GB/T 16886.11-1997
Replaced
YY/T 1754.3-2023
Active
Industry standards-Medicine
YY/T 1754.3-2023 Preclinical animal study of medical devices—Part 3:Animal ventral incisional hernia model for evaluating the histological reaction and biomechanical performance of the hernia repair patch
YY/T 1754.3-2023 Preclinical animal study of medical devices—Part 3:Animal ventral incisional hernia model for evaluating the histological reaction and biomechanical performance of the hernia repair patch
Basic Information
Standard Code:
YY/T 1754.3-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2023-06-20
Implement Date:
2024-07-01
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
本文件描述了腹腔内置补片组织学反应与生物力学性能的测试与评价方法。
本文件适用于腹腔内置补片的临床前动物试验研究。
Development Information
Drafting Units:
山东省医疗器械和药品包装检验研究院、上海长征医院、上海理工大学、江苏科标医学检测有限公司
Drafting Persons:
刘成虎、侯丽、张剑、孙文全、张琦、林振华、周阳飞、朱福余
Referenced Standards
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