Biocompatibility: ISO 10993
Within the general safety-testing framework, the device manufacturer is responsible for selecting and justifying the specific tests most appropriate for product safety and compliance with regulatory requirements.
We recommended that testing be performed to comply with GLP regulations. With years of experience in biocompatibility testing, the Medical Device Testing division provides exceptional expertise to assist medical device manufacturers in designing thorough, well-constructed testing programs that meet global compliance standards.
- Cytotoxicity Testing
Cytotoxicity tests involve exposing cultured cells to substances extracted from your test material. Cell cultures are extremely sensitive to minute quantities of leachable chemicals and readily display characteristic signs of toxicity in the presence of potentially harmful leachables. In vitro cytotoxicity testing is also required to test the biocompatibility of medical devices. Typical testing programs will adhere the ISO test method to meet international regulatory requirements.
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Agarose Overlay - ISO 10993 Part 5
ISO Agarose Overlay Using L-929 Mouse Fibroblast Cells L-929 mouse fibroblast cells are overlaid with a permeable agar film. A solid sample or liquid saturated disc is then placed in triplicate containers on the agar surface. Cells are examined at 24 hours for signs of toxicity.
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MEM Elution
ISO MEM Elution Using L-929 Mouse Fibroblast Cells Solid materials are extracted in cell culture medium, and the extracts are placed in triplicate containers of L-929 mouse fibroblast cells. Cells are examined up to 72 hours for signs of toxicity.
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Quantitative Assays
MTT Cytotoxicity Using L-929 Mouse Fibroblast Cells Solid materials are extracted in cell culture medium. Multiple dilutions of the extract are prepared and added to triplicate wells. After incubation, MTT reagent is added to each well. After a second incubation, the amount of formazan formed is determined. Results are calculated based on the formazan levels.
- Sensitization Testing
Sensitization tests estimate the potential for erythema, swelling, or delayed allergic response through the testing of appropriate materials or extracts.
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ISO Guinea Pig Maximization Sensitization Test
Extracts of the device are prepared, and the skin surface of animals is exposed to the extract in the presence of an adjuvant. After a short waiting period, the animals are challenged with a lower dose of the same extract to estimate the potential for contact erythema, swelling, or delayed allergic response, or other edema responses through the testing of appropriate materials or extracts. Methods for both polymeric devices and liquid test articles available.
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Buehler Dermal Sensitization Test
Extracts of the device are prepared, and the skin surface of animals is exposed to the extract in the absence of an adjuvant for at least 6 hours. After multiple such exposures, the animal is challenged with a sub-irritating dose of the extract, and contact erythema, swelling, or delayed allergic response, or other edema responses are measured.
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Repeated Patch Derma Sensitization Test
Here, animals are sensitized and challenged with the test article itself rather than with an extract from the test article.
Irritation Testing
Irritation tests assess the localized reaction of tissues to device materials or extracts. The selection of a test method is based on intended patient contact type.
- Irritation Testing
Irritation tests assess the localized reaction of tissues to device materials or extracts. The selection of a test method is based on intended patient contact type.
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ISO Intracutaneous Irritation Test
Test material solution or an extract of a device is injected under the top layer of skin to test the possible irritancy of the test article compounds.
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ISO Mucosal Irritation Test
Materials that comes in direct or indirect contact with mucosal tissue receive repeated administration of a dose to observe possible irritation.
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ISO Primary Skin Irritation Test
This test is performed to assess the potential topical irritation from acute exposure or device material.
- Systemic Toxicity Testing
The purpose of this test is to screen solutions or test article extracts for potential toxic effects as the result of systemic injection dosing. Toxicity tests estimate potential harmful systemic effects from a single exposure to polar or nonpolar extracts of device materials.
- Subacute/Subchronic Toxicity Testing
Subacute toxicity is assessed after single or multiple exposures to extracts of device materials. The exposure period is longer than typical acute toxicity tests but not to exceed 10% of the animal's lifespan. Subchronic toxicity is assessed after repeated intravenous injections of the device material's extract. These studies involve expanded evaluations and can include systemic changes, local irritation, body weight, blood values, and tissue changes as part of the protocol. The length of time for the test and the parameters evaluated depend on the end use of the device.
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ISO Subacute Intraperitoneal Toxicity Study
Multiple extracts of a device and controls are prepared and injected for signs of toxicity through gross observation at the end of the study.
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ISO Subchronic Intravenous Toxicity Study
Subchronic toxicity is assessed after repeated intravenous injections of a device material's extract.
- Genotoxicology Testing
Genotoxicology (mutagenicity) tests evaluate the ability of a material to cause mutation or gross chromosomal damage. Any materials intended for implantation or long-term exposure must be evaluated for mutagenic properties. Unpolymerized materials, additives, trace monomers, or oligomers and biodegradative products can all be potential mutagens.
- Implantation Testing
Implantation tests assess the local effects of material or finished product in contact with living tissue. The implant site selection is based on the intended use of the device.
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ISO Intramuscular Implantation Test With Histopathology
The purpose of this study is to evaluate the potential for local effects of a test article implanted intramuscularly to assess the interaction of surrounding tissue. This study may be performed with or without Clinical Chemistry and Hematology.
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The purpose of this study is to evaluate the potential for local effects of a test article implanted intramuscularly to assess the interaction of surrounding tissue. This study may be performed with or without Clinical Chemistry and Hematology.
The purpose of this study is to evaluate the potential for local effects of a test article implanted subcutaneously to assess the interaction of surrounding tissue. This study may be performed with or without Clinical Chemistry and Hematology.
- Hemocompatibility Testing
An important measure of hemocompatibility is the hemolysis test, which measures the ability of a material or material extract to cause red blood cells to rupture. Hemolysis testing should be performed on all materials directly contacting the bloodstream or on any materials used to form a conduit for fluids entering the circulatory system.
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ASTM Hemolysis Assay
This test is intended for materials that directly contact the blood stream or compromised tissues and for materials through which fluid passes before entry into the body. This is performed through direct method, extract method, or both.
- Pyrogenicity Testing (In Vivo)
Pyrogenicity tests determine the potential of materials, extracts, and/or a finished device to induce a pyrogenic (fever) response from sources other than endotoxin.
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USP Rabbit Pyrogen Test
The test articles are injected to determine a significant increase in body temperature compared to the control article.
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ISO Rabbit Pyrogen - Materials Mediated - ISO 10993 Part 11
The test articles are injected to determine a significant increase in body temperature compared to the control article.
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