Healthcare Industry
We specialize in the microbiological and biological control of medical devices, ensuring their safety and sterility.
We perform Bioburden analysis according to ISO 11737-1 to determine microbial load and sterility tests in accordance with ISO 11737-2, validating sterilization processes.
Additionally, we evaluate sterilization residues and conduct biocompatibility tests according to ISO 10993, which include cytotoxicity, sensitization, irritation, toxicity, hemolysis, pyrogens, and endotoxins tests, among others, ensuring the safety and biological compatibility of medical devices.
Análisis de Bioburden according to ISO 11737-1 Standard
- Validación del método y determinación de la población de microorganismos en los productos*
Sterility test according to ISO 11737-2 for the definition, validation, and maintenance of sterilization processes
- Validación del método de control y ensayo de esterilidad*
Determinación de residuos de esterilización en producto sanitario: Ethylene oxide, propylene, and ethylene chlorohydrin
Ensayos de biocompatibilidad según ISO 10993
- Skin sensitization (OECD 406)
- Intradermal test
- Cytotoxicity (assay)
- Systemic injection test
- Hemolysis test (ASTM F796-00)
- Ames test
- Implantation test
Otros Toxicological Assays
- Dermal irritation test
- Mucosal irritation tests (oral, rectal, vaginal...)
- Acute toxicity (LD50) oral and/or dermal
- Pyrogen test
- Endotoxin test (LAL)
