In this study, medical device materials were implanted into animal muscle, subcutaneous tissue or bone, and the biocompatibility of the test samples was evaluated by observing the reaction degree of surrounding tissues after implantation.
According to the implant site, it can be divided into: subcutaneous implant, muscle implant and bone implant.
STANDARDS：
ISO 10993-6, GB/T 16886.6, USP Chapter<88>, EN ISO 10993-6, GB/T 14233.2
IMPLANTATION CYCLE SELECTION
Implantation Test
For non-degradable and non-absorbent materials, short-term reactions from 1 to 4 weeks and long-term reactions over 12 weeks of testing are generally assessed.
For degradable/absorbable materials, the test cycle should be related to the estimated degradation time of the test product. Local tissue responses related to the degradation process of the implant at each time point should be evaluated:
1. In the case of non-degradation or microdegradation, the evaluation is generally conducted 1 to 12 weeks after implantation;
2. When degradation occurs;
3. When the tissue reaches a stable state, it is repaired or nearly completely degraded.
PERIOD：
Implantation Test
2~26 weeks, please contact EPINTEK for details
SAMPLE REQUIREMENTS：
Ø ISO 10993-6, GB/T 16886.6, EN ISO 10993-6, GB/T 14233.2
There were 12 samples in each implantation cycle.
Items
Small Sample Request
Subcutaneous Implant
1、 Sheet material should be made of 10 mm~12 mm, thickness of 0.3 mm~1.0 mm test sample;
2、 Block material should be made of 1.5mm, long 5mm, both ends of the round head test sample;
3、 Non-solid test samples (including powder) should be loaded into the diameter of 1.5 mm, 5 mm long tube.
Muscle Implant
In the test of rabbit paraspic muscle, implants with a width of 1 mm~3 mm and a length of about 10 mm are generally used, or larger objects with a diameter of 10 mm and a thickness of 3 mm can be surgically implanted. The sample shall be rounded with obtuse rounded edges at both ends.
Bone Implant
The implant size is determined according to the size of the selected experimental animal and its bone. The following standard sizes should be considered for axial cortical intraosseous implants:
Rabbits: Cylindrical implant 2 mm in diameter and 6 mm in length
Ø USP Chapter<88>
Items
Small Sample Request
Muscle Implant
8 samples for each implantation cycle, each sample not less than 10 X 1 mm
Subcutaneous Implant
Each implantation cycle included 10 samples with diameters of 10-12 mm and thickness of 0.3-1 mm
