David Saylor commited on
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86aa43e
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1 Parent(s): 2b1c94e

fixed typo

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  1. static/COU.html +1 -2
static/COU.html CHANGED
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  <h1 style="text-align:center"><font color="#0070C0">C</font>olor <font color="#0070C0">H</font>azard and <font color="#0070C0">RIS</font>k calculator (CHRIS) </h1>
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  </header>
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  <h2 id="context-of-use-cou">Context of Use (COU)</h2>
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- <p>The Color Hazard and RISk calculator (CHRIS) is (proposed to be) qualified to conduct screening level risk assessments to aid in the biocompatibility evaluation of polymeric medical device components that contain color additives (CAs)<a href="#fn1" class="footnote-ref" id="fnref1" role="doc-noteref"><sup>1</sup></a>.<br />
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- These assessments can assist device manufacturers by providing instantaneous feedback on whether the presence of CAs or other additives and impurities associated with CAs in a device would require additional justification and/or testing to demonstrate acceptable biological risk. The output of CHRIS is a conservative margin of safety (MOS = toxicological safety limit ÷ exposure dose) value for a CA (and associated additives and impurities) contained within a polymeric medical device component. Based on the MOS value, the calculator determines if further assessment of one or more biocompatibility endpoints is necessary for the CA and/or associated impurities.</p>
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  <p>Because CHRIS only addresses CAs, a favorable outcome by CHRIS does not imply acceptable biological risk for the final finished form of a medical device. CHRIS is also not intended to establish device classification or identify biocompatibility requirements. However, in addition to providing guidance to device manufacturers on acceptable levels of CA in a particular device, CHRIS can potentially be used to:</p>
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  <ul>
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  <li>reduce the amount of biocompatibility testing needed following a supplier or manufacturing changes related to only the presence of the CA in the device;</li>
 
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  <h1 style="text-align:center"><font color="#0070C0">C</font>olor <font color="#0070C0">H</font>azard and <font color="#0070C0">RIS</font>k calculator (CHRIS) </h1>
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  </header>
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  <h2 id="context-of-use-cou">Context of Use (COU)</h2>
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+ <p>The Color Hazard and RISk calculator (CHRIS) is (proposed to be) qualified to conduct screening level risk assessments to aid in the biocompatibility evaluation of polymeric medical device components that contain color additives (CAs)<a href="#fn1" class="footnote-ref" id="fnref1" role="doc-noteref"><sup>1</sup></a>. These assessments can assist device manufacturers by providing instantaneous feedback on whether the presence of CAs or other additives and impurities associated with CAs in a device would require additional justification and/or testing to demonstrate acceptable biological risk. The output of CHRIS is a conservative margin of safety (MOS = toxicological safety limit ÷ exposure dose) value for a CA (and associated additives and impurities) contained within a polymeric medical device component. Based on the MOS value, the calculator determines if further assessment of one or more biocompatibility endpoints is necessary for the CA and/or associated impurities.</p>
 
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  <p>Because CHRIS only addresses CAs, a favorable outcome by CHRIS does not imply acceptable biological risk for the final finished form of a medical device. CHRIS is also not intended to establish device classification or identify biocompatibility requirements. However, in addition to providing guidance to device manufacturers on acceptable levels of CA in a particular device, CHRIS can potentially be used to:</p>
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  <ul>
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  <li>reduce the amount of biocompatibility testing needed following a supplier or manufacturing changes related to only the presence of the CA in the device;</li>