BS EN ISO 20789:2019

This document specifies requirements for so-called “cold bubble-through” or “cold pass-over” humidifying equipment, hereafter referred to as a passive humidifier. Figure1 and Figure2 illustrate these passive humidifiers . NOTE1 Passive humidifier humidification chambers are at room temperature so they have a lower humidification output than active humidifiers. Figure1 Cold pass-over passive humidifier Figure2 Cold bubble-through passive humidifier This document is also applicable to those accessories intended by their manufacturer to be connected to a passive humidifier . A passive humidifier integrated into another medical device is subject to the requirements of the standard of the other medical device. EXAMPLE1 The requirements in ISO80601‑2‑69 [ 4 ] also apply to a passive humidifier integrated into an oxygen concentrator. EXAMPLE2 The requirements in ISO80601‑2‑70 [ 5 ] also apply a passive humidifier integrated into sleep apnoea therapy equipment. This document does not specify the requirements for active heated humidifiers, heated breathing tubes, or active heat and moisture exchangers (HMEs), the requirements for which are given in ISO80601‑2‑74. NOTE2 ISO5367 specifies other safety and performance requirements for breathing tubes. This document is not applicable to a passive HME, which returns a portion of the expired moisture and heat of the patient to the respiratory tract during inspiration without adding heat or moisture, the requirements for which are given in ISO9360‑1 [ 6 ] and ISO9360‑2 [ 7 ]. This document is not applicable to nebulizers used for the delivery of liquids to patients, the requirements for which are given in ISO27427 [ 8 ]. This document is not applicable to equipment commonly referred to as “room humidifiers” or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators. An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in AnnexA. This document has been prepared to support the essential principles of safety and performance of a passive humidifier and related accessories as medical devices in accordance with ISO16142‑1:2016. AnnexD maps the clauses and subclauses of this document with the essential principles of ISO16142‑1:2016.