GB/T 16886.11-1997
Replaced
YY/T 1939-2024
Active
Industry standards-Medicine
YY/T 1939-2024 Test for bacterial endotoxins of medical devices—Recombinant factor C method
YY/T 1939-2024 Test for bacterial endotoxins of medical devices—Recombinant factor C method
Basic Information
Standard Code:
YY/T 1939-2024
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2024-07-08
Implement Date:
2025-07-20
Publisher:
国家药品监督管理局
Technical Committee:
全国医疗器械生物学评价标准化技术委员会(SAC/TC 248)
Pages:
12 pages
Scope
本文件描述了利用重组C因子法检测医疗器械中细菌内毒素含量的试验方法。
本文件适用于对医疗器械进行细菌内毒素的检测。
Development Information
Drafting Units:
山东省医疗器械和药品包装检验研究院、中国食品药品检定研究院、辽宁省医疗器械检验检测院
Drafting Persons:
孙令骁、邵安良、余洋、秦越、王小蕾、王诗琪
Related Standards
GB/T 16886.3-1997
Replaced
GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.6-1997
Replaced
GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.1-2001
Replaced
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.13-2001
Replaced
GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.7-2001
Replaced