Test for in vitro Cytotoxicity(ISO 10993-5)
- Test on Extracts: MEM Elution
- Direct Contact
- Indirect contact: Agar diffusion
- Quantitative Test by MTT
Test for Systemic Toxicity(ISO 10993-11)
Acute systemic toxicity
Biocompatibility testing is a crucial aspect of ensuring the safety and effectiveness of medical devices, which is critical part of the regulatory approval and monitoring process. TheraIndx Lifesciences an ISO/IEC 17025:2017 certified with State-of-the-art testing facility is your preferred partner for medical devices testing. We have a team of subject matter experts in medical devices testing to design of studies as per regulatory guidelines for multicomponent and dynamic extraction processes as per International guidelines.
We provide biocompatibility testing for medical devices ISO 10993 to ensure compliance with industry-leading criteria. Additionally, we also adhere to the Biocompatibility testing ISO/IEC:17025:2017 to emphasize precision and quality in our testing procedures. As one of the leading biocompatibility testing laboratories, we prioritize the safety and effectiveness of medical devices and offer thorough assessments in line with global standards.Contact Us
Biocompatibility testing is conducted to ensure the safety of patients who will be exposed to medical devices or implants.
It helps prevent adverse reactions such as allergies, inflammation, and other harmful responses.
Regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require biocompatibility testing as part of the approval process for medical devices.
Assessing the biological response to materials helps in selecting or designing materials that are more compatible with the human body.
Evaluates the toxic effects of materials on living cells, typically using cell cultures.
Determines whether the material induces an allergic response in the body
Assesses the compatibility of materials with blood, ensuring that devices do not cause adverse effects on blood components.
Examines whether the material has the potential to damage genetic material.
Assesses the overall toxic effects of the material when introduced into the circulatory system.
Involves placing the material or device directly into living tissues to observe the long-term effects, such as inflammation or tissue response.