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Preclinical animal study of medical devices—Part 2:Model of skin defect in induced diabetic rats
Standard in brief
Scope of Application:
YY/T 1754的本部分规定了诱导糖尿病大鼠皮肤缺损模型的构建方法。
本部分适用于治疗糖尿病引起的皮肤溃疡及破损的医疗器械产品的临床前有效性评价。
Basic information
Standard No:YY/T 1754.2-2020
Standard Name:医疗器械临床前动物研究 第2部分:诱导糖尿病大鼠皮肤缺损模型
English Name:Preclinical animal study of medical devices—Part 2:Model of skin defect in induced diabetic rats
Standard Status:现行
Release Date:2020-09-27
Effective Date:2021-09-01
Language of Publication:中文简体
Standard Classification
ICS Number:11.100.20
CCS Number:C30
Related Standards
Referenced Standards:GB/T 16886.2
Publication Information
Number of pages:12
Number of words:14 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2020-11-01
Standard Revision Information
Has Amendment:No
Other Information
Application Dept:国家药品监督管理局
Standard Type:QT
Standard Attribute:YY
Other Standard Number:1754.2
Drafter:韩倩倩、张平、王鸾鸾、刘增祥、王春仁、邢志青、李文婷
Drafting Organization:中国食品药品检定研究院、山东省医疗器械产品质量检验中心、济南磐升生物技术有限公司
Management Organization:全国医疗器械生物学评价标准化技术委员会(SAC/TC 248)
Proposing Department:国家药品监督管理局