David Saylor commited on
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021283d
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1 Parent(s): 2df26be

tried to fix the readme file odd characters

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  1. static/FAQ.html +5 -0
  2. static/README.html +9 -4
  3. static/README.md +5 -5
static/FAQ.html CHANGED
@@ -1,3 +1,8 @@
 
 
 
 
 
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  <header>
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  <img src="images/FDAlogo.png" style="float: left;" height="100"/>
 
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+ <!DOCTYPE html>
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+ <html lang="en">
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+ <head>
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+ <meta charset="UTF-8">
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+ </head>
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  <header>
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  <img src="images/FDAlogo.png" style="float: left;" height="100"/>
static/README.html CHANGED
@@ -1,3 +1,8 @@
 
 
 
 
 
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  <header>
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  <img src="images/FDAlogo.png" style="float: left;" height="100"/>
@@ -14,7 +19,7 @@
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  <li><p>If a color additive associated substance is present in multiple polymer medical device components, CHRIS will not screen the potential risk of the substance from all the polymer components that contain it. CHRIS exposure estimates from each component may be manually summated to estimate total exposure to each substance and manually compared to the TE or TTC for that substance.</p></li>
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  <li><p>If the substance levels present in the device are unknown, the calculator currently cannot be used to screen the risk associated with the respective compound(s).</p></li>
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  <li><p>CHRIS cannot be used to screen the potential risk of polymer medical device components that contact the body by the inhalation route.</p></li>
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- <li><p>The exposure model employed by CHRIS assumes a plane sheet geometry as worst-case. This assumption should be valid for most medical device components; however, potential exceptions exist. Specifically, this assumption can underestimate exposure when the geometry of the exposed surface area is concave, e.g. body contact is limited to the lumen of a catheter. When the exposed surface area is concave, underestimating exposure can be mitigated by assuming the patient will be exposed to all surfaces of the component, i.e. exposed surface area = total component surface area.</p></li>
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  </ol>
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  <h2 id="assumptions">Assumptions</h2>
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  <p>In addition to plane sheet geometry, four additional assumptions were made in the derivation of the exposure model, which include:</p>
@@ -33,9 +38,9 @@
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  <p><em>Amount</em> - Enter the total mass of the substance in the component being evaluated expressed in milligrams.</p>
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  <p><em>Total impurity concentration</em> - If you have selected a color additive, please enter the combined concentration of all impurities associated with the color additive as a percentage (% mass/mass).</p>
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  <h3 id="polymer-matrix">Polymer matrix</h3>
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- <p><em>Matrix</em> - Please select your polymer matrix from the list. If your polymer is not listed below, please select “Other polymer”. For polymer mixtures/blends, co-polymers, or composites (e.g. glass fiber reinforced matrices), the component or phase that is worst-case for exposure, i.e. the softest or least glassy (lowest Tg) component can be selected if listed (which, in turn, assumes the entire system is composed of the worst-case component or phase). In these scenarios, a justification should be provided for the choice of worst-case component of the polymer system.</p>
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  <p><em>Mass</em> - Enter the mass of the polymer matrix in grams.</p>
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- <p><em>Density</em> - Enter the estimated density of the polymer matrix in grams per cubic centimeter. Note that a rough estimate (e.g. +/- 10%) is acceptable.</p>
39
  <h3 id="device-characteristics">Device characteristics</h3>
40
  <p><em>Exposed surface area</em> - Enter the patient contacting surface area of the color additive containing component being evaluated in square centimeters. This includes both direct and indirect patient contact.</p>
41
  <p><em>Exposure type</em> - Select the appropriate exposure category: &gt; 30 days = long-term, &gt; 24 hours - 30 days = prolonged, ≤ 24 hours = limited. For limited exposures (≤ 24 hours), please enter the maximum exposure time in hours.</p>
@@ -44,7 +49,7 @@
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  <p><em>Biostability of the matrix</em> - While many of the matrices listed within CHRIS will not appreciably swell or degrade in any physiological environment, this can not be generalized. For example, silicones may swell in lipid-rich environments. Chemical compatibility of the polymer matrix with the use environment can be assessed based on historical use and/or evaluation of swelling and/or degradation propensity in physiologically relevant media.</p>
45
  <p><em>Particle/aggregate size and distribution</em> - CHRIS relies on the color additive having a distribution that is macroscopically homogeneous within the matrix (e.g. CAs used for surface marking would be excluded); thus, any particles or aggregates must be small relative to the component and homogeneously distributed. This can be confirmed/justified through the use of particle coatings and/or dispersants in the concentrate to prevent aggregation and promote homogeneity, macroscopic observations of color uniformity, and/or microscopic observations to evaluate the potential for surface segregation phenomena, such as blooming.</p>
46
  <p><em>Dilute concentration</em> - The model relies on a concentration independent diffusion coefficient, which assumes any color additives are present only in dilute quantities. Confirming that the total amount of color additives present is ≤ 2 m/v % is sufficient to conform with this assumption. It may be possible to justify that the CHRIS calculation for a dilute compound will remain protective if the total concentration is in excess of 2 m/v %, if the presence of additional compound could reasonably be expected to inhibit rather than promote diffusion, e.g. second phase particulates.</p>
47
- <p><em>Matrix stability</em> - The model parameters/transport properties are established using worst-case values reported in the literature. However, it is unclear if the reported values account for potential degradation (e.g. during sterilization) or other physicochemical changes (e.g. excessive plasticization) that may occur during manufacturing and negatively impact these values. Polymer stability can be confirmed/justified by evidence supporting that manufacturing (including sterilization) does not alter the matrix material of the final device.</p>
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  <h3 id="exposure-assessment">Exposure Assessment</h3>
49
  <p>Once the fields described have been populated for the polymeric component being evaluated, click the <strong>Estimate exposure</strong> button. The risk assessment output includes the following information:</p>
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  <ol type="1">
 
