ISO/TS 19930:2017
关于确保最终灭菌的一次性保健产品无菌性的基于风险的方法的各方面的指南,该产品不能耐受加工以最大限度地实现10 - 6的无菌性保证水平
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