Solid Test Articles:
Shall be manufactured, processed, cleaned and sterilized as for the finished product.
Should be handled in a manner to protect the integrity of the prepared finished product.
Non-Solid Test Articles:
Liquids, pastes, particles may be contained in tubes made of Polyethylene, polypropylene, or polytetraflouroethylene.
Materials that are mixed should be tested for microbial contamination.
Controls:
Should be similar in size, shape, and surface to the test article. If a tube is used for a liquid, paste or particulate test article the control should be a rod made out of and the same size as the tube containing the test article.
Animals:
Consideration to the size of the implants and the life span of the animal should be taken into consideration.
Short term typical animals for subcutaneous and intramusculrar implants are mouse, rats, guinea pigs, and rabbits.
Long term typical animals for subcutaneous, intramuscular and bone implants are rats, guinea pigs, rabbits, dogs , sheep, goats, and pigs.
Short term is up to 12 weeks and long term is over 12 weeks.
Time points chose to ascertain that a steady state of biological response has been achieved. Timepoints for bone implantations need to be extrended.
Histological response evaluations shall include, Fibrosis, quantity and distribution of polymorphonuclear leukocytes, lymphocytes, plasma cells, eosinophils, multinucleated cells, an macrophages, the presence of necrosis, foriegn material, fatty infiltrate, granuloma.
Shall be manufactured, processed, cleaned and sterilized as for the finished product.
Should be handled in a manner to protect the integrity of the prepared finished product.
Non-Solid Test Articles:
Liquids, pastes, particles may be contained in tubes made of Polyethylene, polypropylene, or polytetraflouroethylene.
Materials that are mixed should be tested for microbial contamination.
Controls:
Should be similar in size, shape, and surface to the test article. If a tube is used for a liquid, paste or particulate test article the control should be a rod made out of and the same size as the tube containing the test article.
Animals:
Consideration to the size of the implants and the life span of the animal should be taken into consideration.
Short term typical animals for subcutaneous and intramusculrar implants are mouse, rats, guinea pigs, and rabbits.
Long term typical animals for subcutaneous, intramuscular and bone implants are rats, guinea pigs, rabbits, dogs , sheep, goats, and pigs.
Short term is up to 12 weeks and long term is over 12 weeks.
Time points chose to ascertain that a steady state of biological response has been achieved. Timepoints for bone implantations need to be extrended.
Histological response evaluations shall include, Fibrosis, quantity and distribution of polymorphonuclear leukocytes, lymphocytes, plasma cells, eosinophils, multinucleated cells, an macrophages, the presence of necrosis, foriegn material, fatty infiltrate, granuloma.
Subcutaneous implantation:
Sizes for various types of test articles are suggested. The common measurement is a thickness of of approximately 1.5 mm, but in one instance up to 4 mm.
In the subcutaneous space of rats, mice, guinea pigs, or rabbits
A minimum of 3 animals and a minimum of 10 sites of each material.
Anatomical sites suggested of along the dorsal midline, or in the neck.
Intramuscular Implantation:
The implant should be 1 to 3 mm in diameter and 10 mm long with rounded ends.
The paravertebral muscles of rabbits are the preferred site.
A minimum of 3 animals to yield a minimum of 8 test and 8 control sites.
Implantation using a hypodermic needle is specified although alternative methods can be used when appropriate for the test article.
4 test implants on one side of a rabbit and 4 implants of the control on the other side of the same rabbit.
Implantation into bone:
The implant can be screw shaped to add stability to the implant. Also a cylinder is acceptable. And will be 2 mm in diameter and 5 mm in length if cylinders used in rabbits, 4 mm in diameter and 12 mm in length cylinders used in dogs, sheep, or goats, and 2 to 4.5 mm in diameter if screw shaped in rabbits, dogs, sheep, goats or pigs.
If rabbits are used at least 4 are required and if it is dogs, sheep, goats or pigs at least 2 are required.
Test and control have to be in contralateral locations.
The maximum sites for a rabbit are 3 test and 3 control. The maximum sites for a dog, sheep, goat or a pig is 6 test and 6 control.
The femur or tibia are discussed as the implant sites.
Sizes for various types of test articles are suggested. The common measurement is a thickness of of approximately 1.5 mm, but in one instance up to 4 mm.
In the subcutaneous space of rats, mice, guinea pigs, or rabbits
A minimum of 3 animals and a minimum of 10 sites of each material.
Anatomical sites suggested of along the dorsal midline, or in the neck.
Intramuscular Implantation:
The implant should be 1 to 3 mm in diameter and 10 mm long with rounded ends.
The paravertebral muscles of rabbits are the preferred site.
A minimum of 3 animals to yield a minimum of 8 test and 8 control sites.
Implantation using a hypodermic needle is specified although alternative methods can be used when appropriate for the test article.
4 test implants on one side of a rabbit and 4 implants of the control on the other side of the same rabbit.
Implantation into bone:
The implant can be screw shaped to add stability to the implant. Also a cylinder is acceptable. And will be 2 mm in diameter and 5 mm in length if cylinders used in rabbits, 4 mm in diameter and 12 mm in length cylinders used in dogs, sheep, or goats, and 2 to 4.5 mm in diameter if screw shaped in rabbits, dogs, sheep, goats or pigs.
If rabbits are used at least 4 are required and if it is dogs, sheep, goats or pigs at least 2 are required.
Test and control have to be in contralateral locations.
The maximum sites for a rabbit are 3 test and 3 control. The maximum sites for a dog, sheep, goat or a pig is 6 test and 6 control.
The femur or tibia are discussed as the implant sites.
