YY/T 1457-2016 Active Industry standards-Medicine

YY/T 1457-2016 Non-active surgical implants—Determination method for oligomeric siloxanes in mammary implants

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 1457-2016

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2016-01-26

Implement Date: 2017-01-01

Pages: 10 pages

Scope

This standard specifies the qualitative and quantitative detection methods for oligomeric siloxane substances in silicone rubber shells and silicone gel fillers used in artificial breast implants by gas chromatography-mass spectrometry (GC/MS).
In addition to the methods selected in this standard, other equivalent methods may also be adopted, but they need to undergo appropriate methodological validation.