Anaesthetic and respiratory equipment - Passive humidifiers (ISO 20789:2018)
This document specifies requirements for so-called “cold bubble-through” or “cold pass-over” humidifying equipment, hereafter referred to as a passive humidifier. Figure 1 and Figure 2 illustrate these passive humidifiers.
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.
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 ISO 80601-2-74.
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 ISO 9360-1 and ISO 9360-2.
This document is not applicable to nebulizers used for the delivery of liquids to patients, the requirements for which are given in ISO 27427.
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 Annex A.
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 ISO 16142-1:2016. Annex D maps the clauses and subclauses of this document with the essential principles of ISO 16142-1:2016.
Frequently Asked Questions about ÖNORM EN ISO 20789
When you purchase a standard from the Austrian Standards webshop (e.g. ÖNORM, ISO), a single-user licence is included as standard. This entitles a single person to use the standard. A multi-user licence is required if several employees need access. It enables company-wide, legally compliant use and sharing of standards.
Standardization thrives on expertise and participation. Anyone interested can play an active role in its further development – for example, by joining the relevant committee or a working group. In this way, you can help shape the content and contribute to advancing the state of the art.
If you have an extensive portfolio of standards, we recommend using a professional standards management tool. With effects 2.0, you can manage your standards centrally and efficiently. You can optimise your procurement processes and benefit from an integrated information and subscription service. This ensures you are always up to date and never miss any relevant developments.
Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements (Corrected version 2017-03)
Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
Acoustics — Determination of sound power levels and sound energy levels of noise sources using sound pressure — Engineering methods for an essentially free field over a reflecting plane
Cosmetics - Sun protection test methods - Percentage of water resistance (ISO 18861:2020)
ÖNORM EN ISO 12643-5
Graphic technology - Safety requirements for graphic technology equipment and systems - Part 5: Manually-fed stand-alone platen presses (ISO 12643-5:2023)
ÖNORM EN 13411-7
Terminations for steel wire ropes - Safety - Part 7: Symmetric wedge socket
€218.70
excl. USt.
€240.57
incl. 10% USt.
Standard
ÖNORM EN ISO 20789 - Anaesthetic and respiratory equipment - Passive humidifiers (ISO 20789:2018)
Customize and purchase single-user license
€218.70
excl. USt.
€240.57
incl. 10% USt.
Free delivery
Subscribe to standards
Standards at a fixed price starting from €100 per month.
Always up to date
You automatically work with the latest version of a standard.
Predictable costs
You benefit from flexible solutions at an affordable fixed monthly price.
