TEST METHODISO 10993-23

In-vitro skin irritation testing for medical devices
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Skin irritation testing according to ISO 10993-23 is conducted using the EpiDerm model, which utilizes Reconstructed Human Epidermis (RhE). This method replaces ISO 10993-10, which relied on animal models, aligning with ethical considerations regarding animal testing.
The diagram below summarizes the ISO 10993-23 test method.
ISO 10993-23
TESTING CRITERIA AND CUSTOMER PROCESS
Step 1: Is your product a medical device?

ISO 10993-23 is specifically designed for testing medical devices. If your product falls under biocides, chemicals, or cosmetics, please refer to OECD 439 for skin irritation testing.

Step 2: What is the suitable extraction time and condition?

The general extraction condition is 37°C for 72 hours. The product must be extracted separately using both:

  • 0.9% saline (polar solvent)
  • sesame oil (non-polar solvent)

For medical devices in short-term contact with intact skin or mucosa (not implanted), extraction times can range between 4 to 24 hours.

 

Step 3: What is the passing criteria?

If cell viability is ≤ 50%, the tested product is classified as Irritant (I).

If cell viability is > 50%, the tested product is classified as Non-Irritant (NI).

Step 4: Place an order and send your sample to us

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 our sample delivery service and provide us the tracking code. We will monitor the delivery status and inform you when we receive the sample.

Step 5: Track the status of your request

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

Step 6: Download your password-protected test report

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.

**Disclaimer: NO ANIMAL TESTING. TECOLAB is committed to ethical and cruelty-free testing practices. We do not conduct any form of testing on animals and all our biocompatibility tests are performed on in-vitro models.