What Are the Standards for In Vitro Biocompatibility Tests?

1. Cytotoxicity MTT Assay (Including Serum, Direct Contact, Microscopy Observation)

- Standards: ISO 10993-5:2009, GB/T 16886.5-2017, EN ISO 10993-5:2009, GB/T 14233.2-2005

- Duration: 2 weeks

2. Cytotoxicity (Agar Diffusion Method)

- Standards: ISO 10993-5:2009, GB/T 16886.5-2017, EN ISO 10993-5:2009

- Duration: 2 weeks

3. Cytotoxicity (Filter Diffusion Method)

- Standards: ISO 10993-5:2009, GB/T 16886.5-2017, EN ISO 10993-5:2009

- Duration: 2 weeks

4. Chromosomal Aberration Test - Polar (RPMI-1640 Extract)

- Standards: ISO 10993-3:2014, GB/T 16886.3-2019, EN ISO 10993-3:2014, ISO 10993-3, ISO/TR 10993-33:2015(E), YY/T 0870.2-2019, YY/T 0127.16-2009

- Duration: 7 weeks

5. Chromosomal Aberration Test - Non-Polar (10% Fetal Bovine Serum RPMI-1640 Extract)

- Standards: Same as above

- Duration: 7 weeks

6. Chromosomal Aberration Test - (SC)

- Standards: Same as above

- Duration: 7 weeks

7. Chromosomal Aberration Test - (DMSO)

- Standards: Same as above

- Duration: 7 weeks

8. Ames Test (0.9% Sodium Chloride Extract)

- Standards: ISO 10993-3:2014, GB/T 16886.3-2019, EN ISO 10993-3:2014, ISO 10993-3, ISO/TR 10993-33:2015(E), YY/T 0127.10-2009, YY/T 0870.1-2013

- Duration: 7 weeks

9. Ames Test (DMSO Extract)

- Standards: Same as above

- Duration: 7 weeks

10. Gene Mutation Test - Polar (RPMI-1640 Extract)

- Standards: ISO 10993-3:2014, GB/T 16886.3-2019, EN ISO 10993-3:2014, ISO 10993-3, ISO/TR 10993-33:2015(E), YY/T 0870.3-2019, YY/T 0127.17-2014

- Duration: 7 weeks

11. Gene Mutation Test - Non-Polar (5% Horse Serum RPMI-1640 Extract)

- Standards: Same as above

- Duration: 7 weeks

12. Routine Hemolysis Test (Rabbit Blood)

- Standards: GB/T 16886.4-2003, GB/T 14233.2-2005, GB/T 16886.4-2022, YY/T 1651.1-2019

- Duration: 2 weeks

13. Routine Hemolysis Test (Rabbit Blood) - Indirect + Direct

- Standards: ISO 10993-4:2017, GB/T 16886.4-2022, YY/T 1651.1-2019

- Duration: 3 weeks

14. Routine Hemolysis Test (Rabbit Blood) - Indirect Method

- Standards: ISO 10993-4:2017

- Duration: 3 weeks

15. ASTM Hemolysis Test (Rabbit Blood) - Indirect + Direct

- Standards: ASTM F 756-17, GB/T 16886.4-2022, YY/T 1651.1-2019

- Duration: 3 weeks

16. ASTM Hemolysis Test - Indirect Method (Rabbit Blood)

- Standards: ASTM F 756-17, GB/T 16886.4-2022

- Duration: 3 weeks

17. Partial Thromboplastin Time (PTT) Test

- Standards: ISO 10993-4:2017, GB/T 14233.2-2005, GB/T 16886.4-2022, EN ISO 10993-4:2017

- Duration: 3 weeks

18. Prothrombin Time (PT) Test

- Standards: Same as above

- Duration: 3 weeks

19. Coagulation Reaction (Thrombin TAT+F1.2 and Fibrin FPA)

- Standards: GB/T 16886.4-2022

- Duration: 3 weeks

20. Platelet Count Test

- Standards: ISO 10993-4:2017, GB/T 16886.4-2003, EN ISO 10993-4:2017

- Duration: 3 weeks

21. Platelet Activation Test

- Standards: GB/T 16886.4-2022

- Duration: 4 weeks

22. Hematology (Red & White Blood Cells)

- Standards: ISO 10993-4:2017, GB/T 14233.2-2005, GB/T 16886.4-2022, EN ISO 10993-4:2017

- Duration: 3 weeks

23. Endotoxin Gel Limit Test (Chinese Horseshoe Crab)

- Standards: GB/T 14233.2-2005, YY/T 0618-2017, Chinese Pharmacopoeia 2020 Edition, Part IV, General Rule 1143

- Duration: 2 weeks

24. Endotoxin Tube Quantitative Chromogenic Substrate Test (Chinese Horseshoe Crab)

- Standards: Same as above

- Duration: 2 weeks

25. Endotoxin Gel Limit Test (American Horseshoe Crab)

- Standards: GB/T 14233.2-2005, YY/T 0618-2017, Chinese Pharmacopoeia 2020 Edition, Part IV, General Rule 1143

- Duration: 2 weeks + procurement time

26. Endotoxin Tube Quantitative Chromogenic Substrate Test (American Horseshoe Crab)

- Standards: Same as above

- Duration: 2 weeks + procurement time