Home / Standards / GB/T 16886.9-2022 GB/T 16886.9-2022 Active Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products 医疗器械生物学评价 第9部分：潜在降解产物的定性和定量框架 Standard Type GBT ICS 11.100.20 CCS C30 Status 现行 Issue Date 2022-12-30 Implementation 2024-01-01 Responsible Dept 国家药监局 Drafting Unit N/A