YY/T 0652-2016 Active Industry standards-Medicine

YY/T 0652-2016 Wear of implant materials—Polymer and metal wear particles—Isolation and characterization

Publish Date: 2016-01-26 Implement Date: 2017-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0652-2016

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2016-01-26

Implement Date: 2017-01-01

Pages: 17 pages

Scope

This standard specifies the sampling methods for debris generated by joint replacement implants implanted in humans and simulators. This standard specifies the instruments, reagents, and test methods for separating and characterizing polymer and metal debris (debris from revision surgery or tissue removed from around joint replacement implants during autopsies, or lubricating fluids from joint simulators). Some of these steps can be applied to the separation and characterization of debris in human body fluids (such as joint synovial fluid).
This standard does not quantify the degree of wear generated by implants; nor does it specify the amount of wear on any particular surface. This standard does not include the biological response to debris, nor does it include methods for assessing biosafety.