Biocompatibility generally refers to the compatibility between the material and the host, including histocompatibility and blood compatibility. Biocompatibility does not cause adverse reactions in tissues, blood, etc.
Good biocompatibility is a prerequisite for safe and effective clinical application of medical devices. Biological evaluation of medical devices to determine the risk level of potential toxicity and adverse biological reactions caused by contacting human body is the basis of benefit-risk evaluation of medical devices as a whole. Biocompatibility test is an important part of biological evaluation and provides a solid guarantee for biological evaluation.
- In vitro cytotoxicity test
- Skin sensitization test
- Irritation or intracutaneous reactivity test
- Acute systemic toxicity, subacute toxicity, subchronic toxicity, chronic toxicity test
- Genotoxicity test
- Hemocompatibility test
- Implantation effects test
- Material mediated pyrogenicity
Basis of Testing Method
ISO 10993-5, GB/T 16886.5, ISO 7405, YY 0127.9, GB/T 14233.2, GB/T 16175
ISO 10993-10, GB/T 16886.10, GB/T 14233.2, GB/T 16175
Irritation or intracutaneous reactivity
ISO 10993-10, GB/T 16886.10, USP 88, GB/T 14233.2, GB/T 16175
Material mediated pyrogenicity
GB/T 14233.2, Chinese Pharmacopoeia
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