SIST EN ISO 20789:2019

SLOVENSKI STANDARD
oSIST prEN ISO 20789:2019
01-julij-2019
Anestezijska in dihalna oprema - Pasivni vlažilniki (ISO 20789:2018)
Anaesthetic and respiratory equipment - Passive humidifiers (ISO 20789:2018)
Anästhesie- und Beatmungsgeräte - Passive Anfeuchter (ISO 20789:2018)
Matériel d'anesthésie et de réanimation respiratoire - Humidificateurs passifs (ISO
20789:2018)
Ta slovenski standard je istoveten z: prEN ISO 20789
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 20789:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 20789:2019

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oSIST prEN ISO 20789:2019
INTERNATIONAL ISO
STANDARD 20789
First edition
2018-07
Anaesthetic and respiratory
equipment — Passive humidifiers
Matériel d'anesthésie et de réanimation respiratoire —
Humidificateurs passifs
Reference number
ISO 20789:2018(E)
©
ISO 2018

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oSIST prEN ISO 20789:2019
ISO 20789:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
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Email: copyright@iso.org
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Published in Switzerland
ii © ISO 2018 – All rights reserved

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oSIST prEN ISO 20789:2019
ISO 20789:2018(E)

Contents Page
Foreword .v
Introduction .vi
1 * Scope . 1
2 Normative references . 2
3  Terms and definitions . 3
4 General requirements for testing . 5
4.1 Water level . 5
4.2 Passive humidifier test conditions . 6
4.3 * Gas flowrate and leakage specifications. 6
4.4 * Passive humidifier testing errors . 6
5 General requirements . 6
5.1 Mechanical basic safety for all passive humidifiers . 6
5.1.1 General. 6
5.1.2 * Requirements for instability from unwanted lateral movement . 6
5.1.3 * Requirements for audible acoustic energy . 7
5.1.4 * Overflow . 8
5.1.5 * Overpressure requirement . 8
5.2 Compatibility requirement . 9
5.3 General requirements for mechanical strength . 9
6  Identification, marking and accompanying documentation .10
6.1 Legibility and durability of markings .10
6.1.1 Legibility .10
6.1.2 Durability .10
6.2 Markings on the outside of the passive humidifier or its parts .10
6.2.1 Identification .10
6.2.2 Additional requirements .11
6.2.3 Requirements for physiological effects .12
6.2.4 Requirements for packaging .12
6.2.5 Symbols .12
6.3 Units of measurement . .12
6.4 Instructions for use .12
6.4.1 Identification .12
6.4.2 General requirements .13
6.4.3 * Requirements for warnings and safety notices .14
6.4.4 Requirements for installation .14
6.4.5 Requirements for start-up procedure .14
6.4.6 * Requirements for operating instructions .14
6.4.7 Requirements for cleaning, disinfection, and sterilization.16
6.4.8 Requirements for maintenance .16
6.4.9 Requirements for accessories, supplementary equipment and used material .16
6.4.10 Unique version identifier .16
6.5 Technical description .17
7 * Humidification output.17
8 Systems requirements .17
9  Specific single fault conditions .18
10 * Cleaning and disinfection .18
10.1 General .18
10.2 Home healthcare environment .18
11 * Breathing system connectors and ports .18
11.1 General .18
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11.2 Outlet connector .19
11.2.1 Directly connected to the supply source .19
11.2.2 Indirectly connected to the supply source .19
11.3 Flow-direction-sensitive components .19
11.4 * Accessory port .19
11.5 Monitoring probe port . .20
11.6 Oxygen inlet port .20
11.6.1 Directly connected to the supply source .20
11.6.2 Indirectly connected to the supply source .20
11.7 Air inlet port .20
11.7.1 Directly connected to the supply source .20
11.7.2 Indirectly connected to the supply source .20
11.8 Filling port .20
12 * Requirements for the breathing system and accessories .21
12.1 General .21
12.2 Accompanying documentation .21
12.3 Breathing tubes .21
12.4 Liquid container level .21
12.5 Filling cap.21
13 Compatibility with substances .22
14 * Biocompatibility .22
15  * Requirements for fire prevention .22
16 Usability .23
Annex A (informative) Rationale and guidance .25
Annex B (informative) Symbols on marking.33
Annex C (normative) Determination of humidification output .35
Annex D (informative) Reference to the essential principles .39
Annex E (informative) Terminology — Alphabetized index of defined terms .41
Bibliography .43
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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2. www .iso .org/directives
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received. www .iso .org/patents
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the WTO
principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary
information
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Lung ventilators and related equipment.
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Introduction
This document specifies requirements for so called “cold bubble-through or cold pass-over” respiratory
tract passive humidifiers intended for use on patients in home care and in healthcare facilities.
Passive humidifiers are used to raise the water content of gases delivered to patients. Gases available
for medical use do not contain sufficient moisture and can damage or irritate the respiratory tract or
desiccate secretions of patients whose upper airways have been bypassed. Inadequate humidity at the
patient-connection port can cause drying of the upper airway, or desiccation of tracheo-bronchial
secretions in the tracheal or tracheostomy tube, which can cause narrowing or even obstruction of the
1)
[1][2]
airway .
Passive humidifiers rely on moisture being transferred from a liquid reservoir to the gas at room
temperature, without heating of either the humidification chamber or breathing tubes, to increase
the water content of gases delivered to patients. Hence, such respiratory tract passive humidifiers
have a lower mg/l output than active humidifiers. Refer to ISO 80601-2-74 for basic safety and
