Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

This standard provides guidelines for the biological evaluation of medical devices, focusing on the assessment and testing processes within a risk management framework. It outlines the necessary steps to evaluate potential biological risks associated with medical devices and ensures that these risks are appropriately managed throughout the product lifecycle. The document emphasizes the importance of a systematic approach to identify, assess, and control biological hazards, taking into account the intended use and the characteristics of the device. It also includes information on the selection of appropriate test methods and the interpretation of test results to support the safety and effectiveness of medical devices. The standard is applicable to all types of medical devices and serves as a reference for manufacturers, testing laboratories, and regulatory authorities involved in the evaluation process.