Standard No.:	YY/T 0652-2016
English Name:	Wear of implant materials—Polymer and metal wear particles—Isolation and characterization
Chinese Name:	植入物材料的磨损聚合物和金属材料磨屑分离和表征
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 Adminstration
Issued on:	2016-01-26
Implemented on:	2017-1-1
Status:	valid
Superseding:	YY/T 0652-2008 Wear of implant materials—Polymer and metal wear particles—Isolation characterization and quantification
Target Language:	English
File Format:	PDF
Word Count:	8500 words
Translation Price(USD):	250.0
Delivery:	via email in 1~3 business day

本标准规定了分离和表征聚合物和金属磨屑（磨屑来源于翻修手术或尸检时关节置换植入物周围切除的组织或关节模拟器润滑液）的仪器、试剂和试验方法。
本标准适用于植入人体和模拟器中关节置换植入物所产生的聚合物和金属材料磨屑。
本标准代替YY/T 0652-2008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。