Implantation test

Collagen sponges with microporous structures from tilapia were fabricated reconstituted collagen fibrils using freeze-drying and cross-linked by DHT treatment or additional treatment with WSC treatment. The pellet implantation tests into the paravertebral muscle of rabbits demonstrated that tilapia collagen caused rare inflammatory responses at 1- and... 

Various standards and procedures exist for the evaluation of the biological and immunotoxicity response of an implant [81] from the point of view of biocompatibility. Acute toxicity screening and in vivo implantation tests are fundamental in this respect. Cytotoxicity testing to detect the biological activity of the material on a mammalian cell monolayer is often the first step in assessing biocompatibility of a device. An international standard on the biological evaluation... 

Intracutaneous toxicity (USP) Implantation tests (USP) Non-toxic Non-toxic... 

Similar to in vitro testing, three tests comprise in vivo biological testing (viz., systemic injection test, intracutaneous test, and implantation test). The tests selected for use should be appropriate for the intended use of the product and should reflect a reasonable assessment of risks to the patient. Each test has specified a minimum quantity of material, and this quantity is crucial to the validity of the test. 

The FDA has made several modifications to the tests required by Part 1 of the ISO 10993 standard for the category of surface devices that permanently contact mucosal membranes. The ISO does not require acute, subchronic, or chronic implantation tests as does FDA. FDA requires irritation, systemic toxicity, acute, subchronic, and chronic tests for external communicating devices, tissue/bone/ dentin with prolonged and permanent contact. Device manufacturers are advised to consider tests to detect chemical components of device materials that may be pyrogenic. This matrix is a framework and not a checklist and it is stressed by the FDA that necessary safety testing will be decided on a case-by-case basis. 

The biological reaction of four types of DN gels in muscle and subcutaneous tissues have been evaluated, using implantation tests according to the international guidelines [107, 108], The four gels tested were PAMPS/PDMAAm DN gel, PAMPS/PAAm DN gel, BC/PDMAAm DN gel, and BC/gelatin DN gel. 

The cytotoxicity, acute hemolysis, skin sensitization results suggest that AI2O3 porous ceramics prepared via freeze casting in vitro biological reactions is biosafe and the porous AI2O3 ceramics have a potential application for implants. Further experiments, such as, direct cells contact in vitro, long-term implantation test in vivo will be conducted to meet the practical application requirements. 

Hart P H M and Watkinson F Weld metal implant test ranks Cr-Mo hydrogen cracking resistance . Welding J Res Supp 54 (9) 1975 288s-295s. 

Adhesives used in medical devices that are implanted or in contact with the body must be tested and shown to be non-toxic, biologically inert, and compatible with blood and body fluids. Compatibility with blood and other body fluids is especially critical. Surfaces in contact with blood must not serve as sites for coagulation and clotting of blood. Generally, qualification testing is performed to ISO-10993 or to U.S. Pharmacopoeia (USP) Class VI. The two standards specify slightly different tests. The USP Class VI standard specifies acute systemic (over the tissue), intracutaneous (under the skin), and muscle implantation tests. The lSO-10993 standard is a set of 12 documents that is more universal and more extensive than the USP standard. It specifies ... 

Muscle implantation test - 7 and 30 days Rabbits Non-reactive tissue irritant... 

Both laboratory and clinical examinations confirm that Healon , Viscoat and many other viscoelastics have no inflammatory effects when produced in the proper combinations. Specific tests (such as the owl monkey eye test) carried out prior to the release of a batch of hyaluronic acid confirm this finding in Healon , Healon 5 and Healon GV (see below). For HPMC products, implantation tests... 

The tests for external devices contacting blood are also the same as for implanted devices, although implantation tests are noted as may be applicable. For long-term devices, either external or implants, chronic toxicity and carcinogenicity testing may also be required. 

Applications in the biomedical area require extensive testing of biocom-patibility, including acute, dietary and implant testing, and monitoring... 

There are several standards that medical polymers must adhere to. One of the most common standards observed for polymeric materials is published by the United States Pharmacopeia (USP), which necessitates using animal models (in vivo) to test toxicity of elastomers, plastics, and other polymeric materials, prior to clinical use. The standard and forms of testing it outlines is considered in the medical industry as the minimum requirement for a polymeric material before it is considered for use in healthcare applications. According to the standard the biological response of the test animals are measured and determined via three main techniques (1) Systemic toxicity test Evaluates the effects of leachables of intravenously or intraperitoneally injected materials on systems such as the nervous or immune system (2) Intracutaneous test Evaluates local response to materials injected under the skin (3) Implantation test Both local tissue microscopic and macroscopic parameters evaluated at material implant sites. 

The intramuscular implantation test of the USP assessed toxicity arising from implantation in rabbits for seven days and the new PVC compound proved satisfactory in this test. A further test of this type compared extraction resistant and DEHP medical type PVC over a three week implantation period. While microscopic examination showed no significant difference in reaction, histopathological evidence suggested the DEHP based compound produced more severe reactions than those produced by the new PVC. 

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