ISO 10993-12:2021

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ISO 10993-12:2021 is a standard from the International Organization for Standardization (ISO) that provides guidance on sample preparation and selection of reference materials for biological evaluation of medical devices. Specifically, it focuses on the procedures for preparing extracts and selecting reference materials for various biological tests conducted on medical devices. This standard helps ensure that the testing methods used are reliable and relevant to the intended use of the medical device.