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AAMI 2700-2-1: 2022

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

Association for the Advancement of Medical Instrumentation , 04/22/2022

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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.