David Saylor commited on
Commit ·
2df26be
1
Parent(s): 86aa43e
updated md headers
Browse files- static/COU.html +5 -0
- static/COU.md +6 -1
- static/FAQ.md +5 -0
- static/README.md +5 -0
static/COU.html
CHANGED
|
@@ -1,3 +1,8 @@
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 1 |
|
| 2 |
<header>
|
| 3 |
<img src="images/FDAlogo.png" style="float: left;" height="100"/>
|
|
|
|
| 1 |
+
<!DOCTYPE html>
|
| 2 |
+
<html lang="en">
|
| 3 |
+
<head>
|
| 4 |
+
<meta charset="UTF-8">
|
| 5 |
+
</head>
|
| 6 |
|
| 7 |
<header>
|
| 8 |
<img src="images/FDAlogo.png" style="float: left;" height="100"/>
|
static/COU.md
CHANGED
|
@@ -1,4 +1,9 @@
|
|
| 1 |
```{=html}
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 2 |
|
| 3 |
<header>
|
| 4 |
<img src="images/FDAlogo.png" style="float: left;" height="100"/>
|
|
@@ -14,7 +19,7 @@ The Color Hazard and RISk calculator (CHRIS) is (proposed to be) qualified to co
|
|
| 14 |
to aid in the biocompatibility evaluation of polymeric medical device components that contain color additives (CAs)[^1]. These assessments can assist device manufacturers by providing instantaneous feedback on whether the presence of CAs or
|
| 15 |
other additives and impurities associated with CAs in a device would require additional justification and/or testing to
|
| 16 |
demonstrate acceptable biological risk. The output of CHRIS is a conservative margin of safety (MOS = toxicological
|
| 17 |
-
safety limit
|
| 18 |
medical device component. Based on the MOS value, the calculator determines if further assessment of one or more
|
| 19 |
biocompatibility endpoints is necessary for the CA and/or associated impurities.
|
| 20 |
|
|
|
|
| 1 |
```{=html}
|
| 2 |
+
<!DOCTYPE html>
|
| 3 |
+
<html lang="en">
|
| 4 |
+
<head>
|
| 5 |
+
<meta charset="UTF-8">
|
| 6 |
+
</head>
|
| 7 |
|
| 8 |
<header>
|
| 9 |
<img src="images/FDAlogo.png" style="float: left;" height="100"/>
|
|
|
|
| 19 |
to aid in the biocompatibility evaluation of polymeric medical device components that contain color additives (CAs)[^1]. These assessments can assist device manufacturers by providing instantaneous feedback on whether the presence of CAs or
|
| 20 |
other additives and impurities associated with CAs in a device would require additional justification and/or testing to
|
| 21 |
demonstrate acceptable biological risk. The output of CHRIS is a conservative margin of safety (MOS = toxicological
|
| 22 |
+
safety limit ÷ exposure dose) value for a CA (and associated additives and impurities) contained within a polymeric
|
| 23 |
medical device component. Based on the MOS value, the calculator determines if further assessment of one or more
|
| 24 |
biocompatibility endpoints is necessary for the CA and/or associated impurities.
|
| 25 |
|
static/FAQ.md
CHANGED
|
@@ -1,4 +1,9 @@
|
|
| 1 |
```{=html}
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 2 |
|
| 3 |
<header>
|
| 4 |
<img src="images/FDAlogo.png" style="float: left;" height="100"/>
|
|
|
|
| 1 |
```{=html}
|
| 2 |
+
<!DOCTYPE html>
|
| 3 |
+
<html lang="en">
|
| 4 |
+
<head>
|
| 5 |
+
<meta charset="UTF-8">
|
| 6 |
+
</head>
|
| 7 |
|
| 8 |
<header>
|
| 9 |
<img src="images/FDAlogo.png" style="float: left;" height="100"/>
|
static/README.md
CHANGED
|
@@ -1,4 +1,9 @@
|
|
| 1 |
```{=html}
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 2 |
|
| 3 |
<header>
|
| 4 |
<img src="images/FDAlogo.png" style="float: left;" height="100"/>
|
|
|
|
| 1 |
```{=html}
|
| 2 |
+
<!DOCTYPE html>
|
| 3 |
+
<html lang="en">
|
| 4 |
+
<head>
|
| 5 |
+
<meta charset="UTF-8">
|
| 6 |
+
</head>
|
| 7 |
|
| 8 |
<header>
|
| 9 |
<img src="images/FDAlogo.png" style="float: left;" height="100"/>
|