GB/T 16886.11-1997
Replaced
YY/T 1754.4-2024
Active
Industry standards-Medicine
YY/T 1754.4-2024 Preclinical animal study of medical devices—Part 4:Acute trauma model for evaluating the healing promoting performance of dressing
YY/T 1754.4-2024 Preclinical animal study of medical devices—Part 4:Acute trauma model for evaluating the healing promoting performance of dressing
Basic Information
Standard Code:
YY/T 1754.4-2024
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/TC248)
Pages:
12 pages
Scope
本文件描述了试验用猪背部全皮层急性创伤模型的制备方法。
本文件适用于创面敷料促愈合性能的测试与评价。
Development Information
Drafting Units:
山东省医疗器械和药品包装检验研究院、深圳市药品检验研究院(深圳市医疗器械检测中心)、江苏科标医学检测有限公司、赛克赛斯生物科技股份有限公司
Drafting Persons:
刘成虎、林振华、王书晗、张琦、夏毅然、臧德跃、周阳飞、刘长凤、魏振西
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