Medical Device Vaginal Mucosal Irritation Test

Currently, to predict the effects of personal care products, cosmetics, and pharmaceuticals intended for vaginal use on the human body before they hit the market, vaginal mucosal irritation tests are commonly used. The vaginal mucosal epithelium forms a natural barrier defending the body from viral and bacterial invasion. However, the use of drugs, cosmetics, feminine care products, contraceptives, and antiseptics may cause local irritation and other side effects, leading to damage to the vaginal mucosal epithelium and increased susceptibility to infections. China's JJR Laboratory offers ISO 10993-10:2010 medical device vaginal mucosal irritation test services, certified by CMA and CNAS.

Test Principle  

The test evaluates the potential skin irritation response of materials under test conditions using relevant animal models.

Test Animals  

Rabbits are the preferred test animals. The test evaluates the potential skin irritation response of materials using relevant animal models under test conditions. Three healthy, young albino rabbits of the same strain, weighing no less than 2kg, should be used, with no restriction on gender.

Testing Standards  

Biological Evaluation of Medical Devices, Part 10: Irritation and Skin Sensitization Tests, ISO 10993-10:2010

Service Process  

1. Sample submission: Communicate with the engineer, submit testing requirements, and send us the samples.  

2. Preliminary inspection: Upon receiving the samples, we conduct a preliminary inspection and develop a detailed experimental plan.  

3. Quotation: After the preliminary inspection, we provide a quotation based on the client's testing requirements and the complexity of the experiment.  

4. Agreement: Both parties confirm the terms, sign a confidentiality agreement, and after payment, the experiment begins.  

5. Experiment completion: The time required to complete the experiment depends on the client's testing requirements and the complexity of the experiment.  

6. Report delivery and follow-up service: We send the test report and provide post-service support.