T/GDMDMA 0057-2026 Humidification chamber
T/GDMDMA 0057-2026 Humidification chamber
Basic Information
Scope
This document specifies the structure and materials, performance requirements, packaging, labeling, and user manuals of disposable or reusable humidification tanks used with medical respiratory humidifiers, high-flow respiratory therapy devices, continuous positive airway pressure ventilators, and other respiratory humidification equipment, and describes the corresponding test methods. This document applies to humidification tanks used to humidify respiratory gases. (1) Connection method (2) Connection firmness (3) Water storage capacity (4) Automatic water addition function (5) Leakage (6) Maximum working pressure (7) Liquid sealing (8) Airflow resistance (9) Compliance (10) Overflow (11) Reducing substances (12) pH (13) Total heavy metal content (14) Evaporation residue (non-volatile substances) (15) Ethylene oxide residue (16) Microbial limits (17) Sterility