标准摘要
ISO 10993-1 is the cornerstone standard for biological evaluation of medical devices. It defines the principles and requirements for assessing a device’s biological safety within the broader risk management framework established by ISO 14971. The standard guides manufacturers and evaluators through the process of identifying, assessing, and managing biological risks associated with materials, design choices, and tissue contact during a device’s intended use.
英文名称Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process