T/GDC 343-2025 Abolished Group standards

T/GDC 343-2025 Evaluation specification for the performance of medical device algorithms based on deep learning-assisted decision-making

Publish Date: 2025-08-19 Implement Date: 2025-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/GDC 343-2025

Standard Type: Group standards

Standard Status: Abolished

is_force_gb: no

CCS Name: Video, pulse system equipment

ICS Name: Integrated medical equipment

Publish Date: 2025-08-19

Implement Date: 2025-09-01

Scope

This document specifies the basic requirements, evaluation indicators, evaluation process, evaluation data, evaluation methods, evaluation reports, and supervision and management for the evaluation of the algorithm performance of medical devices (hereinafter referred to as "devices") assisted by deep learning in decision-making. This document applies to the evaluation of the algorithm performance of medical devices that use deep learning technology, take medical device data as input, and assist medical staff in making clinical decisions by providing recommendations for diagnostic and treatment activities. Basic requirements, evaluation indicators, evaluation process, evaluation data, evaluation methods, evaluation reports, supervision and management for the evaluation of the algorithm performance of medical devices (hereinafter referred to as "devices") assisted by deep learning in decision-making.

Development Information

Related Standards

GB/T 16886.11-1997 Replaced

GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity

Publish Date: 1997-06-26

GB/T 16886.3-1997 Replaced

GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity

Publish Date: 1997-06-26

GB/T 16886.6-1997 Replaced

GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

Publish Date: 1997-06-26

GB/T 16886.1-2001 Replaced

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing

Publish Date: 2001-09-24

GB/T 16886.13-2001 Replaced

GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices

Publish Date: 2001-09-24

GB/T 16886.7-2001 Replaced

GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals

Publish Date: 2001-09-24