GB/T 47941.1-2026Artificial intelligence medical device — Quality requirements and evaluation — Part 1: Terminology (English PDF)

3.1 Basic Technical Terminology

3.1.1

The ability of functional units to exhibit various functions related to human intelligence (such as reasoning and learning).

[Source. GB/T 5271.28-2001, 28.01.02]

3.1.2 AIagent

An automated entity that can sense and respond to its environment and take action to achieve its goals.

[Source. ISO /IEC 22989.2022, 3.1.1]

3.1.3

Medical devices that utilize AI technology to achieve their intended purpose.

Note 1.Standalone software that uses technologies such as machine learning, pattern recognition, and rule reasoning for its medical applications.

3.1.4 AIMD component for artificial intelligence medical devices

Functional elements for constructing artificial intelligence medical devices.

[Source. ISO /IEC 22989.2022, 3.1.2, with modifications]

3.1.5

Developed software intended for integration into medical devices under development, or software intended for use as a medical device.

Note. Medical device software includes software components and standalone software. Software components refer to software embedded in or as part of a medical device, while standalone software...

Medical-grade software refers to software that serves one or more medical purposes, can achieve its intended purpose without the need for medical device hardware, and runs on a general-purpose computing platform.

software.

[Source. YY/T 0664-2020, 3.11, modified] […]