[color=rgba(0, 0, 0, 0.85)]ISO/TS 19930:2017 是由国际标准化组织(ISO)发布的技术规范。全称为《Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6》,即《基于风险方法确保最终灭菌一次性医疗产品无菌性的指南,该产品无法承受加工以达到最大 10-6 无菌保证水平》