Implantation with Histopathology Tests

By histopathology, implantation determines the local effects of biomaterials intended for use in medical devices. This test applies to solid / non-absorbable, non-solid (porous materials, liquids, gels, pastes and particles) or degradable and / or absorbable (solid or non-solid) devices. This test allows manufacturers to evaluate the impact of the implanted material on surrounding tissues.

In determining the time the test product will be implanted, the following should be considered: the intramuscular exposure (intramuscular, subcutaneous, or bone) at which the device is implanted, and how long the device must reach a steady state biological response to the implanted test product.

Gross autopsy observations will be made and the implant sites will be harvested and prepared for pathology examination. Histopathology is required to meet ISO requirements. Implantation tests comply with ISO 10993-6 and ISO 10993-12 standards.

Applicable Standards

• ISO 10993-6
• ISO 10993-12

Sample Features

• SCX610: 14, 1 x 1 x 10 mm strips. CSS Approval is required to meet TAT.
• SCX615: 14, 1 x 1 x 10 mm strips. CSS Approval is required to meet TAT.
• SCX620: 14, 1 x 1 x 10 mm strips. CSS Approval is required to meet TAT.
• SCX625: 14, 1 x 1 x 10 mm strips. CSS Approval is required to meet TAT.
• SCX630: 14, 1 x 1 x 10 mm strips. CSS Approval is required to meet TAT.
• SCX635: 14, 1 x 1 x 10 mm strips. CSS Approval is required to meet TAT.
• SCX640: 14, 1 x 1 x 10 mm strips. CSS Approval is required to meet TAT.
• SCX645: 14, 1 x 1 x 10 mm strips. CSS Approval is required to meet TAT.
• SCX650: 14, 1 x 1 x 10 mm strips. CSS Approval is required to meet TAT.
• SCX653: 20, 1 x 1 x 10 mm strips. CSS Approval is required to meet TAT.
• SCX655: 14, 1 x 1 x 10 mm strips. CSS Approval is required to meet TAT.

EUROLAB, with its highly expert team and internationally accredited laboratories, Implantation with Histopathology Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.