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+ <!DOCTYPE html>
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+ <html lang="en">
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+ <head>
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+ <meta charset="UTF-8">
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+ </head>
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  <header>
8
  <img src="images/FDAlogo.png" style="float: left;" height="100"/>
 
19
  <li><p>If a color additive associated substance is present in multiple polymer medical device components, CHRIS will not screen the potential risk of the substance from all the polymer components that contain it. CHRIS exposure estimates from each component may be manually summated to estimate total exposure to each substance and manually compared to the TE or TTC for that substance.</p></li>
20
  <li><p>If the substance levels present in the device are unknown, the calculator currently cannot be used to screen the risk associated with the respective compound(s).</p></li>
21
  <li><p>CHRIS cannot be used to screen the potential risk of polymer medical device components that contact the body by the inhalation route.</p></li>
22
+ <li><p>The exposure model employed by CHRIS assumes a plane sheet geometry as worst-case. This assumption should be valid for most medical device components; however, potential exceptions exist. Specifically, this assumption can underestimate exposure when the geometry of the exposed surface area is concave, e.g., body contact is limited to the lumen of a catheter. When the exposed surface area is concave, underestimating exposure can be mitigated by assuming the patient will be exposed to all surfaces of the component, i.e., exposed surface area = total component surface area.</p></li>
23
  </ol>
24
  <h2 id="assumptions">Assumptions</h2>
25
  <p>In addition to plane sheet geometry, four additional assumptions were made in the derivation of the exposure model, which include:</p>
 
38
  <p><em>Amount</em> - Enter the total mass of the substance in the component being evaluated expressed in milligrams.</p>
39
  <p><em>Total impurity concentration</em> - If you have selected a color additive, please enter the combined concentration of all impurities associated with the color additive as a percentage (% mass/mass).</p>
40
  <h3 id="polymer-matrix">Polymer matrix</h3>
41
+ <p><em>Matrix</em> - Please select your polymer matrix from the list. If your polymer is not listed below, please select “Other polymer”. For polymer mixtures/blends, co-polymers, or composites (e.g., glass fiber reinforced matrices), the component or phase that is worst-case for exposure, i.e., the softest or least glassy (lowest Tg) component can be selected if listed (which, in turn, assumes the entire system is composed of the worst-case component or phase). In these scenarios, a justification should be provided for the choice of worst-case component of the polymer system.</p>
42
  <p><em>Mass</em> - Enter the mass of the polymer matrix in grams.</p>
43
+ <p><em>Density</em> - Enter the estimated density of the polymer matrix in grams per cubic centimeter. Note that a rough estimate (e.g., +/- 10%) is acceptable.</p>
44
  <h3 id="device-characteristics">Device characteristics</h3>
45
  <p><em>Exposed surface area</em> - Enter the patient contacting surface area of the color additive containing component being evaluated in square centimeters. This includes both direct and indirect patient contact.</p>
46
  <p><em>Exposure type</em> - Select the appropriate exposure category: &gt; 30 days = long-term, &gt; 24 hours - 30 days = prolonged, ≤ 24 hours = limited. For limited exposures (≤ 24 hours), please enter the maximum exposure time in hours.</p>
 
