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Karin Nydahl
Laboratorieingenjör
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ISO 10993-23 Skin Irritation - in vitro
Irritation testing is a critical component of the biological evaluation of medical devices and a necessary step to meet the requirements of the Medical Device Regulation (MDR). RISE conducts irritation tests according to ISO 10993-23:2021 and adheres to Good Laboratory Practice (GLP).
Why conduct irritation tests?
Conducting irritation testing is crucial to ensuring that your medical device is safe for use. These tests help identify whether the product may cause irritation when it comes into contact with the skin.
By performing irritation testing, potential issues can be detected and addressed early in the development process, reducing the risk of adverse reactions for users. This is essential not only to protect patient health and safety but also to comply with regulatory requirements under the Medical Device Regulation (MDR) and international standards such as ISO 10993-23:2021.
Furthermore, irritation testing helps build trust among users and healthcare professionals by demonstrating that your product has undergone rigorous safety evaluations. This not only prevents costly recalls and legal challenges but also ensures that your products are reliable and effective.
Which methods do we use?
Our skin irritation tests are based on a model consisting of human epidermal keratinocytes. These have been cultured to form a differentiated model of the human skin layer, which is comparable to the in vivo skin structure.
We perform skin irritation testing according to ISO 10993–23:2021. The product extraction is conducted according to ISO 10993-12:2021. We also conduct skin irritation tests according to OECD Test Guideline 439, where the skin model is directly exposed to a test chemical, without prior extraction.
We follow GLP
We adhere to Good Laboratory Practice (GLP), which ensures that the irritation tests are conducted in a scientifically valid and regulatory-compliant manner.
Delivery
After completing the irritation test according to ISO 10993-23:2021, you will receive a detailed test report in English. The report includes data showing the skin's reaction after exposure to the test material, as well as recommendations for further testing or actions if the test material shows signs of irritation.
More information
At RISE, we are pleased to offer testing services for medical devices according to both ISO 10993-5:2009 and ISO 10993-23:2021.
We also provide services to ensure that your products can be cleaned, disinfected, and sterilized safely and effectively according to ISO 17664-1/2 and ISO 17665:2024.
By combining our services under these standards, we can help ensure that your medical devices are both biocompatible, sterile, and suitable for reuse—critical factors for patient safety and the product's success in the market.
Feel free to contact us for more information or to schedule a consultation.
