• Content Type

IEEE 2801

IEEE Recommended Practice for the Quality Management of Datasets for Medical Artificial Intelligence

Last updated: 11 May 2023

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Pre-draft

Draft

Published

5 Jul 2022
published

Abstract

Promoted in this recommended practice are quality management activities for datasets used for artificial intelligence medical devices (AIMD). The document highlights quality objectives for organizations responsible for datasets. The document describes control of records during the lifecycle of datasets, including but not limited to data collection, annotation, transfer, utilization, storage, maintenance, updates, retirement, and other activities. The document emphasizes special consideration for the dataset quality management system, including but not limited to responsibility management, resource management, dataset realization, and quality control. © Copyright 2023 IEEE – All rights reserved.

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Organisation: IEEE

Referenced standards: ISO 13485 (2016-03), ISO 14155 (2020-07)

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