YY 0459-2003 Active Industry standards-Medicine

YY 0459-2003 Implants for surgery—Acrylic resin cements

Publish Date: 2003-06-20 Implement Date: 2004-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0459-2003

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: 2003-06-20

Implement Date: 2004-01-01

Pages: 19 pages

Scope

This standard specifies the physical, mechanical, labeling, and packaging requirements for non-radiopaque and radiopaque, mainly poly(methyl methacrylate)-based curable polymer resin bone cements. These two types of bone cements are used either in syringe form or as a dough-like substance, primarily for internal fixation of prostheses in artificial joint replacement surgery. The bone cements are provided as a set of measured sterile powders and sterile liquids, suitable for mixing at the time of implantation. This standard does not address the risks to patients or bone cement users when using bone cement. All requirements and all tests apply only to sterile products.