YY/T 0474-2025 Pending Industry standards-Medicine

YY/T 0474-2025 Implants for surgery—Homopolymers,copolymers and blends on poly(lactide)—In vitro degradation testing

YY/T 0474-2025 Implants for surgery—Homopolymers,copolymers and blends on poly(lactide)—In vitro degradation testing

Publish Date: 2025-09-15 Implement Date: 2026-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: YY/T 0474-2025

Standard Type: Industry standards

Standard Status: Pending

is_force_gb: no

CCS Name: Medical devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2025-09-15

Implement Date: 2026-10-01

Pages: 24 pages

Scope

This document describes the method for determining the chemical and/or mechanical properties of polylactide (homopolymers, copolymers, and/or blends composed of L-lactide, D-lactide, and/or D,L-lactide as structural units) under in vitro degradation conditions. This document also describes the basic physical and mechanical property evaluations required for in vitro degradation characterization of absorbable polylactide or other hydrolyzable materials and devices. This document applies to polylactide homopolymers, copolymers, and/or blends used in the production of surgical implants, including raw materials, processed materials, and final products (implants that have been packaged and sterilized). The test methods specified in this document are also used to determine the in vitro degradation rate and related material property changes of polylactide-based copolymers and/or blends containing other comonomers (such as glycolide, trimethylene carbonate, and/or ε-caprolactone). Unless specific devices have been validated, the in vitro test methods described in this document cannot be used to accurately predict the behavior of materials in vivo.

Development Information

Word Count: 27 Thousand words Pages: 24 pages

Replace the following standards

YY/T 0473-2004 Implants for surgery—Copolymers and blends based on polylactide—In vitro degradation testing YY/T 0474-2004 Poly(L-lactide) resins and fabricated forms for surgical implants—In vitro degradation testing

Referenced Standards

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Adopt standards

ISO 13781:2017

Related Standards

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