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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
Standard in brief
Scope of Application：
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。
Basic information
Standard No：YY/T 1754.3-2023
Standard Name：医疗器械临床前动物研究 第3部分：用于评价补片组织学反应与生物力学性能的动物腹壁切口疝模型
English Name：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
Standard Status：现行
Release Date：2023-06-20
Effective Date：2024-07-01
Language of Publication：中文简体
Standard Classification
ICS Number：11.040.01
CCS Number：C30
Related Standards
Referenced Standards：GB/T 16886.2
Publication Information
Number of pages：16
Number of words：23 K
Format：大16
Edition：1
Color Pages：0
Electronic Version：Yes
Color Images：No
Print Publication Date：2023-07-01
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：1754.3
Drafter：刘成虎、侯丽、张剑、孙文全、张琦、林振华、周阳飞、朱福余
Drafting Organization：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
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
