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This document specifies requirements for the measurement of moisture loss from heat and moisture exchangers (HMEs), including those incorporating breathing system filters (HMEFs), intended for the humidification of respired gases for use primarily with patients with a tidal volume equal to or greater than 250 ml.
Breathing system filters (BSF) are also included in scope, as these devices do some amount of moisture to inspired gases.
This document also includes requirements for the measurement of moisture loss from HMEs for use with tracheostomized patients that do not have a machine port and having minimum tidal volumes of 250 mL.
Active HMEs are excluded from this document, the requirements for active HMEs are included in ISO 80601-2-74:2026.
NOTE 1 Wherever the term “device” is used in this document, it may either refer to HME, HMEF or BSF.
*** Add rationale why 250ml lower limit***
NOTE 2 HMEs, HMEFs that do not have a machine port for connection to a breathing tube are intended for patients who are spontaneously breathing via a tracheostomy and do not require mechanical ventilation.
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