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Test for reproductive toxicity
Test for in vitro cytotoxicity
Test for sensitization
Test for irritation
Tests for systemic toxicity
Pyrogenicity test
Test for genotoxicity
Test for carcinogenicity
Test for local effects after implantation
Tests for interactions with blood
Immunotoxicity test
Bio-degrade test
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Test for local effects after implantation

    ISO10993-6 specifies test methods for the assessment of the olcal effects after implantation of biomaterials intended for use in medical devices. The test specimen is implanted into a site and animal species appropriate for the evaluation of biological safety of the material.  The local effects are evaluated by a comparison of the tissue response caused by a test specimen to that caused by control materials used in medical devices of which the clinical acceptability and biocompatibility characteristics have been established.

Methods of test for local effects after implantation includ: Subcutaneous,  Muscle,  Bone    (Bone test method include evaluation of the biodegradation and osteogenesis of porous bioceramic in vivo)

                                 

 

 

 

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