Cytotoxicity testing can be performed using either:
• Extracts of the test sample (most common for medical devices)
• Direct or indirect contact of the test material with the cell monolayer (used when extraction is not suitable)

Extraction must be carried out according to ISO 10993-12, with the typical conditions for standard extraction at 37 °C for 24 hours, extracted separately using both:

• Polar solvents (e.g., 0.9% sodium chloride, MEM with serum)
• Non-polar solvents (e.g., sesame oil or cottonseed oil)

For short-term contact devices (≤24 h exposure), extraction times may range from 4 to 24 hours, based on risk assessment.

A minimum of four concentrations of test sample/extract (including the undiluted extract) is applied to sub-confluent monolayers of a suitable cell line (commonly L929 mouse fibroblasts) and incubated for 24 hours.

Cell viability is calculated as a percentage relative to the untreated negative control.

If cell viability is < 70%, the material is classified as cytotoxic.

If cell viability is ≥ 70%, the material is classified as non-cytotoxic.

Further biocompatibility assessments can be performed using other in vitro assays, such as In vitro skin irritation tests (ISO 10993-23 or OECD 439)

A cytotoxic result does not always mean the product is unsafe; results should be interpreted in the context of clinical use, dose, exposure duration, and risk assessment.

Fill in the test request form and place an order via email at info@tecolab-global.com. We will advise on the quantity of sample required for testing.

You can deliver the sample to us via courier or utilize our sample delivery service. We will monitor the delivery status and inform you when we receive the sample.

Once we have received your sample, we will provide a tracking number to you. You can easily track the status of your request here.

Download your readily available test report online with just a single click using the link and password provided via email notification. We will receive a notification once you have downloaded the test report.

For safety purposes, the uploaded test report will self-destruct after 7 days.