DIN Standards Committee Health Technologies
Anaesthetic and respiratory equipment - Heat and moisture exchangers and breathing system filters (HMEF) for humidifying respired gases in humans - Part 1: Common requirements
Abstract
This part of ISO 9360 specifies the common requirements for heat and moisture exchangers (HME), breathing system filters (BSF), and combined devices (HMEF) intended for anesthetic and respiratory use. This document addresses design, connection ports, leakage, flow resistance, pressure drop, color coding, packaging, labeling, and the information provided. This document also applies to HMEs or HMEFs that do not have a machine connection capable of being connected to a ventilator. NOTE 1 HMEs and HMEFs that do not have a machine connection are intended for patients who breathe spontaneously through a tracheostomy and do not require mechanical ventilation. This document does not apply to other types of filters, such as those intended to protect vacuum sources or gas sampling lines, to filter compressed gases, or to protect testing equipment for physiological respiratory measurements. NOTE 2 A method for evaluating water loss from an HME/HMEF is described in ISO 9360-2. NOTE 3 A procedure for evaluating the filtration performance of BSFs is included in ISO 9360-3. This document also includes requirements for an active HME that actively supplies heat and moisture to increase the moisture content of the gas delivered by the HME to the patient. NOTE 4 Additional requirements for active HMEs are included in ISO 80601-2-74.
Begin
2025-02-18
WI
00215365
Planned document number
DIN EN ISO 9360-1
Project number
17600140
Responsible national committee
NA 176-05-05 AA - Airways and related equipment
Responsible european committee
CEN/TC 215/WG 4 - Airway devices, related equipment and suction devices
