Oral medical devices that are in contact with the oral mucosa tissue temporarily or for a long time need to be tested for their stimulating effect on the oral mucosa.
The cost of the oral irritation test in Huatongwei Lab is US$2500; the test time is 30 days;
Inspection and consultation: email@example.com
Materials that cannot be tested for oral mucosal irritation
1. Materials that are known to be irritating to the skin or eyes, or materials with a PH value of ≤ 2 or PH ≥ 11.5 should not be tested for oral mucosal irritation. The material can be regarded as a potential oral mucosal irritation.
2. The results of the intradermal reaction test show that the material whose average score difference between the sample and the control does not exceed 1.0 cannot be subjected to the oral mucosal irritation test, and the material can be considered as non-irritating to the oral cavity. Mucous membrane.
Oral irritation test standard:
ISO 10993-10, GB/T 16886.10
Test contact method
1. Long-term exposure
It is suitable for materials with contact time of oral mucosa ≥24h. There are two types: suture contact method and loop method.
2. Acute exposure method
According to the actual use of the material, one-time contact mode or multiple contact mode can be selected.
3. Repeated exposure test