Total Organic Carbon (TOC) Analysis

Medical Analyses

Total Organic Carbon (TOC) Analysis in Medical Devices

According to TS 8195 / EN 1484**

1. What is TOC and Why is it Important?

TOC measures the total amount of organic carbon in a liquid. It is widely used to evaluate:
✔ Cleanliness validation of medical devices
✔ Residual organic contaminants after washing/sterilization
✔ Water quality used in production and rinsing (DI / WFI)

2. Relevant Standards

Standard	Description
TS 8195 / EN 1484	Guidelines for determination of Total Organic Carbon in water
ISO 10993-12	Sample preparation and extraction conditions
ISO 15883 & ISO 17664	Medical device cleaning validation requirements

3. Analytical Principle

All organic compounds are oxidized to CO₂ via combustion or UV-persulfate oxidation.
The CO₂ is quantified by a NDIR detector.
TOC is calculated as:

$TOC = TC - IC$

(Where TC = Total Carbon, IC = Inorganic Carbon)

4. Sample Preparation & Extraction (Medical Devices)

Parameter	Condition
Extraction Medium	TOC-free ultrapure water
Surface/Volume	1 cm² per 1 mL (ISO 10993-12)
Temperature	25–37 °C
Duration	30–72 h

5. Acceptance Limits

Sample Type	Limit Value
Extract from medical devices	≤ 2.0 mg/L
Final rinse water of cleaning system	≤ 0.5 mg/L
Purified/WFI water	≤ 0.1 mg/L

6. TTS Laboratory Services Offer

✔ TOC analysis per TS 8195 / EN 1484
✔ Cleaning validation of surgical instruments and implants
✔ EO, gamma sterilization residue monitoring
✔ ISO 10993 & ISO 13485 compliant documentation
✔ Calibration, blank control, quality assurance