essential performance of active humidifiers.
Since the safe use of a passive humidifier depends on the interaction of the passive humidifier
with its accessories, this document sets total system performance requirements up to the patient-
connection port. These requirements are applicable to accessories such as breathing tubes.
[3]
This document also constitutes a major technical revision of a portion of ISO 8185:2007 , which it
replaces in combination with ISO 80601-2-74. The most significant changes relative to ISO 8185:2007
for passive humidifiers are the following modifications:
— extending the scope to include the passive humidifier and its accessories, where the characteristics
of those accessories can affect the basic safety or essential performance of the passive
humidifier, and thus not only the passive humidifier itself;
— modification of the humidification test procedure and the disclosure of humidification performance;
and the following additions:
— requirements for mechanical strength (via IEC 60601-1-11);
— new symbols;
— requirements for a passive humidifier as a component of a system;
— requirements for cleaning and disinfection procedures;
— requirements for biocompatibility;
— requirements for fire prevention;
— requirements for usability.
Passive humidifiers are commonly used with air and air-oxygen mixtures and a passive humidifier
should be able to operate with these gases. Care should be taken if using other gas mixtures such as
helium/oxygen mixtures as their physical properties are different from those of air and oxygen.
In this document, the following print types are used:
— requirements and definitions: roman type;
— test specifications: italic type;
— informative material appearing outside of tables, such as notes, examples and references: in smaller
type. Normative text of tables is also in a smaller type;
1) Figures in square brackets refer to the Bibliography.
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— terms defined in Clause 3 of this document or as noted: small capitals.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
document;
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this document;
— “may” is used to describe a permissible way to achieve compliance with a requirement or test.
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.
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oSIST prEN ISO 20789:2019
INTERNATIONAL STANDARD ISO 20789:2018(E)
Anaesthetic and respiratory equipment — Passive
humidifiers
1 * Scope
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.
NOTE 1 Passive humidifier humidification chambers are at room temperature so they have a lower
humidification output than active humidifiers.
Figure 1 — Cold pass-over passive humidifier
Figure 2 — 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.
[4]
EXAMPLE 1 The requirements in ISO 80601-2-69 also apply to a passive humidifier integrated into an
oxygen concentrator.
[5]
EXAMPLE 2 The requirements in ISO 80601-2-70 also apply a passive humidifier integrated into sleep
apnoea therapy equipment.
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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.
NOTE 2 ISO 5367 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
[6] [7]
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
[8]
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
NOTE 2 Informative references are listed in the Bibliography.
ISO 3744:2010, 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
ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary
ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 5367:2014, Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 7396-1:2016, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases
and vacuum
ISO 10993-1:2009, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes
EN 13544-2:2002+AMD1: 2009, Respiratory therapy equipment — Part 2: Tubing and connectors
ISO 14937:2009, 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
ISO 14971:2007, Medical devices — Application of risk management to medical devices
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ISO 15223-1:2016, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
ISO 16142-1:2016, 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
ISO 17664:2017, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices
ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications —
Part 1: Evaluation and testing within a risk management process
ISO 23328-2:2002, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-
filtration aspects
IEC 60601-1:2005+AMD1: 2012, Medical electrical equipment — Part 1: General requirements for basic
safety and essential performance
IEC 60601-1-11:2015, Medical electrical equipment — Part 1-11: General requirements for basic safety and
essential performance — Collateral standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
IEC 61672-1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
IEC 62366-1:2015, Medical devices — Part 1: Application of usability engineering to medical devices
ISO 80369-1:2010, Small-bore connectors for liquids and gases in healthcare applications — Part 1: General
requirements
ISO 80601-2-12:2011, Medical electrical equipment — Part 2-12: Particular requirements for basic safety
and essential performance of critical care ventilators
ISO 80601-2-74:2017, Medical electrical equipment — Part 2-74: Particular requirements for basic safety
and essential performance of respiratory humidifying equipment
3  Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4135:2001, ISO 7396-1:2016,
ISO 13485:2016, ISO 14971:2007, ISO 16142-1:2016, ISO 17664:2017, ISO 18562-1:2017,
ISO 23328-2:2002, IEC 60601-1:2005+AMD1: 2012, IEC 60601-1-11:2015, IEC 62366-1:2015, ISO 80601-2-
12:2011, ISO 80601-2-74:2017 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http: //www .electropedia .org/
— ISO Online browsing platform: available at https: //www .iso .org/obp
NOTE For convenience, the source
...