Biocompatibility testing primarily assesses the compatibility and potential adverse reactions between medical devices and biological tissues, including both in vitro and in vivo evaluations. This testing is conducted not only on animals but also on human tissues or cells to ensure that the interaction between medical devices and human tissues is safe. To ensure product safety and effectiveness, and to minimize the risk of harm to patients from medical devices or materials after use, a new biomaterial must undergo biocompatibility evaluation before entering clinical use.
Biocompatibility Testing Services:
※ In vitro cytotoxicity test | ※ Acute systemic toxicity test |
※ Sensitization test | ※ Pyrogen |
※ Irritation test | ※ Implantation test |
※ Hemocompatibility test | ※ Chronic systemic toxicity test |
※ Intracutaneous reactivity | ※ Genotoxicity test |
※ Subacute systemic toxicity test | ※ Subchronic systemic toxicity test |
※ Reproductive and developmental toxicity | ※ Immunogenicity and immunotoxicology |
※ Degradation test | ※ In vitro thrombosis test |
Relevant Standards for Some Projects:
Cytotoxicity Test | 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 Test | 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 Test | 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 Test | 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 | GB/T 16175, GB/T 14233.2, GB∕T 16886.11, ISO 10993-11, EN ISO 10993-11, "Chinese Pharmacopoeia" 1142, USP 43 <151> |
CIRS Testing has been accredited by the China National Accreditation Service for Conformity Assessment (CNAS, ISO 17025) and China Metrology Accreditation (CMA). The laboratory specializes in providing precise and comprehensive biocompatibility testing services for medical device enterprises. Our services encompass all relevant tests under international standards, including ISO 10993, GB/T 16886, and the pharmacopoeias of China and the US. These tests include cytotoxicity, skin irritancy, sensitization, as well as assessments of acute and chronic toxicity, ensuring that every product can reliably and safely serve patients in the market.
Our Advantages
Whole Industry Chain Services｜Provide full industry chain technical services, including R&D support, safety evaluation and testing, registration, clinical, quality management system, etc.
Professional Technical Team | A team of experts in the fields of medical device regulations, registration, medicine, toxicology, statistics, biological evaluation, chemical analysis, microorganisms, etc., with comprehensive technical service capabilities
Professional Laboratory｜Own several professional laboratories, including chemical analysis lab, materials lab, microorganisms lab, environment lab, efficacy evaluation lab, animal safety evaluation lab, etc.
Rich Industry Experience｜Successful cases on safety assessment, registration and clinical services in active, non- active and IVD; Rich experience in implantable degradable products, medical beauty products, oral materials, cavity stents, assisted reproductive products and orthopedic ophthalmology field.
If you have any needs or questions, please contact us at test@cirs-group.com.
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