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EN ISO 20789:2019

(Main)

Anaesthetic and respiratory equipment - Passive humidifiers (ISO 20789:2018)

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.

Anästhesie- und Beatmungsgeräte - Passive Anfeuchter (ISO 20789:2018)

Dieses Dokument legt Anforderungen an sogenannte „Sprudelverdunster“ oder „Passover“-Geräte zur Anfeuchtung ohne Beheizung fest, nachfolgend als PASSIVE ANFEUCHTER bezeichnet. Bild 1 und Bild 2 stellen diese PASSIVEN ANFEUCHTER dar.

Matériel d'anesthésie et de réanimation respiratoire - Humidificateurs passifs (ISO 20789:2018)

Le présent document spécifie les exigences relatives aux équipements d'humidification dits à «barbotage à froid» ou «léchage à froid», ci-après désignés un humidificateur passif. La Figure 1 et la Figure 2 représentent ces humidificateurs passifs.

Anestezijska in dihalna oprema - Pasivni vlažilniki (ISO 20789:2018)

Ta dokument določa zahteve za tako imenovano vlažilno opremo, ki ustvarja vodne mehurčke (cold bubble-through) ali aerosol (cold pass-over) ter je v nadaljevanju imenovana pasivni vlažilnik. Sliki 1 in 2 prikazujeta te pasivne vlažilnike.

General Information

Status
Published
Publication Date
17-Sep-2019
Withdrawal Date
30-Mar-2020
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 2 - Lung ventilators
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
18-Sep-2019
Due Date
03-Jun-2021
Completion Date
18-Sep-2019
Ref Project
SIST EN ISO 20789:2019 - Anaesthetic and respiratory equipment - Passive humidifiers (ISO 20789:2018)

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SLOVENSKI STANDARD
01-november-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: EN ISO 20789:2019
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 20789
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2019
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Anaesthetic and respiratory equipment - Passive
humidifiers (ISO 20789:2018)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Passive Anfeuchter
Humidificateurs passifs (ISO 20789:2018) (ISO 20789:2018)
This European Standard was approved by CEN on 28 July 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20789:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 20789:2018 has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken
over as EN ISO 20789:2019 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic
equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by March 2020, and conflicting national standards shall
be withdrawn at the latest by March 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 20789:2018 has been approved by CEN as EN ISO 20789:2019 without any modification.

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
ISO 20789:2018(E)
© 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
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

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
ISO 20789:2018(E)
11.2 Outlet connector .
...

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This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:
a)    a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;
b)    the pressure outlet of a regulator conforming with ISO 10524-1:2018; or
c)    to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets).
This document applies to the following types of flow control devices (FCDs):
a)    flowmeters;
b)    flowgauge FCDs; and
c)    fixed orifice FCDs.
NOTE       Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.
This document applies to flow control devices for the following gases:
—    oxygen;
—    oxygen 93 %;
—    nitrous oxide;
—    medical air;
—    carbon dioxide;
—    oxygen/nitrous oxide mixture 50/50 (% volume fraction);
—    oxygen-enriched air;
—    helium;
—    xenon; and
—    specified mixtures of the gases listed above.
NOTE Flow control devices can be available for other gases.
This document does not apply to flow control devices that are:
a)    for use with gases for driving surgical tools;
b)    an integral part of a regulator (see ISO 10524-1:2018); or
c)           an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).

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CEN
EN ISO 80601-2-55:2018/A1:2023(Amendment)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/Amd 1:2023)
SIST EN ISO 80601-2-55:2018/A1:2024
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