最终灭菌医疗器械包装 第 2 部分∶成形、密封和装配过程的确认的要求
以无菌状态供应的医疗器械的设计、制造和包装宜确保该医疗器械在投放市场时无菌,并在无菌屏障系统被损坏或被打开前在形成文件的心存、运输条件下保持无菌。另外。无菌状态供应的医疗器械官用相应的并被确认过的方法制造和灭菌。
内容简介
无菌屏障系统和包装系统的最关键特性之一是确保无菌的保持。包装过程的开发与确认对于达到并保持无菌屏障系统的完整性至关重要,以确认无菌医疗器械的使用者在打开包装前保持其完整性。它有形 成文件的讨程确认程序来证 灭雨和句装讨程的效率和再现性。不仅仅是灭菌过程。成形。
密封或其他闭合系统、剪切和过程处置也会对无菌屏障系统产生影响。GB/T 19633 的本部分为制造和装配包装系统用的过程进行开发和确认提供了行为和要求框架。GB/T 19633.1 和本部分被设计成满足欧洲医疗器械指令的基本要求。在 ISO 11607-2 的制定过程中,遇到的主要障碍之一是术语的协调。术语"包装""最终包装""初包装"在全球范围内有不同的含 义。因此,选用这些术语中的哪一个被认为是完成 ISO 11607-2 的一个障碍。
协调的结果是,引入了"无菌屏障系统"这样—个术语,用来描述执行医疗器械包装所需的特有功能的最小包装。其特有功能有∶可对其进行灭菌,提供可接受的微生物屏障,可无菌取用。"保护性包装"则用以保护无菌屏障系统,无菌屏障系统和保护性包装组成了包装系统。"预成形无菌屏障系统"可包括任何已完成部分装配的无菌屏障系统,如组合袋、顶头袋、医院用的包装卷材等。
无菌屏障系统是最终灭菌医疗器械安全性的基本保证。管理机构之所以将无菌屏障系统视为医疗器械的—个附件或—个组件,正是认识到了无菌屏障系统的重要特性所在。世界 上许多地方把销往医疗机构用于机构内灭菌的预成形无菌屏障系统视为医疗器械。

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