Standard for the Performance and Safety Evaluation of Artificial Intelligence Based Medical Device: Terminology

Scope

The standard establishes terminology used in artificial intelligence medical device, including definitions of fundamental concepts and methodology that describe the safety, effectiveness, risks and quality management of artificial intelligence medical device.

The standard provides definitions using the following forms, such as but not limited to literal description, equations, tables, figures and legends.

The standard also establishes a vocabulary for the development of future standards for artificial intelligence medical device. ©IEEE 2022. All rights reserved.

Purpose

The establishment of this consistent terminology promotes a more expansive and streamlined research, development, testing and quality control for the medical Artificial Intelligence (AI) industry.

The evaluation of AI will be based on concepts in this standard, which include, but are not limited, to performance metrics, safety hazards, cyber security, and software reliability. The standard also provides vocabulary for the development of future general or specific standards of AI medical device and help different parties clarify understanding of AI quality. ©IEEE 2022. All rights reserved.

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