dmsaylor commited on
Commit
91f8a55
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1 Parent(s): 3e422b7

updated html links

Browse files
color_module/templates/report.html CHANGED
@@ -159,7 +159,7 @@ of {{MOS}}.
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  <font color="red"> *Note*: This assessment assumes that the color additive complies with all relevant medical device
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  specific guidance documents and all relevant Code of Federal Regulations (CFR) color additive listings, if they
161
  exist for the color additive. Examples of CFR listings are provided in the
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- <a href="static/FAQ.html#how-does-chris-deal-with-color-additive-impurities" >FAQ</a>.</font>
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  </p>
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  {% endif %}
@@ -182,7 +182,7 @@ of {{MOS}}.
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  <font color="red"> *Note*: Users should review and confirm compliance of impurity levels with any relevant Code of
183
  Federal Regulations (CFR) listings as part of the submission package, i.e. in addition to any output of CHRIS.
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  A list of relevant CFR listings is provided
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- <a href="static/FAQ.html#how-does-chris-deal-with-color-additive-impurities" >here</a>.</font>
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  </p>
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  {% else %}
@@ -190,7 +190,7 @@ of {{MOS}}.
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  <font color="red"> The total color additive impurity level is {{impurity}} mg. When compared to TTC this results in
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  an MOS = {{iMOS}}. Therefore, further analysis is needed to address the impact of impurities on systemic
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  biocompatibility endpoints. Guidance on alternative methods to address impurities is provided
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- <a href="static/FAQ.html#how-does-chris-deal-with-color-additive-impurities" >here</a>. </font>
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  {% endif %}
 
159
  <font color="red"> *Note*: This assessment assumes that the color additive complies with all relevant medical device
160
  specific guidance documents and all relevant Code of Federal Regulations (CFR) color additive listings, if they
161
  exist for the color additive. Examples of CFR listings are provided in the
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+ <a href="color_module/FAQ.html#how-does-chris-deal-with-color-additive-impurities" >FAQ</a>.</font>
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  </p>
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  {% endif %}
 
182
  <font color="red"> *Note*: Users should review and confirm compliance of impurity levels with any relevant Code of
183
  Federal Regulations (CFR) listings as part of the submission package, i.e. in addition to any output of CHRIS.
184
  A list of relevant CFR listings is provided
185
+ <a href="color_module/FAQ.html#how-does-chris-deal-with-color-additive-impurities" >here</a>.</font>
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  </p>
187
 
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  {% else %}
 
190
  <font color="red"> The total color additive impurity level is {{impurity}} mg. When compared to TTC this results in
191
  an MOS = {{iMOS}}. Therefore, further analysis is needed to address the impact of impurities on systemic
192
  biocompatibility endpoints. Guidance on alternative methods to address impurities is provided
193
+ <a href="color_module/FAQ.html#how-does-chris-deal-with-color-additive-impurities" >here</a>. </font>
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  {% endif %}
exposure_module/static/exposure_COU.html CHANGED
@@ -10,10 +10,10 @@
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  <img src="images/FDAlogo.png" style="float: left;" height="100"/>
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  <img src="images/FDAgraphic.png" style="float: right;" height="100"/>
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  <br clear="all" />
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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>
14
  </header>
15
  <h2 id="context-of-use-cou">Context of Use (COU)</h2>
16
- <p>The bulk chemical module of the CHemical RISk calculator (CHRIS) is (proposed to be) qualified to conduct screening level risk assessments to aid in the biocompatibility evaluation of bulk additives and impurities in polymeric medical device components. These assessments can assist device manufacturers by providing instantaneous feedback on whether the presence of the bulk chemical 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 bulk chemical 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 specific chemical.</p>
17
  <p>Because CHRIS only addresses compounds with a distribution that is macroscopically homogeneous within the matrix, the tool can only be used to assess bulk additives and impurities. Therefore, only compounds that are introduced either intentionally or unintentionally during synthesis (e.g., residual monomers and oligomers, catalysts, initiators) or compounding (e.g., stabilizers, antioxidants, plasticizers) are within scope. Surface residuals from processing, cleaning, and sterilization are excluded. Also, CHRIS requires the total amount of the chemical to be established in advance, e.g., based on a certificate of analysis. Further CHRIS only addresses individual chemicals; therefore, 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.</p>
18
  <p>CHRIS provides clinically relevant, yet still conservative, exposure dose estimates using a physics-based transport model for polymeric systems where transport data are available to support the use of the model. The model applies worst-case boundary conditions for release of a substance from the polymer matrix and is based on four (4) primary assumptions:</p>
19
  <ol type="1">
 
