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Questions and Answers
The rotational velocity is represented at the top and the absolute velocity is represented at the bottom.
The rotational velocity is represented at the top and the absolute velocity is represented at the bottom.
True
The parameter based design exploration involves variations in α1 and α2.
The parameter based design exploration involves variations in α1 and α2.
False
The FDA Round Robin initiative involves testing CFD/PIV globally.
The FDA Round Robin initiative involves testing CFD/PIV globally.
True
The ISO 7199 standard is related to cardiovascular implants and artificial organs for blood-gas exchangers (oxygenators).
The ISO 7199 standard is related to cardiovascular implants and artificial organs for blood-gas exchangers (oxygenators).
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The ISO 14708 standard only covers non-active surgical implants.
The ISO 14708 standard only covers non-active surgical implants.
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Biocompatibility is the ability of a material to perform with an inappropriate host response in a specific application.
Biocompatibility is the ability of a material to perform with an inappropriate host response in a specific application.
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Thrombogenicity testing is not a part of the approval process for medical devices.
Thrombogenicity testing is not a part of the approval process for medical devices.
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DIN (German Institute for Standardization) is not a member of ISO (International Organization for Standardization).
DIN (German Institute for Standardization) is not a member of ISO (International Organization for Standardization).
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The primary focus of ISO 14630 is on cardiovascular implants and artificial organs for blood-gas exchangers.
The primary focus of ISO 14630 is on cardiovascular implants and artificial organs for blood-gas exchangers.
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Hemocompatibility testing assesses the interaction of blood components with artificial material.
Hemocompatibility testing assesses the interaction of blood components with artificial material.
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In-vitro hemocompatibility testing involves the use of only human blood.
In-vitro hemocompatibility testing involves the use of only human blood.
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Thrombosis is a potential outcome of hemolysis.
Thrombosis is a potential outcome of hemolysis.
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The Virchow triad includes blood flow, platelet activation, and complement activation.
The Virchow triad includes blood flow, platelet activation, and complement activation.
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In-vitro thrombogenicity testing involves the examination of blood type, volume, and species.
In-vitro thrombogenicity testing involves the examination of blood type, volume, and species.
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Pre-clinical animal trials for hemocompatibility testing follow the '3R' principle: Replace, Refine, and Refrain.
Pre-clinical animal trials for hemocompatibility testing follow the '3R' principle: Replace, Refine, and Refrain.
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In-vitro tests provide a complete body interaction similar to in-vivo tests.
In-vitro tests provide a complete body interaction similar to in-vivo tests.
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Numerical simulation involves the visualization of flow fields using Particle Image Velocimetry (PIV).
Numerical simulation involves the visualization of flow fields using Particle Image Velocimetry (PIV).
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Mock Circulation Loops aim to simulate pressure and flow in the circulatory system using physiological anatomy.
Mock Circulation Loops aim to simulate pressure and flow in the circulatory system using physiological anatomy.
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Efficiency of a blood pump can be calculated using the formula: 𝜂 = 𝑃 × 𝑉 ÷ Δ𝑝.
Efficiency of a blood pump can be calculated using the formula: 𝜂 = 𝑃 × 𝑉 ÷ Δ𝑝.
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Testing with animal blood for hemolysis requires a minimum volume of 1 L.
Testing with animal blood for hemolysis requires a minimum volume of 1 L.
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Normalized Index of Hemolysis (NIH) accounts for volume flow rate and hematocrit in its calculation.
Normalized Index of Hemolysis (NIH) accounts for volume flow rate and hematocrit in its calculation.
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Study Notes
Rotational Velocity and Absolute Velocity
- Rotational velocity is represented at the top, while absolute velocity is represented at the bottom
Design Exploration and FDA Round Robin
- Parameter-based design exploration involves variations in α1 and α2
- FDA Round Robin initiative involves testing CFD/PIV globally
ISO Standards
- ISO 7199 standard is related to cardiovascular implants and artificial organs for blood-gas exchangers (oxygenators)
- ISO 14708 standard covers non-active surgical implants
- ISO 14630 focuses on cardiovascular implants and artificial organs for blood-gas exchengers
Biocompatibility and Hemocompatibility
- Biocompatibility is the ability of a material to perform with an appropriate host response in a specific application
- Hemocompatibility testing assesses the interaction of blood components with artificial material
- In-vitro hemocompatibility testing involves the use of only human blood
Thrombogenicity and Thrombosis
- Thrombogenicity testing is not part of the approval process for medical devices
- Thrombosis is a potential outcome of hemolysis
- Virchow triad includes blood flow, platelet activation, and complement activation
In-vitro and In-vivo Testing
- In-vitro thrombogenicity testing involves the examination of blood type, volume, and species
- Pre-clinical animal trials for hemocompatibility testing follow the '3R' principle: Replace, Refine, and Refrain
- In-vitro tests do not provide a complete body interaction similar to in-vivo tests
Numerical Simulation and Mock Circulation Loops
- Numerical simulation involves the visualization of flow fields using Particle Image Velocimetry (PIV)
- Mock Circulation Loops aim to simulate pressure and flow in the circulatory system using physiological anatomy
Blood Pump Efficiency and Hemolysis
- Efficiency of a blood pump can be calculated using the formula: 𝜂 = 𝑃 × 𝑉 ÷ Δ𝑝
- Testing with animal blood for hemolysis requires a minimum volume of 1 L
- Normalized Index of Hemolysis (NIH) accounts for volume flow rate and hematocrit in its calculation
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Description
Test your knowledge on biocompatibility testing, regulations, and material-related factors for medical devices. This quiz covers topics such as cytotoxicity, sensitization, irritation, pyrogenicity, toxicity, and implantation.
