Determination of Extractable and Leachable Volatile Organic Compounds (VOC)

According to ISO 10993-18, ISO 10993-12 and ISO 10993-17**

1. Definition

• Extractables: Compounds that can be released from a medical device under exaggerated laboratory conditions.

• Leachables: Compounds that migrate into the patient or clinical environment under actual usage conditions.

• VOC (Volatile Organic Compounds) and SVOC (Semi-Volatile Organic Compounds) are the main chemical groups of concern.

2. ISO 10993-18 – Chemical Characterization

Process steps include:
✔ Material characterization
✔ Determination of extractables and leachables
✔ GC-MS analysis of VOC profiles
✔ AET calculation (Analytical Evaluation Threshold)

3. ISO 10993-12 – Extraction Conditions

4. ISO 10993-17 – Toxicological Risk Assessment

• PDE determination

• Exposure dose calculation

• Margin of Safety:

$$MOS = \\frac{PDE}{Exposure Dose}$$

A MOS equal to or above 1 indicates safety.

5. Analytical Techniques

6. TTS Laboratory Services

✔ ISO 10993-18 compliant chemical characterization
✔ ISO 10993-12 extraction protocols
✔ GC-MS / LC-MS/MS / Headspace analysis
✔ Toxicological assessment according to ISO 10993-17
✔ MDR, FDA, ISO 13485 compliant documentation