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Biocompatibility is one of the key requirements for demonstrating medical device safety, and IETQAN brings decades of experience in testing to support your product launch.
IETQAN performs the full gamut of ISO 10993 biocompatibility tests. Combining our testing experience with our toxicology advisory services, our experts can guide you from strategy development, through all of the testing required for submission of new devices, as well as for evaluation of materials or manufacturing changes.
The ISO 10993-1:2018 matrix (provided below) is a guide to which endpoints need to be considered for different types of devices based upon the nature of body contact and the contact duration, but this is really the starting point in assessment. We can work with you on a risk-based approach to Biocompatibility testing, to help you identify the most appropriate and cost effective strategy for your device.
And you can check below some kinds of Biocompatibility Testings (ISO 10993):
To evaluate biocompatibility and toxicity of materials for medical devices and associated products, mammalian tissue culture systems are used for cytotoxicity testing. These in vitro techniques use various cell types with different relative sensitivity and testing time. Cell culture testing methods are more sensitive to toxic materials and have shown good correlation with animal assays.
Cytotoxicity tests are widely accepted in biomaterial screening, quality control, and audit programs. However, results obtained with cell culture methods must be evaluated in conjunction with in vivo studies and the end use of the product. All medical devices must undergo cytotoxicity tests as part of the ISO-10993 test matrix.
Irritation / Intracutaneous Reactivity Testing is another method of assessing biocompatibility of materials. Irritation can be assessed using many different models, and the choice of assessment should be based on the end use of the medical device or biomaterial.
The most widely used test is the Intracutaneous Reactivity Test which may be found in both the ISO 10993 and USP standards. All medical devices are required to have this assessment to comply with ISO 10993.
Other irritation tests that are available include ocular, mucosal and skin. The objective of these studies are to evaluate localized irritation due to the application or instillation of a test material, test material extract or a test solution.
Sensitization is a component of the ISO-10993 Biocompatibility assessment and refers to a test material’s ability to induce allergenicity or sensitization. To determine if a material will induce a hypersensitivity reaction, sensitization testing involves multiple applications of the test material or its extract.
The testing process includes induction, exposure, and challenge phases over a period of approximately 4 weeks in animals to assess the allergenic properties of the test material.
Chronic Toxicity Testing / Subchronic, ISO 10993-11 outlines the general considerations required to assess toxicity of medical devices. Repeat dose toxicity or continuous dosing over a defined period of time is important to determine the subacute to chronic effects of a device.
These study protocols are developed based on route of patient exposure and contact duration. The typical routes of administration include intravenous or intraperitoneal injection; however, test articles may be assessed through dermal, ocular or mucosal application. In addition, device materials may be implanted subcutaneously or intramuscularly. Longer term studies include hematology, clinical chemistry, necropsy and histopathology.
ISO 10993-11 outlines the general considerations required to assess the toxicity of medical devices. To determine the subacute to chronic effects of a device, repeat dose toxicity or continuous dosing over a defined period of time is crucial. Study protocols are developed based on the route of patient exposure and contact duration. The typical routes of administration include intravenous or intraperitoneal injection, although test articles may also be assessed through dermal, ocular, or mucosal application. Furthermore, device materials may be implanted subcutaneously or intramuscularly. Longer-term studies include hematology, clinical chemistry, necropsy, and histopathology.
The rabbit pyrogen test is used to assess the ability for a test sample, a test sample extract or a test sample eluate to induce a febrile response. This test continues to be used as a development and release test for products that cannot effectively be assessed using the Bacterial Endotoxin Pyrogen Test.
It is also used to assess the ability of extracts of leachables for a medical device or biomaterial to induce a febrile response in accordance with the ISO 10993 standard.
The rabbit pyrogen test is a test used to evaluate whether a test sample, a test sample extract, or a test sample eluate can induce a febrile response. This test is used as a development and release test for products that cannot be effectively assessed using the Bacterial Endotoxin Pyrogen Test.
Additionally, the test is used to determine whether extracts of leachables for a medical device or biomaterial can induce a febrile response in accordance with the ISO 10993 standard.