David Saylor commited on
Commit ·
2b1c94e
1
Parent(s): 75bcb7f
fixed typo
Browse files- static/COU.md +1 -2
static/COU.md
CHANGED
|
@@ -11,8 +11,7 @@
|
|
| 11 |
## Context of Use (COU)
|
| 12 |
|
| 13 |
The Color Hazard and RISk calculator (CHRIS) is (proposed to be) qualified to conduct screening level risk assessments
|
| 14 |
-
to aid in the biocompatibility evaluation of polymeric medical device components that contain color additives (CAs)[^1].
|
| 15 |
-
These assessments can assist device manufacturers by providing instantaneous feedback on whether the presence of CAs or
|
| 16 |
other additives and impurities associated with CAs in a device would require additional justification and/or testing to
|
| 17 |
demonstrate acceptable biological risk. The output of CHRIS is a conservative margin of safety (MOS = toxicological
|
| 18 |
safety limit ÷ exposure dose) value for a CA (and associated additives and impurities) contained within a polymeric
|
|
|
|
| 11 |
## Context of Use (COU)
|
| 12 |
|
| 13 |
The Color Hazard and RISk calculator (CHRIS) is (proposed to be) qualified to conduct screening level risk assessments
|
| 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 ÷ exposure dose) value for a CA (and associated additives and impurities) contained within a polymeric
|