《医疗器械用高分子材料控制指南》团体标准解读  

Interpretation for the Group Standard of“Guidelines for the Control of Polymeric Materials for Use in Medical Devices”

作　　者：唐毓婧[1] 高永平 李未扬 田晓雷 高亦岑 田兴龙 贾轶静 TANG Yu-jing;GAO Yong-ping;LI Wei-yang;TIAN Xiao-lei;GAO Yi-cen;TIAN Xing-long;JIA Yi-jing(SINOPEC Key Laboratory of Research and Application of Medical and Hygienic Materials,SINOPEC(Beijing)Research Institute of Chemical Industry Co.Ltd.,Beijing 100013;SINOPEC Chemical Commercial Holding Co.Ltd.,Beijing 100728;Medical Polymer Products Branch of China Association for Medical Devices Industry,Beijing 100036)

机构地区：[1]中国石化医用卫生材料研究与应用重点实验室,中石化(北京)化工研究院有限公司,北京100013 [2]中国石化化工销售有限公司,北京100728 [3]中国医疗器械行业协会医用高分子制品专业分会,北京100036

出　　处：《中国医疗器械信息》2024年第1期25-30,共6页China Medical Device Information

摘　　要：2021年3月,国家药品监督管理局发布了建立医疗器械主文档数据库的公告,该公告的发布将会促使医用材料与其他应用领域的材料严格区分开来。然而目前我国尚无标准来定义医用级材料的要求。因此,中国医疗器械行业协会医用高分子制品专业分会牵头,组织医用高分子材料的使用方和生产方相关14家单位共同制定《医疗器械用高分子材料控制指南》(T/CAMDI 106-2023),填补了这一标准的空白,在国内首次形成了针对医疗器械用高分子材料的指导性文件。该指南对医疗器械用高分子材料进行了解释和界定,提出了医疗器械用高分子材料所涵盖的配方一致性、安全供应及变更管理等基本要求,建立了对医疗器械用高分子材料控制和评价统一指南。文章对该指南重点内容进行解读并介绍了标准贯彻实施的工作方案。指南的落地和实施对整个医疗器械行业将产生深远的影响。In March 2021,the National Medical Products Administration issued an announcement regarding the registration system of medical device master files.This announcement aimed to strictly differentiate medical materials from materials used in other application areas.However,there is currently no standard to define the requirements for medical grade materials in China.Therefore,under the leadership of the Medical Polymer Products Branch of China Association for Medical Devices Industry,14 relevant organizations from the user and production sides of medical-grade polymeric materials jointly developed the“Guidelines for the control of polymeric materials for medical devices”(T/CAMDI 106-2023).This group standard fills the gap in the existing standards and becomes the first guiding document specifically addressing polymeric materials for medical devices in China.The guidelines provide explanations and definitions for polymeric materials used in medical devices and propose basic requirements for formula consistency,safe supply,and change management of such materials.The document establishes a unified guide for the control and evaluation of polymeric materials used in medical devices.The article introduces the implementation plan for the standard and emphasizes that the adoption and implementation of the guidelines will have a profound impact on the entire medical device industry.

关 键 词：医疗器械用高分子材料 一致性 安全性 主文档数据库 质量保证协议 

分 类 号：TB324[一般工业技术—材料科学与工程]