Biocompatibility Implantation In-Vivo

ISO Muscle Implantation Study (TI250)

Test Options/Variations

TI250-001with Sponsor Control - 1 Wk
TI250-002with Sponsor Control - 2 Wk
TI250-003with Sponsor Control - 3 Wk
TI250-004with Sponsor Control - 4 Wk
TI250-006with Sponsor Control - 6 Wk
TI250-009with Sponsor Control - 9 Wk
TI250-012with Sponsor Control - 12 Wk
TI250-026with Sponsor Control - 26 Wk
TI250-052with Sponsor Control - 52 Wk
TI250-8011 Wk
TI250-8022 Wk
TI250-8033 Wk
TI250-8044 Wk
TI250-8066 Wk
TI250-8099 Wk
TI250-81212 Wk
TI250-82626 Wk
TI250-83R3 Subject, Variable Interval
TI250-84R3 Subject, Variable Interval
TI250-85252 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

This implant study involves placement of a portion of a test article in the para-vertebral muscle.  A negative control is also implanted.  Following  the listed time of implantation, sites are collected, slides prepared and a microscopic  evaluation performed to determine the extent of a local tissue response.

STANDARDS

ISO 10993-6

Related Tests
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