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Biocompatibility Tests (T)
Medical Devices - Biocompatibility
In order to protect against potential biological risks arising from the use of medical devices, it is an obligatory practice to carry out a biological compatibility assessment in medical devices.
Applied Test
Biological Evaluation of Medical Devices According to ISO 10993
The ISO 10993 series of standards includes biological evaluation of a medical device within the risk management process as part of the overall evaluation and development of a medical device. It can be applied to all active, inactive, implantable or non-implantable devices. The ISO 10993 series of standards covers biological assessments and related tests and special aspects.
As stated in the ISO 10993-1:2018 revision, "this document is not intended to provide a strict set of test methods on the development and use of the medical device, including pass/fail criteria, as this may lead to an unnecessary restriction or a false sense of safety in general use." is called. It is also stated that the tests specific to each product will be determined and selected by experts. It is understood that the tests specific to the structure of the product should be determined by the risk assessment.
The biological evaluation of medical devices primarily depends on the medical device itself. Biosafety will be evaluated by our manufacturers not only during the certification process, but throughout the entire life cycle of the product. (As CinarLabs, we can support biocompatibility assessment studies, determine product class and enable you to perform sound risk assessments.)
For biological assessment, risk management activities should be planned first. A biological assessment plan is required. The first step in biological evaluation is the classification of the medical device. Classification is determined by body contact and duration of contact.
Biocompatibility Evaluation Processes
For biological assessment risk analysis, first of all, physical and chemical information should be analyzed. If this information is not available for the current product, we determine with you the tests that will be required according to ISO 10993-18. The extent of chemical/physical characterization depends on material formulation, clinical data (toxicological and safety data etc.), body contact and duration. Characterization should address the chemicals that make up the medical device, any auxiliaries or additives that might create residue. (As CinarLabs, tests are determined according to risks and we perform many tests in our laboratory and/or with our contracted partners.)
In the biological test requirements of medical devices, an evaluation should be made according to ISO 10993-1 and the application steps should be followed. Many tests such as in-vitro cytotoxicity, irritation, sensitization, and genotoxicity may need to be performed. Tests may be performed on the final medical device, on representative samples from the device, or on materials that have been processed in the same way as the medical device. It should be carried out in laboratories with a quality system of "ISO/IEC 17025 or equivalent" in accordance with good laboratory practices when performing biological tests. (ISO 10993-1 Article 6.3.1) (CinarLabs and contracted partner laboratories are laboratories with ISO 17025 and GLP quality system.)
For example: As CinarLabs, we perform the in-vitro cytotoxicity test within the ISO 17025 quality system and in accordance with the requirements, according to the international standard ISO 10993-5. We can document that the method is applied correctly in the laboratory, using reference materials and calibrated devices and working with method verification. We can present all these documents in a traceable way in certification body audits and accreditation bodie's audits)
