首页|医药行业标准《整形外科植入物 聚酯类微球》解读

医药行业标准《整形外科植入物 聚酯类微球》解读

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聚酯类微球具有良好的生物相容性和可降解性,在整形外科领域是一种良好的植入材料.为规范行业发展,提高产品质量,保障群众用械安全,标准起草组制定了《整形外科植入物 聚酯类微球》这一标准,对聚酯类微球的主要技术要求及检验方法进行规定.本文对该标准的制定背景、主要内容及制定意义进行解读和说明,以利于该标准的顺利实施.
Interpretation of the pharmaceutical industry standard for plastic surgery implants-polyester microspheres
Due to good biocompatibility and degradability,polyester microspheres are good implant material in the field of plastic surgery.In order to standardize the development of the industry,improve the quality of products,and ensure the safety of the masses,the standard for plastic surgery implants-polyester microspheres was formulated,and the main technical requirements and inspection methods of polyester microspheres were specified.In this paper,the background,main content and significance of the standard were interpreted and explained in order to facilitate the smooth implementation of the standard.

Polyester microspheresPlastic surgery implantsCopolymerization rateMolecular weight distributionSolvent residueCatalyst residue

刘振齐、韩倩倩

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中国食品药品检定研究院,北京 102629

聚酯类微球 整形外科植入物 共聚率 分子量分布 溶剂残留 催化剂残留

2024

现代仪器与医疗
中国科学器材公司

现代仪器与医疗

影响因子:1.47
ISSN:2095-5200
年,卷(期):2024.30(6)