Biomedical Engineering Reference
In-Depth Information
TABLE 2.3
Biocompatibility Flowchart for the Selection of Toxicity Tests for 510(k)s
USP Acute Systemic Injection Test
Pass
USP <88>
USP Intracutaneous Injection Test
Pass
USP<88>
USP Intramuscular Implantation Test
Pass
USP <88>
USP MEM Elution Method
Non-Cytotoxic
USP <87>
Physiochemical Test for Plastics
Pass
USP <661>
Extractables
TOC After 90
Days (ppm)
pH Shift After
90 Days
Purified Water (pH=7)
<2
-0.79
Acidic Water (pH<2)
<3
+0.01
Basic Water (pH>10)
<4
+0.87
Physical Data
Water Vapor Transmission Rate
(g/100in2/24hrs)
0.017
ASTM F-1249
Carbon Dioxide Transmission Rate
(cc/100in2/24hrs)
0.129
ASTM F-2476
Oxygen Transmission Rate
(cc/100in2/24hrs)
0.023
ASTM F-1927
Average Force
Average MOE
Average Elongation
Tensile
32.73 lbs
25110 psi
1084%
ASTM D 882-02
Min Force
Average Force
Max Force
Tear Resistance
6.77 lbs
7.21 lbs
7.74 lbs
ASTM D1004-03
Puncture Resistance
16.42 lbs
18.61 lbs
19.51 lbs
FTMS 101C
