Standard No.:	YY/T 0652-2008
English Name:	Wear of implant materials—Polymer and metal wear particles—Isolation characterization and quantification
Chinese Name:	植入物材料的磨损 聚合物和金属材料磨屑分离、表征和定量分析方法
Chinese Classification:	C35    Orthopedic devices
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 Administration
Issued on:	2008-04-25
Implemented on:	2009-6-1
Status:	superseded
Superseded by:	YY/T 0652-2016 Wear of implant materials—Polymer and metal wear particles—Isolation and characterization
Superseded on:	2017-1-1
Target Language:	English
File Format:	PDF
Word Count:	6000 words
Translation Price(USD):	180.0
Delivery:	via email in 1~3 business day

本标准规定了从植入人体的或从关节磨损试验机上的全关节假体所产生的颗粒的取样方法。
标准还规定了分离聚合物颗粒的方法以及对这些颗粒进行表征和定量分析的仪器、试剂及试验方法。
本标准规定的方法不对关节假体的磨损做定量分级，也不确定具体关节表面的磨损量。
本标准不包含颗粒的生物学效应，也不提供评价颗粒生物安全性的方法。
本标准列出的方法不适用于测量聚甲基丙烯酸甲酯（PMMA）颗粒。