49
  <p><em>Biostability of the matrix</em> - While many of the matrices listed within CHRIS will not appreciably swell or degrade in any physiological environment, this can not be generalized. For example, silicones may swell in lipid-rich environments. Chemical compatibility of the polymer matrix with the use environment can be assessed based on historical use and/or evaluation of swelling and/or degradation propensity in physiologically relevant media.</p>
50
  <p><em>Particle/aggregate size and distribution</em> - CHRIS relies on the color additive having a distribution that is macroscopically homogeneous within the matrix (e.g. CAs used for surface marking would be excluded); thus, any particles or aggregates must be small relative to the component and homogeneously distributed. This can be confirmed/justified through the use of particle coatings and/or dispersants in the concentrate to prevent aggregation and promote homogeneity, macroscopic observations of color uniformity, and/or microscopic observations to evaluate the potential for surface segregation phenomena, such as blooming.</p>
51
  <p><em>Dilute concentration</em> - The model relies on a concentration independent diffusion coefficient, which assumes any color additives are present only in dilute quantities. Confirming that the total amount of color additives present is ≤ 2 m/v % is sufficient to conform with this assumption. It may be possible to justify that the CHRIS calculation for a dilute compound will remain protective if the total concentration is in excess of 2 m/v %, if the presence of additional compound could reasonably be expected to inhibit rather than promote diffusion, e.g. second phase particulates.</p>
52
+ <p><em>Matrix stability</em> - The model parameters/transport properties are established using worst-case values reported in the literature. However, it is unclear if the reported values account for potential degradation (e.g., during sterilization) or other physicochemical changes (e.g., excessive plasticization) that may occur during manufacturing and negatively impact these values. Polymer stability can be confirmed/justified by evidence supporting that manufacturing (including sterilization) does not alter the matrix material of the final device.</p>
53
  <h3 id="exposure-assessment">Exposure Assessment</h3>
54
  <p>Once the fields described have been populated for the polymeric component being evaluated, click the <strong>Estimate exposure</strong> button. The risk assessment output includes the following information:</p>
55
  <ol type="1">
static/README.md CHANGED
@@ -29,7 +29,7 @@ The Color Hazard and RISk calculator (CHRIS) is a tool under development within
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  (4) CHRIS cannot be used to screen the potential risk of polymer medical device components that contact the body by the inhalation route.
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- (5) The exposure model employed by CHRIS assumes a plane sheet geometry as worst-case. This assumption should be valid for most medical device components; however, potential exceptions exist. Specifically, this assumption can underestimate exposure when the geometry of the exposed surface area is concave, e.g. body contact is limited to the lumen of a catheter. When the exposed surface area is concave, underestimating exposure can be mitigated by assuming the patient will be exposed to all surfaces of the component, i.e. exposed surface area = total component surface area.
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  ## Assumptions
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@@ -58,17 +58,17 @@ The user inputs the following information into CHRIS: (a) the identity, molecula
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  ### Polymer matrix
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- *Matrix* - Please select your polymer matrix from the list. If your polymer is not listed below, please select "Other polymer". For polymer mixtures/blends, co-polymers, or composites (e.g. glass fiber reinforced matrices), the component or phase that is worst-case for exposure, i.e. the softest or least glassy (lowest Tg) component can be selected if listed (which, in turn, assumes the entire system is composed of the worst-case component or phase). In these scenarios, a justification should be provided for the choice of worst-case component of the polymer system.
62
 
63
  *Mass* - Enter the mass of the polymer matrix in grams.
64
 
65
- *Density* - Enter the estimated density of the polymer matrix in grams per cubic centimeter. Note that a rough estimate (e.g. +/- 10%) is acceptable.
66
 
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  ### Device characteristics
68
 
