● Project Introduction:
Toxicological test is an experiment that detects various toxic end points through different routes and different periods of exposure to experimental animals. Through animal experiments and observations on animals, the toxicity and potential hazards of a chemical are clarified. Its purpose is to determine the level of harmless action, type of toxicity, target organs, dose-response relationship and provide important information for safety assessment or risk assessment. Toxicological examination plays an important role in ensuring the safety of food, health food, cosmetics, disinfectant products, pharmaceuticals, medical devices and chemical products.
The biocompatibility of medical devices is mainly discussed from the point of view of toxicology. Everything has a certain toxicity, depending on the dose response effect. In medical device testing, the characteristics and preparation of the test material, the selected test system and the experimental design are important factors determining the test results.
In toxicological experiments of pharmaceuticals, the determination of limit of genotoxic impurities is an important part of drug safety research. Pharmaceutical evaluation is mainly to select appropriate formulation and production strategies to avoid or reduce the generation of genotoxic impurities. Based on the principle of "as low as reasonably practicable cable cable cable (ALARP), toxicological evaluation is carried out to verify its rationality.
● Test items:
| Pharmaceutical pyrogen test | Medical device - Chromosome aberration test of mammal cells in vitro |
| Pharmaceutical hemolysis and agglomeration test | Medical device-erythrocyte micronucleus test |
| Drug allergy test | Cell toxicity test of medical devices (MTT method) |
| Abnormal toxicity of drugs (abiotic) | Animal irritation test (skin irritation) of medical devices |
| Drug Abnormal Toxicity (Biology) | Intradermal Stimulation Test of Medical Devices |
| Bacterial Endotoxin Test of Drugs | Skin Sensitization Test of Medical Devices (Non-leaching) |
| Bacterial endotoxin test for medical devices | Skin sensitization test of medical devices (polar and non-polar extracts) |
| Hemolysis test of medical devices | Eye irritation test of medical devices |
| Pyrogen Check of Medical Devices | Local Reaction Test (Subcutaneous Implantation) after Medical Device Implantation |
| Medical Devices - Acute Systemic Toxicity Test | Local Response Test (Muscle Implantation) after Medical Device Implantation |
| Medical Devices-Subacute Systemic Toxicity Test | Local Response Test after Medical Device Implantation (Bone Implantation) |
| Medical Devices - Subchronic Systemic Toxicity Test | Selection of Interaction Test between Medical Devices and Blood (Hemolysis Test) |
| Medical Device-Bacterial Recovery Mutation Test |
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