YY/T 1833.4-2023
Artificial Intelligence Medical Device Quality Requirements and Evaluation Part 4: Traceability (English Version)

Standard No.

YY/T 1833.4-2023

Language

Chinese, Available in English version

Release Date

2023

Published By

Professional Standard - Medicine

Latest

YY/T 1833.4-2023

Scope

This document specifies the general requirements for traceability of artificial intelligence medical devices and describes the corresponding evaluation methods. This document applies to the traceability activities of the design and development process, use process and update process of artificial intelligence medical devices. This document does not apply to the circulation of artificial intelligence medical devices.

YY/T 1833.4-2023 history

• 2023 YY/T 1833.4-2023 Artificial Intelligence Medical Device Quality Requirements and Evaluation Part 4: Traceability