GB 9706.290-2022

Active

Medical electrical equipment—Part 2-90:Particular requirements for basic safety and essential performance of respiratory high flow therapy equipment

医用电气设备 第2-90部分:高流量呼吸治疗设备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 the particular safety and performance requirements for respiratory high-flow therapy equipment, including devices that deliver heated and humidified breathing gases at high flow rates. It is applied in clinical settings such as hospitals and home care for patients with respiratory insufficiency, covering design, testing, and certification of equipment like high-flow nasal cannula systems. The standard ensures these devices meet essential safety and performance criteria to prevent hazards like overheating, infection, or inaccurate gas delivery.

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.