Biocompatibility Implantation In-Vivo

Muscle Implantation Study, Japanese MHLW (T0593)

Test Options/Variations

T0593-001Sponsor Control - 1 Wk
T0593-002Sponsor Control - 2 Wk
T0593-004Sponsor Control - 4 Wk
T0593-012Sponsor Control - 12 Wk
T0593-026Sponsor Control - 26 Wk
T0593-052Sponsor Control - 52 Wk
T0593-8011 Wk
T0593-8022 Wk
T0593-8044 Wk
T0593-81212 Wk
T0593-82626 Wk
T0593-85252 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

MHLW – Ministry of Health, Labour and Welfare

STANDARDS

ISO 10993-6

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