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Joint replacement implants—Hip joint prostheses
Standard in brief
Scope of Application:
本标准规定了部分和全髋关节假体的术语和定义、分类和尺寸标注、预期性能、设计属性、材料、设计评价、制造、灭菌、包装和制造商提供的信息的要求。
本标准适用于使用本标准所规定的材料和工艺制造的部分和全髋关节假体。
Basic information
Standard No:YY 0118-2016
Standard Name:关节置换植入物 髋关节假体
English Name:Joint replacement implants—Hip joint prostheses
Standard Status:被代替
Release Date:1993-01-01
Effective Date:2018-01-01
Language of Publication:中文简体
Standard Classification
ICS Number:11.040.40
CCS Number:C35
Publication Information
Number of pages:20
Number of words:26 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2016-03-01
Standard Revision Information
Has Amendment:No
Other Information
Application Dept:国家食品药品监督管理总局
Standard Type:QT
Standard Attribute:YY
Other Standard Number:0118
Drafter:焦永哲、马春宝、梁芳慧、程补元、史新立、刘斌、樊铂、宋铎、齐宝芬、覃格姬
Drafting Organization:天津市医疗器械质量监督检验中心、北京百幕航材高科技股份有限公司、施乐辉外科植入物(北京)有限公司、国家食品药品监督管理局医疗器械技术审评中心
Management Organization:全国外科植入物和矫形器械标准化技术委员会骨科植入物分技术委员会(SAC/TC 110/SC 1)
Proposing Department:国家食品药品监督管理总局