T/GDC 309-2024 Active Group standards

T/GDC 309-2024 Deep learning medical device data security basic requirements

Publish Date: 2024-12-14 Implement Date: 2024-12-20 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 309-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Integrated medical equipment

Publish Date: 2024-12-14

Implement Date: 2024-12-20

Scope

Scope: This document specifies the data privacy protection, data integrity and authenticity, data availability and reliability, compliance with cross-border data flow, application of encryption technology, access control and authentication, data backup and recovery strategies, system and data monitoring, regulatory compliance, and continuous improvement for the data security of deep learning-based medical devices. This document is applicable to medical devices or software that use deep learning technology for analysis, assisted diagnosis, treatment planning, or disease prediction. Main technical content: Data privacy protection, data integrity and authenticity, data availability and reliability, compliance with cross-border data flow, application of encryption technology, access control and authentication, data backup and recovery strategies, system and data monitoring, regulatory compliance, and continuous improvement for the data security of deep learning-based medical devices.

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