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2023年7月8日 · 本标准描述了应用于在处理器上执行的软件或由在处理器上执行的其他软件（例如一个解释器）来执行的软件的 过程。 不管用于存储软件的持久存储设备（例如，硬盘、光盘、永久存储器或闪存）是什么，本标准都适用。 无论软件的交付方式（例如，通过网络或电子邮件发送、光盘、闪存或者 EEPROM）如何，本标准均适用。 软件交付方法本身不被视为 医疗器 械软件。 本标准不包括 医疗器械的确认（validation）和最终发布，即使 医疗器械完全由软件组成。 释 …

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更多相关文档 . IEC 62304模板 星级： 22 页 IEC 62304-2015 Medical device software – Software life cycle processes 星级： 176 页 IEC 62304-2006

IEC 62304:2006+A1:2015 Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes.

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IEC 62304 – medical device software – software life cycle processes [1] is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies life cycle requirements for the development of medical software and software within medical devices.