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16 May 2024

What is ISO 10993?

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ISO 10993 is a series of international standards for evaluating the biological safety of medical devices. These standards are developed by the International Organization for Standardization (ISO) and are widely used to assess the potential risks associated with the use of medical devices on humans.

The ISO 10993 series provides guidelines for conducting various biological tests to assess the biocompatibility of medical devices. Biocompatibility refers to the ability of a medical device to perform its intended function without causing adverse reactions in the patient. Adverse reactions could include irritation, allergic reactions, or toxicity.

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