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SIST EN ISO 7396-3:2025

(Main)

Medical gas pipeline systems - Part 3:Proportioning units for the production of synthetic medical air (ISO 7396-3:2025)

Medical gas pipeline systems - Part 3:Proportioning units for the production of synthetic medical air (ISO 7396-3:2025)

1.1        This document specifies requirements relating to the construction and operation of devices producing air through the blending of oxygen and nitrogen for use as sources of supply in supply systems for medical gases.
1.2        This document is applicable to proportioning units intended to produce synthetic medical air and air for driving surgical tools by mixing in defined proportions oxygen and nitrogen.
1.3        This document is applicable to proportioning units intended to be components of a medical gas supply system for medical air which supplies a medical gas pipeline distribution system complying with ISO 7396-1.
1.4        The number of proportioning units within the medical air supply system and their combination with other sources of supply (e.g. cylinder manifolds) to ensure that the supply system consists of at least three sources of supply is outside the scope of this document.
Requirements for the supply systems for medical air are given in ISO 7396-1.

Rohrleitungssysteme für medizinische Gase - Teil 3: Gasmischersysteme für die Herstellung von synthetischer medizinischer Luft (ISO 7396-3:2025)

Dieses Dokument legt die Anforderungen in Bezug auf die Konstruktion und den Betrieb von Geräten zur Herstellung von Luft durch das Mischen von Sauerstoff und Stickstoff zur Verwendung als Versorgungsquellen in Versorgungssystemen für medizinische Gase fest.
1.2   Dieses Dokument ist anwendbar auf Gasmischereinheiten, die dazu bestimmt sind, synthetische medizinische Luft und Luft zum Betreiben chirurgischer Werkzeuge durch Mischen von Sauerstoff und Stickstoff in festgelegten Anteilen zu erzeugen.
1.3   Dieses Dokument ist anwendbar auf Gasmischereinheiten, die dazu bestimmt sind, Bestandteile eines Versorgungssystems für medizinische Gase zu sein, welches ein Rohrverteilersystem für medizinische Gase nach ISO 7396 1 versorgt.
1.4   Die Anzahl der Gasmischereinheiten innerhalb des Versorgungssystems für medizinische Luft und deren Kombination mit anderen Versorgungsquellen (z. B. Flaschenbatterieanlagen), um sicherzustellen, dass das Versorgungssystem aus mindestens drei Versorgungsquellen besteht, fällt nicht in den Anwendungsbereich dieses Dokuments.
Die Anforderungen an die Versorgungssysteme für medizinische Luft sind in ISO 7396 1 enthalten.

Systèmes de distribution de gaz médicaux - Partie 3: Unités mélangeurs pour la production d'air médical reconstitué (ISO 7396-3:2025)

1.1        Le présent document spécifie les exigences relatives à la construction et au fonctionnement des dispositifs produisant de l’air par mélange d’oxygène et d’azote pour une utilisation comme sources d’alimentation dans les systèmes d’alimentation en gaz médicaux.
1.2        Le présent document s’applique aux unités mélangeurs destinées à produire de l’air médical reconstitué et de l’air moteur pour les instruments chirurgicaux en mélangeant des proportions définies d’oxygène et d’azote.
1.3        Le présent document est applicable aux unités mélangeurs destinées à être des composants d’un système d’alimentation en gaz médicaux pour l’air médical qui alimente un système de distribution de gaz médicaux conforme à l’ISO 7396-1.
1.4        Le nombre d’unités mélangeurs du système d’alimentation en air médical et leur combinaison avec d’autres sources d’alimentation (par exemple, rampes de bouteilles) pour s’assurer que le système d’alimentation comprend au moins trois sources d’alimentation ne fait pas partie du domaine d’application du présent document.
Les exigences relatives aux systèmes d’alimentation en air médical sont données dans l’ISO 7396-1.

Sistemi napeljav za medicinske pline - 3. del: Proporcionalne enote za proizvodnjo sintetičnega medicinskega zraka (ISO 7396-3:2025)

General Information

Status
Published
Public Enquiry End Date
25-Jan-2024
Publication Date
19-Aug-2025
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
VAZ - Healthcare
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
31-Jul-2025
Due Date
05-Oct-2025
Completion Date
20-Aug-2025
Ref Project
EN ISO 7396-3:2025 - Medical gas pipeline systems - Part 3:Proportioning units for the production of synthetic medical air (ISO 7396-3:2025)

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SLOVENSKI STANDARD
01-september-2025
Sistemi napeljav za medicinske pline - 3. del: Proporcionalne enote za proizvodnjo
sintetičnega medicinskega zraka (ISO 7396-3:2025)
Medical gas pipeline systems - Part 3:Proportioning units for the production of synthetic
medical air (ISO 7396-3:2025)
Rohrleitungssysteme für medizinische Gase - Teil 3: Gasmischersysteme für die
Herstellung von synthetischer medizinischer Luft (ISO 7396-3:2025)
Systèmes de distribution de gaz médicaux - Partie 3: Unités mélangeurs pour la
production d'air médical reconstitué (ISO 7396-3:2025)
Ta slovenski standard je istoveten z: EN ISO 7396-3:2025
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 7396-3
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2025
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Medical gas pipeline systems - Part 3:Proportioning units
for the production of synthetic medical air (ISO 7396-
3:2025)
Systèmes de distribution de gaz médicaux - Partie 3: Rohrleitungssysteme für medizinische Gase - Teil 3:
Unités mélangeurs pour la production d'air médical Gasmischersysteme für die Herstellung von
reconstitué (ISO 7396-3:2025) synthetischer medizinischer Luft (ISO 7396-3:2025)
This European Standard was approved by CEN on 28 June 2025.

