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现行 AAMI 2700-2-1:2022
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Medical devices and medical systems-Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging 医疗设备和医疗系统构成以患者为中心的综合临床环境(ICE)设备的基本安全和性能要求:第2-1部分:法医数据记录的特殊要求
发布日期: 2022-04-22
ANSI/AAMI 2700-2-1是AAMI 2700系列标准的一部分,以实现安全的综合临床环境(ICE)(ANSI/AAMI 2700-1)。它适用于医疗设备和平台制造商以及系统集成商。它提供了数据记录、存储和回放的要求,以支持医疗设备、应用程序和平台的安全、质量保证和法医分析。本文件通过提供ICE数据记录系统的一般功能、性能、安全性和互操作性要求,支持安全可靠的设备互操作性。
ANSI/AAMI 2700-2-1 is part of the AAMI 2700 family of standards to achieve safe integrated clinical environments (ICE) (ANSI/AAMI 2700-1). It is intended for use by medical device and platform manufacturers and system integrators. It provides requirements for the recording, storage, and playback of data to support safety, quality assurance, and forensic analysis for medical devices, applications, and platforms. This document supports safe and secure device interoperability by providing general functional, performance, security, and interoperability requirements of ICE data logging systems.
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