Robert Elder commited on
Commit
53e90d9
·
2 Parent(s): 5d79b22a9e5ce8

Merge branch 'master' of https://github.com/OSEL-DBCMS/CHRIS

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Files changed (2) hide show
  1. CHRIS.py +5 -5
  2. templates/main.html +6 -123
CHRIS.py CHANGED
@@ -1,13 +1,13 @@
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  from flask import Flask, render_template
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  app = Flask(__name__)
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- app.debug = False
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- from color_module import blueprint
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- app.register_blueprint(blueprint)
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- from exposure_module import blueprint
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- app.register_blueprint(blueprint)
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  from efficiency_module import blueprint
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  app.register_blueprint(blueprint)
 
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  from flask import Flask, render_template
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  app = Flask(__name__)
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+ app.debug = True
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+ #from color_module import blueprint
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+ #app.register_blueprint(blueprint)
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+ #from exposure_module import blueprint
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+ #app.register_blueprint(blueprint)
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  from efficiency_module import blueprint
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  app.register_blueprint(blueprint)
templates/main.html CHANGED
@@ -4,9 +4,6 @@
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  <meta charset="UTF-8">
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  <title>CHRIS</title>
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- <!-- <script src="https://cdn.jsdelivr.net/npm/jquery@3.5.1/dist/jquery.slim.min.js" integrity="sha384-DfXdz2htPH0lsSSs5nCTpuj/zy4C+OGpamoFVy38MVBnE+IbbVYUew+OrCXaRkfj" crossorigin="anonymous"></script> -->
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- <!-- <script src="https://cdn.jsdelivr.net/npm/popper.js@1.16.1/dist/umd/popper.min.js" integrity="sha384-9/reFTGAW83EW2RDu2S0VKaIzap3H66lZH81PoYlFhbGU+6BZp6G7niu735Sk7lN" crossorigin="anonymous"></script> -->
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- <!-- <script src="https://cdn.jsdelivr.net/npm/bootstrap@4.6.1/dist/js/bootstrap.min.js" integrity="sha384-VHvPCCyXqtD5DqJeNxl2dtTyhF78xXNXdkwX1CZeRusQfRKp+tA7hAShOK/B/fQ2" crossorigin="anonymous"></script> -->
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  <script src="{{ url_for('static',filename='jquery.slim.min.js') }}" integrity="sha384-DfXdz2htPH0lsSSs5nCTpuj/zy4C+OGpamoFVy38MVBnE+IbbVYUew+OrCXaRkfj" crossorigin="anonymous"></script>
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  <script src="{{ url_for('static',filename='popper.min.js') }}" integrity="sha384-9/reFTGAW83EW2RDu2S0VKaIzap3H66lZH81PoYlFhbGU+6BZp6G7niu735Sk7lN" crossorigin="anonymous"></script>
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  <script src="{{ url_for('static',filename='bootstrap.min.js') }}" integrity="sha384-VHvPCCyXqtD5DqJeNxl2dtTyhF78xXNXdkwX1CZeRusQfRKp+tA7hAShOK/B/fQ2" crossorigin="anonymous"></script>
@@ -15,17 +12,10 @@
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  </head>
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-
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  <img src="{{ url_for('static',filename='images/FDAlogo.png') }}" style="float: left;" height="100"/>
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  <img src="{{ url_for('static',filename='images/FDAgraphic.png') }}" style="float: right;" height="100"/>
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  <br clear="all" />
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- <!--
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- <img src="{{ url_for('static',filename='images/FDAlogo.png') }}" style="float: left;" height="100"/>
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- <img src="{{ url_for('static',filename='images/FDAgraphic.png') }}" style="float: right;" height="100"/>
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- <br clear="all" />
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- -->
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-
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  <header>
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  <h1 style="text-align:center">CHRIS: <font color="#0070C0">CH</font>emical <font color="#0070C0">RIS</font>k calculators</h1>
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  </header>
@@ -34,29 +24,19 @@
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35
  <p>
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  The CHemical RISk calculators (CHRIS) are a collection of modules to facilitate the use of physics-based models to estimate exposure
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- as part of toxicological risk assessment (TRA) of medical device polymers. There are two different categories of modules, which
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- include Medical Device Development Tools (MDDTs) and Regulatory Science Tools (RSTs). Please click on the information icon for more details about each category.
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- <h2> MDDT qualified modules <button type=button class="Info_btn" data-toggle="modal" data-target="#MDDTModal">&#9432;</button> </h2>
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- &#x2022; <a href="/color"> Color additives MDDT </a>
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  <p>
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- A tool to conduct screening level risk assessments to aid in the biocompatibility evaluation of polymeric medical device components
46
  that contain color additives (CAs). These assessments can assist device manufacturers by providing instantaneous feedback on whether
47
  the presence of CAs or other additives and impurities associated with CAs in a device would require additional justification and/or
48
  testing to demonstrate acceptable biological risk.
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  </p>
50
 
