+AMD1:2015 CSV 医疗器械软件.软件生命周期过程

[中文适用范围]： 本标准定义了医疗器械软件的生命周期要求。本标准描述的过程、活动和任务集为医疗器械软件生命周期过程建立了一个通用框架。 本标准适用于医疗器械软件的开发和维护。 本标准适用于当软件本身就是医疗器械或软件是最终医疗器械的嵌入式或组成部分时的开发和维护。 本标准描述了适用于在处理器上执行的软件或由其他软件（例如解释器）执行的软件的过程。 本标准适用于用于存储软件的任何持久存储设备（例如：硬盘、光盘、永久或闪存）。 本标准适用于软件的交付方法（例如：通过网络或电子邮件传输、光盘、闪存或EEPROM）。软件交付方法本身不被视为医疗器械软件。 本标准不涵盖医疗器械的验证和最终发布，即使医疗器械完全由软件组成。 [外文原描述]： 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. Applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device. This standard does not cover validation and final release of the medical device, even when the medical device consists entirely of software. This consolidated version consists of the first edition (2006) and its amendment 1 (2015). Therefore, no need to order amendment in addition to this publication.