Irritation testing according to ISO 10993-23
ISO 10993-23 is an internationally recognized standard for assessing the irritation potential of medical devices when they come into contact with skin, mucosal membranes, or subcutaneous tissues. Irritation tests performed according to the standard are commonly used to demonstrate compliance with EU MDR and FDA requirements.
The appropriate testing approach is chosen based on the body contact site:
Skin irritation tests evaluate whether a medical device or material causes localized skin irritation when it comes into direct contact with the skin. Testing can be conducted using in vivo or in vitro methods, depending on the device and the market area.
Intracutaneous reactivity tests apply to medical devices or materials that penetrate the skin or come into contact with deeper tissues. The goal is to determine whether extracts from such devices cause localized inflammatory responses in the dermis or subcutaneous layers.
The device itself is tested with a direct contact method, when possible. Alternatively, polar and non-polar solvents are used to prepare extracts that simulate potential leachables from the device.
The displayed example price includes an in vivo direct skin irritation test performed under GLP.
For a more accurate quote, do not hesitate to contact us with a description of your device and any additional requirements you may have for testing (e.g., market area, quality systems, in vivo vs. in vitro methods).
- Suitable sample matrices
- Medical devices
- Typical turnaround time
- 7 weeks after receiving the samples
- Available quality systems
- Accredited test method, GLP test method
- Device types
- Standard
- Method expert
Price
We also charge a 97 € service fee per order.
Large batches of samples are eligible for discounts.
Questions? We're happy to help.
Questions? We're happy to help.
Business hours: Mon–Fri 9 AM – 5 PM Finnish time (EST/EEST)
Other tests we offer
Cleaning validation of medical devices according to ISO 17664
Face mask tests according to EN 14683 for type II and type IIR masks
Biocompatibility evaluation of breathing gas pathways according to ISO 18562
Genotoxicity - Bacterial reverse mutation test (AMES)
Pyrogenicity testing by ISO 10993-11
Sterility tests according to ISO 11737-2: Aerobic bacteria, anaerobic bacteria and fungi
Ethylene oxide (EO) sterilization and sterilization residues according to ISO 10993-7
Biological evaluation plan (BEP)
Hemocompatibility testing according to ISO 10993-4
Skin sensitization testing according to ISO 10993-10
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