EN ISO 10993-18:2020/A1:2023
醫療器械的生物學評估 第 18 部分：風險管理過程中醫療器械材料的化學特性 修正案 1：不確定性因素的確定 (ISO 10993-18:2020/Amd 1:2022)
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/Amd 1:2022)