GB 9706.227-2021

Active

Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

医用电气设备 第2-27部分:心电监护设备的基本安全和基本性能专用要求

Standard Type
GB
ICS
11.040.50
CCS
C39
Status
Active
Issue Date
2021-10-11
Implementation
2023-05-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies safety and performance requirements for electrocardiographic (ECG) monitoring equipment used in clinical settings, such as hospitals and intensive care units. It applies to devices that continuously or intermittently monitor a patient's heart electrical activity, ensuring reliable detection of arrhythmias and other cardiac events. The standard is used by manufacturers for design validation and by regulatory bodies for type testing and certification of ECG monitors.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.