GB 9706.226-2021

Active

Medical electrical equipment—Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

医用电气设备 第2-26部分:脑电图机的基本安全和基本性能专用要求

Standard Type
GB
ICS
11.040.55
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 particular safety and performance requirements for electroencephalographs (EEG) used in medical settings. It is applied during the design, manufacturing, and testing of EEG equipment to ensure basic safety and essential performance, covering aspects like electrical safety, signal accuracy, and artifact rejection. The standard is mandatory for manufacturers and healthcare facilities in China to certify EEG devices used for diagnosing neurological conditions such as epilepsy and sleep disorders.

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.