Standard No.:	T/CSBME 046-2022
English Name:	Fatigue testing of total knee femoral components under closing conditions
Chinese Name:	全膝关节假体股骨部件闭合疲劳测试方法
Chinese Classification:	C35    Orthopedic devices
Professional Classification:	T/    Social Organization Standard
ICS Classification:	11.040.40 11.040.40    Implants for surgery, prosthetics and orthotics 11.040.40
Source Content Issued by:	CSBME
Issued on:	2022-01-15
Implemented on:	2022-3-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	5500 words
Translation Price(USD):	165.0
Delivery:	via email in 1~3 business day

本文件描述了全膝关节置换用的金属全膝关节假体股骨部件闭合疲劳测试方法，用非金属材料（如陶瓷、聚合物）制造的股骨部件也可参考采用本测试方法。
本试验设计目的在于确定股骨部件在闭合加载条件下的最大疲劳载荷。
本文件适用于以下不同种类的全膝关节假体股骨部件，包括但不仅限于后交叉韧带保留型股骨部件(CR)、后交叉韧带切除后稳定型股骨部件(PS)和翻修型股骨部件等。
本文件不适用于识别股骨部件在非闭合加载条件下的风险。