GB/T 16886.11-1997
Replaced
T/GDC 252-2023
Active
Group standards
T/GDC 252-2023 Fetal mother dynamic electrocardiogram monitoring instrument performance and safety requirements
T/GDC 252-2023 Fetal mother dynamic electrocardiogram monitoring instrument performance and safety requirements
Price:
$ 20.00
Basic Information
Standard Code:
T/GDC 252-2023
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Integrated medical equipment
Publish Date:
2023-10-20
Implement Date:
2023-10-23
Scope
Scope: This document specifies the technical requirements related to the performance and safety of fetal maternal dynamic ECG monitors. This document is applicable to the research, development, production, and testing of dynamic ECG monitoring devices that use surface ECG acquisition and processing technologies in pregnant women to detect fetal heart rate and maternal heart rate in real time, and continuously output fetal ECG signals and maternal ECG signals. Main technical content: Technical requirements related to the performance and safety of fetal maternal dynamic ECG monitors.
Development Information
Related Standards
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
GB/T 16886.6-1997
Replaced
GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.1-2001
Replaced
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
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
GB/T 16886.7-2001
Replaced