Standard No.:	YY/T 1679-2021
English Name:	Tissue engineering medical device products-Bone-Standard guide for pre-clinical in vivo evaluation in critical size segmental bone defects
Chinese Name:	组织工程医疗器械产品 骨 体内临界尺寸骨缺损的临床前评价指南
Chinese Classification:	C45    Extracorporeal circulation, artificial organ and prosthesis device
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.40 11.040.40    Implants for surgery, prosthetics and orthotics 11.040.40
Issued by:	National Medical Products Adminstration
Issued on:	2021-03-09
Implemented on:	2022-4-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	11500 words
Price(USD):	345.00
Delivery:	via email in 1~5 business day

本标准规定了预期修复或再生骨组织植入物骨形成活性的体内临界尺寸骨缺损评价通则；对骨缺损动物模型的制备、骨缺损部位及范围、缺损类型、植入物的制备和评价提供了相关参数。
本标准适用于部分临界尺寸骨缺损模型的制备，以及合理利用临界尺寸骨缺损模型对具有诱导或促进骨生长的骨组织工程医疗产品的测试和评价。