YY 0459-2025 Pending Industry standards-Medicine

YY 0459-2025 Implants for surgery—Acrylic resin cements

Publish Date: 2025-02-26 Implement Date: 2028-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0459-2025

Standard Type: Industry standards

Standard Status: Pending

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2025-02-26

Implement Date: 2028-03-01

Pages: 24 pages

Scope

This document specifies the physical, mechanical, labeling, and packaging requirements for non-radiopaque and radiopaque curable polymer resin bone cements primarily based on polymethyl methacrylate. These two types of bone cements are intended for use in syringes or in a dough-like state, and are primarily applied for internal fixation of prostheses in artificial joint replacement surgeries. The bone cements are provided in a set of measured sterile powders and sterile liquids, suitable for mixing at the time of implantation.
This document does not address the risks to patients or bone cement users during the use of bone cement.
All requirements and all tests apply only to sterile products.
Note: For other types of bone cements not intended for artificial joint replacement, refer to this document for guidance.