10
  <img src="images/FDAlogo.png" style="float: left;" height="100"/>
11
  <img src="images/FDAgraphic.png" style="float: right;" height="100"/>
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  <br clear="all" />
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+ <h1 style="text-align:center">CHRIS: <font color="#0070C0">CH</font>emical <font color="#0070C0">RIS</font>k calculator - Bulk leachables</h1>
14
  </header>
15
  <h2 id="context-of-use-cou">Context of Use (COU)</h2>
16
+ <p>The bulk leachable module of the CHemical RISk calculator (CHRIS) is (proposed to be) qualified to conduct screening level risk assessments to aid in the biocompatibility evaluation of bulk additives and impurities in polymeric medical device components. These assessments can assist device manufacturers by providing instantaneous feedback on whether the presence of the bulk chemical 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 bulk chemical 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 specific chemical.</p>
17
  <p>Because CHRIS only addresses compounds with a distribution that is macroscopically homogeneous within the matrix, the tool can only be used to assess bulk additives and impurities. Therefore, only compounds that are introduced either intentionally or unintentionally during synthesis (e.g., residual monomers and oligomers, catalysts, initiators) or compounding (e.g., stabilizers, antioxidants, plasticizers) are within scope. Surface residuals from processing, cleaning, and sterilization are excluded. Also, CHRIS requires the total amount of the chemical to be established in advance, e.g., based on a certificate of analysis. Further CHRIS only addresses individual chemicals; therefore, 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.</p>
18
  <p>CHRIS provides clinically relevant, yet still conservative, exposure dose estimates using a physics-based transport model for polymeric systems where transport data are available to support the use of the model. The model applies worst-case boundary conditions for release of a substance from the polymer matrix and is based on four (4) primary assumptions:</p>
19
  <ol type="1">
exposure_module/static/exposure_COU.md CHANGED
@@ -11,13 +11,13 @@
11
  <img src="images/FDAlogo.png" style="float: left;" height="100"/>
12
  <img src="images/FDAgraphic.png" style="float: right;" height="100"/>
13
  <br clear="all" />
14
- <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>
15
  </header>
16
  ```
17
 
18
  ## Context of Use (COU)
19
 
20
- The bulk chemical module of the CHemical RISk calculator (CHRIS) is (proposed to be) qualified to conduct screening level risk assessments to aid in the biocompatibility evaluation of bulk additives and impurities in polymeric medical device components. These assessments can assist device manufacturers by providing instantaneous feedback on whether the presence of the bulk chemical 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 bulk chemical 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 specific chemical.
21
 
22
  Because CHRIS only addresses compounds with a distribution that is macroscopically homogeneous within the matrix, the tool can only be used to assess bulk additives and impurities. Therefore, only compounds that are introduced either intentionally or unintentionally during synthesis (e.g., residual monomers and oligomers, catalysts, initiators) or compounding (e.g., stabilizers, antioxidants, plasticizers) are within scope. Surface residuals from processing, cleaning, and sterilization are excluded. Also, CHRIS requires the total amount of the chemical to be established in advance, e.g., based on a certificate of analysis. Further CHRIS only addresses individual chemicals; therefore, 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.
23
 
 
11
  <img src="images/FDAlogo.png" style="float: left;" height="100"/>
12
  <img src="images/FDAgraphic.png" style="float: right;" height="100"/>
13
  <br clear="all" />
14
+ <h1 style="text-align:center">CHRIS: <font color="#0070C0">CH</font>emical <font color="#0070C0">RIS</font>k calculator - Bulk leachables</h1>
15
  </header>
16
  ```
17
 
18
  ## Context of Use (COU)
19
 
20
+ The bulk leachable module of the CHemical RISk calculator (CHRIS) is (proposed to be) qualified to conduct screening level risk assessments to aid in the biocompatibility evaluation of bulk additives and impurities in polymeric medical device components. These assessments can assist device manufacturers by providing instantaneous feedback on whether the presence of the bulk chemical 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 bulk chemical 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 specific chemical.
21
 
22
  Because CHRIS only addresses compounds with a distribution that is macroscopically homogeneous within the matrix, the tool can only be used to assess bulk additives and impurities. Therefore, only compounds that are introduced either intentionally or unintentionally during synthesis (e.g., residual monomers and oligomers, catalysts, initiators) or compounding (e.g., stabilizers, antioxidants, plasticizers) are within scope. Surface residuals from processing, cleaning, and sterilization are excluded. Also, CHRIS requires the total amount of the chemical to be established in advance, e.g., based on a certificate of analysis. Further CHRIS only addresses individual chemicals; therefore, 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.
23
 
exposure_module/templates/exposure_index.html CHANGED
@@ -18,10 +18,8 @@
18
  <h1 style="text-align:center"><font color="#0070C0">CH</font>emical <font color="#0070C0">RIS</font>k calculator (CHRIS) - Bulk chemicals </h1>
19
  </header>
20
 
