T/GDC 253-2023 Active Group standards

T/GDC 253-2023 Portable Mother-to-Fetus Dynamic ECG Monitoring Device Technical Specification

Publish Date: 2023-10-21 Implement Date: 2023-10-25 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 253-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Integrated medical equipment

Publish Date: 2023-10-21

Implement Date: 2023-10-25

Scope

Scope: This document specifies the technical requirements related to the performance and safety of portable maternal-fetal dynamic ECG monitors. This document is applicable to the research, development, production, and testing of portable dynamic ECG monitoring devices that use surface ECG acquisition and processing technologies to detect fetal heart rates and maternal heart rates in real time and continuously output fetal ECG signals and maternal ECG signals. Main technical content: This document specifies the technical requirements related to the performance and safety of portable maternal-fetal dynamic ECG monitors. This document is applicable to the research, development, production, and testing of portable dynamic ECG monitoring devices that use surface ECG acquisition and processing technologies to detect fetal heart rates and maternal heart rates in real time and continuously output fetal ECG signals and maternal ECG signals.

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