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- <h2> RST qualified modules <button type=button class="Info_btn" data-toggle="modal" data-target="#RSTModal">&#9432;</button> </h2>
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-
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- &#x2022; <a href="/color2"> Color additives RST (v2) </a>
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-
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- <p>
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- An updated version of the color additive module that contains additional features and more robust parameterization of the underlying
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- transport model used to estimate patient exposure. Note that this version has not been qualified as an MDDT.
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- </p>
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-
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  &#x2022; <a href="/exposure2"> Bulk chemicals (excluding color additives) RST (v2) </a>
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  <p>
@@ -65,7 +45,7 @@ This module can be used similarly to the color additive tool, but can be applied
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  the total amount of the chemical is known, e.g. from a certificate of analysis.
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  </p>
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- &#x2022; <a href="/efficiency"> Extraction efficiency </a>
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  <p>
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  This module can be used to estimate the fraction of the total pool or solvent concentration of a bulk chemical that will
@@ -74,7 +54,7 @@ This module can be used to estimate the fraction of the total pool or solvent co
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  </p>
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- <h2> Modules in development <button type=button class="Info_btn" data-toggle="modal" data-target="#DevModal">&#9432;</button> </h2>
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  &#x2022; <a href="/color3"> Color additives (v3) </a>
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@@ -95,102 +75,5 @@ This module can be used to leverage the results of device extraction testing (ei
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  which can subsequently be used for exposure estimation using the color additives or bulk chemicals modules.
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  </p>
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- <!--<h2> Future modules <button type=button class="Info_btn" data-toggle="modal" data-target="#FutureModal">&#9432;</button> </h2>
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-
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- &#x2022; Updates to exposure model modules to increase the range of applicable systems <br>
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-
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- &#x2022; New module to address layered materials, e.g. coatings <br>
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-
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- &#x2022; New module to leverage the results of standard device extraction testing for exposure estimation <br>-->
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-
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- <!-- Modals -->
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- <div id="MDDTModal" class="modal fade" role="dialog">
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- <div class="modal-dialog">
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-
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- <!-- Modal content-->
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- <div class="modal-content">
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- <div class="modal-header">
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- <h4 class="modal-title">Medical Device Development Tools (MDDTs) </h4>
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- </div>
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- <div class="modal-body">
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- <p> The modules in this category have been qualified as Medical Device Development Tools (MDDTs). This qualification
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- means that the output of the tool will be accepted by the FDA without the need to reconfirm the suitability and
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- utility of the tool, as long as it is used with the qualified context of use. For more information about MDDTs
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- please follow the link <a href="https://www.fda.gov/medical-devices/medical-device-development-tools-mddt"> here</a>.</p>
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- </div>
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- <div class="modal-footer">
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- <button type="button" class="btn btn-default" data-dismiss="modal">Close</button>
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- </div>
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- </div>
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-
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- </div>
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- </div>
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-
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- <div id="RSTModal" class="modal fade" role="dialog">
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- <div class="modal-dialog">
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-
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- <!-- Modal content-->
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- <div class="modal-content">
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- <div class="modal-header">
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- <h4 class="modal-title">Regulatory Science Tools (RSTs) </h4>
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- </div>
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- <div class="modal-body">
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- <p> The modules in this category have been qualified as Regulatory Science Tools (RSTs). RSTs are tools developed by the FDA
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- intended to assist in the design and development of medical devices and test methodologies. RSTs can be
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- used to support regulatory submissions, but suitability is assessed on a case-by-case basis. These tools may
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- become MDDTs in the future. For more information about RSTs
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- please follow the link
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- <a href="https://www.fda.gov/medical-devices/science-and-research-medical-devices/catalog-regulatory-science-tools-help-assess-new-medical-devices
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- "> here</a>.</p>
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- </div>
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- <div class="modal-footer">
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- <button type="button" class="btn btn-default" data-dismiss="modal">Close</button>
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- </div>
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- </div>
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-
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- </div>
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- </div>
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-
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- <div id="DevModal" class="modal fade" role="dialog">
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- <div class="modal-dialog">
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-
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- <!-- Modal content-->
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- <div class="modal-content">
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- <div class="modal-header">
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- <h4 class="modal-title">Development modules </h4>
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- </div>
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- <div class="modal-body">
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- <p> The modules in this category are currently under development. While we intend to submit these tools for RST and/or
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- MDDT qualification in the future, they have not yet been reviewed in any context by the FDA.</p>
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- </div>
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- <div class="modal-footer">
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- <button type="button" class="btn btn-default" data-dismiss="modal">Close</button>
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- </div>
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- </div>
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-
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- </div>
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- </div>
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-
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- <div id="FutureModal" class="modal fade" role="dialog">
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- <div class="modal-dialog">
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-
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- <!-- Modal content-->
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- <div class="modal-content">
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- <div class="modal-header">
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- <h4 class="modal-title">Future modules </h4>
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- </div>
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- <div class="modal-body">
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- <p> We are actively pursuing generation of the evidence base for the modules and updates listed in this category. Stay tuned
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- for future additions to the CHRIS calculators!</p>
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- </div>
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- <div class="modal-footer">
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- <button type="button" class="btn btn-default" data-dismiss="modal">Close</button>
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- </div>
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- </div>
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-
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- </div>
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- </div>
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-
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-
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  </body>
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  </html>
 
