|
Ultimate Elongation |
900%, minimum |
ASTM D412 |
|
Water Absorption (1) |
1 w/o, maximum |
ASTM D570 |
|
Tear Strength (2) |
150 PPI, minimum |
ASTM D624 |
|
Heavy Metals Content (3) |
660 ppm, maximum |
USP, |
|
Pyrogenocity |
Non-pyrogenic |
Monograph #231 USP, |
|
Toxicity |
Non-toxic |
Monograph #151 USP, See #4 |
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
For Parts Inquires call Parts Hangar, Inc (727) 493-0744
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