AAMI - 2700-2-1
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
| Organization: | AAMI |
| Publication Date: | 1 January 2022 |
| Status: | active |
| Page Count: | 48 |
scope:
This document provides general functional, performance, security, and interoperability requirements of ICE data logging systems including the recording and storage of data in support of forensic analysis of ICE systems. DATA LOGs, data logging, and data loggers can play an important role in maintaining and improving the basic safety and essential performance of INTEGRATED CLINICAL ENVIRONMENTs by enabling the forensic assessment of the ICE system and its components.
NOTE 1: In other industries, this type of data logger is referred to as a "black box recorder."
NOTE 2: The ICE data logger is not required to be capable of real-time clinical/patient monitoring.
NOTE 3: The ICE data logger is intended to provide a data store that can be used to assist in confirming that the ICE system and its components were operating as intended.
Clinical patient management is outside the scope of this standard.
Document History