21
- <p><strong>Disclaimer: This module only addresses risk associated with the bulk chemicals, excluding color additives, of known initial quantity.
22
- Therefore, a favorable outcome does not imply acceptable biological risk for the final finished form of a medical device.
23
- Further, a successful evaluation does not address local biocompatibility endpoints, and therefore additional testing
24
- may be needed despite a positive outcome. For color additives, please use the <a href="https://chris-osel.pythonanywhere.com">color additive module</a>. </strong></p>
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26
  For details on how to use CHRIS, please click the information icons next to each section header and read the
27
  <a href="{{url_for('.static', filename='exposure_COU.html')}}"> context of use (COU)</a>.
 
18
  <h1 style="text-align:center"><font color="#0070C0">CH</font>emical <font color="#0070C0">RIS</font>k calculator (CHRIS) - Bulk chemicals </h1>
19
  </header>
20
 
21
+ <p><strong>Note: This module only addresses risk associated with the bulk chemicals, excluding color additives, of known initial quantity.
22
+ For color additives, please use the <a href="/color"> color additive module</a>. </strong></p>
 
 
23
 
24
  For details on how to use CHRIS, please click the information icons next to each section header and read the
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  <a href="{{url_for('.static', filename='exposure_COU.html')}}"> context of use (COU)</a>.
exposure_module/templates/exposure_report.html CHANGED
@@ -36,7 +36,7 @@
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  <br clear="all" />
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  <header>
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- <h1 style="text-align:center"><font color="#0070C0">CH</font>emical <font color="#0070C0">RIS</font>k calculator (CHRIS) Report </h1>
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  </header>
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  <body>
@@ -56,9 +56,11 @@
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  Molecular weight (g/mol) :: {{MW}}
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  {% if ceramic %} :: ceramic detected, assume maximum Mw {% endif %}
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  <br> <br>
 
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  LogKow :: {{'%0.2f'%LogP|float}}{{LogP_origin}}<br> <br>
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  Density (g/cm<sup>3</sup>) :: {{rho}}{{rho_origin}}<br> <br>
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  Melting point (&deg;C) :: {{'%0.1f'%mp|float}}{{mp_origin}}<br> <br>
 
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  SMILES :: {{smiles}}
63
  </div>
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  <div class="column">
 
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  <br clear="all" />
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38
  <header>
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+ <h1 style="text-align:center"><font color="#0070C0">CH</font>emical <font color="#0070C0">RIS</font>k calculator (CHRIS) Report - Bulk chemicals </h1>
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  </header>
41
 
42
  <body>
 
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  Molecular weight (g/mol) :: {{MW}}
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  {% if ceramic %} :: ceramic detected, assume maximum Mw {% endif %}
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  <br> <br>
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+ <!--
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  LogKow :: {{'%0.2f'%LogP|float}}{{LogP_origin}}<br> <br>
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  Density (g/cm<sup>3</sup>) :: {{rho}}{{rho_origin}}<br> <br>
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  Melting point (&deg;C) :: {{'%0.1f'%mp|float}}{{mp_origin}}<br> <br>
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+ -->
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  SMILES :: {{smiles}}
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  </div>
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  <div class="column">
templates/main.html CHANGED
@@ -4,6 +4,8 @@
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  <meta charset="UTF-8">
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  <title>CHRIS</title>
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  </head>
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  <img src="{{ url_for('static',filename='images/FDAlogo.png') }}" style="float: left;" height="100"/>
@@ -21,6 +23,11 @@ The CHemical RISk calculator (CHRIS) is a collection of modules to facilitate th
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  as part of toxicological risk assessment (TRA) of medical device polymers.
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  </p>
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24
  <h2>Modules</h2>
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26
  1. <a href="/color"> Color additives </a>
 
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  <meta charset="UTF-8">
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  <title>CHRIS</title>
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+ <link rel= "stylesheet" type= "text/css" href= "{{ url_for('static',filename='styles.css') }}">
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+
9
  </head>
10
 
11
  <img src="{{ url_for('static',filename='images/FDAlogo.png') }}" style="float: left;" height="100"/>
 
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  as part of toxicological risk assessment (TRA) of medical device polymers.
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  </p>
25
 
26
+ <p>
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+ Note: this is a development version of CHRIS, and therefore, not yet qualified as a medical device development tool (MDDT). The MDDT qualified
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+ version can be found <a href="https://chris-osel.pythonanywhere.com">here</a>.
29
+ </p>
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+
31
  <h2>Modules</h2>
32
 
33
  1. <a href="/color"> Color additives </a>