Irritation
Irritation is one of the three most common tests required to ensure the safety of medical devices. Irritation testing is essential in evaluating a device’s potential to cause an immediate irritation reaction following exposure to the body. There are several methods as in vivo and in vitro assays available. Eurofins Medical Device Testing network of laboratories' methods are selected and performed based upon the specific route of exposure to the body including skin, mucosal or ocular.
Choose Eurofins Medical Device Testing to help you:
- Understand regulatory requirements for Irritation
- Choose the right test method for your product/material according to ISO 10993-23/USP <88> or combination of both
- Identify a device’s to cause skin, mucosal or ocular irritation.
Regulatory:
- ISO 10993-23:2021 Biological evaluation of medical devices Part 23: "Tests for irritation" provides the general requirements for evaluating irritation potential of a medical device.
- ISO 10993-1 Table A.1 – "Endpoints to be addressed in a biological risk assessment”
Testing Available
- Dermal Irritation (in vivo and in vitro assays)
- Intracutaneous Reactivity
- Ocular Irritation (in vivo and in vitro assays)
- Nasal Irritation
- Oral Irritation
- Vaginal Irritation
- Penile Irritation
- Rectal Irritation
