Biocompatibility Implantation In-Vivo

ISO Subcutaneous Implantation Study (TI249)

Test Options/Variations

TI249-001Sponsor Control - 1 Wk
TI249-002Sponsor Control - 2 Wk
TI249-003Sponsor Control - 3 Wk
TI249-004Sponsor Control - 4 Wk
TI249-006Sponsor Control - 6 Wk
TI249-009Sponsor Control - 9 Wk
TI249-012Sponsor Control - 12 Wk
TI249-026Sponsor Control - 26 Wk
TI249-052Sponsor Control - 52 Wk
TI249-8011 Wk
TI249-8022 Wk
TI249-8033 Wk
TI249-8044 Wk
TI249-8066 Wk
TI249-8099 Wk
TI249-81212 Wk
TI249-82626 Wk
TI249-85252 Wk

Implantation tests are performed to evaluate the local pathological effects on living tissue, at both the gross level and microscopic level, after implantation of samples of medical devices or bio-materials.  The implant location is based on the clinical site of use.  Implant duration’s are based on the need to evaluate the tissue response over multiple intervals and along with the sample’s inertness and absorptive characteristics

STANDARDS

ISO 10993-6

Related Tests
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