How to Get a Biocompatibility Testing Report?

The biocompatibility testing report primarily evaluates the compatibility and potential adverse reactions between medical devices and biological tissues, including both in vitro and in vivo assessments. This testing is conducted not only on animals but also on human tissues or cells to ensure that the interactions between medical devices and human tissues are safe. In order to ensure the safety and effectiveness of a product and predict whether a medical device or material will pose a risk to the patient, biocompatibility evaluation is required before a new biomaterial enters clinical use. This minimizes unsafe risks and guarantees that potential harm to patients is reduced to the lowest possible level.

Biocompatibility Testing Service Items:

- In vitro cytotoxicity testing

- Acute systemic toxicity testing

- Sensitization testing

- Pyrogen testing

- Irritation testing

- Implantation testing

- Hemocompatibility testing

- Chronic systemic toxicity testing

- Intradermal reaction testing

- Genotoxicity testing

- Subacute systemic toxicity testing

- Subchronic systemic toxicity testing

- Reproductive and developmental toxicity testing

- Immunogenicity and immunotoxicology testing

- Degradation testing

- In vitro thrombogenicity testing

Relevant Standards for Some Biocompatibility Testing Items:

- Cytotoxicity Testing: GB/T 16886.5, ISO 10993-5, EN ISO 10993-5, ISO 7405, YY/T 0127.9, YY/T 0268, USP 43 <87>, YY 0719.7, GB 11417.2, GB 11417.3, YY 0290.5

- Sensitization Testing: GB/T 16175, GB/T 14233.2, GB/T 16886.10, ISO 10993-10, EN ISO 10993-10, YY 0719.7, GB 11417.2, GB 11417.3, YY 0290.5

- Irritation Testing: EN ISO 10993-10, GB 11417.2, GB 11417.3, GB/T 14233.2, GB/T 16175, GB/T 16886.10, ISO 10993-10, ISO 10993-23, YY 0719.7, YY/T 0127.13

- Acute Toxicity Testing: EN ISO 10993-11, GB 11417.2, GB 11417.3, GB/T 14233.2, GB/T 16175, GB/T 16886.11, ISO 10993-11, YY 0719.7, YY/T 0127.14, YY/T 0127.5

- Pyrogen Testing: GB/T 16175, GB/T 14233.2, GB/T 16886.11, ISO 10993-11, EN ISO 10993-11, Chinese Pharmacopoeia 1142, USP 43 <151>

China JJR Laboratory has obtained authoritative certifications such as GLP, US FDA, EU CE, and China National Accreditation Service for Conformity Assessment (CMA). We focus on providing precise and comprehensive biocompatibility testing services for medical device companies. Our services cover all relevant tests under international standards such as ISO 10993, GB/T 16886, the Chinese and US Pharmacopoeias, including cytotoxicity, skin irritation, sensitization, acute and chronic toxicity assessments, and more. We ensure that every product can safely and reliably serve patients in the market.