DEVICEOPOEIA
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Why Does DEVICEOPOEIA Exist?

Because Medical Devices are Fundamentally Different from Medicines.

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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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Barbed polyester suture, bioabsorbable, non-antimicrobial

DeviceOPOEIA Monograph Status ✓ Monograph Proposed → ✓ Under Development → …

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

  1. Material Identification
  2. Chemical Characterization
  3. Exposure Estimation
  4. Toxicological Threshold Selection
  5. Margin of Safety Calculation
  6. Risk Characterization
  7. Final Toxicological Conclusion
TRA Tool Framework aligned with ISO 10993-1, ISO 10993-17, ISO 10993-18, and ISO 14971 principles.

All OPOEIA's

Polyester suture, bioabsorbable, multifilament, non-antimicrobial

DeviceOPOEIA Monograph Status ✓ Monograph Proposed → ✓ Under Development → …

Polyester suture, bioabsorbable, monofilament

DeviceOPOEIA Monograph Status ✓ Monograph Proposed → ✓ Under Development → …

Nylon suture, bioabsorbable, antimicrobial

DeviceOPOEIA Monograph Status ✓ Monograph Proposed → ✓ Under Development → …

Nylon suture, non-bioabsorbable, monofilament

DeviceOPOEIA Monograph Status ✓ Monograph Proposed → ✓ Under Development → …
Non-absorbable surgical suture (e.g., silk)

Non-absorbable surgical suture (e.g., silk)

Class C Sterile Non-Active Implantable Deviceopoeia ID: MD-3227264 EMDN Codes: H0102020203 • H010202020301 • H01020202030…
Polyolefin/fluoropolymer suture, multifilament (polyethylene)

Polyolefin/fluoropolymer suture, multifilament (polyethylene)

Class C Sterile Non-Active Implantable Deviceopoeia ID: MD-3226268 EMDN Codes: H01020201 • H0102010104 • H0102010299 UN…
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