Biological evaluation of medical devices is the process of scientifically assessing the interaction of medical devices with human biological systems. Its purpose is to assess the biological response that may be triggered when the medical device is used on the patient to ensure the safety and biocompatibility of the device. Our services for biological evaluation of medical devices include: implantation test, irritation test, sensitization test, pyrogen test, etc.
| Projects | Standard (Method) | Period | Reports | ||
|---|---|---|---|---|---|
| Implantation test | Muscle implantation | Short-term | Biological evaluation of medical devices - Part 6: Local response tests after implantation GB-T 16886.6-2022 / ISO 10993-6:2016 | 1 week, 2 weeks, 4 weeks, 12 weeks | 1~2 weeks |
| Long-term | 13 weeks, 26 weeks, 52 weeks | 1~2 weeks | |||
| Subcutaneous implantation | Short-term | 1 week, 2 weeks, 4 weeks, 12 weeks | 1~2 weeks | ||
| Long-term | 13 weeks, 26 weeks, 52 weeks | 1~2 weeks | |||
| Bone implantation | Short-term | 1week, 2 weeks, 4 weeks, 12 weeks | 1~2 weeks | ||
| Long-term | 13 weeks, 26 weeks, 52 weeks | 1~2 weeks | |||
| Brain implantation | Short-term | 1 week, 2 weeks, 4 weeks, 12 weeks | 1~2 weeks | ||
| Long-term | 13 weeks, 26 weeks, 52 weeks | 1~2 weeks | |||
| Stimulation test | Skin stimulation |
1) Biological evaluation of medical devices - Part 10: Stimulation and delayed hypersensitivity tests GB/T 16886.10-2017 6.3 / ISO 10993-10:2010; 2) Test method for biological evaluation of medical organosilicon materials GB/T 16175-2008 7.5; 3) Hygienic standard for disposable sanitary products GB 15979-2002. |
72 hours | 1~2 weeks | |
| Oral mucosa test | Biological evaluation of medical devices - Part 10: Stimulation and delayed hypersensitivity reaction tests GB/T 16886.10-2017 / ISO10993-10:2010 Appendix B.3 | 2 weeks | 1~2 weeks | ||
| Rectal stimulation test | Biological evaluation of medical devices - Part 10: Stimulation and delayed hypersensitivity tests GB/T 16886.10-2017 / ISO10993-10:2010 Appendix B.5 | 2 weeks | 1~2 weeks | ||
| Vaginal stimulation |
1) Biological evaluation of medical devices - Part 10: Irritation and skin sensitization tests GB/T 16886.10-2017 Appendix B.6 / ISO 10993-10:2010; 2) Hygienic standard for disposable sanitary products GB 15979-2002; 3) Biological evaluation of medical devices - Part 23: Irritation tests ISO 10993-23:21 Appendix D.6. |
2 weeks | 1~2 weeks | ||
| Sensitization test |
1) Biological evaluation of medical devices - Part 10: Stimulation and delayed hypersensitivity tests GB/T 16886.10-2017 6.3 / ISO 10993-10:2010; 2) Test method for biological evaluation of medical organosilicon materials GB/T 16175-2008 7.5; 3) Hygienic standard for disposable sanitary products GB 15979-2002. |
21days | 1~2 weeks | ||
| Rabbit pyrogen test |
1) Biological evaluation of medical devices - Part 11: Systemic toxicity tests GB/T 16886.11-2021 / ISO 10993-11:2017; 2) Test methods for medical infusion, blood transfusion and injection apparatus - Part 2: Biological test methods GB-T 14233.2-2005 ; 3) Test method for biological evaluation of medical organosilicon materials GB/T 16175-2008 10; 4) Disposable infusion set gravity infusion GB 8368-2018 8.3. |
1 day | 1~2 weeks | ||