69
  *Exposed surface area* - Enter the patient contacting surface area of the color additive containing component being evaluated in square centimeters. This includes both direct and indirect patient contact.
70
 
71
- *Exposure type* - Select the appropriate exposure category: > 30 days = long-term, > 24 hours - 30 days = prolonged, ≤ 24 hours = limited. For limited exposures (≤ 24 hours), please enter the maximum exposure time in hours.
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  ### Conformance to Assumptions
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@@ -80,7 +80,7 @@ The exposure model relies on assumptions that are typically valid for bulk solut
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  *Dilute concentration* - The model relies on a concentration independent diffusion coefficient, which assumes any color additives are present only in dilute quantities. Confirming that the total amount of color additives present is ≤ 2 m/v % is sufficient to conform with this assumption. It may be possible to justify that the CHRIS calculation for a dilute compound will remain protective if the total concentration is in excess of 2 m/v %, if the presence of additional compound could reasonably be expected to inhibit rather than promote diffusion, e.g. second phase particulates.
82
 
83
- *Matrix stability* - The model parameters/transport properties are established using worst-case values reported in the literature. However, it is unclear if the reported values account for potential degradation (e.g. during sterilization) or other physicochemical changes (e.g. excessive plasticization) that may occur during manufacturing and negatively impact these values. Polymer stability can be confirmed/justified by evidence supporting that manufacturing (including sterilization) does not alter the matrix material of the final device.
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  ### Exposure Assessment
86
 
 
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  (4) CHRIS cannot be used to screen the potential risk of polymer medical device components that contact the body by the inhalation route.
31
 
32
+ (5) The exposure model employed by CHRIS assumes a plane sheet geometry as worst-case. This assumption should be valid for most medical device components; however, potential exceptions exist. Specifically, this assumption can underestimate exposure when the geometry of the exposed surface area is concave, e.g., body contact is limited to the lumen of a catheter. When the exposed surface area is concave, underestimating exposure can be mitigated by assuming the patient will be exposed to all surfaces of the component, i.e., exposed surface area = total component surface area.
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34
  ## Assumptions
35
 
 
58
 
59
  ### Polymer matrix
60
 
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+ *Matrix* - Please select your polymer matrix from the list. If your polymer is not listed below, please select "Other polymer". For polymer mixtures/blends, co-polymers, or composites (e.g., glass fiber reinforced matrices), the component or phase that is worst-case for exposure, i.e., the softest or least glassy (lowest Tg) component can be selected if listed (which, in turn, assumes the entire system is composed of the worst-case component or phase). In these scenarios, a justification should be provided for the choice of worst-case component of the polymer system.
62
 
63
  *Mass* - Enter the mass of the polymer matrix in grams.
64
 
65
+ *Density* - Enter the estimated density of the polymer matrix in grams per cubic centimeter. Note that a rough estimate (e.g., +/- 10%) is acceptable.
66
 
67
  ### Device characteristics
68
 
69
  *Exposed surface area* - Enter the patient contacting surface area of the color additive containing component being evaluated in square centimeters. This includes both direct and indirect patient contact.
70
 
71
+ *Exposure type* - Select the appropriate exposure category: > 30 days = long-term, > 24 hours - 30 days = prolonged, &#8804; 24 hours = limited. For limited exposures (&#8804; 24 hours), please enter the maximum exposure time in hours.
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  ### Conformance to Assumptions
74
 
 
80
 
81
  *Dilute concentration* - The model relies on a concentration independent diffusion coefficient, which assumes any color additives are present only in dilute quantities. Confirming that the total amount of color additives present is ≤ 2 m/v % is sufficient to conform with this assumption. It may be possible to justify that the CHRIS calculation for a dilute compound will remain protective if the total concentration is in excess of 2 m/v %, if the presence of additional compound could reasonably be expected to inhibit rather than promote diffusion, e.g. second phase particulates.
82
 
83
+ *Matrix stability* - The model parameters/transport properties are established using worst-case values reported in the literature. However, it is unclear if the reported values account for potential degradation (e.g., during sterilization) or other physicochemical changes (e.g., excessive plasticization) that may occur during manufacturing and negatively impact these values. Polymer stability can be confirmed/justified by evidence supporting that manufacturing (including sterilization) does not alter the matrix material of the final device.
84
 
85
  ### Exposure Assessment
86