scope:

The standard establishes terminology used in artificial intelligence medical devices, 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 devices.

Purpose

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

The evaluation of AI will use terminology, which include, but are not limited, to terminology related 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 devices and helps different parties clarify understanding of AI quality considerations.