Biocompatibility Testing Services

Biocompatibility Testing Projects

There are numerous biocompatibility testing projects. Medical device manufacturers should select testing projects based on their product's usage characteristics, product standards, the body parts involved, and the duration of contact, in accordance with the relevant standards for their specific products.

JJR Laboratory in China offers customized testing plans for clients based on the characteristics and intended use of the medical device, providing a full range of ISO 10993 and ISO 18562 biocompatibility testing services.

Testing Standards:

Biocompatibility Testing Projects:

- In vitro cytotoxicity test

- Salmonella typhimurium reverse mutation test

- Sensitization test

- Gene mutation test

- Thrombosis test

- Skin irritation test

- Intracutaneous irritation test

- Coagulation test

- Acute systemic toxicity test

- Subacute systemic toxicity test

- Platelet adhesion test

- Complement activation test

- Subchronic systemic toxicity test

- Chronic systemic toxicity test

- Muscle implantation test

- Hemolysis test

- Pyrogenicity test

- Chromosomal aberration test

- Bone implantation test

- Bone marrow micronucleus test

- Material characterization analysis

- Subcutaneous implantation test

Non-powered | Biocompatibility Testing Standards:

1. In vitro cytotoxicity test: ISO10993-5, GB16886.5

2. Sensitization test: ISO10993-10, GB16886.10

3. Skin, intracutaneous, oral mucosa irritation test: ISO10993-10, GB16886.10

4. Irritation test: ISO10993-23

5. Acute systemic toxicity test: ISO10993-11, GB16886.11

6. Subacute systemic toxicity test: ISO10993-11, GB16886.11

7. Subchronic systemic toxicity test: ISO10993-11, GB16886.11

8. Chronic systemic toxicity test: ISO10993-11, GB16886.11

9. Pyrogenicity test: ISO10993-11, GB16886.11

10. Chromosomal aberration test: ISO10993-3, GB16886.3

11. Micronucleus test: ISO10993-3, GB16886.3

12. Gene mutation test: ISO10993-3, GB16886.3

13. Ames test: ISO10993-3, GB16886.3

14. Thrombosis test: ISO10993-4, GB16886.4

15. Coagulation test: ISO10993-4, GB16886.4

16. Platelet adhesion test: ISO10993-4, GB16886.4

17. Complement activation test: ISO10993-4, GB16886.4

18. Hemolysis test: ISO10993-4, GB16886.4

19. Muscle implantation test: ISO10993-6, GB16886.6

20. Subcutaneous implantation test: ISO10993-6, GB16886.6

21. Bone implantation test: ISO10993-6, GB16886.6

22. Material characterization analysis: ISO10993-18

Our Advantages:

- The laboratory holds CNAS/national CMA and OECD GLP qualifications.

- Covers in vivo and in vitro testing.

- Full range of tests in compliance with various standards (such as product standards, ISO 10993, ASTM, MHLW, GBT 16886, USP, EP, BP, etc.).

- Customized testing plans: We can combine local tissue reaction implantation tests with systemic toxicity tests, or integrate biocompatibility testing with preclinical large animal studies, helping to save on testing costs and time.

- Biological risk assessment: By combining all available safety-related data, senior toxicology experts evaluate the biological risks and optimize the testing plan, saving both time and costs!