Standard No.:	YY 0954-2015
English Name:	Nonactive surgical implants―Type Ⅰ collagen implants―Specific requirements
Chinese Name:	无源外科植入物　Ⅰ型胶原蛋白植入剂
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
Source Content Issued by:	China Food and Drug Adminstration
Issued on:	2015-03-02
Implemented on:	2017-1-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	9500 words
Translation Price(USD):	130.0
Delivery:	via email in 1~3 business day

本标准规定了注射型胶原蛋白植入剂(以下简称植入剂)的专用要求,它是以纯化的(非交联的)Ⅰ型胶原蛋白为原料制备的。
本标准规定了植入剂技术要求和检验方法。还对产品预期性能、设计属性、材料、设计评价、检验方法、临床评价、上市后监督、制造、包装和由制造商提供的信息等做了具体说明。同时考虑到植入剂的安全性因素。
本标准所规定的植入剂适用于在临床上用于颜面的真皮层和/或皮下注射,以消除或减轻各种原因引起的颜面皱纹和凹陷。