GB/T 16886.11-1997
Replaced
YY/T 1912-2023
Active
Industry standards-Medicine
YY/T 1912-2023 Biological evaluation and testing of medical devices for soft tissue regeneration
YY/T 1912-2023 Biological evaluation and testing of medical devices for soft tissue regeneration
Basic Information
Standard Code:
YY/T 1912-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2023-09-05
Implement Date:
2024-09-15
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:
16 pages
Scope
本文件描述了软组织再生医疗器械生物学评价和试验方法。
本文件适用于基于GB/T(Z)16886对软组织再生医疗器械进行生物学评价。
Development Information
Drafting Units:
山东省医疗器械和药品包装检验研究院、上海松力生物技术有限公司、国家药品监督管理局医疗器械技术审评中心、四川大学、北京大学深圳研究院、重庆市药品技术审评查验中心、北京邦塞科技有限公司
Drafting Persons:
施燕平、刘成虎、何红兵、刘文博、张凯、奚廷斐、郭绮、林海、赖琛、聂洪涛、高利宏、王璇
Referenced Standards
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
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