GB 9706.204-2022

Active

Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators

医用电气设备 第2-4部分:心脏除颤器的基本安全和基本性能专用要求

Standard Type
GB
ICS
11.040.10
CCS
C39
Status
Active
Issue Date
2022-07-13
Implementation
2024-08-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、国家标准化管理委员会

Application Summary AI generated

This standard specifies particular safety and performance requirements for cardiac defibrillators, including automated external defibrillators (AEDs) and manual devices used in clinical settings. It is applied during the design, manufacturing, and testing of defibrillators to ensure they deliver controlled electrical shocks safely to patients experiencing cardiac arrest. The standard is mandatory for medical device manufacturers and healthcare facilities in China to certify compliance with national safety regulations.

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.