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  <meta charset="UTF-8">
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  <title>CHRIS</title>
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  <script src="{{ url_for('static',filename='jquery.slim.min.js') }}" integrity="sha384-DfXdz2htPH0lsSSs5nCTpuj/zy4C+OGpamoFVy38MVBnE+IbbVYUew+OrCXaRkfj" crossorigin="anonymous"></script>
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  <script src="{{ url_for('static',filename='popper.min.js') }}" integrity="sha384-9/reFTGAW83EW2RDu2S0VKaIzap3H66lZH81PoYlFhbGU+6BZp6G7niu735Sk7lN" crossorigin="anonymous"></script>
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  <script src="{{ url_for('static',filename='bootstrap.min.js') }}" integrity="sha384-VHvPCCyXqtD5DqJeNxl2dtTyhF78xXNXdkwX1CZeRusQfRKp+tA7hAShOK/B/fQ2" crossorigin="anonymous"></script>
 
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  </head>
14
 
 
15
  <img src="{{ url_for('static',filename='images/FDAlogo.png') }}" style="float: left;" height="100"/>
16
  <img src="{{ url_for('static',filename='images/FDAgraphic.png') }}" style="float: right;" height="100"/>
17
  <br clear="all" />
18
 
 
 
 
 
 
 
19
  <header>
20
  <h1 style="text-align:center">CHRIS: <font color="#0070C0">CH</font>emical <font color="#0070C0">RIS</font>k calculators</h1>
21
  </header>
 
24
 
25
  <p>
26
  The CHemical RISk calculators (CHRIS) are a collection of modules to facilitate the use of physics-based models to estimate exposure
27
+ as part of toxicological risk assessment (TRA) of medical device polymers.
 
28
 
29
+ <h2> CHRIS modules </h2>
30
 
31
+ &#x2022; <a href="/color2"> Color additives RST (v2) </a>
32
 
33
  <p>
34
+ A tool to conduct screening level risk assessments to aid in the biocompatibility evaluation of polymeric medical device components
35
  that contain color additives (CAs). These assessments can assist device manufacturers by providing instantaneous feedback on whether
36
  the presence of CAs or other additives and impurities associated with CAs in a device would require additional justification and/or
37
  testing to demonstrate acceptable biological risk.
38
  </p>
39
 
 
 
 
 
 
 
 
 
 
40
  &#x2022; <a href="/exposure2"> Bulk chemicals (excluding color additives) RST (v2) </a>
41
 
42
  <p>
 
45
  the total amount of the chemical is known, e.g. from a certificate of analysis.
46
  </p>
47
 
48
+ &#x2022; <a href="/efficiency"> Extraction efficiency RST </a>
49
 
50
  <p>
51
  This module can be used to estimate the fraction of the total pool or solvent concentration of a bulk chemical that will
 
54
  </p>
55
 
56
 
57
+ <h2> Modules in development </h2>
58
 
59
  &#x2022; <a href="/color3"> Color additives (v3) </a>
60
 
 
75
  which can subsequently be used for exposure estimation using the color additives or bulk chemicals modules.
76
  </p>
77
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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  </body>
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  </html>