Medical Device
Any additive, solvent, or disinfectant in the manufacturing process of a medical device or even the device’s material can cause varying degrees of potential safety concerns when applying in human. It could lead to partial or systemic cytotoxicity, system toxicity and allergic reactions, etc.
The test design is based on the intended use of medical use. Under the ISO 10993 guideline, studies are designed according to the site and duration of body contact. Therefore, the biological compatibility of the final product in the human body can be ensured.
SuperLab also sets up the HBV disinfection efficacy of blood glucose meter, and the test meets FDA standards. The test is still the only one method for HBV disinfection efficacy. SuperLab provides any kind of test for medical devices, including devices for surgery and treatment, in vitro diagnosis, general medical device and supplies (oximeter, blood glucose meter, hemodialysis catheter, contact lenses, or wound dressing), etc.
Contract Research of Medical Devices
1. Biocompatibility study (ISO 10993)
2. General toxicity study
3. Genotoxicity study
4. HBV disinfection efficacy
5. Package testing
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