High density polyethylene rod Negative RM-H

High density polyethylene rod Negative RM-HThe negative control material was developed by Hatano Research Institute (FDSC) and is made of medical grade high-density polyethylene material. It can be used as a negative control sample for in vivo implantation experiments. This material can meet the requirements of relevant standards and specifications such as GB/T 16886, ISO 10993, USP88, etc.

1、 Pre implantation requirements for reference materials

Firstly, the reference material should be prepared and processed according to the ISO 10993 standard, and the size and shape of the reference material should be documented and verified. It is necessary to select materials that are as similar as possible to the test sample; Secondly, when processing the control material, it is necessary to operate under sterile conditions to ensure that the sample is not damaged or contaminated.

2、 Size requirements for control materials at different implantation sites

I. Subcutaneous tissue implantation test:

1. The disc-shaped sample should be made with a diameter of 10-12mm and a thickness of 0.3-1.0mm.

2. Rod or cylindrical materials should be made into samples with a diameter of 1.5-2mm, a length of 5-10mm, and circular shields at both ends.

3. Non solid experimental samples should be placed into tubes with a diameter of 1.5mm and a length of 5mm, and then the material should be implanted into the tissue.

4. When combined with systemic toxicity studies, other sizes that are adapted to the anatomical structure can be used.

II. Muscle implantation test:

The size of the implant depends on the size of the selected muscle group. When using rabbit paraspinal muscles for experiments, implants with a width of 1-3mm and a length of 10mm are generally used, or larger samples with a diameter of 10mm and a thickness of 3mm are used. At the same time, the sample should be made with circular edges and rounded with obtuse angles at both ends.

III. Bone Implantation Test:

The size of the bone implant test sample is related to the size of the selected experimental animal and bone,

1. Rabbit: Choose a cylindrical implant with a diameter of 2mm and a length of 6mm.

2. Dogs and sheep: Choose cylindrical implants with a diameter of 4mm and a length of 12mm.

3. Pigs: Choose 2-4.5mm intraosseous screw implants.

IV. Brain tissue implantation test:

The size of the implanted sample is related to the size of the animal and the implantation site. If it is mouse brain tissue, it is recommended to use rod-shaped or wedge-shaped implants with a diameter of 1mm and a length of 2-6mm; a disc with a diameter of 8mm can also be selected.

3、 Implantation experiment steps:

1. Preparation: Site/cycle/animal, test and control samples, quarantine animals.

2. Surgery: Anesthetize and prepare skin, implant samples according to the location, and provide postoperative suturing care.

3. Feeding observation: Observe daily during the cycle and record any abnormalities.

4. Material fixation: Take the implant and surrounding tissue, fix/decalcify the sample.

5. Evaluation: General observation+pathological blind evaluation, compare and draw conclusions.

6. Conclusion: Organize data and issue a report.

High density polyethylene rod Negative RM-HThe negative control material has stable physical and chemical properties, good batch reproducibility, and complies with GLP laboratory regulations, making it an ideal material for in vitro implantation experiments.