Where can biocompatibility be done? Shenzhen Huatongwei Laboratory Center is a good choice for you. We have biological laboratory, safety laboratory, environmental laboratory, EMC laboratory, radio frequency RF laboratory, etc. The laboratory has CNAS qualification certificate and is authorized by GLP laboratory, the report issued can be double stamped for you;
We have Suzhou Medical Laboratory and Shenzhen Medical Laboratory; we have offices in important cities across the country to undertake national medical device inspection consultation!
Medical device manufacturers should be clear: biocompatibility testing is an integral part of the biorisk safety assessment of medical devices and equipment, and biocompatibility testing evaluates the compatibility of medical devices with human biological systems. It studies the interaction between the device and various living tissues and cells exposed to the device when in contact with the patient.
We provide complete biocompatibility testing reports for medical devices through our state-of-the-art testing laboratory and high standards of data and quality reporting to meet the testing needs of small and large manufacturers.
1. Cytotoxicity - ISO 10993-5: Cytotoxicity testing to assess the general level of toxicity of medical devices or materials to cell cultures by in vitro elution and agarose overlay methods.
2. Genotoxicity - ISO 10993-3 and FDA: Genotoxicity testing is required to determine the presence of toxins that affect the genetic material of cells.
3. Hemocompatibility - ISO 10993-4 and ASTM: Hemocompatibility testing facilitates the evaluation of the effects of blood-contacting medical devices on blood and blood components through hematology and thrombosis testing.
4. Irritability - ISO 10993-10: Irritability Testing The skin irritation of medical devices is evaluated by ie primary skin, ocular and intradermal reactivity testing and in vitro skin irritation testing.
5. Sensitization - ISO 10993-10: Conduct sensitization testing to evaluate possible adverse skin reactions of the immune system to medical devices by in vivo and in vitro test methods.
6. Systemic effects of systemic toxicity and pyrogenicity - ISO 10993-11 and ASTM: Acute to chronic systemic toxicity tests to evaluate the in vivo effects of medical devices. Pyrogenicity testing is done to test for material-mediated heat-generating compounds called pyrogens that affect patients when they come into contact with medical devices.
7. Implantation - ISO 10993-6: Implantation testing evaluates the effect of medical devices on surrounding living tissue at the macroscopic and microscopic levels.
8. Chemical Characterization - ISO 10993-18: Chemical characterization is required to determine the amount of extractables and leachables that migrate from medical devices when in use or when challenged.
9. Toxicological risk assessment - ISO 10993-17: Toxicological risk assessment of extractables and leachables helps to quantify the associated risks in terms of exposure and safe ingestion doses.
10. Sterility Testing - ISO 11737 Series: As part of sterility testing, bioburden testing helps determine the number of microorganisms on unsterile medical devices.
11. Sterile Barrier Systems - ISO 11607 and EN 868 Series: Sterile barrier testing is required to validate packaging systems for medical devices to ensure that the device maintains sterility and sterile quality prior to use.