Chemical Characterization Test

Medical Analyses

Chemical Characterization – According to ISO 10993-18

1. What is Chemical Characterization?

Chemical characterization is the process of identifying and quantifying chemical substances that may leach or be released from a medical device during clinical use. ISO 10993-18 provides the framework for this evaluation as part of the biological risk assessment.

2. Applicable Standards

Standard	Description
ISO 10993-18	Chemical characterization of medical device materials
ISO 10993-12	Sample preparation and extraction conditions
ISO 10993-17	Toxicological risk assessment (PDE, AET)
ISO 10993-1	Biological evaluation and test strategy

3. Test Objective

Identification of Extractables and Leachables (E&L)
Determination of chemical profile under simulated use conditions
Establishment of AET (Analytical Evaluation Threshold)
Toxicological risk assessment compliant with ISO 10993-17

4. Extraction Conditions (ISO 10993-12)

Parameter	Requirement
Extraction Media	Pure water, PBS, 50% ethanol, IPA, oil simulants
Temperature	25°C / 50°C / 70°C
Duration	24–72 hours
Ratio	3–6 cm²/mL or 0.2 g/mL
Device Types	Implantable, mucosal or parenteral devices

5. Analytical Techniques

Technique	Purpose
GC-MS / HS-GC-MS	Volatile organics (VOC)
LC-MS/MS	Semi-volatile and polar extractables
ICP-MS	Elements & heavy metals
FTIR / NMR	Material verification
GC-FID	Organic solvent residues

6. Toxicological Risk Assessment (ISO 10993-17)

$AET = \\frac{PDE \\times A}{B \\times UF}$

Where:

PDE = Permitted Daily Exposure
A = Contact area
B = Extract volume
UF = Uncertainty Factor

Margin of Safety (MoS):

$MoS = \\frac{PDE}{Exposure\\,Dose}$

MoS ≥ 1 → Acceptable risk.

7. TTS Laboratory Services Provide

✔ Full chemical characterization according to ISO 10993-18
✔ Extractables & Leachables profiling (EO, solvents, plasticizers)
✔ GC-MS, LC-MS/MS, ICP-MS validated methods
✔ Toxicological assessment per ISO 10993-17
✔ Reports for CE Marking, FDA 510(k), MDR compliance