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

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
Publisher: 国家药品监督管理局
Technical Committee: 全国外科植入物和矫形器械标准化技术委员会(SAC/TC 110)
Pages: 24 pages

Scope

本文件描述了聚丙交酯(以L-丙交酯、D-丙交酯和/或D,L-丙交酯为结构单元的均聚物、共聚物和/或共混物)在体外降解条件下化学和/或机械性能变化的测定方法。本文件还描述了可吸收聚丙交酯或其他可水解材料及器械进行体外降解表征所需的基本物理和机械性能评价。
本文件适用于生产外科植入物的聚丙交酯均聚物、共聚物和/或共混物,包括原材料、加工材及最终产品(经包装和灭菌的植入物)。
本文件中规定的试验方法,也用于测定含有其他共聚单体(如乙交酯、三亚甲基碳酸酯和/或ε-己内酯)的聚丙交酯基的共聚物和/或共混物的体外降解速率和相关材料特性的变化。本文件中的体外试验方法不能用来准确预测材料在体内的行为,除非对具体器械进行了验证。

Development Information

Drafting Units:

山东省医疗器械和药品包装检验研究院、天津市医疗器械质量监督检验中心、北京市医疗器械检验研究院(北京市医用生物防护装备检验研究中心)、大博医疗科技股份有限公司、国家骨科与运动康复临床医学研究中心(中国人民解放军总医院)

Drafting Persons:

杜福映、李秋迎、李沅、黄永富、曾达、刘婉姮、朱进清、张花美、李建涛、吴晓丽、彭海韵

Word Count: 27 Thousand words Pages: 24 pages

Replace the following standards

Referenced Standards

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Adopt standards

ISO 13781:2017

Related Standards

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