FDA Guidance ISO 10993
The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices. For the purpose of the ISO 10993 family of standards, biocompatibility is defined as the "ability of a medical device or material to perform with an appropriate host response in a specific application".
ISO 10993-1-2018 biocompatibility testing.pdf
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ISO 10993
Non-active | Biocompatibility
Number |
Project |
Standard |
1. |
Evaluation and testing within a risk management process |
ISO10993-1 , G B16886.1 |
2. |
Ethylene oxide sterilization residuals (ETO,ECH,EO) |
ISO10993-7 , G B16886.7 |
3. |
In vitro cytotoxicity test |
ISO10993-5 , G B16886.5 |
4. |
Sensitization test |
ISO10993-10 , GB16886.10 |
5. |
Skin, intradermal and oral mucosal irritation test |
ISO10993-10 , GB16886.10 |
6. |
Irritation test |
ISO10993-23 |
7. |
Acute systemic toxicity test |
ISO10993-11 , GB16886.11 |
8. |
Subacute systemic toxicity test |
ISO10993-11 , GB16886.11 |
9. |
Subchronic systemic toxicity test |
ISO10993-11 , GB16886.11 |
10. |
Chronic systemic toxicity test |
ISO10993-11 , GB16886.11 |
11. |
Material-mediated Pyrogens Test |
ISO10993-11 , GB16886.11 |
12. |
In vitro Mammalian Chromosome Aberration Test |
ISO10993-3 , GB16886.3,ISO10993-33 |
13. |
Micronuclear test |
ISO10993-3 , GB16886.3,ISO10993-33 |
14. |
In Vitro Mammalian Cell Gene Mutation Test |
ISO10993-3 , GB16886.3,ISO10993-33 |
15. |
Ames test |
ISO10993-3 , GB16886.3,ISO10993-33 |
16. |
Thrombogenesis test |
ISO10993-4 , GB16886.4 |
17. |
Coagulation test |
ISO10993-4 , GB16886.4 |
18. |
Platelet adhesion test |
ISO10993-4,GB16886.4 |
19. |
Complement activation test |
ISO10993-4,GB16886.4 |
20. |
Hemolysis test |
ISO10993-4,GB16886.4 |
21. |
Muscle implantation test |
ISO10993-6,GB16886.6 |
22. |
Subcutaneous implantation test |
ISO10993-6,GB16886.6 |
23. |
Bone implant test |
ISO10993-6,GB16886.6 |
24. |
Material characteristic analysis |
ISO10993-18 |
… |
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2. Determine your needs(test report purpose/ test itmes/ standards)
3. Receive the testing/compliance service proposal and quotation
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5.Send samples (please contact us for address info.)
6.Informed project opening and test TAT(turn around time) via email
7.Testing
8.Draft report for your confirmation
9. Formal reports endorsed by ILAC - CNAS (electronic version)
10.Sample Discard or Return
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