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, Türkiye 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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7396-3:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 7396-3:2025) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment " in collaboration with 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 January 2026, and conflicting national standards shall
be withdrawn at the latest by January 2026.
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.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 7396-3:2025 has been approved by CEN as EN ISO 7396-3:2025 without any
modification.
International
Standard
ISO 7396-3
First edition
Medical gas pipeline systems —
2025-07
Part 3:
Proportioning units for the
production of synthetic medical air
Systèmes de distribution de gaz médicaux —
Partie 3: Unités mélangeurs pour la production d'air médical
reconstitué
Reference number
ISO 7396-3:2025(en) © ISO 2025

ISO 7396-3:2025(en)
© ISO 2025
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 7396-3:2025(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Nomenclature . 5
4.1 General .5
4.2 Components of a proportioning unit . .5
5 General requirements . 6
5.1 Safety.6
5.2 Usability .6
5.3 Materials .6
6 Design requirements . 7
6.1 Environmental conditions .7
6.2 Specification for synthetic medical air .7
6.3 Management of the conformity of supply .7
6.4 Sample port.8
6.5 Outlet connector .8
6.6 Inlet connectors: Pressure-equalizing system .8
6.6.1 Inlet connectors .8
6.6.2 Pressure-equalizing system.8
6.7 Requirements for outlet pressure .8
6.8 Indication of the functional parameters .9
6.9 Monitoring and alarm systems .9
6.10 Record capability . .9
6.11 Leakage .10
6.12 Manual shut-off valves .10
6.13 Automatic shut-off valves.10
6.14 Non-return valves .10
6.15 Pressure-relief valves .10
6.16 Mechanical strength .10
6.17 Filtration .11
6.18 Electromagnetic compatibility.11
6.19 Electrical safety .11
6.20 Oxygen analysers .11
6.21 Software . 12
6.22 Enclosure . 12
7 Constructional requirements .12
7.1 Cleanliness . 12
7.2 Lubricants . 12
8 Type test methods .
...

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Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications (ISO 80369-2:2024)
EN ISO 80369-2:2024

This document specifies the design and dimensions for two small-bore connectors intended to be used for connections in respiratory applications of medical devices and accessories. One connector (R1) is intended for use on medical devices and accessories subjected to pressures up to 15 kPa (e.g. a breathing system). The other connector (R2) is intended for use on medical devices and accessories subjected to higher pressures between 15 kPa and 600 kPa (e.g. oxygen therapy tubing).
NOTE 1        The pressure is related to pressure available at the source to which the medical device is connected.
NOTE 2        The intended application does not preclude the use of other connectors on medical devices or accessories within this application.
NOTE 3        Requirements for alternative connectors for this intended application are specified in ISO 80369-1.
This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in device-specific standards.
NOTE 4        If a device-specific standard does not exist, the performance and material requirements specified in ISO 80369-1 can be used as guidance.

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SIST EN ISO 5362:2024(Main)
Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO 5362:2024)
EN ISO 5362:2024

This document specifies requirements for anaesthetic reservoir bags for use with anaesthetic and ventilator breathing systems. It includes requirements for the design of the neck, size designation and elasticity.
This document is not applicable to special-purpose bags, for example bellows, self-inflating bags and bags for use with anaesthetic gas scavenging systems.
The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190). All the common requirements that appear in the general standard for airway devices have been removed from this document.

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SIST EN ISO 16571:2024(Main)
Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
EN ISO 16571:2024

This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.
 This document applies to all types of plume evacuation systems (PESs), including
a)       portable;
b)       mobile;
c)        stationary, including dedicated central pipelines;
d)       PESs integrated into other equipment;
e)       PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic)
This document applies to all healthcare facilities where PESs are used, including, but not limited to
a)       surgical facilities;
b)       medical offices;
c)        cosmetic treatment facilities;
d)       medical teaching facilities;
e)       dental clinics;
f)         veterinary facilities.
This document provides guidance on the following aspects of PESs:
a)       importance;
b)       purchasing;
c)        design;
d)       manufacture;
e)       documentation;
f)         function;
g)       performance;
h)       installation;
i)         commissioning;
j)         testing;
k)       training;
l)         use;
m)     risk assessment;
n)       servicing;
o)       maintenance.
This document does not apply to the following:
a)       anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b)       medical vacuum systems which are covered in ISO 7396-1;
c)        heating, ventilation, and air-conditioning (HVAC) systems;
d)       aspects of laser safety other than airborne contamination; and
e)       aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.

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