ISO 10993 Testing Lab

JJR in China is an ISO 10993 testing lab, and products that typically require biocompatibility testing are usually medical products, including medical devices, pharmaceutical products, and hygiene preventive products. The standards referenced by the lab are primarily ISO 10993 and GB/T 16886, with the contents of the two standards being nearly identical.

ISO 10993 biocompatibility testing is mainly divided into the following parts:

1. Part 1: Evaluation and testing

2. Part 2: Animal protection requirements

3. Part 3: Genetic toxicity, carcinogenicity, and reproductive toxicity tests

4. Part 4: Selection of blood interaction tests

5. Part 5: In vitro cytotoxicity tests

6. Part 6: Implantation local reaction tests

7. Part 7: Ethylene oxide sterilization residuals

8. Part 8: Biological testing reference materials selection and quantitative guidelines

9. Part 9: Qualitative and quantitative framework for potential degradation products

10. Part 10: Irritation and skin sensitization tests

11. Part 11: Systemic toxicity tests

12. Part 12: Sample preparation and reference samples

13. Part 13: Qualitative and quantitative analysis of polymer medical device degradation products

14. Part 14: Qualitative and quantitative analysis of ceramic degradation products

15. Part 15: Qualitative and quantitative analysis of metal and alloy degradation products

16. Part 16: Toxicokinetics study design for degradation products and leachables

17. Part 17: Establishment of allowable limits for leachables

18. Part 18: Chemical characterization of materials

ISO 10993 testing involves many items, but not all products require a full set of tests. The specific tests are determined based on the product’s usage method and performance characteristics.

The most commonly performed tests on the market are:

- Part 5: ISO 10993-5 In vitro cytotoxicity tests (Biological evaluation of medical devices - Tests for in vitro cytotoxicity)

- Part 10: ISO 10993-10 Irritation and skin sensitization tests (Biological evaluation of medical devices - Tests for irritation)

Testing Cycle:

- ISO 10993-5: 25 working days

- ISO 10993-10: 60 working days

Note: These tests involve the use of mice, and the mice require a period of rest. There are limitations on laboratory scheduling and capacity, so the actual testing cycle will depend on the laboratory’s schedule.