Table 1.
Testing guidelines recommended by ISO, USP and ASTM for an implantable device that will contact the body tissue or bone for more than 30 days *.
| Regulatory Body | Recommended Standards |
|---|---|
| ISO |
Initial Evaluation Tests
Cytotoxicity ISO 10993-5: Tests for in-vitro cytotoxicity Sensitization ISO 10993-10: Tests for irritation and delay-type hypersensitivity Genotoxicity ISO 10993-3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Implantation ISO 10993-6: Tests for local effects after implantation Supplementary Evaluation Tests Chronic Toxicity ISO 10993-11: Tests for Systemic Toxicity Carcinogenicity ISO 10993-3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| USP |
Initial Evaluation Tests
Cytotoxicity Biological Reactivity Tests, In Vitro <87> Sensitization Procedure to come Genotoxicity Procedure to come Implantation Biological Reactivity Tests, In Vivo <88> Chronic toxicity Procedure to come Carcinogenicity Procedure to come Additional Tests that may be applicable Irritation or Intracutaneous Reactivity Biological Reactivity Tests, In Vivo <88> Systemic Toxicity (Acute) Biological Reactivity Tests, In Vivo <88> Subchronic Toxicity (Subacute toxicity) Procedure to come |
| ASTM |
Cell Culture Cytotoxicity
Practice F813 and Test Method F895 Application specific method in Practice F 1027 Sensitization Practice F 720 Repeated dermal patch test method also acceptable Skin Irritation or Intracutaneous Practice F 719 (skin irritation) Practice F749 (intracutaneous injection) or USP <88> Systemic Toxicity, Acute or Subchronic Practice F750 or USP <88> Pyrogen Test USP <85> Bacterial Endotoxins Test Short-term Implantation Practice F 1408 – short term subcutaneous Practice F 763 – short term intramuscular or USP <88> Long-term Implantation Practice F 981 other long-term implant tests may also be appropriate Immune Response (Immunotoxicity) No ASTM standard provided Genotoxicity Ames test (preliminary screen of materials) Guide E1262 and Guide E1280 Warns that no single test can detect all possible mutagens Carcinogenicity No standard procedures available Guide F 1439 |