标准摘要
[中文适用范围]： 指定可编程电气医疗系统设计过程的要求。作为特定标准要求的基础，包括作为安全要求指南，以减少和管理风险。该标准涵盖需求规格、架构、详细设计和实施软件开发、修改、验证和确认、标记和随附文件。该合并版本由第一版（1996年）及其修正案1（1999年）组成。因此，无需对本出版物进行修订。 [外文原描述]： Specifies requirements for the process by which a programmable electrical medical system is designed. Serves as the basis of requirements of Particular Standards, including serving as a guide to safety requirements for the purpose of reducing and managing risk. This standard covers requirement specification, architecture, detailed design and implementation software development, modification, verification and validation, marking and accompanying documents. This consolidated version consists of the first edition (1996) and its amendment 1 (1999). Therefore, no need to order amendment in addition to this publication.
英文名称Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems