Cardiac Infusion Pump System Class IIb Sterile Software Enabled Implantable Deviceopoeia ID: IVD-523426 EMDN Codes: Z120302 •…
DEVICEOPOEIA
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Why Does DEVICEOPOEIA Exist?
Because Medical Devices are Fundamentally Different from Medicines.
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Scientific Foundation of DEVICEOPOEIA
Scientific Foundation of DEVICEOPOEIA
Version
1.0
1.0
Category
Medical Device Science
Medical Device Science
Status
Published
Published
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In-Vitro Diagnostic Devices
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Medical Device Nomenclature - Indicators of Risk Classification Level
Risk classification levels are indicated in the IAF MDN with regard to Canadian, European, GHTF Guidance, and US FDA rules as follows:
| Risk Level | Canada | Europe | GHTF | USA |
|---|---|---|---|---|
| Low Risk | 1 | I | A | I |
| Medium Low Risk | 2 | IIa | B | II |
| Medium High Risk | 3 | IIb | C | |
| High Risk | 4 | III | D | III |
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Toxicological Risk Assessment (TRA) Tool
ISO 10993 Risk-Based Toxicological Evaluation Tool for Medical Devices
Device Information
Chemical Characterization
Exposure Assessment
Assessment Results
| Parameter | Result |
|---|---|
| Estimated Daily Exposure ⓘ | - |
| Margin of Safety (MOS) ⓘ | - |
| Exposure Multiplier ⓘ | - |
| Adjusted Threshold ⓘ | - |
| Uncertainty Factor ⓘ | - |
| Risk Score ⓘ | - |
| Risk Category ⓘ | - |
Awaiting assessment...
Risk Interpretation Matrix
| Score | Interpretation |
|---|---|
| < 5 | Low Toxicological Concern |
| 5 – 10 | Moderate Toxicological Concern |
| > 10 | High Toxicological Concern |
ISO 10993 TRA Workflow
- Material Identification
- Chemical Characterization
- Exposure Estimation
- Toxicological Threshold Selection
- Margin of Safety Calculation
- Risk Characterization
- Final Toxicological Conclusion
TRA Tool Framework aligned with ISO 10993-1, ISO 10993-17, ISO 10993-18, and ISO 14971 principles.
All OPOEIA's
Cardiac Infusion Pump System Class IIb Sterile Software Enabled Implantable Deviceopoeia ID: MD-102926 EMDN Codes: Z120…