Implantation Test

Implantation test：refers to the local reaction of the device implanted into the living tissue. This test applies to implanted materials. The evaluation of local reaction is based on the comparison of the tissue reaction induced by the test specimen with the tissue reaction induced by the material used in the medical device that has been clinically proven to be acceptable, and a judgment is made. Depending on the period of implantation, it can be categorized as: short-term implantation (1, 2, 4, 12 weeks) and long-term implantation (13, 26, 52 weeks).
According to the site of implantation, it can be categorized into: subcutaneous implantation, intramuscular implantation and bone implantation. Requirements for sample preparation: Sample processing and sterilization are the same as the finished product.


Subcutaneous implantation

  • Slice: diameter of 10~12 mm, thickness of 0.3~1 mm;

  • Block: diameter of 1.5 mm, length of 5 mm, a round head at both ends;

  • Non-solid (powder) : Into a 1.5 mm diameter, 5 mm long catheter.


Muscle implantation

  • The length is about 10 mm and the width is 1~3 mm.

  • Larger samples with a diameter of 10mm and a thickness of 3mm


Bone implantation

  • 2 mm diameter, 6 mm long column implant (rabbit).


Brain implantation

  • Rod or wedge, diameter/section does not exceed 1mmx1mm, length 2mm~6mm; 8mm diameter disc.