YY/T 0652-2008 Replaced Industry standards-Medicine

YY/T 0652-2008 Wear of implant materials—Polymer and metal wear particles—Isolation,characterization and quantification

Publish Date: 2008-04-25 Implement Date: 2009-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0652-2008

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2008-04-25

Implement Date: 2009-06-01

Pages: 8 pages

Scope

This standard specifies the sampling method for particles generated from total joint prostheses implanted in the human body or from joint wear testing machines. The standard also prescribes methods for separating polymer and metal particles, as well as instruments, reagents, and testing methods for characterizing and quantitatively analyzing these particles, which originate from tissues around prostheses removed during revision surgery or autopsy, or from the liquid test medium in joint wear testing machines. The methods specified in this standard do not quantitatively grade the wear of joint prostheses, nor do they determine the specific amount of wear on the joint surface. This standard does not cover the biological effects of particles or provide methods for evaluating the biological safety of particles. The methods listed in this standard are not applicable to measuring polymethyl methacrylate (PMMA) particles.