GB 9706.255-2022

Active

Medical electrical equipment—Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

医用电气设备 第2-55部分:呼吸气体监护仪的基本安全和基本性能专用要求

Standard Type
GB
ICS
11.040.10
CCS
C46
Status
Active
Issue Date
2022-12-29
Implementation
2026-01-01
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 respiratory gas monitors used in medical environments, including devices that measure gases like oxygen, carbon dioxide, and anesthetic agents during patient ventilation. It applies to the design, testing, and certification of such monitors in hospitals, clinics, and emergency care settings to ensure accurate gas analysis and patient safety. The standard is critical for manufacturers and regulatory compliance in China, covering both standalone monitors and those integrated into anesthesia or ventilator systems.

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.